Mims-Indonesia April 2017 en Sample

Captured directly from mims.
com
in April 2017
INDONESIA by soluXio (contact@soluxio.com)
2017
Product Name Manufacturer

2-4 Zalf Nufarindo
3TC GlaxoSmithKline Pharmaceuticals

3TC-HBV GlaxoSmithKline Pharmaceuticals
5-Fluorouracil Ebewe
8Y Ikapharmindo
A Scabs
Aafact Graha Farma

A-B Vask Lapi
Abajos
Abbotic/Abbotic Abbott Products

Granule/Abbotic XL
Abdelyn
Abilify Discmelt Otsuka
Abilify Injection
Abilify Oral Solution Otsuka

Abilify Tablet Otsuka
Abirom Mahakam Beta Farma
Abixim Actavis
Accolate AstraZeneca
Accupril
Acdat Ifars
Acendril
Acenor-M
Acepress
Acetated Ringer's
Acetensa Fahrenheit
Acetin 600 Sanbe
Acetram Prima Medika
Acetyl Spiramycin Kyowa
Acetylcysteine Yarindo Yarindo Farmatama
Aciblock
Acidrine
Acifar Ifars
Acifar Cream Ifars
Acitral
Aclam/Aclam Forte Lapi
Aclasta Novartis Indonesia
Aclonac
Acna Care Plus Mega Lifesciences
Acna-Care Mega Lifesciences
Acne Feldin Galenium
Acne-Aid
Acnezol
Acpulsif 5 Dexa Medica
Acran Sanbe
Acrios
Actabone Actavis
Actacef
Actal/Actal Plus
Actalipid Actavis
Actapin Actavis
Actaryl Actavis
Actatecan Actavis
Actaxon Actavis
Actazolam Actavis
Act-HIB
Acticoat
Acticoat Flex 3
Actifed Glaxo Wellcome
Actifed Plus Cough Glaxo Wellcome

Suppressant
Actifed Plus Expectorant Glaxo Wellcome

Actigesic
Actilyse Boehringer Ingelheim
Actimmune 250/Actimmune
600
Active Joint
Actonel Actavis
Actonel Once A Month
Actoplatin Actavis
Actos Takeda
Actosmet Takeda
Actrapid HM/Actrapid Penfill Novo Nordisk
Acuatim Otsuka
Acyclovir Cream Indo Farma
Acyclovir Hexpharm
Acyclovir Indo Farma
AD Fluor
A-D Plex
Adalat
Adalat OROS
Adant Dispo Meiji
Adebion
Adecco
Adelysin
Adfer Fahrenheit
Adona (AC-17)/Adona (AC-17)

Forte
Adrenalini Bitartras
Adricin
Adrome
Advantan Bayer Indonesia

Aerius Merck Sharp & Dohme
Aerius D-12 Merck Sharp & Dohme
Aeroson
Aerrane
Aethylcarbonas Chinin
(Euchinin)
Afamed Futamed
Afinitor
Afomix
Afrin Bayer Indonesia
Afucid
Aggravan
Aggrenox
Agrelano Ikapharmindo
Agrezol
Agrippal S1
Agrylin
Agulan
Akilen Sanbe
Akilen Ear Drops Sanbe Vision
Akita
Akrinor
Akrofen
Akta Vol
Aktace
Aktazet
AL 110
Ala 600 Simex
Alabetic Futamed
Alanox
Alaxan FR Medifarma
Albapure 20 CSL Behring

Albendazole Indo Farma
Albiotin
Albothyl Nycomed
Albucid
Albuman 20% Graha Farma
Albuminar-25 CSL Behring
Albumin-Human 20%
Alburaas
Albutein
Alco/Alco Plus/Alco Plus DMP Interbat
Alcon Cilox
Aldactone
Aldapres
Aldazide
Aldiab
Aldin
Aldisa SR Sanbe
Aldomer Mersifarma TM
Aldovas
Alegi Lapi
Alegysal
Alenoxal
Alerdex Armoxindo Farma
Alerfed
Alermax
Alernitis
Aleros Actavis
Alerson Global Multi Pharmalab (GMP)
Alerten 25/Alerten 100 Mega Lifesciences

Alexan
Alflam
Alganax
Algesal Superactive
Algisite M
Algut
Alicron
Alimta Eli Lilly
Alinamin/Alinamin-F Takeda
Alista
Alkeran
Alkohol 70% Berlico
Allerin Darya-Varia
Allevyn Kalbe Farma

Allogon
Allohex
Allopurinol Hexpharm
Allopurinol Indo Farma
Allopurinol Landson
Alloris Sanbe
Alluric
Almacon
Aloclair
Aloclair Plus
Alodan
Alofar
Alomide
Alopros
Alora
Alostil
Alovell Novell Pharma
Aloxid
Aloxtra Pharos
Alpain
Alpara
Alpenaso
Alpentin Actavis
Alphacort
Alphadine
Alphadine Gargle
Alphadryl
Alphagesic
Alphahist
Alphamid
Alphamol
Alprazolam Dexa Medica
Alprazolam OGB Mersi Mersifarma TM
Alsine
Altofen Sanbe
Aludonna
Aludonna D Armoxindo Farma
Alupent
Aluvia
Alveofact Dexa Medica
Alviz Pharos
Alxil
Alynol Pharos
Alzim Fahrenheit
Amadiab Lapi
Amaropo Plus Phapros

Amaryl Sanofi Group Indonesia
Amaryl M Sanofi Group Indonesia
Ambiopi Mersifarma TM
Amboid
Ambril
Ambroxol Indo Farma

Amcillin
Amcor PT. Merck Tbk
Amdixal
Amerol
Aminefron Dexa Medica
Aminofluid Otsuka
Aminofusin Hepar
Aminofusin L 600
Aminofusin Paed
Aminoleban Infusion Otsuka
Aminoleban Oral
Aminophyllin Indo Farma
Aminoral
Aminosteril
Aminosteril Infant Fresenius Kabi
Aminosteril N-Hepa
Aminovel 600 Otsuka
Amiosin Dexa Medica

Amiparen Otsuka
Amiten Sanbe
Amlocor
Amlodipine Besylate Soho
Amlodipine Fahrenheit
Amlodipine Hexpharm
Amlodipine OGB Medikon
Amlogal Galenium
Amlogrix
Amnorel 600 Sanbe

Amobiotic
Amocomb/Amocomb Forte
Amosine
Amoxicillin Dankos
Amoxicillin Hexpharm
Amoxil BID
Amoxil/Amoxil Forte
Amoxillin
Amoxsan/Amoxsan Forte ManufacturerContentsIndications/
UsesDosage/Directions for
UseAdministrationContraindicatio
nsSpecial PrecautionsAdverse
ReactionsInteractionsPreg Safety
(US)MIMS ClassATC
ClassificationRegulatory
ClassificationPresentation/Packing
Amoxycillin Indo Farma
Ampi
Ampicillin Indo Farma
Amtocort Injection Pharos
Amtocort Tablet Pharos
Amvar Simex
Anabion
Anabion Plus DHA

Anacetine
Anadex
Anadium
Anafen
Anaflu
Anafranil
Anakonidin
Analsik Sanbe
Analspec
Analtram Lapi
Anaprin
Anatensol
Anavit
Anbacim Sanbe
Anbiolid Meprofarm
Ancefa Meprofarm
Ancla/Ancla Forte Meprofarm
Andalan Injection
Andalan Pil KB/Andalan Fe
Andalpha
Andantol Transfarma Medica Indah
Andep
Andikap
Andonex
Andriol Testocaps
Androcur
Androlon
Anelat Ifars
Anemolat Rajawali Nusindo
Anerocid
Anesfar Fahrenheit
Anesject
Anexate
Anexia Pharos
Anexin
Anfix Mahakam Beta Farma
Anflat
Anfuhex
Anfuhex Cream
Angeliq
Angintriz MR Novell Pharma
Angioten
Anhissen
Anitid
Anlene
Anlos
Anmerob
Anmum Essential 3
Anmum Essential 4
Anmum Infacare 1
Anmum Infacare 2
Anmum Lacta Chocolate
Anmum Lacta Plain
Anmum Materna Chocolate

Anmum Materna Plain
Anmum/Anmum Chocolate
Anore
Anpiride Sanbe
Anrema 50/Anrema 100
Ansi
Anstrep
Antalgin Berlico
Antalgin Corsa
Antalgin Hexpharm
Antalgin Indo Farma
Antasida Plus Famotidine

Anthramed
Anti Stries
Antidine
Antikun
Anti-Maag
Antion
Antiplat Dexa Medica
Antipres
Antiprestin Pharos
Antiza Coronet
Antox
Antrain
Antrexol
Antrotik
Anuva Novartis Indonesia
Anvomer B6 Dexa Medica
Anxibloc
Anzatax
Apazol
Apecur Simex
Apeton
Apialys Lapi
Apidra Sanofi Group Indonesia
Apisate
Apolar Actavis
Apolar-N Actavis
Aprion Pharos
Aprovel Sanofi Group Indonesia
Aptivium Liver Support
Aptivium Optimum Joint

Formula
Aptivium Osteo Support
Aptor
Araclof Armoxindo Farma
Arava
Arbiten-I
Arcalion 200 Servier

Arcamox Armoxindo Farma
Arcapec Meprofarm
Arclate
Arcodryl
Arcored
Arcoxia Merck Sharp & Dohme
Ardium 500 Servier
Ardium CVD
Ardium HD
Ardivit-PL
Aredia
Arespin Pharos
Arfen Solas
Argensol Solas
Argomed Futamed
Aricept Eisai
Aricept Evess Eisai
Arimed Promed
Arimidex AstraZeneca
Ariski Actavis
Arixtra GlaxoSmithKline Pharmaceuticals
Arkine Pyridam
Armacort
Armolev 500 Armoxindo Farma

Armovit Armoxindo Farma
Arnid
Aromasin Pfizer
Arsigran
Arsinal
Arsitam
Arsitrocin
Artane
Artem
Arteoptic LA Otsuka
Artepid Pharos
Arthrifen Armoxindo Farma
Arthrifen Plus Armoxindo Farma
Artoflam
Artovit
Artricom
Artrilox
Artriox
Artritin
Artro
Artro Plus
Asam Mefenamat Indo Farma
Asam Mefenamat Landson
Asamnex
Ascardia
Ascarzan
Ascavin Dexa Medica
Ascomin
Ascoplex
Ascorbec
Asedas Pyridam
Asepta
Asering-5 Otsuka
Asidrat
Asimat Mersifarma TM
Askorbin
Asmacare
Asmadex
Asmano
Asmasolon Darya-Varia
Aspar
Aspar-K
Aspil Fahrenheit
Aspilets Darya-Varia
Aspirin Bayer
Aspitrom
Asta Plus
Astamax
Astaplus Simex
Astar-C Yarindo Farmatama
Astatin Novell Pharma
Astaxanthin
Asten
Astharol Sanbe
Asthma Soho
Astika
Astina Puspa Pharma
Astria Landson
Asvex
Atarax Mersifarma TM
Ataroc Novell Pharma
Ativan
Atmacid
Atofar Fahrenheit
Atopiclair Transfarma Medica Indah
Atorsan
Atorvastatin Yarindo Yarindo Farmatama

Atorwin Sanofi Group Indonesia
Atostin
ATP Dankos
Atracurium Besylate DBL
Atracurium-Hameln
Atranac
Atrocox 7.5/Atrocox 15 Simex
Atrovent Boehringer Ingelheim
Augmentin BID
Augmentin IV
Augmentin/Augmentin Forte GlaxoSmithKline Pharmaceuticals
Aurorix
Auspilic
AV F AZA Acne Foundation Ikapharmindo
Avamys GlaxoSmithKline Pharmaceuticals
Avandamet
Avandaryl
Avandia
Avaxim 80/Avaxim 160
Avelox
Avemar Lapi
Avil
Aviter Interbat
Avloclor
Avocel Pharos
Avodart GlaxoSmithKline Pharmaceuticals
Avogin Lapi
Axamed Futamed
Axamed Plus Futamed
Axanthin
Axtan Solas
Axtan Syr Solas

Aza 20
Azathioprine
Combiphar/Pharmachemie
Aziwin
Azmacon Armoxindo Farma
Azol PT. Merck Tbk

Azomax Dexa Medica
Azopt
Aztrin/Aztrin DS Pharos
Azvit
Azyter
bacbutINH/bacbutINH Forte Armoxindo Farma
Bacbutol Armoxindo Farma
Bactazon
Bactesyn Kalbe Farma
Bactigras
Bactiprox Erlimpex
Bactirom Sanbe
Bactoderm Ikapharmindo
Bactoprim Combi/Bactoprim
Combi Forte
Bactricid/Bactricid Forte
Bactrizol/Bactrizol Forte
Bactroban GlaxoSmithKline Pharmaceuticals
Baliin Q10
Balticin
Bamgetol Mersifarma TM
Banadoz
Bantif Child Caprifarmindo
Baquinor Eye Drops Sanbe Vision
Baquinor/Baquinor Forte Sanbe

Baraclude Taisho Pharmaceutical
Bartolium
Barzepin Novell Pharma
Batrafen
Batugin
Baxcef Solas
Baxima
Baycuten-N
B-Beta
Bd-GARD Mahakam Beta Farma
Bebelac 1
Bebelac 3
Bebelac 4
Bebelac Complete
Bebelac Complete Fruit &
Veggie
Bebelac EC
Bebelac FL
Bebelove 1 Nutricia
Bebelove 2 Nutricia
Bebelove FL Nutricia
Bebemama Nutricia
Becantex Pharos
Bececar
Becefort Phapros
Beclomet Easyhaler
Beclomet Nasal Aqua
Beclov Sanbe
Becombion Grow
Becombion Injection
Becombion Syrup/Drops/Forte
Becom-C Sanbe
Becom-Zet Sanbe
Beconase
Befozi
Bekamin C Forte
Bekarbon
Bellacid
Bellamox/Bellamox Forte
Bellapheen
Bellatram
Belvin Drops Pharos
Benacol DTM
Benacol Expectorant
Benadryl
Benadryl CM
Benadryl DMP
Benadryl DMP Child
Benechol
Beniazide
Benocetam
Benocid
Benodin
Benofat
Benofomin
Benohist
Benolicrol
Benomet 300
Benoson
Benoson G
Benoson M
Benostan
Benoviplex
Benovit C
Benovit M
Benoxuric
Benozym
Benutrion VE Sanbe
Benzolac
Benzolac Cl
Benzomid
Benzoquin
Bepanthen Bayer Indonesia
Beprosalic
Beprosone
Berea Zenith Pharmaceuticals
Beriplast P Combi-Set CSL Behring
Berlicort
Berlifed
Berlison
Berlosid
Berloson-N
Bernesten
Berno Yeast
Bernoflox
Berocca Performance Bayer Indonesia
Berodual Boehringer Ingelheim

Berotec Boehringer Ingelheim
Berry Vision Sanbe Vision
Bersol
Berthyco
Berzymplex
Bestalin Lapi
Bestocol
Beston
Bestypro Futamed
Beta-Adalat
Betablok
Betaclav
Betadine
Betadine Mouthwash
Betadine Shampoo
Betadine Vaginal Preparations
Betaferon
Betaflox
Betafort
Betagentam Sanbe Vision
Betalans Mahakam Beta Farma
Betalitik
Betam-Ophtal Sanbe Vision

Beta-One
Betarhin Mahakam Beta Farma
Betaserc Abbott Products
Betaslim Global Multi Pharmalab (GMP)
Betason
Betason-N
Betaver Pyridam
Betiga
Betnovate-N
Betodermin
Betopic Armoxindo Farma
Betoptima
Betrix Mahakam Beta Farma
Bevalex
Bevita Gracia Pharmindo
Bevitran
Bevizil Sanbe
Bexce/Bexce Plus
Bexicom Fit
Bexicom/Bexicom-Z
Bezalip/Bezalip Retard Actavis
Biatron Pharos
Bicolax Armoxindo Farma
Bicrolid Sanbe
Bidicef
Biferce Sanbe
Bifotik Sanbe
Bilotec
Binapro Puspa Pharma
Binomic Pharos
Binotal
Binozyt
Bintapen
Bioacne Ikapharmindo
Bioads (Anti Difteri Serum Biofarma

20,000 IU)
Bio-ATP Phapros
Biobran
Biocalcin
Biocombin/Biocombin 5000 Meprofarm
Biocream PT. Merck Tbk
Biodasin Promed
Bioderm Galenium
Biodiar
Biodroxil
Bio-E 200
Bioferron Ikapharmindo
Biofos Meprofarm
BioGaia Lozenges
Biogesic Probus
Bio-GI
Biogrisin
Biolastin
Biolectra Ikapharmindo
Biolite Ikapharmindo
Biolysin
Biolysin Kids
Biolysin Smart
Biomega
Biomex
Biomoist
Bion 3
Bionam
Bion-C
Bionect Fidia
Bionemi Gracia Pharmindo
Bioneuron
Bionutrion
Bion-W
Bioplacenton
Bioplacenton Tulle
Bioplan
Bioprexum Servier
Bioprexum Plus Servier
Bio-Prolis
Bioquin/Bioquin Forte Ikapharmindo
Bioquinone Puspa Pharma
Bio-Retin
Biosan Teguhsindo Lestaritama

Biosanbe Sanbe
Biosat 1.5 (Serum Anti Tetanus Biofarma

1,500 IU)
Biosave (Snake Anti Biofarma

Venom/Abu Polivalen I)
Biostatik
Bio-Strath
Biostrum Lapi
Biotamin
Biothicol Sanbe
Biotopix Eye Bag & Dark Circle Meprofarm

Biotopix Specific Lifting Cream Meprofarm
Biotriax
Biovit
BioXtra
Bipro Fahrenheit
Biscor
Bisoltussin
Bisolvon
Bisolvon Extra
Bisolvon Flu
Bisolvon Kids
Bisoprolol Fumarate
Fahrenheit
Bisoprolol Hexpharm
Bisoprolol OGB Dexa
Bisovell
Bisovell Plus
Bital Solas
Blecidex Ear Drops Sanbe Vision
Blecidex Eye Drops Sanbe Vision
Bledstop Caprifarmindo
Blenamax
Bleocin Nippon Kayaku
Blephagel
Blesifen Caprifarmindo
Blistra Pharos
BloodCare
Blopress Takeda
Blopress Plus Takeda
Blorec Fahrenheit
Blue Cap Capsule

Blue Cap Cream/Blue Cap
Spray/Blue Cap Shampoo
BMT Gold Kalbe Nutritionals
BMT P-HP Kalbe Nutritionals

BMT Platinum Kalbe Nutritionals
BMT Soya Kalbe Nutritionals
BMT with Lactoferrin
bodrex
bodrex EXTRA
bodrex Flu & Batuk
bodrex Flu & Batuk Berdahak
Bodrex Forte
bodrex Migra
bodrexin
bodrexin Demam
bodrexin Flu & Batuk
bodrexin Pilek Alergi

bodrexin Syrup
Bondi
Bonefos
Bonepatit 800
Bonevell Novell Pharma
Bonic DS
Bonic Plus
Bonilav
Bon-One Teijin
Bonvit Global Health Pharma
Boostrix
Borraginol-N Takeda
Borraginol-S Takeda
Botox Allergan
Brainact Kalbe Farma
Brainolin Dexa Medica
Brainvit Mahakam Beta Farma
Bralifex Sanbe Vision
Bralifex Plus Sanbe Vision
Bralin
Bravelle Dipa Pharmalab Intersains
Bravoderm Bufa Aneka
Bravoderm-N Bufa Aneka
Braxidin Sanbe
Brazine Solas
Breathy Novell Pharma
Brenaris
Brenax
Brentan
Brexel Kalbe Farma
Bricasma AstraZeneca
Bricasma Expectorant
Brilinta AstraZeneca
Broadced Kalbe Farma
Brochifar/Brochifar Plus Ifars

Bromifar/Bromifar Plus Ifars
Bromika
Brommer 30 Mersifarma TM
Bronchitin
Broncholit
Bronchophylin
Bronchopront
Bronchosal
Broncho-Vaxom Actavis
Broncozol
Brondisal 2/Brondisal 4
Bronkris
Bronsolvan
Brospec
Brospec 1000
Broxal
Brufen Abbott Products
Bucain
Budenofalk Dr Falk
Bufabron Bufa Aneka
Bufacardo Bufa Aneka
Bufacomb IOB Bufa Aneka
Bufaflam Emulgel Bufa Aneka
Bufamoxy Bufa Aneka
Bufaramine Bufa Aneka

Bufect/Bufect Forte Sanbe
Bunascan Fahrenheit
Bunascan Spinal 0.5% Heavy Fahrenheit
Burnazin Darya-Varia
Buscopan
Buscopan Plus
Buscotica
Buspar
Butamidon
Buvanest 0.5%
Buvanest Spinal 0.5% Heavy
Buventol Easyhaler
Bycolen
Cado Simex
Caduet Pfizer
Caelyx
Cafergot
Cal-95 Lapi
Calacort Galenium
Calapol/Calapol Forte
Calbio
Calbon Global Health Pharma
Calcianta Armoxindo Farma
CalciD Tunggal Idaman Abdi
Calcido Yarindo Farmatama
Calcidol
Calcifar Plus
Calciflavone
Calcimega Solas
Calcimex
Calcimex Vitagold
Plain/Calcimex Vitagold
Cokelat
Calcimex Vitalize
Cokelat/Calcimex Vitalize Plain
Calcit
Calcium Ad Armoxindo Farma
Calcium Folinate Ebewe
Calcium Lactate Nufarindo
Calciumlevofolinat Ebewe
calciviton
Caldece Sanbe
Caldetri Global Multi Pharmalab (GMP)
Calix Meprofarm
Calmin-AF
Calnat
Calnic Gracia Pharmindo

Calnic Plus
Caloma Plus Novell Pharma
Calorex Drops
Calos Fahrenheit
Calosbon
Calostrum Meprofarm
Calplex Mahakam Beta Farma
Calporosis D 500/Calporosis D Mersifarma TM

800
Calsan
Calsiro
Calsivas Fahrenheit
CalSource/CalSource Novartis Indonesia

Forte/CalSource Plus Vitamin
C/CalSource Junior
Caltrate 600 +D Pfizer

Caltrate 600 Plus Pfizer
Caltrax Pyridam
Caltron Pyridam
Caltum
Calvit-D Promed
Calvitos
Calvitran
Calvonin
Cameloc
Camidexon
Camigesik
Campain
Campto Pfizer
Candacort
Candazole
Canderin Dexa Medica

Candesartan TI
Candipar
Candistin Pharos
Candotens Novell Pharma
candyvit-C
Canergy Meprofarm
Canesten Cream Bayer Indonesia
Canesten Powder
Canesten SD/Canesten VT Bayer Indonesia
Canicol Caprifarmindo
Cantil
Caprazol Caprifarmindo
Caprenafil Caprifarmindo
Caprenem Caprifarmindo
Caprifim Caprifarmindo
Capritazin Caprifarmindo
Caprocef Caprifarmindo
Caprol
Caproliv Caprifarmindo
Capsinat Caprifarmindo
Capsinat Injection Caprifarmindo
Captensin
Captopril Hexpharm
Captopril Indo Farma
Captopril Landson
Capzacin Cream
Carbamazepine Indo Farma
Carbloxal
Carboplatin DBL
Carboplatin Ebewe
Carboplatin Kalbe Kalbe Farma
Carboplatine Merck
Carbosin
Combiphar/Pharmachemie
Carcan
Carcinocin Kalbe Farma

Cardace Sanofi Group Indonesia
Cardiavit
Cardicap Caprifarmindo
Cardiject
Cardio Aspirin
Cardiomin Darya-Varia
Cardioplegia
Cardiotone Pharos
Cardiover
Cardisan Sanbe
Cardismo Phapros
Cardivask
Cardura Pfizer
Cardyne
Cariamyl
Carmed
Carni Plus
Carniq
Carniten Solas
Carnon
Caronem Pyridam
Carpiaton-25/Carpiaton-100 Fahrenheit
Car-Q
Car-Q100 Kalbe Farma
Carsive Landson
Cartiflex Galenium
Cartin
Cartogen Futamed
Cartos Pyridam
Cartrilet
Casodex AstraZeneca
Caspol
Cataflam Drops
Cataflam Fast
Cataflam/Cataflam D Novartis Indonesia
Catalin
Catanac
Catapres Boehringer Ingelheim
Cataro Pyridam
Cationorm
Cavea
Cavit D3 PT. Merck Tbk

Cavital
Cazetin Ifars
CDR Bayer Indonesia
CDR Fortos Bayer Indonesia
Cealb
Cebactam Lapi
Cebelia Intensive Anti-Aging Althea Pharma
Cebelia LCE Balm Althea Pharma
Cebelia Reinforced Althea Pharma

Depigmenting
Cebion
Cedantron/Cedantron Syrup
Cedocard/Cedocard Retard Nycomed
Ceelin
Cefabiotic
Cefacef Caprifarmindo
Cefadroxil Hexpharm
Cefadroxil Indo Farma

Cefadroxil Soho
Cefarin Gracia Pharmindo
Cefarox Gracia Pharmindo
Cefat Sanbe
Cefaxon
Cefazol Kalbe Farma
Cefazolin Indo Farma

Cefazolin OGBdexa
Cefdime
Cefemet
Cefepime Hexpharm
Cefika
Cefila Lapi
Cefim Lapi
Cefinov Novell Pharma

Cefir Fahrenheit
Cefixime Hexpharm
Cefixime OGB Dexa Medica
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Contents
Salicylic acid 2%, sulfur precipitated 4%
Lamivudine
Lamivudine
5-fluorouracil
Antihemophilic factor VIII (human)
Permethrin
Human factor VIII

Amlodipine besylate
Paracetamol 500 mg, thiamine HCl 50 mg,

pyridoxine HCl 100 mg, cyanocobalamin 100 mcg
Clarithromycin
Per mL Vit A 2,000 IU, vit B1 2 mg, vit B2 3 mg,

vit B6 2 mg, vit B12 2 mcg, vit D3 400 IU,
nicotinamide 20 mg, l-lysine HCl 25 mg, d-
panthenol 5 mg
Aripiprazole
Aripiprazole
Aripiprazole
Aripiprazole
Cefpirome sulfate
Cefixime
Zafirlukast
Quinapril HCl
Fusidic acid
Captopril
Fosinopril Na
Captopril
Per L NaCl 6 g, anhydrous Na acetate 2.28 g, KCl
300 mg, CaCl2 dihydrate 200 mg
Losartan K
Acetylcysteine
Tramadol 37.5 mg, paracetamol 325 mg
Acetylspiramycin
Acetylcysteine
Ranitidine
Nopoxamine lauryl sulfate 2.5 mg, Al amino

acetate 250 mg, galactane sulfate 200 mg
Acyclovir
Acyclovir
Per tab/5 mL liqd Mg(OH)2 200 mg, dried

Al(OH)3 gel 200 mg, simethicone 20 mg.
Per caplet Co-amoxiclav: Amoxycillin 500 mg,

clavulanic acid 125 mg. Per 5 mL dry syr Co-
amoxiclav: Amoxycillin 125 mg, clavulanic acid
31.25 mg. Per 5 mL forte dry syr Co-amoxiclav:
Amoxycillin 250 mg, clavulanic acid 62.5 mg
Zoledronic acid
Diclofenac K
Methionine-bound Zn complex 75 mg, Zn 15 mg,
vit C 60 mg, D salina extr 20 mg, natural -
carotenoids & other carotenoids 6 mg, natural vit
E 15 IU, chromium picolinate 1.04 mg, providing
chromium 130 mcg, selenium yeast 70 mg,
providing selenium 70 mcg, soy extr 100 mg, soy
isoflavone 10 mg
APC Complex (600 mg) contains methionin

bound Zn complex 75 mg (providing Zn 15 mg),
chromium picolinate 1.04 mg (providing
chromium 130 mcg), D. salina extr 20 mg, vit C
60 mg, natural vit E 15 IU
Precipitated sulfur
Per bar Sulphonated surfactant blend
Per g Curcuma rhizoma extr (xanthorrhizol oil 28-

30%) 20 mg
Cisapride
Ranitidine HCl
Acarbose
Disodium clodronate
Cefepime HCl
Per Actal tab Creamaline spray dried powd 360

mg [equiv to Al(OH)3 216 mg]. Per Actal Plus tab
Creamaline spray dried powder 360 mg [equiv to
Al(OH)3 216 mg], Mg(OH)2 monohydrate [equiv
to Mg(OH)2 150 mg], simethicone 25 mg
Atorvastatin Ca
Amlodipine besylate
Glimepiride
Irinotecan HCl trihydrate

Ceftriaxone
Alprazolam
H influenzae type b polysaccharide conjugated to

tetanus protein
Nanocrystalline Ag
Nanocrystalline Ag
Per 5 mL Pseudoephedrine HCl 30 mg,
triprolidine 1.25 mg
Per 5 mL Dextromethorphan HBr 10 mg,

pseudoephedrine HCl 30 mg, triprolidine HCl
1.25 mg, ethanol 9.9% v/v
Per 5 mL Pseudoephedrine HCl 30 mg,

guaiphenesin 100 mg, triprolidine HCl 1.25 mg,
ethanol 6.93% v/v
Triprolidine HCl 2.5 mg, pseudoephedrine HCl 60
mg, paracetamol 500 mg
Alteplase (recombinant human tissue-type

plasminogen activator)
Per Actimmune 250 caplet Echinacea 250, potent

herbs, multivit. Per Actimmune 600 caplet
Echinacea 600 mg, potent herbs, multivit
Glucosamine HCl 750 mg, chondroitin sulfate 250

mg, MSM 250 mg, vit C 50 mg
Risedronate Na
Risedronate Na
Carboplatin
Pioglitazone
Pioglitazone HCl 15 mg, metformin HCl 850 mg
Neutral soln of human monocomponent (HM)
insulin. Recombinant DNA origin
Nadifloxacin
Acyclovir
Acyclovir
Acyclovir
Per 0.3 mL (6 drops) Na fluoride 0.5 mg, l-lysine

HCl 25 mg, vit A 2,500 iu, vit D 400 iu, vit B1 0.6
mg, vit B2 0.6 mg, vit B6 0.5 mg, vit B12 1.5 mcg,
niacinamide 6 mg, d-panthenol 2.5 mg
Per 0.3 mL Vit A 1,500 iu, vit B1 0.6 mg, vit B2 0.5
mg, vit B3 5 mg, vit B5 2.5 mg, vit B6 0.5 mg, vit
B12 1.5 mcg, vit D 400 iu
Nifedipine
Nifedipine GITS (GI Therapeutic System)
Na hyaluronate
Per mL Vit A 5,000 iu, vit D 500 iu, vit B1 2 mg, vit
B2 3 mg, vit B6 2 mg, vit B12 2 mcg, nicotinamide
20 mg, D-panthenol 5 mg, L-lysine HCl 25 mg
Metformin HCl
Per mL Vit A 5,000 iu, vit B1 2 mg, vit B2 3 mg, vit

B6 2 mg, vit B12 2 mcg, vit D 500 iu,
nicotinamide 20 mg, panthenol 5 mg, lysine HCl
25 mg
Fe gluconate 250 mg, manganese sulfate 200

mcg, copper sulfate 200 mcg, vit C 50 mg, folic
acid 1,000 mcg, vit B12 7.5 mcg, sorbitol 25 mg
Carbazochrome Na sulfonate
Adrenaline
Doxorubicin HCl
Carbazochrome Na sulfonate
Methylprednisolone aceponate
Desloratadine
Desloratadine 2.5 mg, pseudoephedrine sulphate
120 mg
Dimethicone
Isoflurane
Quinine ethyl carbonate
Aphanizomenon flos-aquae
Everolimus
Folic acid 1,000 mcg, vit B1 100 mg, vit B6 100
mg, vit B12 100 mcg, DHA powd 60 mg, amino
acid 5 mg, ginger extr 50 mg
Oxymetazoline HCl
Per cream Fusidic acid. Per oint Na fusidate
Cilostazol
Dipyridamole 200 mg, acetylsalicylic acid 25 mg
Clopidogrel
Cilostazol
Influenza virus surface antigen inactivated

Anagrelide HCl
Ticlopidine HCl
Ofloxacin
Ofloxacin
Attapulgite 600 mg, pectin 50 mg
Cafedrine HCl 100 mg, theodrenaline HCl 5 mg
Phenylbutazone
Per 5 mL Vit A 4,000 IU, vit B1 2.5 mg, vit B2 2.5

mg, vit B6 0.75 mg, nicotinamide 15 mg,
panthenol 5 mg, vit C 60 mg, vit D 200 IU, Fe 3.6
mg. Per mL Vit A 3,600 IU, vit B1 1.2 mg, vit B2
1.8 mg, vit B6 0.3 mg, nicotinamide 15.8 mg,
panthenol 1 mg, vit C 60 mg, vit D 666 IU
Vit C 500 mg, niacinamide 100 mg, Ca

pantothenate 20 mg, vit B1 15 mg, vit B2 10 mg,
vit B6 5 mg, vit B12 4 mcg
Vit E 30 mg, vit C 500 mg, folic acid 0.4 mg, vit B1
15 mg, vit B2 15 mg, nicotinamide 100 mg, vit B6
20 mg, vit B12 12 mcg, Ca pantothenate 20 mg,
Zn 22.5 mg
Per 100 g Fat 25 g, protein 10.8 g, carbohydrate

(maltodextrin) 58.6 g, linoleic acid 3.19 g,
linolenic acid 400 mg, vit A 428 mcg-RE, vit D
5.36 mcg, vit E 5.2 mg, vit K 30.6 mcg, vit B1 0.4
mg, vit B2 0.44 mg, vit B3 4.24 mg, vit B5 4.16
mg, vit B6 0.28 mg, vit B9 64 mcg, vit B12 1.12
mcg, vit C 69.8 mg, biotin 9.1 mcg, choline 40
mg, inositol 28.6 mg, taurine 26.3 mg, L-carnitine
6.4 mg, Ca 357 mg, P 208 mg, Mg 42 mg, Fe 4.3
mg, Zn 3.2 mg, manganese 101 mcg, copper 0.3
mg, iodine 54.4 mcg, Na 170 mg, K 510 mg, Cl
314 mg, selenium 8 mcg, fluoride 30 mcg,
nucleotides 10.9 mg, LA/ALA=8, Ca/P=1.7,
casein:whey=40:60. Energy: 503 kCal
a-lipoic acid
a-lipoic acid (ALA) 300 mg, folic acid 400 mcg,

cyanocobalamin (vit B12) 100 mcg
a-lipoic acid
Ibuprofen 200 mg, paracetamol 325 mg
Human albumin
Albendazole
Clindamycin HCl
Policresulen (Condensation product of

metacresolsulfonic acid & methanal)
Sulfacetamide Na
Human albumin
Human albumin
Human albumin.
Human albumin
Human albumin
Per 0.8 mL Alco drops Pseudoephedrine HCl 7.5
mg. Per 5 mL Alco Plus syr Pseudoephedrine HCl
30 mg, brompheniramine maleate 2 mg. Per 5
mL Alco Plus DMP syr Pseudoephedrine HCl 30
mg, brompheniramine maleate 2 mg,
dextromethorphan HBr 10 mg
Ciprofloxacin HCl
Spironolactone
Indapamide hemihydrate
Spironolactone 25 mg, thiabutazide 2.5 mg
Glipizide
Ranitidine HCl
Loratadine 5 mg, pseudoephedrine sulfate 120

mg
Donepezil HCl
a-lipoic acid 300 mg, biotin 0.03 mg, chromium

picolinate 0.2 mg
Dexamethasone 0.5 mg, dexchlorpheniramine
maleate 2 mg
Pemirolast K
Alendronate Na trihydrate
Dexamethasone 0.5 mg, dexchlorpheniramine

maleate 2 mg
Per tab Triprolidine HCl 2.5 mg, pseudoephedrine

HCl 60 mg. Per 5 mL Triprolidine HCl 1.25 mg,
pseudoephedrine HCl 30 mg
Chlorpheniramine maleate
Loratadine
Desloratadine
Betamethasone Na phosphate
Coenzyme Q10
Cytarabine
Diclofenac K
Alprazolam
Per 100 g Diethylamine salicylate 10 g,

nopoxamine 1 g
Ca alginate
Allopurinol
a-lipoic acid 300 mg, biotin 0.03 mg, chromium

picolinate 0.2 mg
Pemetrexed disodium
Alinamin Fursultiamine HCl. Alinamin-F
Fursultiamine HCl (& vit B2 5 mg for tab).
Cilostazol
Melphalan
Ethanol
Per 5 mL Glyceryl guaiacolate 50 mg, Na citrate

180 mg, diphenhydramine HCl 12.5 mg,
phenylpropanolamine HCl 12.5 mg, alcohol 5%
Polyurethane foam
Mefenamic acid
Loratadine
Allopurinol
Allopurinol
Allopurinol
Loratadine
Allopurinol
Al(OH)3 gel 300 mg, Mg(OH)2 gel 300 mg,

simethicone 40 mg
Aqua, maltodextrin, propylene glycol,

polyvinylpyrrolidone (PVP), aloe vera extr, K
sorbate, Na benzoate, hydroxyethylcellulose, PEG
40, hydrogenated castor oil, disodium edetate,
benzalkonium Cl, saccharin Na, Na hyaluronate,
glycyrrhetic acid
Polyvinylpyrrolidone (PVP), aloe vera extr, Na

hyaluronate, glycyrrhetic acid
Allopurinol
Allopurinol
Lodoxamide
Finasteride
Vit A 5,000 IU, vit C 100 mg, vit D 100 IU, vit E 10
IU, vit K 85 mcg, thiamine 1.2 mg, riboflavin 1.2
mg, vit B6 2 mg, folic acid 800 mcg, vit B12 1.3
mcg, Ca 128 mcg, Fe 20 mg, phosphorus 100 mg,
iodine 150 mcg, Mg 200 mg, Zn 20 mg, copper
1.5 mg, DHA 50 mg
Amikacin sulfate
Alendronate Na
Minoxidil
Donepezil HCl
Mefenamic acid
Per caplet Paracetamol 500 mg,
phenylpropanolamine HCl 12.5 mg,
chlorpheniramine maleate 2 mg,
dextromethorphan HBr 15 mg. Per 5 mL syr
Paracetamol 125 mg, phenylpropanolamine HCl
3.125 mg, chlorpheniramine maleate 0.5 mg,
dextromethorphan HBr 3.75 mg
Terfenadine
Gabapentin
Betamethasone valerate
Povidone-iodine
Povidone-iodine
Per 5 mL Diphenhydramine HCl 13.5 mg,

ammonium Cl 131.5 mg, alcohol 5%
Paracetamol
Cyproheptadine HCl
Loperamide HCl
Paracetamol
Alprazolam
Alprazolam
Per 5 mL Vit A 4,000 iu, vit D 300 iu, vit B1 3 mg,

vit B2 2 mg, vit B6 1 mg, vit B12 5 mcg, vit C 50
mg, niacinamide 20 mg, Ca pantothenate 5 mg,
L-lysine HCl 200 mg
Ketoprofen
Per tab Mg carbonate & Al(OH)3 co-precipitate

250 mg, Ca carbonate 50 mg, caffeine 7.5 mg,
diastase 7.5 mg, chlorpheniramine maleate 1 mg,
scopolamine HBr 0.05 mg. Per 5 mL susp Al oxide
219 mg, Mg oxide 54 mg, hyoscyamine HBr 51
mcg, atropine sulfate 9.5 mcg, hyoscine HBr 3
mcg
Per chewable tab/5 mL susp Al(OH)3 dried gel

200 mg, Mg(OH)2 200 mg, simethicone 20 mg
Orciprenaline sulfate
Per 200 mg/50 mg Lopinavir 200 mg, ritonavir 50
mg. Per 100 mg/25 mg Lopinavir 100 mg,
ritonavir 25 mg
Phospholipid fraction from bovine lung

(surfactant)
Alprazolam
Cefadroxil monohydrate
Allylestrenol
Donepezil HCl
Glimepiride
-carotene 6 mg, vit C 100 mg, vit E 25 mg,

lycopene 6 mg
Glimepiride
Per 1/250 mg Glimepiride 1 mg, metformin HCl
250 mg. Per 2/500 mg Glimepiride 2 mg,
metformin HCl 500 mg
Ampicillin trihydrate
Per g Al subacetate 35 mg, hydrocortisone

acetate 2.5 mg, lidocaine HCl 50 mg, Zn oxide
180 mg
Ambroxol HCl
Ambroxol HCl
Amlodipine besylate
Amlodipine maleate
Loperamide HCl
a-ketoisoleucine Ca salt 67 mg, a-ketoleucine Ca
salt 101 mg, a-ketophenylalanine Ca salt 68 mg,
a-hydroxymethionine Ca salt 59 mg, a-ketovaline
Ca salt 86 mg, L-tryptophan 23 mg, L-threonine
53 mg, L-histidine 38 mg, L-tyrosine 30 mg, L-
lysine acetate 105 mg
Per L Glucose 75 g, total free amino acids 30 g,

total nitrogen 4.7 g, essential/non-essential
amino acids 1.44 g, branched-chain amino acids
30% w/w. Energy: 420 kCal
High content of branched-chain amino acids 45%

& low content of methionine, phenylalanine &
tryptophan
Per L Amino acids 50 g, sorbitol 50 g, xylitol 50 g,

vit, electrolytes
Per L Amino acids 50 g, vit, electrolytes

High conc of branched chain amino acid & low
conc of aromatic amino acid (no tyrosine), Na, Cl,
other important amino acids
Per sachet Protein 13.5 g, fat (rice oil) 3.5 g,

carbohydrate 32.35 g, L-isoleucine 1.92 g, L-
leucine 2.04 g, L-valine 1.6 g, other important
amino acids, vits & minerals. Energy: 210 kCal.
Aminophylline
a-keto isoleucine Ca salt 67 mg, a-ketoleucine Ca

salt 101 mg, a-ketophenylalanine Ca salt 68 mg,
a-ketovaline Ca salt 86 mg, a-hydroxymethionine
Ca salt 59 mg, L-lysine acetate 105 mg, L-
threonine 53 mg, L-tryptophan 23 mg, L-histidine
38 mg, L-tyrosine 30 mg, total nitrogen 36 mg,
total Ca 50 mg
Amino acids
Amino acids
Amino acids
Per L L-amino acids 50 g, sorbitol 100 g,
electrolytes, vit
Amikacin sulfate
Per L Total free amino acids 100 g, nitrogen 15.7
g, Na 2 meq, acetate 120 meq
Per 1,000 mL Amino acid 7.2% (BCAA 45.8%), L-

leucine 14 g, L-isoleucine 9 g, L-valine 10 g, L-
lysine acetate 7.1 g, L-threonine 3.5 g, L-
tryptophan 2.5 g, L-methionine 3 g, L-
phenylalanine 5 g, L-cysteine 1 g, L- tyrosine 0.5
g, L-arginine 4.5 g, L-histidine 3.5 g, L-alanine 2.5
g, L-proline 3 g, L-serine 3 g, L-aspartic acid 1 g,
L-glutamic acid 1 g. Osmolarity: 592 mOsm.
Energy: 288 kCal
Amlodipine besylate
Amlodipine besylate
Amlodipine besylate
Amlodipine besylate
Amlodipine besylate
Amlodipine besylate
Amlodipine besilate
Per 1,000 mL Amino acid 5% (BCAA 16.4%) (L-

isoleucine 3.2 g, L-leucine 2.4 g, L-lysine, L-
malate 3.83 g, L-methionine 3 g, L-phenylalanine
4 g, L-threonine 2 g, L-tryptophan 1 g, L-valine
3.2 g, L-arginine HCl 7.5 g, L-histidine 1 g, L-
alanine 6 g, glycine 14 g, L-proline 2 g, L-malic
acid 0.56 g, d-sorbitol 50 g), sorbitol 5%, vit B2,
vit B3, vit B6, vit C, Na 35 meq, K 25 meq, Mg 10
meq, acetate 35 meq, malate 22 meq, Cl 38 meq.
Osmolarity: 1,286 mOsm/L. Energy: 600 kCal
Amoxicillin trihydrate
Per captab Co-amoxiclav: Amoxycillin 500 mg,

clavulanic acid 125 mg. Per 5 mL syr Co-
amoxiclav: Amoxycillin 125 mg, clavulanic acid
31.25 mg. Per 5 mL forte syr Co-amoxiclav:
Amoxycillin 250 mg, clavulanic acid 62.5 mg.
Amoxycillin trihydrate
Per 875-mg tab Amoxicillin 650 mg, clavulanic

acid 250 mg
Amoxicillin
Amoxicillin (Oral: Trihydrate; Inj: Na)
Amoxycillin
Ampicillin (Tab/Caplet/Syr:trihydrate Vial:Na)
Triamcinolone
Triamcinolone
Citrus bioflavonoids 500 mg (diosmin 450 mg,

hesperidin 50 mg)
Per 5 mL Vit B1 5 mg, vit B2 2 mg, vit B6 2.5 mg,

vit B12 3 mcg, nicotinamide 20 mg, D-panthenol
3 mg, lysine HCl 200 mg
DHA 10 mg, lysine HCl 200 mg, vit B1 5 mg, vit B2

2 mg, vit B6 25 mg, vit B12 3 mcg
Per 5 mL Acetaminophen 120 mg, guaifenesin 25
mg, phenylpropanolamine HCl 3.5 mg,
chlorpheniramine maleate 0.5 mg
Per drag Paracetamol 500 mg,

dextromethorphan HBr 15 mg, chlorpheniramine
maleate 1 mg, phenylpropanolamine HCl 15 mg.
Per 5 mL syr Paracetamol 120 mg,
dextromethorphan HBr 3.5 mg,
chlorpheniramine maleate 0.5 mg,
phenylpropanolamine HCl 3.5 mg
Diosmin 450 mg, hesperidin 50 mg
Ibuprofen
Paracetamol 200 mg, salicylamide 200 mg,

caffeine 50 mg, chlorpheniramine maleate 1 mg
Clomipramine HCl
Per 5 mL Dextromethorphan HBr 5 mg,

guaifenesin 25 mg, pseudoephedrine HCl 7.5 mg,
chlorpheniramine maleate 1 mg
Methampyrone 500 mg, diazepam 2 mg
Mefenamic acid
Tramadol 37.5 mg, paracetamol 325 mg
Per 5 mL Paracetamol 120 mg, glyceryl

guaiacolate 25 mg, Na citrate 50 mg,
Fluphenazine HCl
Vit A 2,500 iu, vit B1 0.6 mg, vit B2 phosphate 0.5

mg, vit B6 0.5 mg, vit B12 1.5 mcg, vit D 500 iu,
niacinamide 5 mg, Ca pantothenate 2.5 mg
Cefuroxime (Caplet: Axetil; inj: Na)
Roxithromycin
Per FC tab Co-amoxiclav: Amoxicillin trihydrate
500 mg, K clavulanate 125 mg. Per 5 mL Forte dry
susp Co-amoxiclav: Amoxicillin trihydrate 250 mg,
K clavulanate 62.5 mg
Medroxyprogesterone acetate
Per Andalan PIL KB active tab Levonorgestrel 0.15

mg, ethinylestradiol 0.03 mg. Per Andalan Fe
active tab Levonorgestrel 0.15 mg,
ethinylestradiol 0.03 mg plus placebo tab
contains Fe fumarate 75 mg
Tramadol HCl
Isothipendyl HCl
Fluoxetine HCl
Activated colloidal attapulgite 650 mg, pectin 65

mg
Per 5 mL Diphenhydramine HCl 7.5 mg,

dextromethorphan HBr 10 mg, phenylephrine 5
mg, glyceryl guaiacolate 100 mg, ipecac tinct 0.5
mL
Testosterone undecanoate
Cyproterone acetate
Mesterolone
Folic acid
Folic acid
Clindamycin HCl
Midazolam
Ketamine HCl
Flumazenil
Ramipril
Sertraline HCl
Cefixime
Mg(OH)2 400 mg, dried Al(OH)3 gel 400 mg,

simethicone 100 mg
Ketoconazole
Ketoconazole
Estradiol 1 mg, drospirenone 2 mg
Trimetazidine diHCl
Losartan K
Loratadine
Ranitidine HCl
Per 100 g Protein 37 g, carbohydrate 48.8 g,
lactose 48.8 g, fat 0.8 g, vit A 990 mcg, vit D3 12
mcg, vit C 15 mg, vit B1 0.3 mg, vit B2 1.7 mg, vit
B6 0.3 mg, pantothenic acid 3 mg, folate 69 mcg,
vit B12 3.7 mcg, Ca 2,000 mg, phosphorus 1,520
mg, Mg 160 mg, Zn 5.8 mg, iodine 98 mcg, Na
430 mg, K 1,510 mg. Energy: 340 kCal.
Loratadine
Metronidazole
Per 32 g Total fat 7 g, protein 7 g, carbohydrate

17 g, Na 55 mg, vit A 120 mcg, vit C 19 mg, vit D3
2 mcg, vit E 1.4 mg, vit K1 8 mcg, vit B1 160 mcg,
vit B2 352 mcg, vit B3 1,340 mcg, vit B6 160 mcg,
folic acid 17 mcg, vit B12 0.7 mcg, Ca 210 mg, Fe
1.9 mg, phosphorus 140 mg, Mg 16 mg, Zn 1 mg,
iodine 27 mcg, linoleic acid 1,216 mg, linolenic
acid 128 mg, DHA 2.6 mg, arachidonic acid 2.6
mg, gangliosides 2.1 mg, whey protein 4 g, a-
lactalbumin 480 mg, sialic acid 72 mg, biotin 5.4
mcg, pantothenic acid 480 mcg, K 260 mg, Cl 130
mg, copper 58 mcg. Energy: 160 kCal.

16 g, Na 60 mg, vit A 130 mcg (440 iu), vit C 13
mg, vit D 1.9 mcg (77 iu), vit E 1.4 mg (2.1 iu), vit
B1 154 mcg, vit B2 384 mcg, vit B3 1,280 mcg, vit
B6 128 mcg, folic acid 22 mcg, vit B12 0.7 mcg,
Ca 320 mg, Fe 2.6 mg, Mg 18 mg, Zn 1.3 mg,
iodine 16 mcg, linoleic acid 800 mg, linolenic acid
96 mg, DHA 1.9 mg, arachidonic acid 1.9 mg,
ganglioside 2.1 mg, whey protein 4 g, a-
lactalbumin 416 mg, sialic acid 68 mg. Energy:
150 kCal.
Per 100 kCal Protein 2.6 g, whey protein 1.6 g,
alpha- lactalbumin (alpha-protein) 176.5 mg,
taurine 6.3 mg, nucleotides 4.9 mg, fat 5.5 g,
carbohydrate 11 g, lactose 10.5 g, water 0.5 g,
linoleic acid 588.2 mg, linolenic acid 58.8 mg,
DHA 7.8 mg, arachidonic acid 11.8 mg, lipid
complex 0.9 mg, vit A 92.2 mcg, -carotene 25.5
mcg, vit D 1.2 mcg, vit E 1 mg, vit K 7.6 mcg, vit
B1 98 mcg, vit B2 176.5 mcg, vit B3 1,058.8 mcg,
vit B5 647.1 mcg, vit B6 58.8 mcg, folic acid 11.6
mcg, vit B12 0.6 mcg, vit C 11.6 mg, biotin 2.2
mcg, choline 17.6 mg, Ca 96.1 mg, phosphorus
64.7 mg, Mg 12.4 mg, Fe 1.7 mg, manganese
15.3 mcg, copper 82.4 mcg, iodine 82.4 mcg, Na
36.5 mg, K 111.8 mg, Cl 96.1 mg. Energy: 100
kCal.

18 g, Na 75 mg, vit A 5 mcg, vit C 19 mg, vit D3 2
mcg/82 iu, vit E 2.2 mg/3.2 iu, vit K1 16 mcg, vit
B1 132 mcg, vit B2 296 mcg, vit B3 1,612 mcg, vit
B6 132 mcg, folic acid 18 mcg, vit B12 1 mcg, Ca
181 mg, Fe 2.4 mg, phosphorus 135 mg, Mg 21
mg, Zn 1.3 mg, iodine 32 mcg, manganese 25
mcg, linoleic acid 855 mg, linolenic acid 99 mg,
DHA 13 mg, arachidonic acid 13 mg, lipid
complex 1.9 mg, whey protein 2.7 g, a-
lactalbumin 329 mg, taurine 10.5 mg,
nucleotides 8.2 mg, -carotene 43 mcg, biotin
3.2 mcg, choline 30 mg, pantothenic acid 1,283
mcg, K 191 mg, Cl 161 mg, copper 135 mcg.
Energy: 160 kCal.
Per 46 g Total fat 5 g, saturated fat 2.5 g, trans
fat, cholesterol 13 mg, linoleic acid (omega 6) 0.3
g, protein 13 g, total carbohydrate 23 g, fiber 3.4
g, sugar 10 g, Na 170 mg, K 550 mg, vit A 360
mcg, vit B3 8.5 mg, vit C 39 mg, vit D3 2.5 mcg,
vit B1 0.7 mg, vit B2 1.3 mg, vit B3 8.5 mg, vit B5
3.1 mg, vit B6 0.8 mg, vit B9 250 mcg, vit B12 1.4
mcg, Ca 500 mg, Fe 11 mg, Mg 51 mg,
phosphorus 396 mg, Zn 1.5 mg, iodine 56 mcg, a-
linolenic acid (omega 3) 0.08 g, DHA 25 mg, sialic
acid 94 mg, lactose 6.3 g, biotin 14 mcg, choline
359 mg, Cl 398 mg. Energy: 190 kCal.
Per 37.5 g Total fat 4.5 g, saturated fat 2.5 g,

cholesterol 10 mg, linoleic acid (omega 6) 0.3 g,
protein 12 g, total carbohydrate 17 g, fiber 2.5 g,
Na 130 mg, K 520 mg, vit A 360 mcg, vit C 39 mg,
vit D3 2.5 mcg, vit B1 0.7 mg, vit B2 1.2 mg, vit
B3 8.5 mg, vit B5 2.6 mg, vit B6 0.8 mg, vit B9
250 mcg, vit B12 1.4 mcg, Ca 500 mg, Fe 7.4 mg,
Mg 40 mg, phosphorus 316 mg, Zn 1.4 mg,
iodine 56 mcg, a-linolenic acid (omega 3) 0.1 g,
DHA 25 mg, sialic acid 66 mg, lactose 4.8 g,
biotin 8.4 mcg, choline 322 mg, Cl 42 mg. Energy:
160 kCal.
Per 40 g Total fat 5 g, saturated fat 2.5 g, trans fat

6 g, cholesterol 13 mg, linoleic acid (omega 6) 0.3
g, protein 13 g, carbohydrate 24 g, sugar 10 g, Na
170 mg, K 550 mg, vit A 240 mcg, vit C 30 mg, vit
D3 2.5 mcg, vit B1 94 mcg, vit B2 0.7 mg, vit B5
0.7 mg, vit B6 1 mg, folic acid 340 mcg, vit B12 1
mcg, Ca 500 mg, Fe 7.5 mg, Mg 52 mg,
phosphorus 337 mg, Zn 1.6 mg, iodine 35 mcg,
linolenic acid 0.09 g, DHA 25 mg, gangliosides 4.2
mg, fiber 3 g, sialic acid 98 mg, lactose 9 g, biotin
13 mcg, choline 46 mg, Cl 403 mg. Energy: 190
kCal.
Per 37.5 g Total fat 4.5 g, saturated fat 2 g, trans
fat 4 g, cholesterol 10 mg, linoleic acid (omega 6)
0.3 g, protein 12 g, carbohydrate 18 g, sugar, Na
135 mg, K 530 mg, vit A 240 mcg, vit C 30 mg, vit
D3 2.5 mcg, vit B1 56 mcg, vit B2 0.9 mg, vit B5
1.1 mg, vit B6 1.1 mg, folic acid 340 mcg, vit B12
0.8 mcg, Ca 500 mg, Fe 75 mg, Mg 39 mg,
phosphorus 374 mg, Zn 1.6 mg, iodine 35 mcg,
linolenic acid 0.09 g, DHA 25 mg, gangliosides 3.4
mg, fiber 2.5 g, sialic acid 80 mg, lactose 7 g,
biotin 9 mcg, choline 41 mg, Cl 320 mg. Energy:
160 kCal.
Per 100 g Anmum powd Protein 32.8 g,

carbohydrate 45.1 g, lactose =22 g, fat 12.3 g,
linoleic acid 0.8 g, a-linolenic acid 0.2 g, food
fibre 6.4 g, vit A 640 mcg, vit D3 6.7 mcg, vit C 80
mg, vit B1 180 mcg, vit B2 1.7 mg, vit B6 230
mcg, pantothenic acid 3 mg, folic acid 900 mcg,
vit B12 3.2 mcg, biotin 32 mcg, choline 130 mg,
Ca 1,330 mg, phosphorus 860 mg, Fe 20 mg, Mg
110 mg, Zn 3.6 mg, iodine 94 mcg, Na 410 mg, K
1,350 mg, Cl 1,060 mg. Energy: 420 kCal. Per 100
g Anmum chocolate powd Protein 27.3 g,
carbohydrate 51.9 g, fat 10.3 g, linoleic acid 0.7 g,
a-linolenic acid 0.2 g, food fibre 7 g, vit A 530
mcg, vit D3 5.4 mcg, vit C 66 mg, vit B1 130 mcg,
vit B2 1.3 mg, vit B6 190 mcg, pantothenic acid 2
mg, folic acid 740 mcg, vit B12 2.9 mcg, biotin 28
mcg, choline 110 mg, Ca 1,090 mg, phosphorus
750 mg, Fe 17 mg, Mg 120 mg, Zn 3.4 mg, iodine
77 mcg, Na 340 mg, K 1,340 mg, Cl 900 mg.
Energy: 410 kCal.
Norethisterone
Glimepiride
Ketoprofen
Fluoxetine HCl
Per 5 mL syr Psidii folium extr 100 mg, Curcuma

domestica rhizoma extr 50 mg, Piper betle folia
50 mg, Cimicifuga racemosa rhizome extr equiv
to 20 mg root & rhizome
Methampyrone
Metamizole Na
Metamizole Na
Metamizole
Famotidine 10 mg, Ca carbonate 800 mg,

Mg(OH)2 165 mg
Dithranol
Lactobacillus algae ferment, glyceril

polymethacrylate, palmitoyl oligopeptide,
phenoxyethanol, methylparaben, lactoferin,
hydrolysed wheat protein, thioxanthine
Famotidine
Piracetam
Mg oxide 300 mg, Mg carbonate 50 mg, Na

bicarbonate 100 mg, Ca carbonate 150 mg,
bismuth subcarbonate 100 mg
-carotene 6 mg, vit C 100 mg, vit E 25 mg
Cilostazol
Sertraline
Fluoxetine HCl
Per drag Paracetamol 500 mg,
dextromethorphan HBr 15 mg, chlorpheniramine
maleate 1 mg, phenylpropanolamine HCl 12.5
mg. Per 5 mL syr Paracetamol 250 mg,
dextromethorphan HBr 7.5 mg,
chlorpheniramine maleate 1 mg,
phenylpropanolamine HCl 6.25 mg
Lycopene 2 mg, grapeseed extr 40 mg, green tea

extr 50 mg, -carotene 6 mg, vit B3 20 mg, vit B6
25 mg, vit B12 6 mcg, vit C 100 mg, vit E 25 mg,
Zn 15 mg, selenium 50 mcg
Metamizole Na
Per cap Psidii folium extr 150 mg, Curcuma

domestica rhizoma extr 50 mg, Piper betle folia
50 mg, Cimicifuga racemosa rhizome extr 25 mg,
Areca catechu 15 mg
Ticlopidine HCl
Diclofenac free acid
Pyrathiazine chlorotheophyllinate 40 mg, vit B6

30 mg
Clobazam
Paclitaxel
Alprazolam
Curcuminoid 2 mg, -carotene 10% 4 mg, vit B1 3

mg, vit B2 2 mg, vit B6 5 mg, vit B12 5 mcg, vit D
100 IU, dexpanthenol 3 mg, Ca pidolate 300 mg,
fructooligosaccharides 300 mg
Cyproheptadine HCl
Per 5 mL syr Vit A 5,000 IU, vit B1 3 mg, vit B2 2

mg, vit B6 6 mg, vit B12 5 mcg, vit C 50 mg, vit D
400 IU, nicotinamide 20 mg, lysine HCl 250 mg,
d-pantothenol 5 mg, l-glutamic acid 25 mg. Per
0.6 mL Vit A 2,000 IU, vit C 30 mg, vit D 400 IU,
vit B1 1 mg, vit B2 1.2 mg, vit B6 1 mg, vit B12 2
mcg, nicotinamide 10 mg, pantothenol 5 mg,
lysine HCl 25 mg
Insulin glulisine
Diethylpropion HCl 75 mg, vit B1 5 mg, vit B2 4

mg, vit B6 2 mg, nicotinamide 30 mg
Desonide
Per g Desonide 0.5 mg, neomycin sulfate 5 mg

Pregabalin
Irbesartan
Silymarin 150 mg, turmeric 12.5 mg, a- lipoic acid

50 mg, pantothenic acid 5 mg, vit C 125 mg, vit E
50 iu, vit B1 0.75 mg, vit B2 0.85 mg, vit B6 1 mg,
vit B12 3 mcg, niacinamide 10 mg
Glucosamine sulfate 500 mg, chondroitin sulfate

25 mg, MSM 200 mg, vit C 100 mg
Ca (carbonate, hydroxyapatite, citrate) 250 mg,
Mg (oxide, amino acid chelate) 100 mg, vit D3
100 iu, Zn 3.75 mg, vit B6 1 mg, copper 200 mcg,
manganese 0.8 mg, isoflavone 2.5 mg, boron 0.4
mg, silicon 200 mcg
Acetylsalicylic acid
Diclofenac K
Leflunomide
Irbesartan
Sulbutiamine
Attapulgite 600 mg, pectin 50 mg
Doxycycline
Diphenhydramine HCl
Vit B12
Etoricoxib
Micronized purified flavonoid fraction
Vit A 0.8 mg, vit B1 1.5 mg, vit B2 1.6 mg, vit B6
2.2 mg, vit B12 2.5 mcg, vit C 100 mg, vit D 0.01
mg, vit E 10 mg, vit K 0.055 mg, folic acid 1 mg,
Fe fumarate 90 mg, nicotinamide 17 mg, Ca
lactate 250 mg, Zn 15 mg, iodine 0.15 mg, Mg 6
mg, biotin 0.03 mg, selenium 0.03 mg
Pamidronate disodium
Norepinephrine
Ibuprofen
Gentamycin sulphate 1 mg, betamethasone

dipropionate 1 mg
Pelargonium sidoides radix dry extr
Donepezil HCl
Donepezil HCl
Meloxicam
Anastrozole
Aripiprazole
Fondaparinux Na
Trihexyphenidyl HCl
Per g Chloramphenicol 20 mg, hydrocortisone

acetate 25 mg
Levofloxacin anhydrate
Lyophilized Royal jelly 6 mg, ginseng powd 50
mg, vit A 5,000 IU, vit C 150 mg, vit E 10 mg, vit D
400 IU, vit B1 5 mg, vit B2 5 mg, vit B6 10 mg, vit
B12 5 mcg, niacinamide 100 mg, pantothenate
Ca 10 mg, folic acid 100 mcg, copper 0.25 mg,
iodine 0.05 mg, phosphorus 60 mg, manganese
0.25 mg, Mg 0.375 mg, K 0.25 mg, Zn 0.05 mg,
rutin 1.25 mg, Ca 1.6 mg, Fe 30 mg
Nimesulide
Exemestane
Cyproheptadine HCl
Metamizole Na 300 mg, vit B1 100 mg, vit B6 50

mg, vit B12 0.1 mg, vit E 30 iu
Ethambutol HCl
Erythromycin ethylsuccinate
Trihexyphenidyl HCl
Artemether
Carteolol
Clopidogrel
Ibuprofen
Ibuprofen 200 mg, paracetamol 325 mg
Diacerein
Vit B6 3 mg, vit C 500 mg, Zn 20 mg, -carotene

4.5 mg, vit B12 3 mcg, vit E 200 IU, selenium 50
mcg, lecithin 175 mg
Tenoxicam
Meloxicam
Glucosamine 500 mg, chondroitin sulfate 200
mg, MSM 200 mg, Zn 5 mg
Glucosamine 100 mg, chondroitin sulfate 75 mg,

MSM 300 mg

mg, vit C 25 mg, Zn 2.5 mg, manganese 250 mcg,
Mg 5 mg

mg, MSM 350 mg, vit C 50 mg, selenium 12.5
mcg, Zn 2.5 mg, manganese 1 mg
Mefenamic acid
Mefenamic acid
Tranexamic acid
Piperazine hexahydrate
Astaxanthin
Piperazine hexahydrate
Vit B1 50 mg, vit B2 25 mg, vit B6 10 mg, vit B12
5 mcg, vit C 175 mg, nicotinamide 100 mg, Ca
pantothenate 25 mg, folic acid 0.5 mg
Per 5 mL Vit B1 8.33 mg, vit B2 4.16 mg, vit B6

1.67 mg, vit B12 8.33 mcg, vit C (as Na ascorbate)
83.33 mg, nicotinamide 8.33 mg, pantothenol
3.33 mg
Per 5 mL DHA 32 mg, curcuma extr 2 mg, vit A

2,400 IU, vit D3 200 IU, vit C 60 mg, vit B1 4 mg,
vit B2 1.2 mg, vit B6 1.2 mg, vit B12 4 mcg,
nicotinamide 16 mg, Ca pantothenate 6 mg,
choline bitartrate 12 mg, inositol 12 mg, Ca
gluconate 300 mg, Ca hypophosphite 20 mg, Na
hypophosphite 20 mg, L-lysine HCl 200 mg
Povidone-iodine
Per L Na 130 meq, K 4 meq, Cl 109 meq, Ca 3

meq, acetate 28 meq, anhydrous dextrose 50 g
Per chewtab 400 Magaldrate anhydrous 400 mg,

simethicone 40 mg. Per chewtab 800 Magaldrate
anhydrous 800 mg, simethicone 40 mg. Per 5 mL
susp Magaldrate anhydrous 400 mg, simethicone
30 mg
Mefenamic acid
Vit C
Salbutamol
Theophylline anhydrous 130 mg, ephedrine HCl

10 mg
Theophylline anhydrous 130 mg, ephedrine HCl

12.5 mg
Ephedrine HCl 12.5 mg, theophylline anhydrous

130 mg
K L-aspartate 100 mg, Mg L-aspartate 100 mg,

bisbentiamine 10 mg, vit B6 5 mg
K L-aspartate
Cefotiam
Aspirin
Astaxanthin 4 mg, selenium 15 mcg

Natural astaxanthin 2 mg, fish collagen 250 mg
Astaxanthin 4 mg, selenium 15 mcg
Astaxanthin 4 mg, vit C 300 mg
Natural astaxanthin
Pure natural astaxanthin
Vit B1 25 mg, vit B6 25 mg, vit B12 50 mcg, vit C

75 mg, vit D 400 iu, vit E 75 mg, taurine 100 mg,
-carotene 5 mg, l-arginine 50 mg, glutamic acid
50 mg, Mg l-aspartate 10 mg
Salbutamol sulfate
Ephedrine HCl 12.5 mg, theophylline 125 mg
Natural astaxanthin
Astaxanthin
Tipepidine hibenzate
Alprazolam
Procaterol HCl
Lorazepam
Per chewable tab Al(OH)3 300 mg, Mg(OH)2 300

mg, dimethicone 50 mg. Per 5 mL susp Al(OH)3
300 mg, Mg(OH)2 300 mg, dimethicone 50 mg
Atorvastatin Ca
Na hyaluronate, Vitis vinifera, Butyrospermum

parkii butter, telmesteine, glycyrrhetinic acid
Atorvastatin Ca
Atorvastatin Ca
Atorvastatin
Atorvastatin Ca
Adenosine triphosphate disodium
Atracurium besylate
Atracurium besilate
Diclofenac Na
Meloxicam
Ipratropium Br
Per 875-mg tab Amoxicillin 650 mg, clavulanic

acid 250 mg
Per '500' vial Amoxycillin Na 500 mg, clavulanic
acid 100 mg. Per '1000' vial Amoxycillin Na 1000
mg, clavulanic acid 200 mg.
Per 625 mg tab Amoxicillin 500 mg, clavulanate K

125 mg. Per 1 g tab Amoxicillin trihydrate 875
mg, clavulanate K 125 mg. Per 5 mL oral susp
Amoxicillin trihydrate 125 mg, clavulanate K
31.25 mg. Per 5 mL Forte oral susp Amoxicillin
trihydrate 250 mg, clavulanate K 62.5 mg
Moclobemide
Co-amoxiclav: Amoxycillin 500 mg, clavulanic

acid 125 mg
Azelaic acid
Fluticasone furoate
Per 2 mg/500 mg Rosiglitazone maleate 2 mg,

metformin HCl 500 mg. Per 4 mg/500 mg
Rosiglitazone maleate 4 mg, metformin HCl 500
mg
Per 4 mg/1 mg Rosiglitazone maleate 4 mg,

glimepiride 1 mg. Per 4 mg/2 mg Rosiglitazone
maleate 4 mg, glimepiride 2 mg. Per 4 mg/4 mg
Rosiglitazone maleate 4 mg, glimepiride 4 mg
Rosiglitazone maleate
Inactivated hepatitis A virus
Moxifloxacin HCl
2-methoxy benzoquinone (MBQ), 2,6-dimethoxy

benzoquinone (DMBQ)
Pheniramine maleate
Per 6 g sachet Malic acid 700 mg, glucosamine

HCl 800 mg, L-arginine HCl 800 mg, glycine 333
mg, glycyrrhizinic acid 33.3 mg, Zn sulfate 5 mg,
Ca pantothenate 3 mg, pyridoxine 0.6 mg, folic
acid 133 mcg, cyanocobalamin 0.5 mcg, Cistus
incanus 125 mg
Chloroquine phosphate
Levocetirizine diHCl
Dutasteride
Ginger extr 400 mg, vit B6 25 mg
Astaxanthin
Astaxanthin 4 mg, melon juice conc 10 mg
Natural Astaxanthin 4 mg (AstaREAL 200 mg)
Natural astaxanthin
Natural astaxanthin
Azelaic acid
Azathioprine
Azithromycin dihydrate
Salbutamol sulfate
Danazol
Brinzolamide
Azithromycin
-carotene 5,000 IU, vit C 500 mg, vit E 100 IU,

selenium 20 mcg, Zn 8 mg
Per tab Ethambutol HCl 250 mg, INH 100 mg, vit
B6 5 mg. Per Forte tab Ethambutol HCl 500 mg,
INH 200 mg, vit B6 10 mg
Ethambutol
Per vial Cefoperazone Na 500 mg, sulbactam Na

500 mg
Sultamicillin: Ampicillin, sulbactam
Chlorhexidine acetate
Ciprofloxacin HCl
Cefpirome sulfate
Mupirocin
Per tab Co-trimoxazole: Trimethoprim 80 mg,

sulfamethoxazole 400 mg. Per 5 mL syr Co-
trimoxazole: Trimethoprim 40 mg,
sulfamethoxazole 200 mg. Per forte caplet Co-
sulfamethoxazole 400 mg
Per 400 mg/80 mg tab Sulfamethoxazole 400 mg,

trimethoprim 80 mg. Per 5 mL of 200 mg/40 mg
susp Sulfamethoxazole 200 mg, trimethoprim 40
mg. Per 800 mg/160 mg Forte caplet
Sulfamethoxazole 800 mg, rimethoprim 160 mg
Per adult tab Co-trimoxazole: Trimethoprim 80
mg, sulfamethoxazole 400 mg. Per forte caplet
Co-trimoxazole: Trimethoprim 160 mg,
sulfamethoxazole 800 mg. Per 5 mL syr Co-
sulfamethoxazole 200 mg
Mupirocin
Coenzyme Q10 30 mg, safflower oil 181.7 mg,

purified fish oil (contains DHA) 5 mg, vit E 5 mg,
folic acid 0.12 mg, vit B6 1 mg, nicotinamide 1
mg, vit B12 1 mcg
Gentamicin sulfate
Carbamazepine
Cefpodoxime proxetil
Per 5 mL Dextromethorphan HBr 7.5 mg,

Ciprofloxacin
Ciprofloxacin HCl
Entecavir
Flunarizine
Oxcarbazepine
Ciclopiroxolamine
Per 30 mL Strobilanthes crispus leaf extr 0.3 g,

Sonchus arvensis leaf extr 3 g
Sulbactam Na 500 mg, cefoperazone Na 500 mg

Cefotaxime Na
Per g Dexamethasone 0.4 mg, clotrimazole 10 mg
Bisoprolol fumarate
Lactoferrin 100 mg, colostrum bovine 100 mg,

Echinacea angustifolia 50 mg, vit C 50 mg, Zn
picolinate 10 mg
Per 100 g Protein 10.8 g, fat 25 g, carbohydrate

58.8 g, moisture =2.7 g, linolenic acid 3,650 mg,
a-linolenic acid 365 mg, arachidonic acid 51.8
mg, DHA 25.9 mg, fiber 1.5 g, fructo-
oligosaccharide 1.5 g, lactoferrin 48.9 mg, vit A
440 mcg, -carotene 200 mcg, vit D3 6.1 mcg, vit
E 12 mg a-TE, vit K1 33 mcg, vit B1 0.4 mg, vit B2
0.89 mg, vit B3 3.6 mg, vit B5 2,700 mcg, vit B6
0.29 mg, vit B9 75 mcg, vit B12 1.8 mcg, vit C 61
mg, biotin 13 mcg, choline 100 mg, inositol 20
mg, L-carnitine 7 mg, taurine 36 mg, Ca 310 mg,
phosphorus 170 mg, Mg 32 mg, Fe 5 mg, Zn 3.2
mg, manganese 48 mcg, copper 315 mcg,
selenium 10 mcg, iodium 71 mcg, Na 135 mg, K
445 mg, Cl 300 mg
Per 235 mL Total fat 6 g, saturated fat 1.5 g,
cholesterol 15 mg, linoleic acid 338 mg, protein 6
g, carbohydrate 28 g, fiber 1 g, soluble fiber 1 g,
sugar 24 g, lactose 18 g, sucrose 4 g, Na 75 mg, K
300 mg, vit A 25%, vit D3 40%, vit E 30%, vit K1
40%, vit C 40%, vit B1 40%, vit B2 70%, vit B3
35%, vit B5 40%, vit B6 40%, vit B9 40%, vit B12
80%, Ca 45%, P 45%, Mg 30%, Fe 40%, Zn 45%,
iodine 45%, selenium 30%, probiotic FOS & GOS
1.4 g, DHA 9 mg, AA 9 mg, phospholipid 68 mg,
a-linoleic acid 52 mg, choline 24 mg, taurine 3.4
mg, L-carnitine 3.3 mg, biotin 5.9 mcg, inositol 12
mg, Cl 200 mg, copper 155 mcg. Energy: 190 kCal
Per 235 mL Total fat 6 g, saturated fat 2.5 g,

cholesterol 20 mg, linolenic acid 104 mg, protein
7 g, carbohydrate 28 g, fiber 1 g, soluble fiber 1 g,
total sugar 23 g, lactose 18 g, sucrose 4 g,
fructose 1 g, Na 90 mg, K 380 mg, vit A 30%, vit
D3 45%, vit E 30%, vit C 40%, vit B1 45%, vit B2
30%, vit B12 30%, Ca 35%, P 35%, Mg 10%, Fe
45%, Zn 35%, iodium 40%, selenium 45%,
prebiotic FOS 0.14 g, prebiotic GOS 1.3 g, DHA 9
mg, AA 66 mg, a-linoleic acid 35 mg, choline 23
mg, L-carnitine 2.9 mg, biotin 6.5 mcg, inositol 16
mg, Cl 251 mg, copper 161 mg. Energy: 190 kCal
Per 225 mL Protein 7 g, fat 8 g, carbohydrate 33

g, fiber 1 g, lactose 13 g, Na 85 mg, K 340 mg, vit
A 40%, vit D3 35%, vit E 30%, vit K1 30%, vit C
40%, vit B6 40%, vit B9 60%, vit B12 95%, Ca
50%, P 60%, Mg 35%, Fe 35%, Zn 35%, iodium
35%, manganese 45%, fluoride 35%, selenium
45%, linolenic acid 130 mg, lysine 537 mg, fructo-
oligosaccharide 1 g, DHA 2 mg, AA 4 mg, a-
linolenic acid 32 mg, choline 22 mg, L-carnitine
3.1 mg, biotin 5.1 mcg, inositol 19 mg, Cl 227 mg,
copper 91 mcg, molybdenum 13 mcg, chromium
6.8 mcg. Energy: 225 kCal
Per serving (43 g) Total fat 7 g, saturated fat 3 g,
linoleic acid (omega 6) 133 mg, protein 7 g, total
carbohydrate 26 g, food fiber 1 g, total sugar 14
g, lactose 12 g, maltose 2 g, Na 95 mg, K 380 mg,
protein 36%, vit A 35%, vit D3 25%, vit E 30%, vit
K1 30%, vit C 35%, vit B1 25%, vit B2 85%, vit B3
120%, Ca 55%, phosphorus 65%, Mg 45%, Fe
30%, Zn 30%, iodine 35%, selenium 25%, fructo-
oligosaccharides 1 g, DHA 10 mg, a-linolenic acid
(omega 3) 46 mg, choline 25 mg, L-carnitine 3.4
mg, -carotene 32 mcg, biotin 6.5 mcg, inositol
20 mg, chloride 252 mg, copper 100 mcg,
manganese 23 mcg. Energy: 190 kCal
Per 100 g Vegetable fat 25.5 g, linoleic acid 3.7 g,

a-linolenic acid 0.37 g, protein 11.2 g, casein 4.5
g, whey protein 6.7 g, carbohydrate 58.9 g,
lactose 33.7 g, dextrin (including glucose) 25.2 g,
moisture 2 g, vit, minerals, taurine, L-carnitine.
Energy: 510 kCal.
Per 100 g Carbohydrate 55.9 g, fat 27.3 g, protein

12.4 g, moisture =3 g, vit A 633 mcg, -carotene
197 mcg, vit D3 10 mcg, vit E 5.5 mg-a-TE, vit K1
36 mcg, vit B1 0.41 mg, vit B2 1 mg, niacinamide
3.1 mg, pantothenic acid 2.1 mg, vit B6 0.34 mg,
folic acid 52 mcg, vit B12 1 mcg, biotin 10 mcg,
vit C 52 mg, L-carnitine 11 mg, choline 67 mg,
inositol 23 mg, taurine 31 mg, L-cystine HCl 170
mg, Na 160 mg, K 465 mg, Cl 335 mg,
phosphorus 205 mg, Fe 6.7 mg, Zn 5.2 mg,
copper 410 mcg, manganese 90 mcg, iodium 52
mcg
Per 100 mL Protein 1.4 g, fat 3.4 g, linoleic acid
474 mg, a-linolenic acid 50 mg, DHA 6.7 mg, AA
6.7 mg, phospholipid 42 mg, carbohydrate 7.8 g,
lactose 7 g, fiber 0.55 g, fructo-oligosaccharides
0.04 g, galacto-oligosaccharides 0.36 g, L-
carnitine 1.7 mg, taurine 5.2 mg, vit A 63 mcg-RE,
-carotene 25 mcg, vit D3 0.84 mcg, vit E 1.3 mg
a-TE, vit K1 6.4 mcg, vit B1 63 mcg, vit B2 159
mcg, vit B3 0.53 mg, vit B5 0.46 mg, vit B6 53
mcg, vit B9 13 mcg, vit B12 0.38 mcg, vit C 14
mcg, biotin 3.3 mcg, choline 16 mg, inositol 6.5
mg, Ca 52 mg, P 29 mg, Mg 6.1 mg, Fe 1.1 mg, Zn
0.72 mg, manganese 9.5 mcg, copper 44 mcg,
selenium 1.6 mcg, iodine 13 mcg, Na 12 mg, K 82
mg, Cl 50 mg. Energy: 70 kCal
Per 100 mL Total fat 6 g, linoleic acid 833 mg,

protein 5 g, carbohydrate 17 g, fiber 1 g, soluble
fiber 1 g, lactose 14 g, Na 60 mg, K 230 mg, vit A
45%, vit C 75%, vit D3 55%, vit E 50%, vit K 95%,
vit B1 30%, vit B2 80%, vit B3 25%, vit B5 50%, vit
B6 30%, vit B9 40%, vit B12 100%, Ca 40%, P
40%, Mg 30%, Fe 25%, iodine 30%, Zn 30%,
selenium 25%, fructo-oligosaccharides 0.08 g,
galacto-oligosaccharides 0.73 g, DHA 12 mg, AA
12 mg, phospholipid 81 mg, a-linolenic acid 87
mg, choline 34 mg, taurine 10 mg, L-carnitine 4.9
mg, biotin 5.9 mcg, inositol 14 mg, Cl 146 mg,
copper 96 mcg. Energy: 140 kCal
Per 100 mL Protein 1.7 g, fat 3.6 g, carbohydrate

7.5 g, moisture =3 g, linolenic acid 555 mg, a-
linolenic acid 53 mg, AA 7.3 mg, DHA 7.3 mg, vit
A 63 mcg-RE, vit D3 0.83 mcg, vit E 0.94 mg a-TE,
vit K1 3.4 mcg, vit B1 41 mcg, vit B2 92 mcg, vit
B3 0.29 mg, vit B5 0.291 mg, vit B6 32 mcg, vit
B9 7 mcg, vit B12 0.1 mcg, vit C 9.4 mg, biotin 1.1
mcg, choline 7.5 mg, inositol 3 mg, L-carnitine
1.3 mg, taurine 3.8 mg, Ca 44 mg, P 24 mg, Mg
4.5 mg, Fe 0.53 mg, Zn 0.52 mg, manganese 9.4
mcg, copper 43 mcg, iodium 7.5 mcg, Na 23 mg,
K 53 mg, Cl 41 mg. Energy: 69 kCal
Per serving size (40 g) Total fat 3 g, saturated fat 1
g, linoleic acid (omega 6) 93 mg, protein 10 g,
total carbohydrate 25 g, food fiber 1 g, soluble
food fiber 1 g, FOS 1 g, total sugar 7 g, sucrose 4
g, fructose 3 g, Na 105 mg, K 450 mg, vit A 25%,
vit C 35%, vit D3 25%, vit E 35%, vit B1 20%, vit
B2 25%, vit B3 25%, vit B5 20%, vit B6 25%, vit B9
35%, vit B12 25%, Ca 30%, phosphorus 40%, Mg
10%, Fe 25%, iodine 30%, Zn 30%, selenium 20%,
a-linolenic acid (omega 3) 23 mg, DHA 41 mg,
biotin 6.2 mcg, choline 27 mg, chloride 277 mg.
Energy: 160 kCal
Rebamipide
-carotene 6 mg, vit C 100 mg, vit E 25 mg
Per tab Vit B1 15 mg, vit B2 10 mg, vit B6 5 mg,

vit B12 100 mcg, vit C 500 mg, vit E 30 mg, Ca
pantothenate 20 mg, nicotinamide 50 mg. Per 5
mL syr Vit B1 10 mg, vit B2 6 mg, vit B6 10 mg, vit
B12 10 mcg, vit C 100 mg, nicotinamide 50 mg,
niacinamide 50 mg, d-pantothenol 10 mg
Beclomethasone dipropionate
Citicoline
Per 5 mL Thiamine HCl 5 mg, riboflavin sodium
phosphate 2 mg, nicotinamide 20 mg, pyridoxol
HCl 2.5 mg, vit B12 3 mcg, vit C 60 mg, vit D3
1,000,000 iu/g, vit D 400 iu, D- pantothenyl
alcohol 3 mg, inulin 500 mg, tricalcium
phosphate 100 mg
Per 2 mL amp Vit B1 10 mg, vit B2 4 mg,

nicotinamide 40 mg, d(+) pantothenol 6 mg, vit
B6 4 mg, vit B12 8 mcg, d(+) biotin 0.5 mg
Per 5 mL Becombion syr Vit B1 5 mg, vit B2 2 mg,

vit B3 20 mg, vit B5 3 mg, vit B6 2.5 mg, vit B12 3
mcg. Per mL Becombion drops Vit B1 2.5 mg, vit
B2 1 mg, vit B3 10 mg, vit B5 1.5 mg, vit B6 1 mg,
vit B12 2 mcg, D-biotin 0.125 mg, ethanol 1.57%.
Per Becombion Forte sugar-coated tab Vit B1 15
mg, vit B2 15 mg, vit B3 50 mg, vit B5 25 mg, vit
B6 10 mg, vit B12 10 mcg, D (+) biotin 0.15 mg
Per FC caplet Vit B1 50 mg, vit B2 25 mg, vit B6

10 mg, vit B12 5 mcg, vit C 500 mg, nicotinamide
100 mg, pantothenic acid 18.4 mg
Vit E 30 IU, vit C 750 mg, vit B1 15 mg, vit B2 15

mg, vit B6 20 mg, vit B12 12 mcg, folic acid 400
mcg, pantothenic acid 20 mg, Zn 22.5 mg, niacin
100 mg
Fe sulfate 80 mg, folic acid 500 mcg, Zn sulfate

monohydrate 61.8 mg
Vit C
Activated charcoal
Per Bellamox caplet Co-amoxiclav: Amoxicillin

trihydrate 500 mg, clavulanate K (equiv w/
clavulanate acid) 125 mg. Per 5 mL Bellamox syr
Co-amoxiclav: Amoxicillin trihydrate 125 mg,
clavulanate K (equiv w/ clavulanate acid) 31.25
mg. Per 5 mL Bellamox Forte syr Co-amoxiclav:
Amoxicillin trihydrate 250 mg, clavulanate K
(equiv w/ clavulanate acid) 62.5 mg
Per drag Belladonna total alkaloid 0.1 mg,

ergotamine tartrate 0.3 mg, phenobarb 20 mg
Tramadol HCl
Per mL Ferrazone (Na feredetate) equiv w/

ferrous (Fe2+) 12.5 mg, folic acid 50 mcg

diphenhydramine HCl 12.5 mg, ammon Cl 100
mg, K guaiacolsulfonate 30 mg, ethanol 4%
Per 5 mL Diphenhydramine HCl 12.5 mg, ammon

Cl 100 mg, K guaiacolsulfonate 30 mg, menthol 1
mg, ethanol 4%
Diphenhydramine HCl
Per 5 mL Diphenhydramine HCl 12.5 mg, ammon

Cl 125 mg, Na citrate 50 mg, menthol 1 mg,
alcohol 5%
Per 5 mL Diphenhydramine HCl 5 mg,
dextromethorphan HBr 7.5 mg, phenylephrine
HCl 5 mg

Plant Stanol Ester (PSE) 900 mg.
INH 400 mg, pyridoxine HCl 10 mg
Piracetam
Indomethacin
Povidone-iodine
Sucralfate
Metformin HCl
Pheniramine maleate
Mg trisilicate 300 mg, Al(OH)3 gel 300 mg,

papaverine HCl 10 mg, chlordiazepoxide HCl 5
mg, vit B1 2 mg, vit B2 1 mg, vit B6 500 mcg, vit
B12 10 mcg, nicotinamide 5 mg
Cimetidine
Betamethasone
Betamethasone valerate 0.1%, gentamicin sulfate

0.1%
Betamethasone valerate 0.1%, miconazole

nitrate 2%
Mefenamic acid

25 mcg, vit C 300 mg, Ca pantothenate 25 mg,
folic acid 0.5 mg, NZA 100 mg

5 mcg, vit C 500 mg, niacinamide 50 mg, Ca
pantothenate 20 mg
Vit A acetate 25,000 IU, vit B1 10 mg, vit B2 10

mg, vit B6 5 mg, vit B12 5 mcg, vit C 200 mg, vit
D2 400 IU, vit E 15 IU, vit K1 0.15 mg,
niacinamide 100 mg, Ca pantothenate 20 mg, Fe
fumarate 12 mg, copper sulfate 2 mg, Mg oxide
65 mg, Zn sulfate 1.5 mg, manganese sulfate 1
mg
Allopurinol
Per tab Pancreatin 150 mg, bromelain 50 mg, ox
bile 30 mg
Per 1,000 mL Amino acid 5% (BCAA 14.8%), vit

B6, Na 30 mEq, K 25 mEq, Cl 10 mEq, Ca 10 mEq,
Mg 5 mEq, acetate 5 mEq, L-isoleucine 2,512 g, L-
leucine 2,792 g, L-lysine 2,092 g, L-methionine
0.976 g, L-phenylalanine 1.816 g, L-threonine
1.744 g, L-tryptophan 0.56 g, L-valine 2,092 g, L-
arginine 3,488 g, L-histidine 0.6 g, L-alanine 9,256
g, L-aspartate acid 4,048 g, n-acetylcysteine 0.16
g, L-glutamic acid 9.5 g, glycine 3,848 g, L-proline
4,188 g, N-acetyl-L-tyrosine 0.344 g,
nicotinamide 0.06 g, pyridoxine HCl 0.04 g,
riboflavin-5-phosphate Na 2.5 mg. Osmolarity:
600 mOsm. Energy: 200 kCal
Benzoyl peroxide
Benzoyl peroxide 5%, clindamycin phosphate

1.2%
Benzocaine 3%, cetrimide 0.5%
Monobenzone
Dexpanthenol
Betamethasone dipropionate 0.5 mg, salicylic

acid 30 mg
Betamethasone dipropionate
Ambroxol HCl
Per mL Fibrinogen conc w/ 90 mg human

fibrinogen & 60 u coagulation factor XIII,
aprotinin soln 1 mL w/ 1000 KIU (kininogen
inactivator u)/mL, lyophilized human thrombin
w/ thrombin activity 500 IU, 1 mL CaCl2 soln
equiv to 5.9 mg/L
Hydrocortisone acetate
Per 5 mL Promethazine HCl 5 mg,

pseudoephedrine HCl 15 mg, Na citrate 57 mg,
ammon Cl 135 mg, ethanol 0.02 mg
Phenylbutazone
Per tab/5 mL Al(OH)3 dried gel 261.44 mg,

Mg(OH)2 200 mg, dimethicone 40 mg
Betamethasone valerate 0.1%, neomycin sulfate

0.5%
Clotrimazole
Primary dried yeast 100 mg, vit B1 2 mg, vit B2 2

mg, vit B6 2 mg, vit B12 2 mcg, niacinamide 15
mg, Ca pantothenate 5 mg
Ciprofloxacin

23 mg, vit B6 10 mg, vit B12 10 mg, vit C 500 mg,
biotin 150 mcg, folic acid 400 mcg, Mg 100 mg,
Ca 100 mg, Zn 10 mg
Per actuation Ipratropium Br 0.021 mg, fenoterol

HBr 0.05 mg
Fenoterol HBr
Per tab Bilberry dry extr 80 mg, retinol 1,600 IU,

vit E 40 mg, -carotene 5 mg. Per Dispersible tab
Bilberry dry extr 40 mg, retinol 800 IU, vit E 20
mg, -carotene 2.5 mg
Clobetasol propionate
Mecobalamin
Pancreatin 112.5 mg, ox bile 30 mg,

dimethylpolysiloxane 25 mg, vit B1 10 mg, vit B2
5 mg, vit B6 5 mg, vit B12 5 mcg, niacinamide 10
mg, Ca pantothenate 5 mg
Hydroxyzine diHCl
Paracetamol 500 mg, chlorpheniramine maleate

2 mg, phenylpropanolamine HCl 12.5 mg,
guaifenesin 50 mg
Bisbentiamine (50 mg as vit B1 HCl) 57.2 mg
Ciprofloxacin HCl
Atenolol 50 mg, nifedipine retard 20 mg
Atenolol
Per 250 mg Co-amoxiclav: Amoxicillin 250 mg, K

clavulanate 125 mg. Per 500 mg Co-amoxiclav:
Amoxicillin 500 mg, K clavulanate 125 mg
Povidone-iodine
Povidone-iodine
Povidone-iodine
Povidone iodine
Interferon -1b
Ofloxacin
Per 5 mL Vit B1 1 mg, vit B2 1.2 mg, vit B6 1.4

mg, vit B12 1.4 mcg, d-pantothenol 5 mg,
niacinamide 13 mg, vit C 45 mg, -carotene 4.2
mg, vit D 10 mcg
Per mL Betamethasone dihydrogen phosphate

disodium 1 mg, gentamicin sulfate 5 mg
Lansoprazole
Ambroxol HCl
Betamethasone dihydrogen phosphate disodium

Bisoprolol fumarate
Cetirizine diHCl
Betahistine diHCl
Per FC caplet Chitosan 250 mg, Garcinia

cambogia extr 250 mg, L-carnitine 50 mg,
chromium picolinate 50 mcg, vit C 25 mg
Betamethasone
0.5%
Betahistine mesylate
Per g Salicylic acid 5 mg, Zn oxide 10 mg,

menthol 5 mg, triclosan 1 mg, Al chlorohydrate
30 mg

0.5%
Betaxolol HCl
Ceftriaxone
Per g Betamethasone valerate 1 mg, neomycin

sulfate 5 mg
Per 5 mL Curcuminoid 2 mg, -carotene 10% 4
mg, dexpanthenol 3 mg, Ca gluconate 300 mg, vit
B1 3 mg, vit B2 2 mg, vit B6 5 mg, vit B12 5 mcg
Per 5 mL Vit A 125 IU, vit B1 2 mg, vit B2 1 mg,

vit B6 0.5 mg, vit B12 5 mcg, vit C 30 mg, vit D 25
SI, nicotinamide 7 mg, Ca pantothenate 3 mg
-carotene 10% 30 mg (5,000 IU), vit C 200 mg,

vit E 50 mg, Zn 15 mg, selenium 25 mcg
Per Bexce caplet Vit B1 15 mg, vit B2 10 mg, vit

B6 5 mg, vit B12 10 mcg, vit C 500 mg, Ca
pantothenate 20 mg, nicotinamide 100 mg. Per 5
mL Bexce syr Vit B1 10 mg, vit B2 6 mg, vit B6 10
mg, vit B12 10 mcg, vit C 100 mg, panthenol 10
mg, nicotinamide 50 mg. Per mL Bexce Plus
drops Vit A 3,000 iu, vit B1 1 mg, vit B2 1.2 mg,
vit B6 0.8 mg, vit C 50 mg, nicotinamide 16 mg,
vit B12 3 mcg, panthenol 5 mg, vit D 400 iu, vit E
10 iu
Vit B1 mononitrate 15 mg, vit B2 10 mg, vit B6 10

mg, vit B12 100 mcg, vit C 500 mg, vit E 20 mg,
Ca pantothenate 20 mg, nicotinamide 50 mg, L-
carnitine tartrate 100 mg
Per Bexicom caplet Vit B1 15 mg, vit B2 10 mg,

vit B6 10 mg, vit B12 100 mcg, vit C 500 mg, vit E
20 mg, Ca pantothenate 20 mg, niacinamide 50
mg. Per Bexicom-Z caplet Vit B1 15 mg, vit B2 15
mg, vit B6 20 mg, Ca pantothenate 20 mg,
nicotinamide 100 mg, vit B12 12 mcg, folic acid
400 mcg, vit C 750 mg, vit E 30 IU, Zn 22.5 mg
Bezafibrate
Metronidazole
Bisacodyl
Clarithromycin
Vit C
Cefoperazone Na
Brahmi (Bacopa monnieri) 67.5 mg, ginkgo biloba

20 mg, vit E 30 mg
Per softcap L-proline 81 mg, L-hydroxyproline 78
mg, L-glutamic acid 65 mg, L-alanine 51 mg, L-
aspartic acid 40 mg, L-serine 24 mg, L-lysine 23
mg, L-leucine 22 mg, L-phenylalanine 16 mg, L-
hydroxylysine 6 mg, L-valine 14 mg, L-threonine
14 mg, L-isoleucine 10 mg, L-cysteine 10 mg, L-
glycine 140 mg, L-arginine 51 mg, L-histidine 10
mg, L-methionine 5 mg, L-tyrosine 3 mg, taurine
12 mg, soya bean oil 423 mg
Zn sulfate monohydrate 54.9 mg (equiv to

mineral Zn 20 mg)
Azithromycin
Ampicillin
Per g Cetrimide 5 mg, resorcinol 5 mg, sulfur 50

mg
Per mL Diphtheria antitoxin 20,000 IU, phenol 2.5

mg
ATP 20 mg, vit B1 100 mg, vit B6 200 mg, vit B12
200 mcg, vit E 30 mg
Arabinoxylan derivatives
Per 5 mL Vit A 3,000 iu, vit B1 3 mg, vit B2 2 mg,
vit B6 1 mg, vit B12 5 mcg, vit C 30 mg, vit D3
600 iu, niacinamide 20 mg, Ca gluconate 300 mg,
Ca hypophosphite 10 mg, Ca pantothenate 5 mg,
Na hypophosphite 10 mg, Ca glycerophosphate
100 mg
Per Biocombin FC tab Thiamine mononitrate 100

mg, pyridoxine HCl 200 mg, cyanocobalamin 200
mcg. Per 3 mL inj Thiamine HCl 100 mg,
pyridoxine HCl 100 mg, cyanocobalamin 5,000
mcg
Hypoallergenic ambiphilic cream base
Clindamycin
Gentamicin sulfate
Colloidal activated attapulgite
Natural vit E
Fe fumarate equiv to Fe 5 mg, ascorbic acid 50

mg, folic acid 250 mcg, cyanocobalamin 10 mcg
Per 5 mL Echinacea extr 250 mg, curcuminoid 2
mg, fructooligosaccharide 300 mg, taurine 100
mg, Phyllanthus niruri extr 25 mg
Lactobacillus reuteri prodentis
Paracetamol
Lactobacillus acidophilus LA-5, Bifidobacterium

animalis sp Lactis BB-12, Lactobacillus delbruekii
sp Bulgaricus LBY-27, Streptococcus
thermophilus STY-31
Griseofulvin (ultramicrocrystalline)
Collagen, hydrolastan
Mg
Thioctic acid, arbutin, AHA, Na ascorbyl

phosphate, vit E
Per drag Vit A 2,000 IU, vit B1 3 mg, vit B2 1 mg,
vit B6 1 mg, vit B12 5 mcg, vit C 50 mg, vit D3
400 IU, D-panthenol 3 mg, L-lysine HCl 300 mg,
niacinamide 20 mg. Per 5 mL Vit A 2,000 IU, vit
B1 3 mg, vit B2 1 mg, vit B6 1 mg, vit B12 5 mcg,
vit C 50 mg, vit D3 400 IU, L-lysine HCl 300 mg,
niacinamide 20 mg, D-panthenol 3 mg
Per chewable tab Vit A 1,500 IU, vit B1 1.4 mg, vit
B2 1.6 mg, vit B6 1.6 mg, vit B12 3 mg, vit C 60
mg, vit D3 400 IU, vit E 5 mg, niacinamide 10 mg,
Ca pantothenate 3 mg, L-lysine HCl 100 mg
Arachidonic acid 60 mg, DHA 20 mg, vit A 1,500

iu, vit B1 1 mg, vit B2 0.8 mg, vit B6 0.8 mg, vit
B12 3 mcg, vit C 50 mg, vit D3 400 iu, D-
panthenol 3 mg, niacinamide 10 mg, L-lysine HCl
100 mg
Per film-coated caplet Methampyrone 500 mg,

vit B1 50 mg, vit B6 100 mg, vit B12 100 mg
Vit B1 100 mg, vit B6 200 mg, vit B12 300 mcg
a-Hydroxy acids (AHA), squalene, vit E
Lactobacillus acidophilus, Bifidobacterium

bifidum, Bifidobacterium longum, vit A 800 mcg,
vit D3 5 mcg, vit E 10 mg, vit C 60 mg, vit B1 1.4
mg, vit B2 1.6 mg, vit B3 18 mg, vit B6 2 mg, vit
B12 1 mcg, folic acid 200 mcg, biotin 150 mcg,
pantothenic acid 6 mg, Ca 90 mg, phosphorus 38
mg, Fe 5 mg, Mg 5 mg, Zn 5 mg, iodine 100 mcg,
manganese 1.2 mg, chromium 25 mcg,
molybdenum 25 mcg, selenium 30 mcg, Cl 4.5
mg, K 5 mg
Per 15 g Shorea robusta 0.3 g, Azadirachta indica
0.3 g, Pongamia pinnata 0.3 g, Cassia tora 0.3 g,
Ficus infectoria 0.45 g, Glycyrrhiza glabra 0.6 g,
Jasad bhasma 0.045 g, Celastrus panniculatus
0.09 g
L-ascorbic acid 2-glucoside 2%, Aloe vera gel
Hyaluronic acid
Fe fumarate 360 mg, folic acid 1.5 mg, vit B12 15

mcg, vit C 75 mg, vit D3 400 IU, Ca carbonate 200
mg
Per drag Vit B1 disulfide 100 mg, vit B6 200 mg,

vit B12 200 mcg. Per 3 mL amp Vit B1 100 mg, vit
B6 100 mg, vit B12 1,000 mcg, lidocaine HCl 15
mg
Per 5 mL Vit B1 1 mg, vit B2 2 mg, vit B6 2 mg, vit

B3 6 mg, vit D3 100 iu, vit E 3 mg, Ca
pantothenate 3 mg, Ca hypophosphite 150 mg,
lysine HCl 200 mg
a-arbutin 3%, L-ascorbic acid 2-glucoside 2%,

disodium edetate, Na metabisulfite, Na citrate,
hydroxyethyl cellulose, methyl hydroxybenzoate,
propylene glycol, glycerol, Aloe vera gel,
polydimethylsiloxanic, citric acid, ethanol
Neomycin sulfate 0.5%, placenta extr 10%
Ca alginate
Per g Bovine placenta extr 100 mg, neomycin

sulfate 5 mg
Perindopril arginine
Perindopril arginine 5 mg, indapamide 1.25 mg
Propolis extr
Hydroquinone
Per softcap Co-enzyme Q10 100 mg, L-carnitine

500 mg, vit E 100 IU, soya bean oil 323.1 mg
Dry bilberry extr 100 mg, Tribulus terrestris extr

100 mg, natural -carotene 5 mg
Tribulus terrestris L
Fe gluconate 250 mg, manganese sulfate 200
mcg, copper sulfate 200 mcg, vit C 50 mg, folic
acid 1 mg, cyanocobalamin w/ intrinsic factor 7.5
mcg, sorbitol 25 mg
Per mL Tetanus antitoxin 1,500 IU, phenol 2.5 mg
Per mL Agkistrodon rhodostoma =10 LD50,

Bungarus fasciatus =10 LD50, Naja sputatrix =25
LD50, phenol 2.5 mg
Roxithromycin
Per tab Plasmolysed herbal yeast, corn starch.

Per liqd Plasmolysed herbal yeast, malt extr,
natural honey, orange juice
Colostrum bovine 300 mg, DHA 200 mg, cod liver

oil 10 mg, lysine HCl 200 mg, vit A 2,000 IU, vit D
200 IU, vit B1 0.6 mg, vit B2 0.15 mg, vit B6 0.6
mg, vit B12 1.5 mcg, nicotinamide 5 mg,
dexpanthenol 2.5 mg, Zn picolinate 5 mg
Benfotiamine
Thiamphenicol
Niacinamide, tetrapeptide, oak extr

Locust bean gum, 4 active peptides
Ceftriaxone Na
Per 5 mL Vit A 5,000 iu, vit B1 3 mg, vit B2 1 mg,

vit C 50 mg, vit D3 1,000 iu, niacinamide 20 mg
Per oral gel Polyglyceryl methacrylate, maltitol,

sorbitol, xylitol, aqua, glucose,
hydroxyethylcellulose, colostrum, K thiocyanate,
glucose oxidase, lactoperoxidase, lysozyme,
lactoferrin, Aloe barbadensis leaf powd. Per
mouthspray Aqua, xylitol, hydroxyethylcellulose,
sorbitol, maltitol, Na benzoate, Na
methylparaben, K sorbate, KCl, citric acid, NaCl,
Na propylparaben, dipotassium phosphate, Na
monofluorophosphate, saccharin Na, Ca chloride,
lactoperoxidase, colostrum, Mg chloride. Per
toothpaste Sorbitol, silica, glycerin, xylitol, Na
monofluorophosphate, lactoperoxidase,
colostrum, lactoferrin, lysozyme, aqua. Per
mouthwash Aqua, propylene glycol, xylitol, Na
monofluorophosphate, poloxamer, colostrum,
lactoferrin, lysozyme, lactoperoxidase, aloe
barbadensis powd
Bisoprolol fumarate
Bisoprolol fumarate
Dextromethorphan HBr
Bromhexine HCl
Per 5 mL Bromhexine HCl 4 mg, guaiphenesin

100 mg
Per 5 mL Bromhexine HCl 4 mg, paracetamol 150

mg, chlorpheniramine maleate 2 mg,
phenylephrine HCl 5 mg
Bromhexine HCl
Bisoprolol fumarate
Bisoprolol
Bisoprolol fumarate
Bisoprolol hemifumarate
Bisoprolol fumarate 2.5 mg, hydrochlorothiazide

6.25 mg
Camphor 5%, menthol 2%, anise oil 1%,
eucalyptus oil 2%
Per mL Framycetin sulfate 5 mg, gramicidin 0.05

mg, dexamethasone 0.5 mg
Per mL Framycetin sulfate 5 mg, gramicidin 0.05

mg, dexamethasone 0.5 mg
Methylergometrine maleate
Bleomycin
Bleomycin HCl
Aqua, poloxamer 188, PEG-90, Na borate,

carbomer
Clomiphene citrate
Nicardipine HCl
Crataegus oxyacantha (hawthorn) 50 mg, ginkgo
biloba 5 mg, garlic oil 150 mg, Melissa officinalis
(lemon balm) 10 mg, Morinda citrifolia (noni) 30
mg, vit E 30 IU
Candesartan cilexetil
Candesartan cilexetil 16 mg, hydrochlorothiazide
12.5 mg
Carvedilol
Hydrolyzed vegetable protein 111 mg, fumaric

acid 36 mg, vit C 10 mg, lettuce extr 150.5 mg, Ca
pantothenate 1 mg, vit B6 0.33 mg, folic acid 33
mcg, vit B12 0.16 mcg, green tea extr 7.5 mg,
blueberry extr 334 mg, Zn sulphate 10 mg
Per Blue Cap cream Zn pyrithione 0.2%, moisture
base 50 g. Per Blue Cap shampoo Zn pyrithione
1%, menthol 0.25%. Per Blue Cap spray Zn
pyrithione 0.2%, isopropyl myristate.
Per 100 g Protein 11 g, fat 27 g, carbohydrate 57

g, linoleic acid 3 g, a-linolenic acid 0.4 g, DHA 50
mg, choline 80 mg, arachidonic acid (AA) 50 mg,
taurine 40 mg, phospholipids 230 mg, inositol 50
mg, L-carnitine 10 mg, lactoferrin 50 mg,
lactulose 300 mg, vit A 1,500 IU, vit C 80 mg, vit
D 350 IU, vit E 11 IU, vit K 30 mcg, vit B1 0.4 mg,
vit B2 0.7 mg, vit B3 4.2 mg, vit B5 5 mg, vit B6
0.3 mg, vit B9 100 mcg, vit B12 1.5 mcg, biotin 10
mcg, -carotene 45 mcg, Na 160 mg, K 540 mg,
Ca 380 mg, phosphorus 210 mg, Mg 45 mg, Fe 6
mg, manganese 50 mcg, selenium 7 mcg, Zn 3.3
mg, iodine 65 mcg, Cl 330 mg. Energy: 515 kCal

56 g, carnitine 10 mg, taurine 40 mg, cystein 200
mg, nucleotide 20 mg, arachidonic acid (AA) 100
mg, DHA 50 mg, a-linolenic acid 400 mg, linoleic
acid 3 g, phospholipids 600 mg, lactulose 300
mg, vit A 1,800 IU, vit D 350 IU, vit E 8.8 IU, vit K
25 mcg, vit B1 0.4 mg, vit B2 0.7 mg, vit B3 4.2
mg, vit B5 3 mg, vit B6 0.3 mg, vit B9 100 mcg, vit
B12 1.5 mcg, vit C 100 mg, biotin 10 mcg, choline
80 mg, inositol 50 mg, Ca 380 mg, phosphorus
210 mg, Mg 45 mg, Fe 6 mg, Zn 3.3 mg,
manganese 30 mcg, copper 320 mcg, iodine 65
mcg, Na 160 mg, K 540 mg, Cl 330 mg, selenium
7 mcg. Energy: 514 kCal
57.3 g, linoleic acid 3 g, a-linolenic acid 0.4 g,
DHA 50 mg, choline 80 mg, arachidonic acid (AA)
100 mg, taurine 40 mg, phospholipid 230 mg, a-
lactalbumin 1.8 g, inositol 50 mg, L-carnitine 10
mg, nucleotide 20 mg, lactoferrin 50 mg, cystein
0.2 g, lactulose 300 mg, vit A 1,500 IU, vit C 80
mg, vit D 350 IU, vit E 10 IU, vit K 30 mcg, vit B1
0.4 mg, vit B2 0.7 mg, vit B3 4.2 mg, vit B5 4 mg,
vit B6 0.3 mg, vit B9 100 mcg, vit B12 1.5 mcg,
biotin 10 mcg, -carotene 45 mcg, Na 160 mg, K
540 mg, Ca 380 mg, phosphorus 210 mg, Mg 45
mg, Fe 6 mg, manganese 50 mcg, selenium 7
mcg, Zn 3.3 mg, iodine 65 mcg, Cl 330 mg.
Energy: 515 kCal
Per 100 g Protein 13 g, fat 23 g, carbohydrate 59

g, carnitine 10 mg, taurine 40 mg, cystein 300
mg, methionine 200 mg, nucleotide 20 mg,
arachidonic acid (AA) 100 mg, DHA 50 mg, a-
linolenic acid 400 mg, linoleic acid 3 mg,
phospholipid 230 mg, vit A 1,800 IU, vit C 65 mg,
vit D 350 IU, vit E 8.8 IU, vit K 25 mcg, vit B1 0.4
mg, vit B2 0.7 mg, vit B3 5 mg, vit B5 3 mg, vit B6
0.3 mg, vit B9 100 mcg, vit B12 2 mcg, biotin 10
mcg, choline 80 mg, inositol 80 mg, Ca 400 mg,
phosphorus 220 mg, Mg 45 mg, Fe 6 mg, Zn 3.3
mg, manganese 150 mcg, copper 320 mcg,
iodine 90 mcg, Na 160 mg, K 540 mg, Cl 330 mg,
selenium 12 mcg. Energy: 495 kCal

55.5 g, ash 2.2 g, moisture 2.7 g, lactoferrin 50
mg, -carotene 45 mcg, lactulose 300 mg, mucin
10 mg, taurine 20 mg, vit, minerals. Energy: 515
kCal
Paracetamol 600 mg, caffeine 50 mg

Paracetamol 350 mg, ibuprofen 200 mg, caffeine
50 mg

pseudoephedrine HCl 30 mg, dextromethorphan
HBr 12 mg. Per 5 mL syr Paracetamol 150 mg,
pseudoephedrine HCl 10 mg, dextromethorphan
HBr 4 mg

pseudoephedrine HCl 30 mg, glyceryl guaiacolate
50 mg, bromhexine HCl 8 mg. Per 5 mL syr
Paracetamol 150 mg, pseudoephedrine HCl 10
mg, glyceryl guaiacolate 50 mg, bromhexine HCl
2.6 mg
Paracetamol
Paracetamol 350 mg, propyphenazone 150 mg,

caffeine 50 mg
Acetylsalicylic acid 80 mg
Paracetamol
Paracetamol 100 mg, pseudoephedrine HCl 7.5

mg, glyceryl guaiacolate 20 mg, bromhexine HCl
2 mg, chlorpheniramine maleate 0.5 mg
Per 5 mL Pseudoephedrine HCl 7.5 mg,

chlorphenamine maleate 0.5 mg
Per 5 mL Paracetamol 80 mg, chlorpheniramine
maleate 0.4 mg, phenylpropanolamine HCl 2 mg,
glyceryl guaiacolate 20 mg, Na citrate 60 mg
Diacerein
Disodium clodronate
Microcrystalline hydroxyapatite
Ibandronate Na

mg, vit C 100 mg, vit E 10 mg, manganese 0.25
mg, Zn 2.5 mg, Ca 100 mg, selenium (yeast) 5
mcg

mg, MSM 200 mg
Glucosamine HCl 500 mg, isoflavone 50 mg
Alfacalcidol
MSM 300 mg, chondroitin sulfate 200 mg,
glucosamine sulfate 250 mg, vit B1 5 mg, vit B6
25 mg, Mg 0.5 mg, selenium 6 mcg
Per 0.5 mL dose Diphtheria toxoid not <2 IU,

tetanus toxoid not <20 IU, Bordetella pertussis
antigens (pertussis toxoid 8 mcg, filamentous
haemagglutinin 8 mcg, pertactin 2.5 mcg)
Lithospermi radix extr, dibucaine HCl,

diphenhydramine HCl, cetrimide, aethylis
aminobenzoas
Lithospermi radix extr, prednisolone, lidocaine,

cetrimide, aethylis aminobenzoate, lecithinum
ovi
Botulinum toxin type A

Citicoline
Citicoline
Per 5 mL Colostrum bovine 300 mg, DHA 250 mg,

arachidonic acid 50 mg, -carotene 4 mg, vit B1
0.5 mg, vit B2 0.5 mg, vit B6 0.5 mg,
nicotinamide 5 mg, vit B12 1 mcg, dexpanthenol
3 mg, vit D 100 IU, Ca citrate 250 mg
Tobramycin
Per mL Tobramycin 3 mg, dexamethasone 1 mg
Citicoline
Highly purified urofollitropin
Fluocinolone acetonide
Fluocinolone acetonide 0.25 mg, neomycin

sulfate 5 mg
Chlordiazepoxide 5 mg, clidinium Br 2.5 mg
Cinnarizine
NaCl
Piracetam
Extr of Ginkgo biloba dried leaves

Miconazole nitrate 2%, hydrocortisone 1%
Docetaxel
Terbutaline sulfate
Per 5 mL Terbutaline sulfate 1.5 mg, guaifenesin

66.5 mg
Ticagrelor
Ceftriaxone disodium
Per Brochifar caplet Paracetamol 500 mg,

dextromethorphan HBr 15 mg,
phenylpropanolamine HCl 15 mg,
chlorpheniramine maleate 2 mg. Per Brochifar
Plus caplet Paracetamol 500 mg, guaifenesin 100
mg, dextromethorphan HBr 15 mg,
phenylpropanolamine HCl 15 mg,
Per Bromifar caplet Bromhexine HCl. Per
Bromifar Plus tab Bromhexine HCl 8 mg,
guaiphenesin 100 mg. Per Bromifar Plus syr
Bromhexine HCl 4 mg, guaiphenesin 100 mg
Bromhexine HCl, ethanol 3.5%
Ambroxol
Per 5 mL Ephedrine HCl 8 mg, glyceryl

guaiacolate 50 mg, paracetamol 200 mg,
chlorpheniramine maleate 2.5 mg
Carbocisteine
Theophylline
Ambroxol HCl
Salbutamol sulfate
H. influenzae, D. pneumoniae, K. pneumoniae &

ozaneae, S. aureus, S. pyogenes & viridans, N.
catarrhalis
Ambroxol HCl
Salbutamol
Bromhexine HCl
Theophylline
Ambroxol HCl
Ibuprofen
Bupivacaine HCl
Budesonide
Theophylline
Amlodipine besylate
Triamcinolone acetonide
Diclofenac diethylamine
Amoxicillin
Dexchlorpheniramine maleate
Ibuprofen
Bupivacaine HCl anhydrate
Bupivacaine
Silver sulfadiazine
Hyoscine-N-butylbromide
Hyoscine-N-butylbromide 10 mg, paracetamol

500 mg
Hyoscine-N-butylbromide
Buspirone HCl
Phenylbutazone 100 mg, propyphenazone 150

mg, vit B1 mononitrate 25 mg
Bupivacaine
Bupivacaine
Salbutamol
Per 5 mL Paracetamol 125 mg, glyceryl

guaiacolate 30 mg, ammon Cl 90 mg, Na citrate
50 mg, chlorpheniramine maleate 2 mg
Ca carbonate 400 mg, Mg 75 mg, vit C 1,000 mg,

vit D3 50 IU, vit B6 3,000 mcg, Zn 2,500 mcg
Per 5/10 mg FC tab Amlodipine besylate 5 mg,
atorvastatin Ca (crystalline form) 10 mg. Per
10/10 mg FC tab Amlodipine besylate 10 mg,
atorvastatin Ca (crystalline form) 10 mg. Per 5/20
mg FC tab Amlodipine besylate 5 mg,
atorvastatin Ca (crystalline form) 20 mg. Per
10/20 mg FC tab Amlodipine besylate 10 mg,
atorvastatin Ca (crystalline form) 20 mg
Pegylated liposome encapsulated doxorubicin

HCl
Ergotamine tartrate 1 mg, caffeine 100 mg
Coral Ca 500 mg, natural soy isoflavone 20 mg,

vit D3 200 IU, vit K1 25 mcg, Mg 100 mg, Zn 5
mg, boron 1 mg
Desonide
Paracetamol
Per 5 mL Ca glubionate equiv to 115 mg

elemental Ca
Ca citrate 300 mg, vit D3 50 IU, isoflavone 50 mg,

Zn 5 mg, Mg 15 mg, manganese 2 mg, vit C 25
mg
Nifedipine
Ca phosphate 333.34 mg, Ca citrate 666.66 mg,

vit D3 400 IU
Algas calcareas sp powd (Algaecal) 750 mg, vit D3

CWS 400 IU
Per 5 mL Vit B12 5 mcg, vit B1 3 mg, vit B2 1.25

mg, vit B6 0.5 mg, vit C 50 mg, vit A 3,000 iu, vit
D 400 iu, nicotinamide 10 mg, Ca pantothenate 5
mg, Ca 77 mg, phosphorus 25 mg, DHA 10 mg,
lysine 125 mg
Ca hydrogen phosphate dihydrate 500 mg, vit D3

200 IU
Per tab Isoflavone 50 mg (including genisteine &

diadzeine from soy isoflavone 40% 125 mg),
elemental Ca 300 mg, elemental Mg 75 mg, vit
D3 200 IU
Dibasic Ca phosphate 500 mg, DHA 100 mg,

omega-3 fatty acids 20 mg, thiamine HCl 2 mg,
pyridoxine HCl 1.5 mg, cyanocobalamin 5 mcg,
vit D3 400 IU, nicotinamide 10 mg
Per 30 g Fat 0.1 g, carbohydrate 17 g, protein 8 g,
vit A, vit D3, vit E, vit K1, vit C, Ca, phosphorus,
Mg, Fe, vit B1, vit B2, niacin, vit B6, folic acid, vit
B12, Zn, iodine, selenium, Na. Energy: 100 kCal.
Per 30 g (Plain) Total fat 2 g, protein 8 g, total

carbohydrate 16 g, fiber 1 g, Na 120 mg, K 370
mg, vit A 793 iu, vit D3 122 iu, vit E 5.1 mg, vit C
19 mg, vit B1 0.4 mg, vit B2 0.5 mg, niacin 5 mg,
vit B6 0.5 mg, folic acid 102 mcg, vit B12 1.5 mcg,
Ca 600 mg, phosphorus 265 mg, Mg 46 mg, Fe 4
mg, Zn 1.4 mg, iodine 8 mcg, selenium 3.2 mcg.
Energy: 110 kCal. Per 35 g (Cokelat) Total fat 2 g,
protein 7 g, total carbohydrate 22 g, fiber 2 g, Na
105 mg, K 400 mg, vit A 756 iu, vit D3 149 iu, vit
E 6.3 mg, vit C 24 mg, vit B1 0.4 mg, vit B2 0.6
mg, niacin 5.6 mg, vit B6 0.5 mg, folic acid 100
mcg, vit B12 1.6 mcg, Ca 600 mg, phosphorus
238 mg, Mg 55 mg, Fe 4.3 mg, Zn 1.1 mg, iodine
8.2 mcg, selenium 2.5 mcg. Energy: 130 kCal.
Per 30 g (Plain) Total fat 1 g, protein 8 g, total

carbohydrate 17 g, fiber 2 g, Na 115 mg, K 380
mg, vit A 708 iu, vit D3 121 iu, vit E 5 mg, vit C 21
mg, vit B1 0.4 mg, vit B2 0.5 mg, niacin 4.4 mg,
vit B6 0.5 mg, folic acid 105 mcg, vit B12 1.5 mcg,
Ca 500 mg, phosphorus 241 mg, Mg 54 mg, Fe
4.2 mg, Zn 1 mg, iodine 7.8 mcg, selenium 3.3
mcg. Energy: 110 kCal. Per 35 g (Cokelat) Total fat
2.5 g, protein 7 g, total carbohydrate 22 g, fiber 2
g, Na 100 mg, K 400 mg, vit A 748 iu, vit D3 148
iu, vit E 6.2 mg, vit C 23 mg, vit B1 0.4 mg, vit B2
0.6 mg, niacin 5.6 mg, vit B6 0.5 mg, folic acid
100 mcg, vit B12 1.6 mcg, Ca 505 mg,
phosphorus 219 mg, Mg 54 mg, Fe 4.2 mg, Zn 1
mg, iodine 8.1 mcg, selenium 2.5 mcg. Energy:
130 kCal
Calcitriol
Ca gluconate 50 mg, dicalcium phosphate 150
mg, vit A 300 IU, vit D 100 IU
Ca folinate
Ca lactate
L-leucovorin
Per 6 g sachet Ca 500 mg, vit C 500 mg, vit D 100

iu, vit K 60 mcg, Mg 20 mg, manganese 1 mg, Zn
10 mg
Vit B6 15 mg, vit C 1,000 mg, vit D 300 IU, Ca

carbonate 625 mg (equiv to elemental Ca 250
mg)
Ca hydrogen phosphate anhydrate 500 mg,

cholecalciferol 133 IU
Per 5 mL Ca pidolate 300 mg, curcuminoid 2 mg,

fructo-oligosaccharide 300 mg, vit A 2,000 iu, vit
D3 100 iu, vit B1 3 mg, vit B2 2 mg, vit B6 5 mg,
vit B12 5 mcg
Vit A 5,000 iu, vit D 400 iu, vit C 100 mg, vit B1 10
mg, vit B2 2.5 mg, vit B6 15 mg, vit B12 4 mcg,
niacinamide 20 mg, Ca pantothenate 7.5 mg,
folic acid 0.4 mg, Fe fumarate 90 mg, Ca lactate
250 mg, iodine 0.1 mg
Ca carbonate (equiv to 500 mg elemental Ca)
Ca
Per caplet Ca 400 mg, vit D3 200 IU. Per 5 mL oral
susp Ca 200 mg, vit D3 200 IU
Cod liver oil 200 mg, vit A 120 IU, vit D3 17 IU,
omega-3 fatty acids, EPA 16 mg, DHA 14 mg, vit E
5 mg, vit B12 1 mcg, folic acid 0.3 mg, vit B6 0.6
mg, Ca 40 mg, Mg 25 mg, Fe 4.76 mg
Paracetamol
Ca carbonate (equiv to elemental Ca 500 mg)
Ca citrate 300 mg, vit D3 50 IU, isoflavone 50 mg
Per 5 mL Colostrum bovine 300 mg, DHA 200 mg,

cod liver oil 10 mg, lysine HCl 200 mg, vit A 2,000
mg, vit D2 200 IU, vit B1 0.6 mg, vit B2 0.15 mg,
vit B6 0.6 mg, vit B12 1.5 mcg, nicotinamide 5
mg, dexpanthenol 2.5 mg, Zn picolinate 5 mg, Ca
gluconate 300 mg, Ca hypophosphite 20 mg
Coral Ca 500 mg, soy fiber germ (natural soy

isoflavone) 20 mg, vit D3 200 IU, vit K1 25 mcg,
Zn 5 mg, Mg 100 mg, boron 1 mg
Calporosis D 500 Ca carbonate 500 mg, vit D 100

IU. Calporosis D 800 Ca carbonate 800 mg, vit D
300 IU
Ca carbonate (equiv to 500 mg elemental Ca)

1,250 mg
Ca coral 588.24 mg, vit D3 100 IU
Amlodipine besylate
Per 5 mL CalSource syr Ca gluconolactobionate

1.437 g, Ca lactobionate 0.295 g. Per CalSource
Forte tab Ca lactate-gluconate 2.94 g, Ca
carbonate 0.3 g. Per CalSource Plus Vitamin C tab
Ca lactate-gluconate 1 g, Ca carbonate 0.327 g,
vit C 1 g. Per CalSource Junior Strength tab Ca
carbonate 625 mg equiv to Ca 250 mg. Per
CalSource Junior Growth tab Ca 250 mg, Fe 5 mg,
Zn 5 mg
Ca carbonate 1,500 mg (equiv to elemental Ca

600 mg), cholecalciferol 10 mcg (vit D3 400 IU)
Ca carbonate 1,500 mg (equiv to elemental Ca
600 mg), cholecalciferol 10 mcg (vit D3 400 IU),
Mg 50 mg (in oxide form), Zn 7.5 mg (in oxide
form), copper 500 mcg (in sulphate form),
manganese 1.8 mg (in sulphate form)
Milk Ca 1,042 mg (equiv to Ca 250 mg), vit C

1,000 mg, vit D 300 IU, vit B6 15 mg
Ca carbonate (equiv to elemental Ca 600 mg)

1,500 mg, vit D3 200 IU, Mg 40 mg, Zn 7.5 mg,
copper 1 mg, manganese 1.8 mg, boron 250 mcg
Ceftazidime pentahydrate
Ca hydrogen phosphate 500 mg, cholecalciferol

133 IU
Ca 400 mg, vit D3 200 iu, vit K1 40 mcg, Zn 5 mg
Per 5 mL Vit A 1,500 iu, vit D 300 iu, Ca 150 mg,

Mg 30 mg, Zn 5 mg, folic acid 100 mcg, fructo-
oligosaccharide 500 mg
Isoflavone
Meloxicam
Dexamethasone Na phosphate
Tramadol HCl
Piroxicam
Irinotecan HCl trihydrate
Clotrimazole 10 mg, hydrocortisone 10 mg
Clotrimazole
Fluconazole
Nystatin
Vit C
L-carnitine fumarate 500 mg, a-lipoic acid 100

mg, coenzyme Q10 30 mg, thiamine mononitrate
3 mg, riboflavin 3 mg, pyridoxine HCl 2 mg,
cyanocobalamine 3 mcg, ascorbic acid 50 mg
Clotrimazole
Clotrimazole
Clotrimazole
Thiamphenicol
Mepenzolate Br
Lansoprazole
Sildenafil citrate
Meropenem
Cefepime
Cetirizine HCl
Cefpirome
Pantoprazole
Silybin phosphatidylcholine complex 70 mg,

Schizandrae fructus extr 135 mg, Curcuma
domestica C95 extr equiv to curcuminoid 25 mg,
Liquiritae radix extr 135 mg, choline bitartrate
150 mg, vit B6 2 mg
Co-amoxiclav (amoxicillin & clavulanic acid). Per
500 mg FC caplet Amoxicillin 500 mg, clavulanic
acid 125 mg. Per 5 mL dry syr Amoxicillin 125 mg,
clavulanic acid 31.25 mg. Per 5 mL Forte dry syr
Amoxicillin 250 mg, clavulanic acid 62.5 mg
Amoxicillin 1 g, clavulanate K 0.2 g
Captopril
Captopril
Captopril
Captopril
Capsaicin
Carbamazepine
Carvedilol
Carboplatin
Carboplatin
Carboplatin
Carboplatin
Carboplatin
Carboplatin
Doxorubicin HCl
Ramipril
Vit B6 2 mg, folic acid 400 mcg, vit C 100 mg, vit
E 40 iu, vit B12 100 mcg.
Amlodipine besylate
Dobutamine HCl
Vit B6 25 mg, vit B12 25 mcg, folic acid 500 mcg,
natural vit E 400 IU
Per 20 mL MgCl2 16 mmol, KCl 16 mmol,

procaine HCl 1 mmol
Dobutamine HCl
Verapamil HCl
Amlodipine besylate
Isosorbide 5-mononitrate
Amlodipine besylate
Doxazosin mesylate
Diltiazem HCl
Heptaminol acefyllinate
Urea
L-carnitine 250 mg, choline bitartrate 25 mg,

inositol 25 mg, Dl-methionine 25 mg, vit B6 5 mg,
nicotinamide 3 mg, Zn amino acid chelate 3 mg,
Mg amino acid chelate 3 mg, manganese amino
acid chelate 1.5 mg.
Coenzyme Q10 30 mg, L-carnitine fumarate 500

mg
Per cap L-carnitine fumarate 500 mg, coenzyme
Q10 30 mg
L-carnitine fumarate 500 mg, ubiquinone 60 mg
Meropenem trihydrate
Spironolactone

mg

mg
Nicardipine HCl
Glucosamine 500 mg, chondroitin sulfate 400

mg, MSM 300 mg
Chondroitin sulfate, glucosamine, vit

Nattokinase 100 mg, coenzyme Q10 100 mg
Glucosamine K sulfate
Ticlopidine HCl
Bicalutamide
Phenylpropanolamine HCl 25 mg, paracetamol

250 mg, salicylamide 150 mg, chlorpheniramine
maleate 2 mg
Diclofenac resinate
Diclofenac K
Diclofenac K
Pirenoxine Na
Diclofenac K
Clonidine HCl
Microencapsulated tricalcium phosphate 546 mg

(equiv to Ca 200 mg), vit C 25 mg, vit D3 100 IU,
vit B6 20 mg
Light mineral oil 0.5% w/w, heavy mineral oil

0.5% w/w, glycerol, tyloxapol, poloxamer 188,
tris-hydrochloride, tromethamine, cetalkonium
chloride
Ca hydrogen phosphate dihydrate 500 mg,

Per tab Ca hydrogen phosphate 500 mg,

Per 5 mL Ca gluconate 250 mg, Ca
glycerophosphate 100 mg, vit A 2,000 IU, vit D
400 IU, vit B1 1.05 mg, vit B2 1.2 mg, vit B6 1.05
mg, vit B12 4.5 mcg, vit C 60 mg, niacinamide
13.5 mg, pantothenol 7.5 mg, lysine HCl 200 mg
Nystatin
Ca (in Ca carbonate 625 mg) 250 mg, vit B6 15

mg, vit C 1,000 mg, vit D 300 iu
Per tab Ca elemental 600 mg, vit D3 400 iu
Human albumin
Cefoperazone Na 500 mg, sulbactam Na 500 mg
Oligopeptide 69 0.0001%, allantoin 0.2%,

tocopheryl acetate 0.5%, Prunus amygdalus
dulcis (sweet almond) oil 7%, squalene 4.25%
Oligopeptide 69 0.0005%, Ribes nigrum

(blackcurrant) fruit extr 0.175%, escin 0.5%,
cyclopentasiloxane 24.5%
Bromophenyl propenaminoethyl
isoquinolinesulfonamide HCl 0.00067%,
niacinamide 5%, ascorbyl glucoside 2%, glycolic
acid 5.6%
Per tab Na ascorbate 112.5 mg, vit C 100 mg.
Drops Vit C.
Ondansetron (tab & inj: HCl)
Isosorbide dinitrate
Per 5 mL syr Ascorbic acid 100 mg. Per mL drops

Na ascorbate 100 mg
Cefalexin monohydrate
Cefixime
Cefadroxil
Cefadroxil
Cefotaxime Na
Cefixime
Ceftriaxone Na
Cefazolin Na
Cefazolin
Cefazolin Na
Ceftazidime pentahydrate
Cefepime
Cefepime
Cefixime trihydrate
Cefixime
Ceftizoxime
Cefepime HCl
Cefpirome
Cefixime
Cefixime
Indications/Uses
3TC, in combination with other anti-retroviral agents, is indicated

for the treatment of HIV infected adults and children.
Treatment of patients with chronic hepatitis B infection with
evidence of hepatitis B viral replication.
Classic hemophilia A.
Acute hemorrhage, pre- & post-op treatment & prophylaxis in

hemophila A patients (congenital factor VIII deficiency) & in
patients w/ an acquired reduction in factor VIII activity.
HTN; angina pectoris.
Treatment of mild to moderate infections caused by susceptible

strains of the designated microorganisms in the following
conditions: Upper Respiratory Tract Infections:
Pharyngitis/tonsillitis due to Streptococcus pyogenes and acute
maxillary sinusitis due to Streptococcus pneumoniae, H.
influenzae and M. catarrhalis.
There is insufficient evidence of efficacy to support the use of
clarithromycin in acute bronchitis in young children.
Lower Respiratory Tract Infections: Acute bacterial exacerbation
of chronic bronchitis due to Haemophilus influenzae, Moraxella
catarrhalis or Streptococcus pneumoniae. Pneumonia due to
Mycoplasma pneumoniae or Streptococcus pneumoniae.
Uncomplicated skin and skin structure infections (eg, impetigo,
folliculitis, cellulitis, abscesses) due to Staphylococcus aureus or
Streptococcus pyogenes. Abscesses usually require surgical
drainage.
Acute otitis media (with Abbotic Granules only).
Disseminated mycobacterial infections due to Mycobacterium
avium and Mycobacterium intracellulare (Abbotic 500-mg filmtab
only).
Abbotic 500-mg filmtab in the presence of acid suppression is
indicated for the eradication of H. pylori resulting in decreased
recurrence of duodenal ulcer (see Note as follows).
Note: Helicobacter pylori is strongly associated with peptic ulcer
disease. Ninety to one hundred percent (90-100%) of patients
with duodenal ulcers are infected with this pathogen. Eradication
of H. pylori has been shown to markedly reduce the rate of
duodenal ulcer recurrence, thereby reducing the need for
maintenance antisecretory therapy.
Acute agitation in schizophrenia and bipolar disorders; acute
(adult and adolescents) and maintenance (adult) treatment in
patients with schizophrenia; acute mania and mixed episodes
treatment in patients with bipolar disorder for adult, adolescents
and children; maintenance (adult) treatment in patients with
bipolar disorder; adjunctive therapy for major depressive disorder.
Irritability associated with autistic disorder.

Schizophrenia: The efficacy of Abilify in the treatment of
schizophrenia was established in short-term (4- and 6-week)
controlled trials of schizophrenic inpatients (see Pharmacology
under Actions). The efficacy of Abilify in maintaining stability in
patients with schizophrenia who had been symptomatically stable
on other antipsychotic medications for periods of =3 months were
discontinued from those other medications, and were then
administered Abilify 15 mg/day and observed for relapse during a
period of up to 26 weeks was demonstrated in a placebo-
controlled trial (see Pharmacology under Actions). The physician
who elects to use Abilify for extended periods should periodically
re-evaluate the long-term usefulness of Abilify for the individual
patient (see Dosage & Administration).
Bipolar Disorder: Treatment of acute manic and mixed epithelial
episodes associated with bipolar disorder. The efficacy of Abilify
was established in 2 placebo-controlled trials (3 weeks) of
inpatient with DSM-IV criteria for bipolar I disorder who were
expecting an acute manic or mixed episodes with or without
psychotic features (see Pharmacology under Actions). The efiicacy
of Abilify in maintaining efficacy in patients with bipolar I disorder
with a recent manic or mixed episode who had been stabilized
and then maintained for at least 6 weeks was demonstrated in a
double-blind, placebo-controlled trial. Prior to entering the
double-blind, randomization phase of this trial, patients were
clinically stabilized for 6 consecutive weeks on Abilify. Following
this 6-week maintenance phase, patients were randomized to
either placebo or Abilify and monitored for relapse (see
Pharmacology under Actions).
Physicians who elect to use Abilify for extended periods ie, >6
weeks, should periodically re-evaluate the long-term usefulness
of the drug for the individual patient (see Dosage &
Administration).
Adjunctive therapy for major depressive disorder.
Infections of lower resp tract, complicated upper & lower urinary

tract, skin & soft tissue. Bacteriaemia/septicaemia. Infections in
neutropenic & immunocompromised patients.
Uncomplicated UTI caused by E. coli & P. mirabilis, otitis media

caused by H. influenzae, Moraxella catarrhalis; uncomplicated
cervical/urethral gonorrhea caused by Neisseria gonorrhoeae.
ACCOLATE is indicated for the prophylaxis and chronic treatment
of asthma in adults and children aged 12 years and over.
Skin infection due to staphylococcus or other fusidic acid-

susceptible bacteria eg, impetigo contagiosa, superficial
folliculitis, furunculosis, sycosis barbae, hidradenitis axillaris,
abscess, paronychia, erythrasma.
HTN.
Resp affections characterized by thick & viscous hypersecretions

eg, acute or chronic bronchitis & its exacerbations; pulmonary
emphysema, mucoviscidosis & bronchieactasis.
Moderate to severe acute & chronic pain; painful diagnostic or

therapeutic measures, post-op pain. As sport & rehabilitation
medicine.
Voluntary or accidental paracetamol poisoning.

Treatment of herpes simplex infections in skin & mucous
membrane, including initial & recurrent genital herpes.
Prevention of recurrent herpes simplex infections in
immunocompetent patients. Prophylaxis of herpes simplex in
immunocompromised patients. Treatment of herpes zoster.
Herpes simplex infections in skin & mucous membrane, including

initial & recurrent genital & labial herpes.
Upper & lower resp tract infections, UTI, skin & soft tissue
infections, pelvic inflammatory disease, septicemia, osteomyelitis,
post-op infections.
Osteoporosis in postmenopausal women w/ increased fracture

risk. Increase bone mineral density in men w/ osteoporosis.
Treatment & prevention of glucocorticoid-induced osteoporosis.
Paget's bone disease.
Helps maintain healthy skin.
Maintains skin health.
Acne vulgaris.
Adult: GI motility disorders especially gastroparesis & reflux

esophagitis. Childn: Severe gastroesophageal reflux.
Peptic ulcer. Zollinger-Ellison syndrome.
Listed in Dosage.
Adjunct for the reduction of elevated total cholesterol, LDL
cholesterol, apolipoprotein B & triglycerides in patients w/
primary hypercholesterolemia, combined or mixed
hyperlipidemia, heterozygous & homozygous familial
hypercholesterolemia when diet response & nonpharmacological
measures are inadequate. Prevention of CV complications.
HTN, stable &/or Prinzmetal's/variant angina.
Type 2 DM inadequately controlled by diet, physical exercise & wt

reduction alone. May be used in combination w/ metformin or
insulin.
Patients w/ advanced colorectal cancer in combination w/ 5-

fluorouracil (5-FU) & folinic acid (FA) in patients w/o prior
chemotherapy for advanced disease; as a single agent in patients
who have failed an established 5-fluorouracil-containing
treatment regimen.
Resp tract infectins, UTI, infections of bones, joints & skin, intra-
abdominal infections, uncomplicated gonorrhea, septicaemia,
peri-op prophylaxis of infections, meningitis.
Short-term treatment of moderate or severe anxiety &

depression-associated anxiety.
Symptomatic relief of upper respiratory tract disorders, eg allergic,
common cold and influenza.
To relief the symptoms of rhinitis and dry tickly cough.
To relief cold and cough with phlegm.

Thrombolytic treatment in acute myocardial infarction: 90-min
(accelerated) dose regimen (see Dosage & Administration): For
patients in whom treatment can be started within 6 hrs of
symptom onset; 3-hr dose regimen (see Dosage &
Administration): For patients in whom treatment can be started
between 6-12 hrs after symptom onset. Actilyse has proven to
reduce 30-day-mortality in patients with acute myocardial
infarction.
Thrombolytic treatment in acute massive pulmonary embolism
with haemodynamic instability: The diagnosis should be
confirmed whenever possible by objective means eg, pulmonary
angiography or noninvasive procedures eg, lung scanning. There
are no clinical trials on mortality and late morbidity related to
pulmonary embolism.
Thrombolytic treatment of acute ischaemic stroke: Treatment
should only be initiated within 3 hrs after the onset of stroke
symptoms and after exclusion of intracranial haemorrhage by
appropriate imaging techniques eg, cranial computerised
tomography (CT).
Treatment & prevention of postmenopausal osteoporosis.
Treatment & prevention of glucocorticoid-induced osteoporosis in
men & women.
Advanced ovarian carcinoma of epithelial origin, small cell lung

carcinoma.
Adjunct to diet and exercise to improve glycemic control in

patients with type 2 diabetes. Monotherapy or dual combination
therapy use in combination with a sulfonylurea or metformin
when diet and exercise plus the single agent does not result in
adequate glycemic control. Triple combination therapy for use in
combination with metformin and sulfonylurea, in patients
(particularly owerweight patients) with insufficient glycemic
control despite dual oral therapy.
Adjunct to diet and exercise to improve glycemic control in adults
with type 2 diabetes mellitus who are already treated with a
thiazolidinedione and metformin, or who have inadequate
glycemic control on a thiazolidinedione alone or metformin alone.
Treatment of diabetes mellitus.
For IV treatment in acute situations, including stress
hyperglycemia.
Treatment of severe acne vulgaris.
Treatment of pain in osteoarthritis (OA) of the knee in patients
who have failed to respond adequately to conservative
nonpharmacologic therapy and to simple analgesics (eg,
acetaminophen).
Fe-deficiency anemia, anemia following traumatic or endogenous,
hemorrhagic anemia during growth, old age & convalescence,
pregnancy, lactation, anemia due to general malnutrition or diet.
Atopic dermatitis (endogenous eczema, neurodermatitis), contact

eczema, degenerative, dyshidrotic, vulgar eczema & eczema in
childn.
Allergic Rhinitis: Relief of nasal and non-nasal symptoms of
allergic rhinitis (including intermittent and persistent allergic
rhinitis) in patients =12 years.
Chronic Idiopathic Urticaria: Symptomatic relief of pruritus,
reduction in the number and size of hives in patients =12 years.
Relief of the nasal and non-nasal symptoms of allergic rhinitis
including nasal congestion.
To help maintain body resistance.

To relief the symptoms of nasal congestion & nasopharynx due to
cold, sinusitis, hay fever or upper resp tract allergy.
Prevention of atherothrombotic events in patients suffering from

MI, ischaemic stroke or established peripheral arterial disease; in
patients suffering from acute coronary syndrome: Non-ST
segment elevation acute coronary syndrome (unstable angina or
non-Q-wave MI) including patient undergoing stent placement
following percutaneous coronary intervention, in combination w/
ASA; ST segment elevation acute MI, in combination w/ ASA in
medically treated patients eligible for thrombolytic therapy.
Listed in Dosage.
Chronic suppurative otitis media & externa.

Diabetic neuropathy.
Supplement for DM.
Relief of muscle pain, headache, toothache, primary

dysmenorrhea & to reduce fever.
Hypoproteinemia in acutely ill patient. Shock. Severe burns.

Local haemostatic. Cleansing & tissue regeneration in burns,
wounds, chronic inflammatory processes, decubitus lesions, crural
ulcers, condyloma acuminata, stomatitis aphthosa. Bacterial
vaginosis, vag candidiasis, trichomoniasis.
Restoration & maintenance of circulating blood vol where vol

deficiency has been demonstrated & use of a colloid is
appropriate: Shock hypovolemia, hypoalbuminemia, adult resp
distress syndrome (ARDS) & nephrosis, bypass surgery, hemolytic
disease in the newborn (HDN).
Emergency treatment of shock & other similar conditions.

Prevention of marked hemoconcentration & maintenance of
electrolyte balance. Hypoproteinemia w/ or w/o edema.
Alco drops & Alco Plus syr Symptomatic relief of sneezing & nasal
congestion due to flu. Alco Plus DMP syr Relief of cough w/
sneezing & nasal congestion due to flu.
Relief of symptoms associated w/ allergic rhinitis & common cold

including nasal congestion, sneezing, rhinorrhea, pruritus &
lacrimation.
Symptomatic treatment of mild to moderate Alzheimer's

dementia.
Allergic disorders which respond to corticosteroid therapy, allergic
rhinitis, urticaria, dermatitis, allergic conjunctivitis, hay fever.
Allergic condition which needs corticosteroid therapy.
Relief of symptoms associated w/ allergic rhinitis, chronic

idiopathic urticaria.
Acute & chronic allergy w/ inflammation.
Helps body's health. Antioxidant.

Malignant Pleural Mesothelioma: Treatment of chemotherapy-
naive patients with unresectable malignant pleural mesothelioma,
in combination with cisplatin.
Non-Small Cell Lung Cancer: First-line treatment of patients with
locally advanced or metastatic non-small cell lung cancer other
than predominantly squamous cell histology (see Pharmacology:
Pharmacodynamics under Actions), in combination with cisplatin.
As a monotherapy for the maintenance treatment of locally
advanced or metastatic non-small cell lung cancer other than
predominantly squamous cell histology in patients whose disease
has not progressed immediately following platinum-based
chemotherapy. First-line treatment should be a platinum based
with other cytotoxics chemotherapy (see Pharmacology:
Pharmacodynamics under Actions).
As a single-agent for the treatment of patients with locally
advanced or metastatic nonsquamous non-small cell lung cancer
after prior chemotherapy (as second line).
Alimta is not indicated for treatment of patients with squamous
cell non-small cell lung cancer.
Prevention and treatment of vitamins B1 and B2 (Alinamin-F only)
deficiencies eg, beri-beri and neuritis.
Supplement to fulfill daily vitamin B1 requirement (Alinamin).
Productive, irritative, spasmodic & allergic coughs.
Wound management by secondary intention on shallow,

granulating wounds. Chronic & acute exudating wounds, full &
partial thickness wounds eg, pressure, leg & diabetic foot ulcers,
infected & malignant wounds.
Relief of symptoms associated w/ allergic rhinitis, chronic urticaria
& other allergic dermatologic disorders.
Osteoporosis.
Symptomatic treatment of mild to moderate dementia in

Alzheimer's disease (AD).
Adjunct therapy for simple & complex partial seizures &
secondary generalized tonic-clonic seizures in patients not
satisfactorily controlled w/ antiepileptics.
Management of anxiety disorders & anxiety associated w/
depression symptoms.
Symptoms of RA, ankylosing spondylitis, gout & OA.
Relief of gastric hyperacidity in gastric & duodenal ulcer, gastritis,

heartburn, peptic esophagitis, relief of flatulence.
Treatment & preventive use in resp distress syndrome (RDS) in
premature neonates.
Management of anxiety disorders or short-term symptomatic

relief of anxiety. Mixed anxiety-depression, panic disorder.
Threatened abortion, habitual abortion, threatened premature

abortion.
Symptomatic treatment of mild or moderate Alzheimer's

dementia.
Type 2 diabetes inadequately controlled by diet, physical exercise

& wt reduction alone.
Vit supplement.
Type 2 diabetes mellitus inadequately controlled by diet, physical
exercise and weight reduction alone. May be used in combination
with metformin or insulin.
As an adjunct to diet and exercise in patients with type II diabetes
mellitus (NIDDM) when monotherapy with glimepiride or
metformin do not result in adequate glycemic control; as
replacement of glimepiride and metformin combination therapy.
UTI, resp tract infections, gonorrhoea.

Treatment of hypertension and can be used as a sole agent to
control blood pressure in the majority of patients. Patients not
adequately controlled on a single antihypertensive agent may
benefit from the addition of amlodipine, which has been used in
combination with a thiazide diuretic, -adrenoceptor blocking
agent or an ACE inhibitor.
First-line treatment of myocardial ischemia, whether due to fixed
obstruction (stable angina) and/or vasospasm/vasoconstriction
(prinzmetal's or variant angina) of coronary vasculature.
Amlodipine may be used where the clinical presentation suggests
a possible vasospastic/vasoconstrictive component but where
vasospasm/vasoconstriction has not been confirmed. Amlodipine
may be used alone, as monotherapy or in combination with other
antianginal drugs in patients with angina that is refractory to
nitrates and/or adequate doses of -blockers.
Chronic kidney dysfunction in concomitant w/ high-calorie low-
protein diet, in compensated & decompensated retention.
Provision of amino acids, electrolytes and water in inadequate

oral intake before and after surgery.
Treatment of hepatic encephalopathy in patients with chronic
liver disease.
Parenteral nutrition for prophylaxis & treatment of protein

deficiency in pediatrics when oral food intake is contraindicated.
Parenteral nutrition supply in the following conditions: As a
supplement nutrition in the case of GI tract impairment as in
clinical situation of short-bowel syndrome, anorexia and severe
gastrointestinal disorder.
Prolonged GI rest is necessary as in the case of enterocutaneous
fistulae and involving the GIT.
In increased metabolic need, as in the cases of severe burns,
trauma and after surgery.
In other critical cases which require exogenous nutrition eg,
tumor, severe infections, severe stress and protein deficiency.
Short-term therapy for serious infections due to amikacin-

sensitive organisms.
Amino acid supply in hypoproteinemia, malnutrition and pre-
and/or postoperative conditions.
Provision of amino acids in patients w/ acute or chronic renal

failure & during hypoproteinemia, malnutrition, pre- & post-op.
HTN, stable angina pectoris &/or Prinzmetal or variant angina.
Supplementary nutrition in cases of GIT impairment as in clinical

situation of short-bowel syndrome, anorexia & severe GI disorder;
in cases of severe burns, trauma & after surgery; other critical
cases which require exogenous nutrition eg tumor, severe
infections, severe stress & protein deficiency.
Listed in Dosage.
Bronchial asthma, allergic rhinits, RA, urticaria, atopic & contact

dermatitis.
Bronchial asthma, allergic rhinits, RA, urticaria, atopic & contact

dermatitis.
Varicose, venous insufficiency, phlebitis, hemorrhoids.

Relief of moderate to severe pain, especially colic & post-op when
the combination w/ tranquilizer is needed.
Short-term treatment of acute pain.
Infection of lower resp tract, urinary tract, soft tissue, bone &
joint, O & G infection, gonorrhoea, septicaemia & meningitis.
Prophylaxis against infection in abdominal, pelvic, orthopaedic,
cardiac, pulmonary, esophageal & vascular surgery when there is
increased risk from infection.
ENT infection, bronchopulmonary, genital (excluding gonococcal

infections) & skin infections.
GUT, resp tract, skin & soft tissue infections due to susceptible
microorganisms.
Upper & lower resp tract, skin & soft tissue, GUT infections, bone
& joint & other infections (septic abortion, peripheral & intra-
abdominal sepsis, post-op infections).
Reduce allergic symptoms eg, itching, urticaria & allergy caused

by insect bites.
Folic acid supplement in anemia & pregnant women.
Folic acid deficiency; supplement in pregnancy & lactation; any

conditions w/ increased folic acid requirement; megaloblastic
anemia due to folic acid deficiency.
Premed before induction of anesth. Basal sedation before

diagnostic or surgical interventions. Induction & conscious
sedation.
HTN. In stable patients who have demonstrated clinical signs of

CHF w/in the 1st few days after sustaining acute MI & as
adjunctive therapy to diuretics w/ or w/o cardiac glycoside.
Reduces risk of MI, stroke, CV death, or need for revascularization
procedures in patients >55 yr who have clinical evidence of CAD,
systolic BP >160 mmHg or diastolic BP >90 mmHg, total
cholesterol >200 mg/dL, HDL cholesterol <35 mg/dL, current
smoker, history of microalbuminuria, or any evidence of previous
vascular disease.
UTI, otitis media, pharyngitis & tonsillitis, acute bronchitis &
exacerbations of chronic bronchitis, uncomplicated gonorrhea
(cervical & urethral), typhoid fever.
Adjunct to established antianginal therapy.

Type 2 DM inadequately controlled by diet, physical exercise & wt
reduction. May be used in combination w/ metformin or insulin.
Treatment of ischemic symptoms including ulceration, pain &
coldness of extremities, in chronic arterial occlusion. Prevention
of recurrence of cerebral infarction (excluding cardiogenic
cerebral embolism).
Antidepressant.
Relief of fever & symptoms of cough & cold.
Acute & chronic treatment of RA, OA & ankylosing spondylitis.

Management of pain & primary dysmenorrhea. Short-term
treatment of acute migraine attacks, post-op pain & inflammation
following dental & orthopedic surgery.
Prevention of vomiting during pregnancy, after surgery, motion

sickness.
Supplement to increase appetite in childn during the growth
period.
Stimulation of appetite & stamina in growing childn, vit

supplement.
Treatment of adult patients and children =8 years with diabetes
mellitus.
Atopic & contact dermatitis, various forms of eczema especially in

childn, psoriasis, pruritus ani & vulvae, erythema sunburn & other
types of dermatitis.
Infected dermatitis, atopic & seborrheic dermatitis, pruritus ani &

vulvae, otitis externa.
Neuropathic pain, epilepsy.
Treatment of essential hypertension. To decrease micro- and

macro-albuminuria in hypertensive patients with nephropathic
diabetes caused by non-insulin dependent diabetic mellitus
(NIDDM).
Short-term treatment of acute painful post-traumatic
inflammatory states eg, sprains & post-op inflammation & pain eg,
dental/orthopaedic surgery. Adjuvant in severe painful
inflammatory ENT infections eg, pharyngotonsillitis, otitis.
Symptomatic treatment of functional asthenia.

Upper resp tract infections; otitis media; acute & chronic
bronchitis, pneumonia, cystitis, urethritis, pyelonephritis,
asymptomatic bacteriuria during pregnancy, gonorrhea, skin &
soft tissue infections.
Nonspecific diarrhea.
Symptomatic relief in the treatment of osteoarthritis (OA). Relief
of chronic musculoskeletal pain and acute pain associated with
dental surgery.
Symptomatic treatment of acute and chronic hemorrhoids, and

symptomatic treatment of organic and idiopathic chronic venous
insufficiency of the lower limbs eg, heavy legs, pain, heat
sensation, edema,functional impairment and nocturnal cramps.
BP control in acute hypotensive states
(pheochromocytomectomy), sympathectomy, poliomyelitis, spinal
anesth, MI, septicemia, blood transfusion & drug reactions.
Mild to moderate pain, post-op pain, rheumatoid diseases &

muscle pain.
Relief of inflammatory manifestations of corticosteroid-responsive

dermatoses when complicated by secondary infections.
Helps relieve cough & cold.
Symptomatic treatment of mild to moderate dementia in

Alzheimer's disease (AD).
Symptomatic treatment of mild, moderate & severe Alzheimer's

disease (AD).
Short-term symptomatic treatment for acute exacerbation of OA

& long-term symptomatic treatment of RA.
Treatment of advanced breast cancer in postmenopausal women
who are estrogen-receptor positive and/or progesterone-receptor
positive.
Adjuvant treatment of postmenopausal women with hormone-
receptor positive early invasive breast cancer.
Adjuvant treatment of early breast cancer in hormone-receptor
positive postmenopausal women who have received 2-3 years of
adjuvant tamoxifen.
Schizophrenia.
Prevention of venous thromboembolic events (VTE) in patients
undergoing major orthopaedic surgery of the lower limbs eg, hip
fracture including extended prophylaxis, knee or hip replacement
surgery. Prevention of VTE in patients undergoing abdominal
surgery who are at risk of thromboembolic complications.
Prevention of VTE in medical patients who are at risk of
thromboembolic complications due to restricted mobility during
acute illness. Treament of acute deep vein thrombosis (DVT).
Treatment of acute pulmonary embolism (PE). Treatment of
unstable angina or non-ST segment elevation myocardial
infarction (UA/NSTEMI) in patients for whom urgent (<120 min)
invasive management [percutaneous coronary intervention (PCI)]
is not indicated. Adjunctive treatment of ST segment elevation
myocardial infarction (STEMI) in patients who are managed with
thrombolytics or who initially are to receive no other form of
reperfusion therapy.
Parkinsonism; drug-induced parkinsonism.
Listed in Dosage.
Fatigue, to increase energy & stamina, antioxidant supplement.
Nutritional supplement during the convalescence period for
elderly, pregnancy, lactation & menopause. Helps metabolism &
RBC formation.
Advanced breast cancer in women w/ natural or induced

postmenopausal status whose disease has progressed following
antiestrogen therapy. Patient selection should be based on
positive oestrogen &/or progesterone receptor status, because
efficacy has not been demonstrated when it is absent. Adjuvant
treatment of postmenopausal women w/ estrogen-receptor +ve
early breast cancer, following 2-3 yr of initial adjuvant tamoxifen
therapy.
Chronic open-angle glaucoma & ocular HTN.
Reduction of atherothrombotic events in patients suffering from

MI, ischaemic stroke or established peripheral arterial disease;
unstable angina.
RA & OA. Susp To relieve fever in childn, mild to moderate pain of

toothache or after tooth extraction. Headache.
Relief of pain in toothache, headache, muscle & back pains,

primary dysmenorrhea & to reduce fever.
Helps maintain body health.
Multivit supplement. To enhance appetite & as brain nutrition in
childn.
Acute replacement of fluid loss; glucose supplement.
Relief of mild to moderate pain of traumatic, arthritic or muscular

origin, post-op & postpartum pain, dysmenorrhea, headache,
dental pain.
Bronchial asthma, asthmatic bronchitis, chronic bronchitis w/
emphysema, emphysematous bronchospasm, asthma associated
w/ allergic rhinitis.
Bronchitis, peritonitis, osteomyelitis, pre-op prophylaxis.
Treatment & prophylaxis of angina pectoris & MI.

Helps in maintaining body resistance. Antioxidant to prevent
cellular damage due to free radicals.
To help maintain health.
Helps maintain the immune system.
Bronchospasm in all types of bronchial asthma, chronic bronchitis

& emphysema.
Antioxidant to prevent free radical-induced cell damages.
Supplement for maintenance of health.

Management of anxiety disorders & anxiety associated w/
depression symptoms.
Dyspnea due to bronchial asthma, chronic & acute bronchitis,

pulmonary emphysema.
Adjunct to diet for the reduction of elevated total cholesterol, LDL

Moisturizes & reduces the sensitivity of inflamed tissue & helps

relieve burning, itching & pain by protecting from further
irritation. Enhances healing process of the skin.
Adjunct to diet for the reduction of elevated total cholesterol, LDL

Adjunct to diet for the reduction of elevated total cholesterol,
LDL-cholesterol, apolipoprotein B, and triglycerides in patients
with primary hypercholesterolemia, combined (mixed)
hyperlipidemia and heterozygous and homozygous familial
hypercholesterolemia when response to diet and other non
pharmacological measure are inadequate.
Pediatric Patients (10-17 years): Adjunct to diet to reduce total-C,
LDL-C, and apo-B levels in boys and postmenarchal girls, 10-17
years of age, with heterozygous familial hypercholesterolemia if
after an adequate trial of diet therapy the following findings are
present: LDL-C remains =190 mg/dL or LDL-C remains =160 mg/dL
and there is a positive family history of premature cardiovascular
disease or =2 other CVD risk factors are present in the pediatric
patient.
Short-term symptomatic treatment of acute exacerbation of OA.
Long-term symptomatic treatment of RA (chronic polyarthritis).
Metered-Dose Inhaler/Metered-Aerosol: Bronchodilator for

maintenance treatment of bronchospasm associated with chronic
obstructive pulmonary disease, including chronic bronchitis and
emphysema.
Solution for Inhalation: Bronchodilator for the prevention and
treatment of symptoms in chronic obstructive airway disorders
with reversible bronchospasm eg, bronchial asthma and especially
chronic bronchitis with or without emphysema.
Adult Formulations: Short-term treatment of bacterial infections
at the following sites when caused by amoxicillin-clavulanate
susceptible organisms: Upper Respiratory Tract Infections
(including ear, nose and throat): Recurrent tonsillitis, sinusitis,
otitis media, typically caused by Streptococcus pneumoniae,
Haemophilus influenzae*, Moraxella catarrhalis* and
Streptococcus pyogenes.
Lower Respiratory Tract Infections: Acute exacerbations of chronic
bronchitis, lobar and bronchopneumonia, typically caused by
Streptococcus pneumoniae*, Haemophilus influenzae* and
Moraxella catarrhalis*.
Genitourinary Tract Infections: Cystitis, urethritis, pyelonephritis,
female genital infections typically caused by Enterobacteriaceae*
(mainly Escherichia coli*), Staphylococcus saprophyticus and
Enterococcus spp.
Skin and Soft Tissue Infections: Typically caused by
Staphylococcus aureus*, Streptococcus pyogenes and Bacteroides
spp*.
Bone and Joint Infections: Osteomyelitis typically caused by
Staphylococcus aureus*, where more prolonged therapy may be
appropriate.
Other Infections: Septic abortion, puerperal sepsis, intra-
abdominal sepsis.
Pediatric Formulations: Short-term treatment of bacterial
infections at the following sites when caused by amoxicillin-
clavulanate sensitive organisms: Upper Respiratory Tract
Infections (including ear, nose and throat): Recurrent tonsillitis,
sinusitis, otitis media typically caused by Streptococcus
pneumoniae, Haemophilus influenzae*, Moraxella catarrhalis*
and Streptococcus pyogenes.
Lower Respiratory Tract Infections: Acute exacerbations of chronic
bronchitis, lobar and bronchopneumonia typically caused by
Streptococcus pneumoniae, Haemophilus influenzae* and
Moraxella catarrhalis*.
Genitourinary Tract Infections: Cystitis, urethritis, pyelonephritis,
female genital infections typically caused by Enterobacteriaceae*
(mainly Escherichia coli*) Staphylococcus saprophyticus and
Enterococcus spp.
Dry acne & protect skin from sun rays.
Treatment of the symptoms of allergic rhinitis in adults,

adolescents =12 years and children 6-11 years.
Supplement for supportive cancer treatment.
Maintenance of body resistance.
Symptoms associated w/ allergic conditions eg, seasonal allergic

rhinitis (including ocular symptoms), perennial allergic rhinitis,
chronic idiopathic urticaria.
Treatment and prevention of the progression of benign prostatic
hyperplasia (BPH) through alleviation of symptoms, reduction of
prostate size (volume), improvement of urinary flow rate and
reduction of the risk of acute urinary retention (AUR) and the
need for BPH-related surgery.
Avodart in combination with a-blocker tamsulosin, is indicated for
the treatment of moderate to severe symptomatic BPH in men
with enlarged prostate.
Supplement to prevent nausea & vomiting.
Helps maintain health.
Helps maintain health.
Antioxidant to prevent free radical-induced cell damage.
Antioxidant to prevent free radical-induced cell damage.

Asthma, chronic bronchitis, emphysema & bronchopulmonary
disorders involving bronchospasm.
Endometriosis: Treatment of visually-proven (eg, laparoscopy)

endometriosis, where the required endpoint of treatment is
fertility or for the control of symptoms when surgery is
contraindicated or has been unsuccessful.
Menorrhagia: Short-term (up to 6 months) management of
intractable primary menorrhagia.
Fibrocystic Breast Disease: Short-term treatment (up to 6 months)
of severe benign (fibrocystic) breast disease or mastalgia
associated with severe symptomatic benign breast disease, in
patients refractory to other treatments.
Mild to moderate upper & lower resp tract, skin & soft tissue
infections; non-gonococcal urethritis & cervicitis due to Chlamydia
trachomatis.
Upper & lower resp tract infections, community acquired

pneumonia (CAP).
Pulmonary & extrapulmonary TB.
Resistant pulmonary TB.

Upper & lower resp tract infections; bacterial pneumonia; UTI &
pyelonephritis; intra-abdominal infections; bacterial septicaemia;
skin, soft tissue, bone & joint infections, gonococcal infections.
Prophylaxis of post-op infection in patients undergoing abdominal
or pelvic surgery. Prophylaxis of post-op sepsis in termination of
pregnancy or caesarean section.
Listed in Dosage.
Infections of lower resp tract, complicated upper & lower urinary

tract, skin & soft tissue. Bacteraemia/septicaemia. Infections in
neutropenic & immunocompromised patients.
Acute primary skin infections eg, impetigo, folliculitis,

furunculosis.
Cream: Topical treatment of secondarily infected traumatic
lesions eg, small lacerations, sutured wounds or abrasions.
Ointment: Bacterial skin infections eg, impetigo, folliculitis and
furunculosis.
Epilepsy (except petit mal). Trigeminal neuralgia, idiopathic

glossopharyngeal neuralgia.
For relieving nonproductive cough & nasal congestion due to
influenza.
Corneal ulcer caused by Pseudomonas aeruginosa, Serratia

marcescens, Staph aureus, Strep epidermidis, Strep pneumoniae,
Strep viridans. Conjunctivitis caused by Staph aureus, Strep
epidermidis, Strep pneumoniae.
Listed in Dosage.
Treatment of chronic hepatitis B virus infection in adults with
evidence of active viral replication and either evidence of
persistent elevations in serum aminotransferases (ALT or AST) or
histologically active disease.
This indication is based on histologic, virologic, biochemical, and
serologic responses in nucleoside-treatment-naive and
lamivudine-resistant adult subjects with HBeAg-positive or
HBeAg-negative chronic HBV infection with compensated liver
disease and virology, biochemical, serologic and safety data are
available from a controlled study in adult subjects with chronic
HBV infection with decompensated liver disease and on more
limited data in adult subjects with HIV/HBV co-infection who have
received prior lamivudine therapy.
Primary generalized tonic-clonic seizures & partial seizures, w/ or

w/o secondary generalization.
Upper & lower resp tract infection, UTI, peritonitis, cholecystitis,

cholangitis, & other intra-abdominal infections, skin & soft tissue
infections.
Supportive therapy to stimulate the immune system during acute
or chronic infection. Supportive treatment for cancer.
Infant formula for babies 0-6 mth.
Follow-on formula for infant 6-12 mth.
Lactose-free formula for babies 0-12 mth.

Nutritional supplement for pregnant women.
Gastric ulcers in combination w/ offensive factor inhibitors

(proton-pump inhibitors, anticholinergic, H2-antagonist) &
gastritis.
Growth, malnutrition, convalescence, elderly.
Unconsciousness resulting from brain damage or surgery, cerebral

trauma & infarction. Promotes upper extremity rehabilitation in
patients w/ hemiplegia following cerebral apoplexy; patients w/
relatively mild paralysis of the lower extremities in those w/ 1 yr
of onset & under rehabilitation & usual oral drug therapy.
Growing childn, prevention & treatment of vit B complex & vit C
deficiencies, convalescence.
Vit B-complex, vit C, vit E & Zn deficiencies.

As a supplement to help fullfil the requirement of iron & folic
acid.
Partial parenteral nutrition for childn. Building blocks, electrolytes,
vit & water supplement in cases of inadequate or impossible oral
food intake, increased protein requirements, protein deficiency or
catabolism; malnutrition.
Adjunctive treatment for diaper rash, abrasion, minor wound, dry

& cracked skin, skin irritation, skin inflammation, skin ulcer.
As a secretolytic for acute & chronic resp tract disorders,
especially in exacerbation of chronic asthmatic bronchitis &
bronchial asthma.
Tissue adhesion, suture support, hemostasis, wound care, sealing

of body cavities & subarachnoid space.
As a supplement to help fulfill vit & mineral requirement.
As a bronchodilator for the prevention and treatment of

symptoms in chronic obstructive airway disorders with reversible
bronchospasm eg, bronchial asthma and especially chronic
bronchitis with or without emphysema. Concomitant anti-
inflammatory therapy should be considered for patients with
bronchial asthma and steroid-responsive COPD.
Symptomatic treatment of acute asthma attacks; prophylaxis of
exercise-induced asthma; symptomatic treatment of bronchial
asthma and other conditions with reversible airway narrowing eg,
chronic obstructive bronchitis. Concomitant anti-inflammatory
therapy should be considered for patients with bronchial asthma
and steroid-responsive COPD.
Food supplement for maintenance of eye health.

Pruritus due to allergic conditions eg, chronic urticaria, atopic &
contact dermatoses. Relief of anxiety.
UTI including prostatitis; GIT infections including typhoid fever

due to S. typhi; resp tract infections except pneumonia due to
Streptococcus; skin & soft tissue, bone & joint infections;
urethritis, cervicitis gonorrhoeae.
External infections of the eye & its adnexa caused by susceptible
organisms. Corticosteroid-responsive inflammation of the eye.
Duodenal ulcer & recurrent gastric ulcer. Reflux/erosive

oesophagitis.
Acute & chronic allergy w/ inflammation.

Management of allergic symptoms eg, perennial & seasonal
allergic rhinitis, chronic urticaria.
Meniere's syndrome as defined by the following triad of core

symptoms: Vertigo (with nausea/vomiting), hearing loss (hardness
of hearing), tinnitus.
Wt loss & fat reduction.

Vertigo & dizziness associated w/ Meniere's disease, Meniere's
syndrome & peripheral vertigo.
Eczema including atopic, infantile, stasis & discoid eczema &

prurigo.
Lower resp tract, genitourinary, bones & joints, skin &

gynecological infections; CNS infections; UTI; bacteremia &
septicemia; intra-abdominal infections; pre-op prophylaxis.
Vit B complex & -carotene supplementation; help improve
appetite.
Vit supplement.
Primary hyperlipidemia of type IIa, IIb, III, IV & V (Fredrickson
classification), if dietary treatment alone proves inadequate.
Secondary hyperlipidemia, which persists in spite of treatment of
underlying disease.
Urethritis & vaginitis due to Trichomonas vaginalis; amoebiasis

due to Entamoeba histolytica. Prophylaxis of post-surgical
anaerobe infection. Giardiasis due to Giardia lamblia.
Chronic & acute constipation. Bowel evacuation before

radiological exam of the abdomen, or endoscopy, & before or
after surgery.
Listed in Dosage.
Prevention & treatment of vit C deficiency.
Infection of resp tract, peritonitis & other intra-abdominal

infections, septicaemia, skin & soft tissue infection, UTI, GUT
infections, endometritis.
Amino acid supplement.
Adjunctive therapy for diarrhea in childn in concomitant use w/

oral rehydration salts.
Assist in the prevention & elimination of acne.
Diphteria.
Muscular or neuromuscular asthenia, cardiac-muscle metabolism

disturbance, physical exhaustion.
Thiamine (vit B1), pyridoxine HCl (vit B6), cyanocobalamine (vit
B12) eg beri-beri, alcoholic polyneuritis, pernicious anemia.
Moisturiser for dry skin, protective cream for radiotherapy.
Serious infections due to susceptible organisms esp Strep,

pneumococcus, Staph & anaerobic bacteria which cause lower
resp tract, skin & soft tissue infections.
Primary skin infection: Impetigo contagiosa, superficial folliculitis.

Secondary skin infection: Acne pustularis, excoriation & infected
burns, infected dermatitis.
Help maintain body health.

Helps maintain immunity, improve appetite & maintain digestive
function.
Fever, dysmenorrhea, musculoskeletal disorder. Other painful

conditions eg, headache, toothache, arthritis & other
musculoskeletal disorders.
Daily supplementation of Mg.
Keeps skin moisture; used on face & neck to whiten & brighten
skin; helps conceal smooth lines on the face.
Cutaneous irritations & lesions. Cover acute & chronic wounds
(abrasions, donor sites & post-op incisions, 1st & 2nd degree
burns, vascular & metabolic ulcers & pressure ulcers). Protection
against abrasion, friction, & dessication.
Vit & mineral supplement in anemia during pregnancy &

lactation.
Treatment of hypertension and symptomatic heart failure.
Stable Coronary Artery Disease: Reduction of risk of cardiac
events in patients with history of myocardial infarction and/or
revascularisation.
Treatment of essential hypertension in patients whose blood
pressure is not adequately controlled on perindopril alone.
Cutaneous hyperpigmentation.
Supplement for energy production; antioxidant.
Helps improve quality & quantity of sperm.

Fe-deficiency anemia, anemia during growth, or due to
haemorrhage, convalescence. Pegnancy & lactation, old age,
malnutrition or diet.
Prevention of tetanus in wound which is contaminated by soil,

dust or any other materials which may cause Clostridium tetani
infections.
Venomous snake bites of Agkistrodon rhodostoma (Malayan pit

viper), Bungarus fasciatus (banded krait), Naja sputatrix (cobra
snake).
A dietary supplement for improved immune function, good

appetite, prevention & treatment of vit deficiency, strong bones &
teeth & adjuvant in diarrhoea.
Infections caused by Salmonella, H influenzae (especially

meningococcal infections), rickettsia, gm-ve organisms which
cause bacteremia, meningitis.
Minimizes the appearance of under-eye darkness & puffiness.

To help mask wrinkles & smooth lines on the face, to maintain
skin elasticity.
HTN, as monotherapy or in combination w/ other

antihypertensives.
Common cold, flu, stuffy nose, headache, stomachache, insect
bites.
Acute & chronic otitis externa.
Eye: Short-term treatment of steroid-responsive conditions of the

eye when prophylactic antibiotic treatment is also required. Eye
lid: Non-purulent blepharitis.
Smoothing 3rd partum after delivery of the head or anterior

shoulder of fetus, post-partum uterine hemorrhage, post-abortion
(including hemorrhage on caesarean op) & after placental release.
Atonic uterus, subinvolution at puerperal uterus & lochiometra.
Cancer of the skin, head & neck, esophageal, uterine cervix.

Malignant lymphoma. Pleural effusions.
Female infertility due to ovulatory dysfunction, polycystic ovary,

amenorrhea-galactorrhea, psychogenic & post-OC amenorrhea;
oligospermia.
Emergency treatment of acute HTN during surgery. Hypertensive

emergencies.
Hypertension.
Treatment of patients with heart failure and impaired left
ventricle systolic function (left ventricular ejection fraction =40%)
when ACE inhibitors are not tolerated.
Blopress Plus is indicated for the treatment of hypertension which
is not controlled by candesartan cilexetil 16 mg or
hydrochlorothiazide 12.5 mg in monotherapy.
Essential HTN.
Special infant formula for babies 0-6 mth to reduce risk of allergy.
Special infant formula for babies 0-6 mth w/ cow's milk allergy,
lactose intolerance & galactosemia.
Metastatic bone disease; to reduce the risk of skeletal
complications of malignant disease including hypercalcemia, pain,
the need for radiotherapy against painful bone lesions &
impending fractures, & decrease the risk of bone fractures.
Treatment of tumour-induced hypercalcemia.
Improvement of various symptoms due to abnormal metabolism

of vit D in chronic renal failure, hypoparathyroidism, vit D-
resistant rickets & osteomalacia.
Relieves pain & inflammation of joints; inhibits enzyme that cause
cartilage damage; helps boost collagen production & formation of
protective layer of joints.
Internal and external hemorrhoids, lacerated anal wounds, anal

prolapse, periproctitis, hemorrhoidal bleeding and anal pruritus.
Internal and external hemorrhoids, hemorrhoidal bleeding, anal

prolapse, anal fistula, periproctitis, lacerated anal wounds, anal
pruritus, lacerated perineal wounds.
Strabismus & blepharospasm associated w/ dystonia, including

benign essential blepharospasm or VII nerve disorders in patient
=12 yr. Temporary improvement in the appearance of moderate to
severe glabellar lines associated w/ corrugator &/or procerus
muscle activity in adult <65 yr.
Unconsciousness due to brain damage, head injury or brain
surgery & cerebral infarction. Accelerates rehabilitation of upper
extremities in apoplectic hemiplegic patients. Mild lower
extremities paralysis w/in 1 yr & receiving usual oral treatment.
Manage the reduction of cognitive function in elderly.
Unconsciousness due to brain damage, head injury or brain

surgery & cerebral infarction. Accelerates rehabilitation of upper
extremities in apoplectic hemiplegic patients.
Dietary supplement for brain nutrition, strong bones & teeth,

improved immune function & adjuvant in diarrhea.
External infections of the eye & its adnexa caused by susceptible

bacteria.
Steroid-responsive inflammatory ocular conditions for which a

corticosteroid is indicated & where bacterial infection or a risk of
bacterial ocular infection exists.
Female infertility. Anovulation, including PCOD, in women who
have been unreponsive to treatment w/ clomiphene citrate.
Controlled ovarian hyperstimulation to induce the development
of multiple follicles for ART.
Relief of inflammatory & pruritic manifestations in corticosteroid-

responsive dermatoses.
Dermatitis due to Neomycin-susceptible microorganisms.
Autonomic & somatic symptoms because of anxiety. Symptomatic

treatment of peptic ulcer, hypersecretory & hypermotility of GIT,
nervous dyspepsia, spastic & irritable colon, biliary, dyskinesia,
ureter spasm & ureter dyskinesia, irritable bowel syndrome,
colitis, diarrhoea, dysmenorrhoea.
Listed in Dosage.
Moisten dry & inflamed nasal membrane due to cold, allergy, low
moisture, minor nose bleeds & other minor nasal irritation.
Breast & ovarian cancer. Non-small cell lung cancer.
For the relief of bronchospasm in bronchial asthma, chronic

bronchitis, emphysema and other lung diseases and
bronchopulmonary disorders, where bronchospasm is a
complicating factor.
Brilinta Co-administered with Acetylsalicylic Acid (ASA) 75-100 mg
prevention is indicated of the thrombotic events (cardiovascular
death, myocardial infarction and stroke) in patients with acute
coronary syndromes (ACS) [unstable angina, non-ST elevation
myocardial infarction (NSTEMI) or ST elevation myocardial
infarction (STEMI)] including patients managed with percutaneous
coronary intervention (PCI) or coronary artery bypass grafting
(CABG).
Infection of lower resp tract, urinary tract, bone & joint, intra-
abdominal, skin; gonorrhoea, bacterial septicaemia, peri-op
prophylaxis, if there is a possibility of severe infection
complication.
Symptomatic relief of flu ie fever, headache, nasal congestion,

sneezing associated w/ non-productive (Brochifar) cough.
Bromifar Cough where expectoration is needed. Bromifar Plus
Relief of productive cough & facilitates expectorant.
Acute & chronic resp tract disorders associated w/ abnormal

bronchial secretion, particularly in exacerbations of chronic
bronchitis, asthmatic bronchitis & bronchial asthma.
Immunotherapy. Prevention of recurrent infections of airways &

acute infectious exacerbations of chronic bronchitis. Co-
medication in the treatment of acute airway infections.
BRUFEN is indicated to reduce fever in children; relief mild to
moderate pain, such as dental pain or dental extraction pain,
headache, postoperative pain, pain in rheumatic conditions of
bones and joints, pain in association with sprains.
Induction of remission in patients w/ mild to moderate Crohn's
disease w/ involvement of the ileum &/or descending colon.
Relief & treatment of bronchial asthma.
HTN. Myocardial ischaemia due to fixed obstruction (stable

angina) &/or vasospasm/vasoconstriction (Prinzmetal or variant
angina) of coronary blood vessel.
As additional treatment & alleviate the symptoms associated w/

inflammatory or ulcerative lesion in oral mucosal due to trauma.
Traumatic inflammatory of tendon, ligament, muscle & joint due

to strain, sprain & bruise. Localized soft tissue rheumatic eg
tendovaginitis, bursitis, arm-shoulder syndrome, &
periarthropathy. Localized rheumatic disease eg, OA in peripheral
joint & vertebral column.
Resp tract, GIT, GUT, skin & soft tissue infections due to
susceptible gm+ve & gm-ve microorganisms.
Symptomatic treatment of allergic conditions including urticaria,

angioedema, rhinitis, conjunctivitis.
Mild to moderate pain eg primary dysmenorrhoea, toothache or
post-extraction dental pain, post-op pain, headache; mild to
moderate pain symptom in rheumatic disease, muscle pain &
sprain; fever reduction.
Epidural block for surgery, field block (minor & major nerve blocks
& infiltration); post-op or labour pain.
Spinal anesth for abdominal, urological & lower limb surgery.
All degrees of burns.

Protects bone health & fulfills Ca requirements.
Caduet is indicated in patients for whom treatment with both
amlodipine and atorvastatin is appropriate.
Amlodipine is indicated for treatment of hypertension and can be
used as the sole agent to control blood pressure in the majority of
patients. Patients not adequately controlled on a single
antihypertensive agent may benefit from the addition of
amlodipine, which has been used in combination with a thiazide
diuretic, -adrenoreceptor blocking agent or an angiotensin-
converting enzyme inhibitor.
Amlodipine is indicated for the treatment of myocardial
ischaemia, whether due to fixed obstruction (stable angina)
and/or vasospasm/vasoconstriction (prinzmetal's or variant
angina) or coronary vasculature. Amlodipine may be used where
the clinical presentation suggests a possible
vasospastic/vasoconstriction has not been confirmed.
Amlodipine may be used alone, as monotherapy, or in
combination with other antianginal drugs in patients with angina
that is refractory to nitrates and/or adequate doses or -blockers.
Atorvastatin is indicated as an adjunct to diet for the reduction of
elevated total cholesterol, LDL-cholesterol, apoliprotein B and
triglycerides in patients with primary hypercholesterolemia,
combined (mixed) hyperlipidemia, and heterozygous and
homozygous familial hypercholesterolemia when response to diet
and other non-pharmacological measure are inadequate.
Supportive treatment of osteoporosis of various origin eg,

postmenopausal, senile, corticosteroid-induced; as a
consequence of gastrectomy or immobilization. Increased
demand for Ca eg, in growing childn & in pregnancy & lactation.
Dermatitis, atopic dermatitis, contact dermatitis, pruritus,

urticaria, psoriasis, other dermatitis.
Prevents & reduces the risk of osteoporosis in men & women.
Relieves premenopausal & menopausal symptoms.
Treatment & prophylaxis of chronic coronary insufficiency,

particularly angina pectoris, cardiac infarction & as adjunct to
antihypertensives.
To help fulfill the requirement of Ca & vit D in pregnancy &

lactation.
To help fulfill Ca & vit D requirement.
Ca supplement.
Prevention & treatment of Ca deficiency. Ca, vit A & vit D
supplementation in pregnancy & lactation. For development of
healthy bones & teeth.
Ca, vit B, C & D deficiencies particularly in pregnant women &

growing childn. Helps maintain healthy bone.
Ca supplement in growth period, pregnancy & lactation.

Prevention of osteoporosis in menopausal women.
To help maintain healthy bone function. Vit B supplement for

childn, adult, pregnant & nursing mother. To help increase
appetite in childn & to maintain healthy GI function.
To help fulfill Ca requirement.

Vit & mineral supplementation during pregnancy & lactation.
Prevention of Ca & Mg deficiency during menopausal period &
elderly.
Prevention & treatment of disorders of Ca metabolism or

deficiency eg, rickets, osteomalacia due to malabsorption,
osteoporosis.
Helps improve immune system, enhance bone & teeth growth; as

a brain nutrient.
Supportive treatment in osteoporosis. Ca supplement during

pregnancy, lactation & bone fracture.

deficiency eg, rickets, osteomalacia due to malabsorption,
osteoporosis, development of healthy bones & teeth. Prevention
& treatment of Ca & vit D deficiency during pregnancy &
lactation.
HTN; myocardial ischemia due to stable angina, or Prinzmetal's or
variant angina.
CalSource/CalSource Forte: Increased demand for calcium eg, in

growing children and in pregnant and lactating women.
Latent tetany. Rickets and osteomalacia, in addition to specific
therapy.
Supportive treatment of osteoporosis of various origin
(postmenopausal, senile, corticosteroid-induced, as a
consequence of gastrectomy or of immobilization).
CalSource Plus Vitamin C: Increased demand for calcium and
vitamin C eg, in pregnant and lactating women, during periods of
rapid growth (childhood, adolescence), in old age, and during
convalescence.
Treatment of calcium and vitamin C deficiency.
As an adjuvant in colds and influenza.
To help optimize the absorption of calcium and to maintain the

healthy bones.
To help optimize the absorption of calcium and to help maintain
the healthy bone.
Supplement to fulfill Ca, vit C, D & B6 requirement especially in

pregnant women & childn during growth period. As an
antioxidant.

deficiency (rickets, osteomalacia due to malabsorption,
osteoporosis), Ca & vit D3 deficiency during pregnancy &
lactation. Development of healthy bones & teeth.
Ca supplement for pregnant & nursing mother. Prevention of

osteoporosis in menopausal women.
Treatment of patients with advanced colorectal cancer: In
combination with 5-fluorouracil and folinic acid in patients
without prior chemotherapy for advanced disease; as a single
agent in patients who have failed an established 5-fluorouracil-
containing treatment regimen.
HTN. Heart failure & impaired left ventricular systolic function (left
ventricular ejection fraction =40%) when ACE inhibitors are not
tolerated.
Treatment & prevention of oral or intestinal candidiasis.
HTN. Patients w/ heart failure & impaired left ventricular systolic

function (LVEF <40%) when ACE inhibitors are not tolerated.
To help metabolism process of fat, carbohydrate & protein to

become energy.
Candidiasis due to Candida albicans, pityriasis versicolor due to

Malassezia furfur, tinea pedis, tinea cruris, tinea corporis due to
Trichophyton rubrum, Trichophyton menta grophytes,
Epidermophyton floccosum & Microsporum canis. Diaper rash.
Vaginitis caused by fungi mainly candida &/or trichomonas.
Superinfection w/ sensitive bacteria.
Infections caused by Salmonella sp, H influenza, rickettsia,

lymphogranuloma-psittacosis; gm-ve bacteria causing bacteremia,
meningitis.
Duodenal ulcer & reflux esophagitis; benign gastric ulcer.
Erectile dysfunction.
Listed in Dosage.
Adult =16 yr: Lower resp tract (pneumonia &

bronchopneumonia), skin & skin structure, intra-abdominal
(peritonitis, biliary tract infection), severe or complicated
gynecological infections; septicemia; empiric treatment in febrile
neutropenia. Childn 2 mth-<16 yr: Severe pneumonia, empiric
treatment in febrile neutropenia, complicated upper
(pyelonephritis) & lower UTI.
Perennial & seasonal allergic rhinitis, & chronic idiopathic

urticaria.
Lower resp tract (bronchopneumonia & lobar pneumonia),

complicated upper (pyelonephritis), lower urinary tract, skin &
soft tissue infections; infections in neutropenic (except those
caused by Pseudomonas aeruginosa) & immunocompromised
patients; severe infections in ICU patients; septicemia.
Supplement to maintain health of liver function.

Upper & lower resp tract, GUT, skin & soft tissue, bone & joint,
dental & other infections eg septic abortion, puerperal & intra-
abdominal sepsis.
Upper resp tract infections eg, tonsillitis, sinusitis, otitis media.

Lower resp tract infections eg, acute & chronic bronchitis, lobar &
bronchopneumonia. GUT infections eg, urethritis, cystitis,
pyelonephritis. Skin & soft tissue infections eg, abscesses,
cellulitis, boils. Bone & joint infections eg, osteomyelitis. Other
infections eg, abortion sepsis, puerperal sepsis, intra-abdominal
sepsis, septicemia, peritonitis, post-op infections. Prophylaxis
against infection which may be associated w/ major surgical
procedures eg, GI, pelvic, cardiac, renal, head & neck, joint &
biliary tract surgery.
Palliative treatment of ovarian cancer after relapsing to
chemotherapy. Small cell & nonsmall cell lung cancer, head &
neck cancer, bladder cancer, cervix cancer.
Regression in disseminated neoplastic conditions eg, acute

leukemia, Wilm's tumor, neuroblastoma, soft tissue & bone
sarcomas; breast, ovarian, transitional cell bladder, thyroid
carcinoma, lung cancer, Hodgkin's disease & non-Hodgkin's
lymphoma, bronchogenic & gastric carcinoma.
Hypertension.
Ramipril is indicated in stable patients who have demonstrated
clinical signs of congestive heart failure within the 1st few days
after sustaining acute myocardial infarction, and as adjunctive
therapy to diuretics with or without cardiac glycosides.
Risk reduction of myocardial infarction, stroke, cardiovascular
death or need for revascularization procedures in patients =55
years who have clinical evidence of coronary artery disease,
stroke or peripheral vascular disease; in diabetic patients =55
years who have =1 of the following risk factors: Systolic blood
pressure >160 mmHg or diastolic blood pressure >90 mmol/L,
total cholesterol >5.2 mmol/L, HDL cholesterol <0.9mmol/L,
current smoker, known microalbuminuria, or any evidence of
previous vascular disease.
1st-line treatment or in combination treatment of HTN & angina

ie refractory to nitrates or -blockers. 1st-line treatment for
myocardial ischemia due to stable &/or Prinzmetal's or variant
angina.
Supplement for vit deficiency. Antihomocysteine.
Inotropic support in the short-term treatment of patients w/

cardiac compensation due to depressed contractility resulting
from either organic heart disease or cardiac surgical procedures.
Atrial fibrillation w/ rapid ventricular response.
HTN, angina.
Long-term treatment of CHD & prophylaxis of angina pectoris.

Adjunctive therapy in CHF not responding adequately to cardiac
glycosides &/or diuretics.
Hypertension: Treatment of hypertension and as an initial agent
to control blood pressure in the majority of patients. In patients
not adequately controlled on a single antihypertensive agent,
Cardura may be used in combination with another agent eg, a
thiazide diuretic, a -blocker, a calcium antagonist or an
angiotensin-converting enzyme inhibitor.
Benign Prostatic Hyperplasia: Treatment of clinical symptoms in
BPH and reduced urinary flow associated with BPH. Cardura may
be used in BPH patients who are either hyper- or normotensive.
While the blood pressure changes in normotensive patients with
BPH are clinically insignificant, patients with hypertension and
BPH have had both conditions effectively treated with Cardura
monotherapy.
Amino acid supplement. Helps in lipid, carbohydrate & protein
metabolism for energy production.
Adult & childn infections eg, pneumonia including nosocomial

pneumonia, UTI, intra-abdominal & gynecological infection
(including endometritis), skin & soft tissue infections, meningitis,
septicemia. Empiric treatment for inj in adult patients w/ febrile
neutropenia (as a monotherapy or combined therapy w/ antiviral
or antifungal). Polymicrobial infections.
Listed in Dosage.
Helps maintain cardiac health; antioxidant.
Hypertensive emergencies. Emergency treatment of acute

hypertensive crisis during surgery.
Maintenance of healthy joints.

Fibrinolytic & antioxidant agents.
OA & maintainance of healthy joints.
Casodex 50 mg: Treatment of advanced prostate cancer in

combination with LHRH analogue therapy or surgical castration.
Casodex 150 mg: As immediate therapy either alone or as
adjuvant to treatment by radical prostatectomy or radiotherapy in
patients with locally advanced prostate cancer (T3-T4, any N, MO;
T1-T2, N+, MO) (see Pharmacology: Pharmacodynamics under
Actions).
Management of patients with locally advanced, nonmetastatic
prostate cancer for whom surgical castration or other medical
intervention is not considered appropriate or acceptable.
Acute and chronic treatment of signs and symptoms of
rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.
Management of pain and primary dysmenorrhoea, when prompt
pain relief is desired.
Short-term treatment in acute migraine attacks and in
postoperative pain and inflammation following dental and
orthopaedic surgery.
Treatment of hypertension. Catapres may be employed alone or
concomitantly with other antihypertensive agents.
For the treatment of hypertensive crises, slow parenteral
administration is especially suitable due to rapid onset of action.
Supplemet to fulfill Ca, vit C, D3 & B6 requirements particularly in

pregnant & lactating women, menopause & elderly. Development
of healthy bones & teeth.
As calcium supplement in pregnancy and lactation. Prevention of

osteoporosis in menopausal women.
Oral & GIT candidiasis.
Ca, vit C, D & B6 supplement during pregnancy & lactation,

growth period, convalescence, malnutrition & malabsorption.
Helps in the development of bones & teeth.
Prevents reduction of bone density & osteoporosis due to

menopause or aging. Prophylaxis/treatment for osteoporosis due
to Ca & vit D deficiency. Treatment of osteomalacia. Enhances
bone fracture healing.
Upper & lower resp tract infections, upper & lower UTI,
peritonitis, cholecystitis, cholangitis, other intra-abdominal
infections, skin & soft tissue infections.
Skin aging, wrinkles, maintain visibly youthful skin,

complementary treatment post-peeling & -laser procedure.
Repairs superficial damage as well as soothes bruising, swelling &

rash. Used for wounds, cracks, scrape lesions, sutures, for pre- &
post-medical aesthetic procedure eg post-laser, pre- & post-inj of
fillers, aesthetic surgery, post-mesolift.
For face, neck & hand usage eg, chloasma, freckles, age spots,
hyperpigmentation post-inflammation, pre- & post-laser
intervention, pre- & post-peeling, post liqd nitrogen therapy.
Cedocard 5/Cedocard 10/Cedocard Retard 20 Angina pectoris,
prophylaxis of anginal attacks in chronic coronary diseases,
anginal disorders after MI, heart failure. Cedocard 20 Treatment &
prevention of angina pectoris; for treatment of severe, refractory
CHF. Cedocard IV infusion Unresponsive CHF, particularly after MI.
Control of refractory angina pectoris.
Uncomplicated UTI, otitis media, pharyngitis, tonsillitis, acute

bronchitis & acute exacerbations of chronic bronchitis,
uncomplicated gonorrhea.
Resp tract infections especially pneumonia, ENT infections; UTI;
genital infections including gonorrhoea; bone, joint, soft tissue,
skin & wound infections; sepsis; endocarditis; meningitis;
abdominal infections ie peritonitis, gallbladder infections, GI
infections; pre-op prophylaxis; infection in immunocompromised
patients.
Uncomplicated UTI, otitis media; pharyngitis, tonsillitis, acute

bronchitis, acute exacerbation of chronic bronchitis.
Resp tract, skin & soft tissue & GUT infection, osteomyelitis,
arthritis, septicaemia, peritonitis, puerperal sepsis.
Septicemia, subacute bacterial endocarditis, peritonitis, lower

resp tract infections; bone, skin & soft tissue infections;
gynecological infections; UTI; biliary tract infections;
otorhinological infections.
Uncomplicated gonorrhea, UTI, otitis media, pharyngitis &
tonsillitis, bronchitis, typhoid fever.
Septicemia, bacterial endocarditis, secondary wound or burn

infections, bronchitis, infected bronchiectasis, secondary
infections of chronic resp tract diseases, pneumonia, pulmonary
suppuration, pyothorax, cholangitis, cholecystitis, peritonitis,
pyelonephritis, cystitis, prostatitis, meningitis caused by H.
influenza.
Lower resp tract infections (pneumonia & bronchopneumonia),

complicated upper (pyelonephritis) & lower UTI, skin & soft tissue
infections, intra-abdominal infections (peritonitis & biliary tract
infections), severe or complicated gynaecologic infections,
septicaemia. Empiric treatment in febrile neutropenia.
Septicemia, febrile neutropenia, nosocomial pneumonia, infection
in the ICU & other severe infections.
Dosage/Directions for Use
3TC therapy should be initiated by a physician experienced in the management of HIV infection.
3TC can be taken with or without food. To ensure administration of the entire dose, the tablet(s) should ideally be
swallowed without crushing. For patients who are unable to swallow tablets, lamivudine is available as an oral solution.
Alternatively, the tablets may be crushed and added to a small amount of semisolid food or liquid, all of which should be
consumed immediately.
Adults and Adolescents Weighing at least 30 kg: The recommended dose is 300 mg daily. This may be administered as
150 mg (15 ml oral solution or 1 x 150 mg tablet) twice daily or 300 mg (30 ml oral solution or 2 x 150 mg tablet) once
daily.
Children >3 months and Weighing <30 kg: Oral Solution: The recommended dose is 4 mg/kg twice daily up to a
maximum of 300 mg daily.
Tablets: Children Weighing 21-30 kg: The recommended oral dose of lamivudine is tablet (150 mg) taken in the
morning and 1 whole tablet taken in the evening.
Children Weighing 14-21 kg: The recommended oral dose of lamivudine is of a scored tablet taken twice daily.
Since an accurate dosing cannot be achieved with this formulation, dosing according to weight bands is recommended
for 3TC tablets. This dosing regimen for paediatric patients weighing 14-30 kg is based primarily on pharmacokinetic
modelling, with supporting data from clinical studies.
Children <3 months: The limited data available are insufficient to propose specific dosage recommendations (see
Pharmacokinetics under Actions).
Elderly: No specific data are available, however special care is advised in this age group due to age-associated changes
eg, the decrease in renal function and alteration of hematological parameters.
Renal Impairment: Lamivudine plasma concentrations (AUC) are increased in patients with moderate to severe renal
impairment due to decreased clearance (see Pharmacokinetics under Actions). The dosage should therefore be reduced
for patients with a creatinine clearance <50 mL/min. The same percentage reduction in dose applies for pediatric
patients with renal impairment. When doses <150 mg are needed, the use of the oral solution is recommended. (See
Tables 1 and 2.)
Hepatic Impairment: No dose adjustment is necessary in patients with moderate or severe hepatic impairment unless
accompanied by renal impairment (see Pharmacokinetics under Actions).
Adults: Recommended Dosage: 100 mg once daily.
The dose in children has not yet been established.
Treatment discontinuation may be considered when HBe and HBs antigen seroconversion occurs. There is insufficient
data to confirm that seroconversion will be sustained once treatment with 3TC-HBV is stopped.
Patient compliance should be monitored while on therapy. If 3TC-HBV is discontinued, patients should be observed
carefully as there may be a small risk of exacerbation of hepatitis in some patients.
3TC-HBV should be initiated and monitored by a physician experienced in the management of chronic hepatitis B
infection.
Mild hemorrhage & prophylaxis 10 IU/kg as single-dose IV. Moderate hemorrhage 15-25 IU/kg IV. If required, repeated
doses of 10-15 IU/kg 8-12 hrly may be given. Severe hemorrhage Initially 40-50 IU/kg IV. Maintenance: 20-25 IU/kg 8-12
hrly. Surgery Pre-op dose: 50 IU/kg IV. To maintain hemostatic levels, repeated infusions may be necessary 6-12 hrly
initially & for 10-14 days until healing is complete.
Individualized dosage.
HTN & angina 5 mg once daily, may be increased to a max of 10 mg once daily.
Abbotic: Filmtab: Usual Recommended Dose: 250 mg twice daily. In more severe infections, the dosage can be increased
to 500 mg twice daily.
The usual duration of therapy is 7-14 days.
Treatment of Legionella pneumophila Infection: 500 mg twice daily for 4 weeks is appropriate.
In Patients with Renal Impairment (CrCl <30 mL/min): Dosage should be reduced by ie, 250 mg once daily or 250 mg
twice daily, in more severe infections. Treatment should not be continued beyond 14 days in these patients.
Administration: Abbotic filmtab may be given with or without meals (see Pharmacokinetics under Actions).
Note: In the treatment of haemolytic streptococcal infections, a therapeutic regimen should be administered at least 10
days.
Abbotic Granule: Dry Syrup: Children: Recommended Daily Dose: 7.5 mg/kg twice daily up to a maximum of 500 mg
twice daily for severe infections. The usual duration of treatment is 5-10 days depending on the pathogen involved and
the severity of the condition. Treatment for streptococcal pharyngitis should be at least 10 days.
Prepared suspension can be taken with or without meals and can be taken with milk.
The following is a guide for determining dosage in children based on body weight in kg: Dosage in standard 5 mL (125
mg/5mL): Children 30-40 kg: 2 tsp; 20-29 kg: 1.5 tsp; 12-19 kg: 1 tsp; 8-11 kg: 0.5 tsp. To be given twice daily.
Dosage in standard 5 mL (250 mg/5mL): Children 30-40 kg: 1 tsp; 20-29 kg: 0.75 tsp; 12-19 kg: 0.5 tsp. To be given twice
daily.
Children <8 kg should be dosed on a per kg basis (approximately 7.5 mg/kg twice daily).
Abbotic XL: Usual Recommended Dose: Adults: 500 mg once daily with food.
More Severe Infections: Dosage may be increased to 1000 mg once daily (2 x 500 mg).
The usual duration of therapy is 7-14 days.
Renal Impairment (CrCl <30 mL/min): Clarithromycin modified-release should not be used in patients with significant
renal impairment (CrCl <30 mL/min). Clarithromycin 500 mg immediate-release tablets may be utilized in this patient
population (see Contraindications).
Usual Dose: Schizophrenia: Adults: Recommended Starting and Target Dose: 10 or 15 mg once daily without regard to
meals.
Abilify Discmelt has been systematically evaluated and shown to be effective in a dose range of 10-30 mg daily. However,
doses higher than 10 or 15 mg daily were not more effective than 10 or 15 mg daily. Dosage increases should not be
made 2 weeks before the time needed to achieve steady state.
Adolescents: Starting Daily Dose: 2 mg titrated to 5 mg after 2 days and to the target dose of 10 mg after 2 additional
days. Subsequent dose increases should be administered in 5 mg increments. The 30 mg daily dose was not shown to be
more efficacious than the 10 mg daily dose.
Bipolar Disorder: Adults: Starting Dose: 30 mg once daily without regard to meals. A dose of 30 mg daily was found to be
effective when administered as the tablet formulation. Approximately 15% of patients had their dose decreased to 15
mg based on tolerability assessment. The safety of doses above 30 mg daily has not been evaluated in clinical trials.
Children and Adolescents: The efficacy of aripiprazole has been established in the treatment of children and adolescent
patients 10-17 years with bipolar I disorder at doses of 10 or 30 mg daily. Recommended Target Dose: 10 mg daily.
Starting Daily Dose: 2 mg daily titrated to 5 mg daily after 2 days and to the target dose of 10 mg after 2 additional days.
Subsequent dose increases should be administered without regard to meals.
Major Depressive Disorder: Adults: Recommended Starting Dose: Adjunctive Treatment for Patients Taking an
Antidepressants: 2-5 mg daily. The efficacy as an adjunctive therapy was established within a dose range of 2-15 mg
daily.
Dose adjustment of up to 5 mg daily should occur gradually at intervals of no less than 1 week.
Pediatric Patients 6-17 years: 5-15 mg daily. The dosage of Abilify Oral Solution should be individualized according to
tolerability and response. Dosing should be initialized at 2 mg daily. The dose should be increased to 5 mg daily with
subsequent increases to 10 or 15 mg daily, if needed. Dose adjustments of up to 5 mg daily should occur gradually at
intervals of no less than 1 week.
Schizophrenia: Recommended Starting and Target Dose: 10 or 15 mg once a day without regard to meals. Abilify has
been systematically evaluated and shown to be effective in a dose range of 10-30 mg/day, when administered as a tablet
formulation; however, doses >10 or 15 mg/day, the lowest doses in these trials, were not more effective than 10 or 15
mg/day. Dosage increases should be made before 2 weeks, the time needed to achieve steady state.
Special Populations: Dosage adjustments are not routinely indicated on the basis of age, gender, race or renal or hepatic
impairment status (see Pharmacokinetics under Actions).
Dosage Adjustments: Patients Taking Aripiprazole Concomitantly with Potential CYP3A4 or CYP2D6 Inhibitors: When
concomitant administration of CYP3A4 inhibitor eg, ketoconazole and potential CYP2D6 inhibitors eg, quinidine,
fluoxetine or paroxetine with aripiprazole occurs, aripiprazole dose should be reduced to of the usual dose. When the
CYP3A4 or CYP2D6 inhibitor is withdrawn from the combination therapy, aripiprazole dose should then be increased.
Patients Taking Potential CYP3A4 Inducers: When a potential CYP3A4 inducer eg, carbamazepine is added to aripiprazole
therapy, the aripiprazole dose should be doubled (to 20-30 mg). Additional dose increases should be based on clinical
evaluation. When carbamazepine is withdrawn from the combination therapy, the aripiprazole dose should be reduced
to 10-15 mg.
Maintenance Therapy: While there is no body of evidence available to answer the question of how long a patient treated
with aripiprazole should remain on it, systematic evaluation of patients with schizophrenia who had been
symptomatically stable on other antipsychotic medications for periods of =3 months were discontinued from those
medications, and were then administered Abilify 15 mg/day and observed for relapse during a period of up to 26 weeks,
demonstrated a benefit of such maintenance treatment (see Pharmacology under Actions). Patients should periodically
be reassessed to determine the need for maintenance treatment.
Switching From Other Antipsychotics: There are no systematically collected data to specifically address switching patients
with schizophrenia from other antipsychotics to Abilify or concerning concomitant administration with other
antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some
patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of
overlapping antipsychotic administration should be minimized.
Bipolar Disorder: Usual Starting Dose: 30 mg once a day. A dose of 30-mg/day was found to be effective when
administered as the tablet formulation. Approximately 15% of patients had their dose decreased to 15 mg based on
assessment of tolerability. The safety of doses >30 mg/day has not been evaluated in clinical trials.
Special Populations: See Schizophrenia.
Maintenance Therapy: While there is no body of evidence available to answer the question of how long a patient treated
with aripiprazole should remain on it, patients with bipolar I disorder who had been symptomatically stable on Abilify
tablets (15 or 30 mg/day with a starting dose of 30 mg/day) for at least 6 consecutive weeks and then randomized to
Abilify (15 or 30 mg/day) or placebo, and monitored for relapse demonstrated a benefit of such maintenance treatment
(see Pharmacology under Actions). While it is generally agreed that pharmacological treatment beyond an acute
response in mania is desirable, both for maintenance of the initial response and for prevention of new manic episodes,
there are no systematically obtained data to support the use of aripiprazole in such longer-term treatment (ie, beyond 6
weeks).
Complicated upper & lower UTI, skin & soft tissue infections 1 g. Lower resp tract infections 1 or 2 g.
Bactericaemia/septicaemia & infections in neutropenic patients 2 g. All doses are given 12 hrly.
Cap Adult & childn weighing =30 kg 50-100 mg twice daily. Severe or intractable infections May be increased up to 200
mg twice daily. Dry syr Childn 1.5-3 mg/kg twice daily. Severe or intractable infections May be increased up to 6 mg/kg
twice daily. Cervical/urethral gonorrhea 400 mg as single dose.
Adult and Children Aged 12 Years and Over: The dosage is one 20 mg tablet twice daily. This dosage should not be
exceeded. Higher doses may be associated with elevations of one or more liver enzymes consistent with hepatotoxicity.
Children: There is no clinical experience of the use of ACCOLATE in children under 12 years of age. Until safety
information is available, the use of ACCOLATE in children is contraindicated.
Elderly: The clearance of zafirlukast is significantly reduced in elderly patients (>65 years old), such that Cmax and AUC
are approximately twice those of younger adults. However, accumulation of zafirlukast is no greater than that seen in
multiple-dose trials conducted in adult subjects with asthma, and the consequences of the altered kinetics in the elderly
are unknown. Clinical experience with ACCOLATE in the elderly (>65 years old) is limited and caution is recommended
until further information is available.
Renal Impairment: No dosage adjustment is necessary in patients with mild renal impairment. However, experience is
limited in patients with moderate to severe renal impairment (see Pharmacology: Pharmacokinetics under Actions) so
clear dose recommendations cannot be given; ACCOLATE should be used with caution in this patient group.
Administration: ACCOLATE should be taken continuously. As food may reduce the bioavailability of zafirlukast, ACCOLATE
should not be taken with meals.
Adult & childn Open lesion Apply 3-4 times daily. Closed lesion Apply more frequent. Duration of therapy: Approx 7 days.
Initially 50 mg daily, may be increased to 100 mg daily. To be given 1-2 times daily.
Resp tract 1 tab daily (preferably at night). Paracetamol toxication (accidental or non-accidental) Early dose: 140 mg/kg.
10 hr after toxication: 70 mg/kg every 4 hr for 1-3 days. Uropathy from iso & cyclophosphamide 1 g 4 times daily.
Relief of pain 1-2 tab 4-6 hrly. Max: 8 tab/day. Patient w/ CrCl <30 mL/min Not >2 tab 12 hrly.
Loading dose: 150 mg/kg in 60 min, followed by subsequent dose w/ 50 mg/kg at slow infusion rate every 4 hr for 72-hr
treatment.
Adult Herpes simplex 200 mg 5 times daily 4 hrly w/o night dose for 5 days, may be increased to 400 mg daily.
Suppression of herpes simplex in immunocompetent patient 200 mg 4 times daily 6 hrly. Prophylaxis of herpes simplex in
immunocompromised patient 200 mg 4 times daily 6 hrly. Doses may be increased to 400 mg in severe
immunocompromised patients (post-bone marrow transplant) or indigestion. Herpes zoster 800 mg 5 times daily 4 hrly
w/o night dose for 5 days. Childn Treatment & prophylaxis of herpes simplex in immunocompromised patient Childn =2
yr Adult dose, <2 yr adult dose. Severe renal dysfunction (CrCl 10 mL/min) 200 mg twice daily 12 hrly. Herpes zoster in
patients w/ severe renal dysfunction 800 mg twice daily 12 hrly. Herpes zoster in patient w/ moderate renal dysfunction
(CrCl 10-25 mL/min) 800 mg 3 times daily.
Apply 5 times daily 4 hrly w/o night dose. Duration of treament: 5 days, may be continued until 10 days.
Adult & childn >12 yr 1 caplet 3 times daily. Childn 7-12 yr 2 tsp dry syr or 1 tsp forte dry syr, 3 times daily, 2-7 yr 1 tsp
dry syr or tsp forte dry syr, 3 times daily.
Osteoporosis in postmenopausal women & men; treatment & prevention of glucocorticoid-induced osteoporosis in
women & men 5 mg as a single IV infusion for =15 min once a yr. Patients w/ a recent low-trauma hip fracture Loading
dose of vit D 50,000-125,000 IU orally or IM is recommended prior to 1st Aclasta infusion. Paget's disease 5 mg as single
IV infusion.
1 cap daily.
1 cap daily.
Apply on pimples as required.
Adult Initially 5 mg 3-4 times daily. Max: 40 mg 3-4 times daily. Childn Initially 0.2 mg/kg in 3-4 times daily, may be
increased to max 0.8 mg/kg/day but not >20 mg daily.
Tab/Caplet Peptic ulcer 150 mg 2 times daily. Zollinger-Ellison syndrome 150 mg 2 times daily. Severe cases Up to 6
g/daily. Amp IM 50 mg/2 mL 6-8 hrly. IV intermittent bolus 50 mg (2 mL) 6-8 hrly.
Hypercalcemia due to malignancy 2,400 or 3,200 mg daily depending on patient's response which may be reduced
gradually to 1,600 mg. Osteolysis due to malignancy 1,600 mg daily, may be increased to max 3,200 mg if necessary.
Single infusion: 1,500 mg diluted in 500 mL of NaCl 9% or glucose 5% soln to be given as IV infusion over a 4-hr period.
Multiple infusion: 300 mg/day diluted in 500 mL soln to be given as IV infusion over a period of 2 hr until normocalcemia
is achieved or to max of 7 days.
Initially =10 mg once daily, adjusted at =4-wk intervals. Max: 80 mg once daily. Primary hypercholesterolemia &
combined or mixed hyperlipidemia 10 mg daily for 2 wk & up to 4 wk for max response. Homozygous familial
hypercholesterolemia 80 mg. Heterozygous familial hypercholesterolemia Childn 10-17 yr 10 mg daily. Max: 20 mg daily.
Initially 5 mg daily, may be increased to 10 mg daily. Elderly & patients w/ hepatic insufficiency Initially 2.5 mg once daily.
Initially 1 mg/day once daily. Daily dose may be increased at stepwise manner w/ 1-2 wk intervals between each step to
1 mg/day-2 mg/day-3 mg/day-4 mg/day & in exceptional cases, 4 mg/day. Max: 6 mg/day.
IV infusion For previously treated patients 350 mg/m2 for 30-90 min every 3 wk in monotherapy. For previously
untreated patients 180 mg/m2 for 30-90 min once every 2 wk in combination w/ 5-FU & FA. Patients w/ a bilirubin level
up to 1.5 times the ULN 350 mg/m2, 1.5-3 times the ULN 200 mg/m2.
Adult & childn >12 yr 1-2 g once daily. Severe infections Up to 4 g daily. Neonate <2 wk 20-50 mg/kg daily. Infant & childn
15 days-12 yr 20-80 mg/kg daily >50 kg Adult dose <50 kg Administer for minimum of 30 min. Meningitis 100 mg/kg
daily. Max: 4 g. Duration: N. meningitis 4 days. H. influenzae 6 days. S. pneumoniae 7 days. Gonorrhoea 250 mg IM as
single dose. Pre-op prophylaxis 1-2 g over 30-90 min.
Adult 0.25-0.5 mg 3 times daily, may be increased at intervals of 3-4 days in divided doses. Max: 4 mg. Elderly &
debilitated patients, severe liver dysfunction 0.25 mg 2-3 times daily, may be increased gradually.
Syrup: Adults and Children >12 years: 5 mL; 6-12 years: 2.5 mL; 2-6 years: 1.25 mL. All doses are to be taken 3 times a
day.
These dilutions should be stored at 25C.
Adults and Children >12 years: 5 mL; 6-12 years: 2.5 mL; 2-6 years: 1.25 mL. To be taken 3 times daily.
Adults and children >12 years: 5 mL; 6-12 years: 2.5 mL; 2-6 years: 1.25 mL. To be taken 3 times daily.
Actilyse should be given as soon as possible after symptom onset.
Myocardial Infarction: 90-min (accelerated) dose regimen in whom treatment can be started within 6 hrs after symptom
onset: 15 mg as an IV bolus, 50 mg as an infusion over the first 30 min, followed by an infusion of 35 mg over 60 min,
until the maximal dose of 100 mg. In patients with a body weight <65 kg, the total dose should be weight-adjusted with
15 mg as an IV bolus and 0.75 mg/kg body weight over 30 min (maximum of 50 mg), followed by an infusion of 0.5
mg/kg over 60 min (maximum of 35 mg).
3-hr dose regimen in whom treatment can be started between 6 and 12 hrs after symptom onset: 10 mg as an IV bolus,
50 mg as an IV infusion over the 1st hour, followed by infusions of 10 mg over 30 min, until the maximal dose of 100 mg
over 3 hrs. In patients with a body weight <65 kg, the total dose should not exceed 1.5 mg/kg.
The accepted maximum dose in acute myocardial infarction is alteplase 100 mg.
Adjunctive Therapy: Acetylsalicylic acid should be initiated as soon as possible after symptom onset and continued for
the 1st month after myocardial infarction. The recommended dose is 160-300 mg/day.
Heparin should be administered concomitantly for =24 hrs (at least 48 hrs with the accelerated dose regimen). It is
recommended to start with an initial IV bolus of 5000 units prior to thrombolytic therapy and to continue with an
infusion of 1000 units/hr. The dose of heparin should be adjusted according to repeated measurements of activated
partial thromboplastin time values (aPTT) of 1.5- to 2.5-fold of the initial value.
Pulmonary Embolism: A total dose of 100 mg should be administered in 2 hrs. Most experience available is with the
following dose regimen: 10 mg as an IV bolus over 1-2 min, 90 mg as an IV infusion over 2 hrs.
The total dose should not exceed 1.5 mg/kg in patients with a body weight <65 kg.
Adjunctive Therapy: After treatment with Actilyse, heparin therapy should be initiated (or resumed) when aPTT values
are less than twice the upper limit of normal. The infusion should be adjusted according to aPTT values of 1.5- to 2.5-fold
of the initial value.
Acute Ischaemic Stroke: Recommended Dose: 0.9 mg/kg (maximum of 90 mg) infused over 60 min with 10% of the total
dose administered as an initial IV bolus. Therapy should be initiated as early as possible within 3 hrs after onset of
symptoms.
Adjunctive Therapy: The safety and efficacy of this regimen with concomitant administration of heparin and
acetylsalicylic acid during the first 24 hrs after the symptom onset has not been sufficiently investigated. Therefore,
administration of acetylsalicylic acid or IV heparin should be avoided in the first 24 hrs after treatment with Actilyse. If
heparin is required for other indications (eg, prevention of deep vein thrombosis) the dose should not exceed 10,000
IU/day administered SC.
Administration: Instructions for Use/Handling: Under aseptic conditions, the contents of an injection vial of Actilyse (50
mg) dry substance is dissolved with water for injection (50 mL) to obtain a final concentration of 1 mg/mL. Thus, for
reconstitution to the final concentration of alteplase 1 mg/mL, the full volume of solvent provided should be transferred
to the vial containing Actilyse dry substance. For this purpose a transfer cannula is included with a pack size of 50 mg.
The reconstituted solution should then be administered IV as described above. The reconstituted solution may be
diluted further with sterile physiological saline solution (0.9%) up to a minimal concentration of 0.2 mg/mL.
It may not, however, be diluted with water for injections or carbohydrate infusion solutions eg, dextrose.
Actilyse must not be mixed with other drugs, neither in the same infusion-vial nor via the same venous line (not even
Treatment & prevention of postmenopausal osteoporosis 5 mg daily or 35 mg once wkly. Treatment & prevention of
glucocorticoid-induced osteoporosis 5 mg once daily.
Monotherapy: Recommended dose: 10 mg. Adults (previously untreated) 400 mg/m2 IV as a single dose administered in
15-60 min. Renal failure CrCl 41-59 mL/min 250 mg/m2 as a single dose, CrCl 16-40 mL/min 200 mg/m2 as a single dose.
Adult: Monotherapy: Starting Dose: 15 or 30 mg once daily. Combination Therapy: In combination with metformin or
sulfonylurea, may be initiated at 15 or 30 mg once daily. The current metformin or sulfonylurea dose can be continued
upon initiation of Actos therapy.
If patients report hypoglycemia, the dose of sulfonylurea should be decreased.
Elderly: No dosage adjustment is necessary for elderly patients.
Renal Impairment: No dosage adjustment is necessary in patients with impaired renal function (creatinine clearance >4
mL/min). No information is available from dialysed patients, therefore, Actos should not be used in such patients.
Hepatic Impairment: Actos should not be used in patients with hepatic impairment.
Administration: Tablets are taken orally, once daily with or without food.
General: The use of Actosmet in the management of type 2 diabetes should be individualized on the basis of
effectiveness and tolerability.
Dosage Recommendations: Usual Starting Dose: 15 mg/850 mg once or twice daily with food to reduce the
gastrointestinal side effects associated with metformin.
After initiation of Actosmet or with dose increase, patients should be carefully monitored for adverse events related to
fluid retention (see Warnings).
The dosage of Actosmet should be gradually titrated, as needed, based on the adequacy of the therapeutic response.
Maximum Daily Dose: 45 mg/2550 mg of pioglitazone/metformin. This maximal dosage should be administered in
divided doses with meals.
No studies have been performed specifically examining the safety and efficacy of Actosmet in patients previously treated
with other oral hypoglycaemic agents and switched to Actosmet. Any change in therapy of type 2 diabetes should be
undertaken with care and appropriate monitoring as changes in glycemic control can occur.
Sufficient time should be given to assess adequacy of therapeutic response. Ideally, the response to therapy should be
evaluated using HbA1c, which is a better indicator of long-term glycemic control than FPG alone. HbA1c reflects glycemia
over the past 2-3 months. In clinical use, it is recommended that patients be treated with Actosmet for a period of time
adequate to evaluate change in HbA1c (8-12 weeks) unless glycemic control as measured by FPG deteriorates.
Actrapid is a fast-acting insulin and may be used in combination with longer-acting insulin products. An injection should
be followed by a meal or a snack containing carbohydrates within 30 min.
Dosage is individualized and determined by the physician in accordance with the needs of the patient. The individual
insulin requirement is usually between 0.3 and 1 IU/kg daily. The daily insulin requirement may be higher in patients
with insulin resistance (eg, during puberty, in the young or due to obesity) and lower in patients with residual,
endogenous insulin production.
In patients with diabetes mellitus, optimized glycemic control delays the onset of late diabetic complications. Optimized
metabolic control, including close blood glucose monitoring, is therefore recommended.
Dosage Adjustment: Renal or hepatic impairment may reduce insulin requirement.
Administration: For SC and IV use.
Actrapid HM/Penfill is usually administered SC into the abdominal wall. The thigh, the gluteal region or the deltoid
region may also be used.
Subcutaneous injection into the abdominal wall ensures faster absorption than from other injection sites.
Injection into a lifted skinfold minimizes the risk of unintended IM injection.
Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy.
Intramuscular administrations are possible under guidance by a physician.
Actrapid HM/Penfill may also be administered IV, which should only be carried out by healthcare professionals.
Actrapid HM: Actrapid HM vials are for single-person use only with insulin syringes with the corresponding unit scale.
Injecting Actrapid HM on Its Own: Disinfect the rubber membrane. Draw the same amount of air into the syringe as the
dose of insulin needed. Inject the air into the vial by pushing the needle through the rubber stopper then press the
plunger.
Turn the vial and syringe upside down and draw the right insulin dose into the syringe. Withdraw the needle and expel
the air from the syringe and check if the dose is correct. Inject immediately.
Mixing Actrapid HM with Long-Acting Insulin: Disinfect the rubber membrane.
Just before use, roll the vial of long-acting insulin between the palms of the hands until the liquid is uniformly white and
cloudy.
Draw into the syringe the same amount of air as the dose of cloudy insulin. Inject the air into the vial containing cloudy
insulin and withdraw the needle.
Draw into the syringe the same amount of air as the dose of Actrapid HM needed. Inject the air into the Actrapid HM
vial. Turn the vial and syringe upside down and draw the right dose of Actrapid HM into the syringe. Withdraw the
needle and expel the air from the syringe and check the dose.
Push the needle into the vial of long-acting insulin, turn the vial and syringe upside down and withdraw the right dose.
Pull the needle out of the vial. Expel any air from the syringe and check the dose. Inject the mixture immediately.
Always mix fast-acting and long-acting insulin in this order.
How to Inject: Inject the insulin under the skin. Keep the needle under the skin for at least 6 sec to make sure the full
dose has been delivered.
Actrapid Penfill: Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or
NovoTwist needles.
Acuatim cream should be applied to the lesions twice daily, and in the case of acne vulgaris, Acuatim should be applied
after cleansing the skin.
Route and Method of Administration: Acuatim is intended for topical (dermal) application only and is not intended for
ophthalmological use. Acuatim should not be applied to the cornea or conjunctiva.
Adults: Usually 2 mL once a week for 5 consecutive weeks, administered by injection in the cavity of the knee joint.
Frequency of injection may be adjusted according to condition of the disease.
As Adant Dispo is injected into the joint, injection should be performed according to a strict aseptic procedure.
Administration: How to Use: After Adant Dispo is restored to room temperature, take out the syringe from the blister
pack.
Cut and sever by hand the tips of finger-wing at the central part of the syringe and expand it until it is fixed and firm.
Turn the stopper and pull it away.
Syringe needle (22-23 G size) is fixed by screwing it in.
Push the plunger rod and start administration. Before administration, the site of injection should be cleaned and
disinfected. After administration, separate the components of Adant Dispo kit and discard.
Initially 1-2 cap daily.
Apply thinly once daily. Duration: Adult Not >12 wk. Childn Not >4 wk.
Tablet: Adults and Children =12 years: Recommended Dose: 5 mg once daily.
Patients with Liver or Renal Impairment: Starting Dose: 1 tab every other day is recommended based on
pharmacokinetic data.
Syrup: Adults and Adolescents =12 years: 10 mL (5 mg) once daily.
Children 6-11 years: 5 mL (2.5 mg) once daily; 1-5 years: 2.5 mL (1.25 mg) once daily. All doses to be taken with or
without meals.
Adults and Adolescents =12 years: One (1) tab 2 times daily regardless of mealtime.
Administration: For oral use. May take with or without food. Do not chew, break or crush tab. Swallow whole.
Adult 1 cap twice daily.

Nasal spray Adult & childn =6 yr 2-3 spray in each nostril twice daily, in the morning & afternoon. Nasal drops Childn 2-5
yr 2 or 3 drops in each nostril twice daily, in the morning & afternoon.
Adult 75 mg once daily. Unstable angina or non-Q-wave MI 300 mg, then continued to 75 mg once daily.
Tab UTI 100-400 mg twice daily for 1-10 days. Severe & complicated infections Up to 600 mg daily for 20 days. Resp tract
infections 200-400 mg twice daily. Uncomplicated gonococcal urethritis & cervicitis (including PPNG infections) 200-600
mg as single dose. Non-gonococcal urethritis 400 mg daily in single or divided doses for 9 days. Skin & soft tissue, O&G
infections, bacterial enteritis 400 mg daily for 7 days.
Adult 6-10 drops twice daily. Childn Decrease adult dose.

1 caplet once daily.
Adult 1 cap once daily.
Adult 1 cap 3-4 times daily.
IV infusion only. Hypoproteinemia in acutely ill patient Adult 50-75 g at 2 mL/min. Shock Initially 20 g at 2-4 mL/min.
Total dose should not exceed 2 g/kg in the absence of active bleeding. Severe burns Usual dose: 20-80 g daily at 1
mL/min.
Local haemostasis Apply conc directly. Burns 1:3 to 1:8 dilutions of conc. Extensive burns Diluted conc alone or coating of
Albothyl gel or gauze pad over affected area. Vag supp To be inserted into the vagina. Gel Intravag application every
other day.
Alco drops Childn 2-5 yr 0.8 mL 3 times daily. Alco Plus syr/Alco Plus DMP syr Adult & childn >12 yr 5 mL. Childn 6-12 yr
2.5 mL, 2-5 yr 1.25 mL. To be taken 3 times daily.
Adult & childn =12 yr 1 cap twice daily.
Adult Initially 5 mg/day in the evening before bedtime for 1 mth then may be increased up to 10 mg once daily.
Adult 1 tab. Childn 6-12 yr tab, 2-6 yr tab. To be taken 3-4 times daily.
1 tab 4 times daily.
Adult & adolescent (=12 yr) 10 mL (5 mg). Childn 6-11 yr 5 mL (2.5 mg), 1-5 yr 2.5 mL (1.25 mg). All doses to be taken
once daily.
Initially 1-2 drops/hr in the morning & every 2 hr in the evening. Reduce to 1 drop 4 hrly & then to 1 drop 3-4 times daily.
25 mg: 1-4 softcaps daily. 100 mg: 1 softcap daily.

Combination Use with Cisplatin: The recommended dose of Alimta is 500 mg/m2 of body surface area (BSA)
administered as an IV infusion over 10 min on the 1st day of each 21-day cycle. The recommended dose of cisplatin is 75
mg/m2 BSA infused over 2 hrs approximately 30 min after completion of the pemetrexed infusion on the 1st day of each
21-day cycle.
Patients must receive adequate antiemetic treatment and appropriate hydration prior to and/or after receiving cisplatin.
Single Agent Use: Non-Small Cell Lung Cancer (NSCLC): In patients treated for NSCLC after prior chemotherapy, the
recommended dose of Alimta is 500 mg/m2 BSA administered as an IV infusion over 10 min on the 1st day of each 21-
day cycle.
Premedication Regimen: To reduce the incidence and severity of skin reactions, a corticosteroid should be given the day
prior to, on the day of and the day after pemetrexed administration. The corticosteroid should be equivalent to
dexamethasone 4 mg administered orally twice daily (see Precautions). To reduce toxicity, patients treated with
pemetrexed must also receive vitamin supplementation (see Precautions). Patients must take oral folic acid or a
multivitamin containing folic acid (350-1000 mcg) on a daily basis. At least 5 doses of folic acid must be taken during the
7 days preceding the 1st dose of pemetrexed and dosing must continue during the full course of therapy and for 21 days
after the last dose of pemetrexed. Patients must also receive an IM injection of vitamin B12 (1000 mcg) in the week
preceding the 1st dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be
given on the same day as pemetrexed.
Monitoring: Patients receiving pemetrexed should be monitored before each dose with a complete blood count,
including a differential white cell count (WCC) and platelet count. Prior to each chemotherapy administration, blood
chemistry tests should be collected to evaluate renal and hepatic function. Before the start of any cycle of
chemotherapy, patients are required to have the following: Absolute neutrophil count (ANC) should be =1,500 cells/mm3
and platelets should be =100,000 cells/mm3; CrCl should be =45 mL/min.
The total bilirubin should be =1.5 times upper limit of normal. Alkaline phosphatase (AP), aspartate transaminase (AST or
SGOT) and alanine transaminase (ALT or SGPT) should be =3 times upper limit of normal. Alkaline phosphatase, AST and
ALT =5 times upper limit of normal is acceptable if liver has tumour involvement.
Dose Adjustments: Dose adjustments at the start of a subsequent cycle should be based on nadir haematologic counts
or maximum non-haematologic toxicity from the preceding cycle of therapy. Treatment may be delayed to allow
sufficient time for recovery. Upon recovery, patients should be retreated using the guidelines in Tables 4, 5 and 6 (see
Tables 4,5 and 6), which are applicable for Alimta used as a single agent or in combination with cisplatin. (See Tables 4.)
If patients develop non-haematologic toxicities =Grade 3 (excluding neurotoxicity), Alimta should be withheld until
resolution to less than equal to the patient's pre-therapy value. Treatment should be resumed according to the
guidelines in Table 5. (See Table 5.)
In the event of neurotoxicity, the recommended dose adjustment for Alimta and cisplatin is documented in Table 6.
Patients should discontinue therapy if Grade 3 or 4 neurotoxicity is observed. (See Table 6.)
Treatment with Alimta should be discontinued if a patient experiences any haematologic or non-haematologic Grade 3
Alinamin: Usually, 1 tab daily or based on medical instructions.
Alinamin-F: Tablet: 1 tab daily after meals.
Ampoule: 10 mL, 1-2 times daily by slow IV.
Adult 1-2 tsp. Childn 7-12 yr 1-1 tsp, 2-6 yr -1 tsp. Infant - tsp. To be taken 3-4 times daily.
Dressing capacity: Up to 7 days except for the sacral area.

Adult & childn =12 yr 1 tab or 10 mL daily. Childn 2-12 yr >30 kg 10 mg (2 tsp) daily; <30 kg 5 mg (1 tsp) daily.
1 tab once weekly.
5 mg daily, may be increased to 10 mg daily following 1 mth clinical assessment.

Adult & childn >12 yr 900-1,800 mg/day. Day 1: 300 mg once daily. Day 2: 300 mg twice daily. Day 3: 300 mg 3 times
daily. The dose may be increased to 1,200 mg/day in 3 equally divided doses & if necessary, further titration can occur
using increments of 300 mg/day in 3 divided doses. Max: 2,400 mg/day. Patients w/ renal failure CrCl >60 mL/min 400
mg 3 times daily, 30-60 mL/min 300 mg twice daily, 15-30 mL/min 300 mg once daily, <15 mL/min 300 mg every other
day. Hemodialysis patients Initially 300-400 mg daily. Maintenance dose: 200-300 mg 4 hr after hemodialysis.
Anxiety 0.25-0.5 mg 3 times daily. Geriatric patients or in the presence of debilitating disease 0.25 mg 2-3 times daily.
100 mg/day by deep IM but may be increased to 200 mg in severe cases. The duration of administration can range from
5-10 days & may be continued through oral or rectal routes.
Chewable tab 1-2 tab between meals & at bedtime. Susp 1-2 tsp between meals & at bedtime.
Prevention: Single dose & w/in the 1st hr after birth is recommended. Treatment: Administered early in the course of
RDS, preferably <6 hr of age. Max: Should not exceed 216 mg total phospholipids/kg w/in the 1st 2 days of life.
Adult 0.25-0.5 mg 3 times daily. Geriatric or debilitated patients 0.25 mg 3 times daily.
Threatened abortion 1 tab 3 times daily for 5-7 days. May be extended if necessary. Habitual abortion 1-2 tab daily after
pregnancy is diagnosed, continue for =1 mth after the critical period. Threatened premature labour Individualized
dosage. Max: 40 mg daily.
5 mg once daily before bedtime for 1 mth. After 1 mth, doses may be increased to 10 mg once daily. Max daily dose: 10
mg.
1-8 mg daily. Initial dose & dose titration: 1 mg once daily. Daily dose may be increased at intervals of 1-2 wk, & carried
out stepwise as follows: 1 mg-2 mg-3 mg-4 mg-6 mg, & in exceptional cases, 8 mg.
1 caplet 1-2 times daily.

In principle, the dosage of Amaryl is governed by the desired blood sugar level. The dosage of glimepiride must be the
lowest which is sufficient to achieve the desired metabolic control.
Treatment with Amaryl must be initiated and monitored by a physician. Amaryl must be taken at the times and in the
doses prescribed. Mistakes eg, forgetting to take a dose, must never be corrected by subsequently taking a larger dose.
Measures for dealing with such mistakes (in particular, forgetting a dose or skipping a meal) or situations where a dose
cannot be taken at the prescribed time must be discussed and agreed between physician and patient beforehand. A
physician must be notified immediately if the dose taken is too high, or an extra dose has been taken.
The initial and the maintenance doses are set based on the results of regular checks of glucose in blood and urine.
Monitoring of glucose levels in blood and urine also serves to detect either primary or secondary failure of therapy.
Initial Dose and Dose Titration: Usual Initial Dose: 1 mg once daily. If necessary, the daily dose can be increased. Any
increase should be based on regular blood sugar monitoring and should be gradual ie, at intervals of 1-2 weeks, and
carried out stepwise, as follows: 1 mg - 2 mg - 3 mg - 4 mg and in exceptional cases, 8 mg.
Usual Dose Range in Patients with Well-Controlled Diabetes: 1-4 mg daily. Only some patients benefit from daily doses of
>6 mg.
Distribution of Doses: Timing and distribution of doses are decided by the physician, taking into consideration the
patient's current lifestyle. Normally, a single daily dose of Amaryl is sufficient. The dose should be taken immediately
before a substantial breakfast or, if none is taken, immediately before the first main meal. It is very important not to skip
meals after taking Amaryl.
Secondary Dosage Adjustment: As the control of diabetes improves, sensitivity to insulin increases, therefore,
glimepiride requirements may fall as treatment proceeds. To avoid an excessive reduction in blood sugar
(hypoglycaemia), a timely dose reduction or cessation of Amaryl therapy must be considered.
A dose adjustment must also be considered whenever the patient's weight or lifestyle changes, or other factors causing
an increased susceptibility to hypoglycaemia or to an excessive increase in blood sugar levels (hyperglycaemia) arise (see
Precautions).
Duration of Treatment: Treatment with Amaryl is normally a long-term therapy.
Changeover from Other Oral Antidiabetics to Amaryl: There is no exact dosage relationship between Amaryl and other
oral blood sugar-lowering agents. When substituting Amaryl for other such agents, the initial daily dose is 1 mg; this
applies even in changeovers from the maximum dose of another oral blood sugar-lowering agent. Any Amaryl dose
increase should be in accordance with guidelines given previously in Initial Dose and Dose Titration.
Consideration must be given to the potency and duration of action of the previous blood sugar-lowering agent. It may be
necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.
Use in Combination with Metformin: Whenever blood sugar levels cannot be controlled adequately with the maximum
daily dose of either Amaryl or a metformin-containing antidiabetic alone, both medicines may be used concomitantly. In
such cases, the dose of the established medicine remains unchanged. Treatment with the additional medicine is started
at a low dose which, depending on the desired blood sugar level, may then be increased gradually up to the maximum
daily dose. Combined treatment should be initiated under close medical supervision.
Use in Combination with Insulin: Whenever blood sugar levels cannot be controlled adequately with the maximum daily
dose of Amaryl, insulin may be given concomitantly. In this case, the current dose of Amaryl remains unchanged. Insulin
Dosage should be individualized based on the patient's blood glucose levels. Generally, it should be recommended to
initiate the lowest effective dose and increase the dose depending on the patient's blood glucose levels. Adequate
monitoring of blood glucose levels should be performed.
Amaryl M should be administered once or twice per day, before or with a meal.
When switching from combination therapy of glimepiride plus metformin as separate tablets, Amaryl M should be
administered on the basis of dosage currently being taken.
Adult & childn >20 kg 250-500 mg 4 times daily. Childn <20 kg 50-100 mg/kg/day in 4 divided doses. Gonococcal
urethritis 3.5 g ampicillin w/ 1 g probenecid as a single dose.
Hypertension and Angina: Adults: Initially 5 mg once daily, may be increased to maximum dose of 10 mg depending on
the individual patient's response and severity.
Small, Fragile or Elderly Patients or Hepatic Insufficiency: May be started on 2.5 mg once daily and this dose may be used
when adding amlodipine to other antihypertensive therapy.
Majority of hypertensive patients taking 5 mg/day, the dose may not necessarily be increased. For those who need
higher dose, amlodipine can be increased to 7.5 mg/day with maximum dose of 10 mg/day.
Chronic Stable or Vasospastic Angina: Recommended Dose: 5-10 mg, with the lower dose suggested in the elderly and in
patients with hepatic insufficiency. No dose adjustment of amlodipine is required upon concomitant administration of
thiazide diuretics, -blockers and ACE inhibitors.
Children: No experience is available on the use of amlodipine in children.
Chronic kidney insufficiency GFR 5 & 50 mL/min 4-8 FC caplet 3 times daily.
Adult: Usual Dose: 500 mL/dose via peripheral vein infusion. The usual infusion rate in adults is 500 mL/120 min and
should be slowed in the elderly and critically ill patients. The dosage may be adjusted according to the patient's
condition, body weight and age. Maximum Dosage: 2500 mL/day.
Method of mixing 2 solutions (never fail to mix 2 solutions): Be sure to press the lower chamber to break the center seal
between the 2 chambers. When the upper chamber is pressed, the checker does not open. To open the package: Tear
outer wrap at notch and remove solution container. To break the center seal: Press the lower chamber with both hands
until the center seal breaks immediately after removing the product. The checker opens upon the seal breaking. (Admix
other drugs, when needed, after mixing 2 solutions). To mix: Remove the open checker and press both chambers
alternately to mix the solutions thoroughly.
Adults: Usual Dose: 500-1000 mL/dose by IV drip infusion. Usual Peripheral Infusion Rate: 500 mL over 180-300 min
(approximately 25-40 drops/min) in adults. For total parenteral nutrition, 500-1000 mL of Aminoleban Infusion should be
suitably combined with dextrose solutions and administered over 24 hrs via the central vein. The dosage may be
adjusted depending on the patient's age, symptoms and body weight.
1.5-2.5 g amino acids/kg body wt/day.

Adults: Internal Disorder or Presurgical Protein Deficiency: Usual Dosage: 500 mL by IV drip infusion over 4-6 hrs (20-30
drops/min) simultaneously or followed by a 10% sugar solution 500 mL over 2 hrs (60-80 drops/min). These infusions are
repeated at 12-hr intervals for 5-7 days. The intervals may be prolonged to 24 hrs according to patient's condition and
response.
Postsurgical Impairment of Protein Synthesis: Usual Dosage: 500 mL by IV drip infusion over 4-6 hrs (20-30 drops/min)
following drip infusion of Darrow's solution 1000 mL over 4 hrs (60-100 drops/min) and followed by drip infusion of a
10% sugar solution 500 mL over 2 hrs (60-100 drops/min). These infusions are started on the 3rd postsurgical day and
repeated at 24-hr intervals for 5-7 days.
IM Neonates Initially 10 mg/kg/day, followed by 7.5 mg/kg 12 hrly. Max: 15 mg/kg/day or 1.5 g/day. Duration of therapy:
7-10 days. IV Infusion Adult & childn 500 mg in 100-200 mL of 0.9% NaCl or 5% Dextrose soln infused over 30-60 min.
Infant Adult dose infused over 1-2 hr.
Central Vein Infusion: Usual Adult Dosage: 1000 mL/day by drip infusion via the central vein.
Peripheral Vein Infusion: Usual Adult Dosage: 500 mL/dose by drip infusion via the peripheral vein. The usual peripheral
infusion rate is such a rate as to provide about 10 g of amino acids over 60 min of infusion in order to achieve optimal
physiological utilization of amino acids. A typical infusion rate in adults is 100 mL over 60 min (about 25 drops/min), and
the rate should be adjusted downward in the case of children, elderly patients and severely ill patients.
The dosage may be increased or decreased depending on the patient's age, symptoms and body weight.
Combination of Amiparen with a carbohydrate solution is highly recommended for efficient utilization of amino acids in
the body.
Adult Usual dose: Chronic renal failure 200 mL/day via peripheral vein w/ infusion rate of 100 mL over 60 min (25
drops/min) or 400 mL/day via central vein by TPN. Acute renal failure 600 mL/day via central vein by TPN. >300 kCal of
non-protein cal/g of nitrogen should be administered for efficiency of amino acid utilization. Childn, elderly, seriously ill
patients Individualized dosage via slow infusion.
HTN Initially 5 mg once daily. Max: 10 mg daily. Fragile, elderly patients or patients w/ liver insufficiency Initially 2.5 mg
once daily. Chronic stable & vasospastic angina 5-10 mg once daily.
Adult Internal disorder of presurgical protein deficiency Usual dosage: 500 mL by IV drip infusion over 4-6 hr (20-30
drops/min) simultaneously or followed by drip infusion of Darrow's soln 1000 mL over 4 hr (60-100 drops/ min) &
followed by drip infusion of a 10% sugar soln 500 mL over 2 hr (60-80 drops/min). Post-op impairment of protein
synthesis Usual dosage: 500 mL by IV drip infusion over 4-6 hr (20-30 drops/min) following drip infusion of Darrow's soln
1,000 mL over 4 hr (60-100 drops/min).
Cap/Dispersible tab Adult & childn =20 kg 250-500 mg 8 hrly. Childn <20 kg 20-40 mg/kg 8 hrly in divided doses. Syr
Childn >8 kg 125-250 mg 8 hrly. Paed drops All indications except infections of lower resp tracts, Childn =6 mth 6-8 kg
0.5-1 mL 8 hrly, =6 kg 0.25-0.5 mL 8 hrly. Infections of lower resp tract Childn =6 mth 6-8 kg 1-1.5 mL 8 hrly, =6 kg 0.5-1
mL 8 hrly. Inj Adult 250-500 mg IM 8 hrly. 500 mg-1 g IV/infusion 6 hrly in severe infections. Childn 35-100 mg/kg/day IM
in divided doses or up to 100 mg/kg/day IV/infusion in divided doses 6 hrly over 30-min infusion. Typhoid & paratyphoid
Adult 4 g daily in divided doses for 14-21 days. Childn 100 mg/kg/day in divided doses for 14-21 days. Typhoid carrier
states 3-4 g daily in divided doses for min of 1 mth. Gonorrhea Single dose of 3 g + 1 g probenecid. Uncomplicated UTI
Single dose of 3 g. Syphilis 250 mg 6 hrly for 4 wk up to 5 mth. Severe or recurrent lower resp tract infection 3 g twice
daily. Dental abscess 3 g twice daily 8 hrly. Otitis media Adult & childn 3-10 yr 750 mg 2 times daily for 2 days.
Adult & childn =12 yr 4-48 mg/day. Childn <12 yr 416 mcg-1.7 mg/kg/day.
Adult & Childn =12 yr 4-48 mg/day. Childn <12 yr 416 mcg-1.7 mg/kg/day.
Chronic venous disease 2 caplet daily. Acute hemorrhoidal attacks 6 caplet for the 1st 4 days, then 4 caplet daily for 3
days, 2 caplet thereafter. Chronic hemorrhoids 2 caplet daily.
Adult 1 caplet, if pain persist, followed by 1 cap 6-8 hrly. Max: 4 caplet daily.
Adult & adolescent =16 yr Initially 2 caplet/day & as needed in not <6 hr dose interval. Max dose: 8 caplet/day.
Caplet Adult & childn >12 yr 250 mg 2 times daily, may be increased up to 500 mg 2 times daily. Infant & childn =12 yr
125 mg 2 times daily. Uncomplicated UTI 125-250 mg 2 times daily. Uncomplicated gonococcal urethritis 1 g as a single
dose. Otitis media Childn =2 yr 250 mg, <2 yr 125 mg. To be taken 2 times daily. Inj Adult 750 mg-1.5 g 8 hrly IM or IV for
5-10 days. If necessary, may increase to 3-6 g/day 6 hrly. Childn & infant >3 mth 50-100 mg/kg/day 6-8 hrly, severe &
serious infections: 100 mg/kg/day. Bone & joint infections 150 mg/kg/day 8 hrly (not exceeding max dosage of adult).
Bacterial meningitis 200-240 mg/kg/day IV 6-8 hrly.
Adult 150 mg twice daily, morning & evening. Childn >4 yr 5-8 mg/kg daily in 2 divided doses & not for >10 days.
Adult & childn >40 kg 1-2 g daily in 2 divided doses. Childn <40 kg 25 mg/kg daily in 2 divided doses.
FC tab Adult & childn >12 yr Mild to moderate infections tab 3 times daily. Severe infections 1 tab 3 times daily. Dry
susp Childn 31.25 mg/kg daily in divided doses every 8 hr. >6 yr 5 mL 3 times daily; 1-6 yr 2.5 mL 3 times daily; <1 yr 1 mL
3 times daily.
Apply sparingly 3 times daily.

Folic acid deficiency Initially 0.25-1 mg/day. Maintenance: 0.25-0.5 mg/day. Supplement in pregnancy & lactation 0.5-1
mg/day. Megaloblastic anemia 0.5-1 mg/day.
IM Pre-op med Adult 0.07-0.1 mg/kg. Elderly & debilitated patients 0.025-0.05 mg/kg to be administered 30 min before
induction of anesth. IV Basal sedation Initially 2.5 mg 5-10 min pre-op. Severe illness Initially 1-1.5 mg. Max total dose:
3.5 mg. Induction of anesth & conscious sedation 10-15 mg.
Initially 2.5 mg once daily, may be increased by doubling the dose at intervals of 2-3 wk. Usual maintenance dose is 2.5-5
mg daily, max dose of 10 mg daily.
Cap/caplet Adult & childn >30 kg 50-100 mg twice daily, may be increased to 200 mg twice daily for more severe cases.
Dry syr 1.5-3 mg/kg twice daily. Typhoid fever in childn 10-15 mg/kg/day for 2 wk.
1 tab in the morning & evening.

1-8 mg daily. Initial dose & dose titration: 1 mg once daily, may be increased at intervals of 1-2 wk & stepwise as follows:
1 mg, 2 mg, 3 mg, 4 mg, 6 mg & in exceptional cases, 8 mg.
100 mg twice daily.
Initially 20 mg daily. Max: 80 mg/day in single or divided dosage.

Drag Adult 1 drag. Syr Adult 2 tsp. Childn 6-12 yr 1 tsp. To be taken 3-4 times daily.
Adult Initially 100-150 mg daily in 2-3 divided doses. Pain management & OA Max dose: 150 mg/day. RA Max dose: 225
mg/day. Ankylosing spondylitis Max dose: 125 mg/day. Migraine Initially 50 mg at the 1st signs of an impending attack.
In cases where pain relief w/in 2 hr after the 1st dose is not sufficient, dose may be repeated. Further doses may be
taken 4-6 hrly, if needed. Max dose: 200 mg/day.
Adult 1-2 sugar-coated tab daily. Prevention of motion sickness sugar-coated tab 1 hr before travelling & when
necessary. Childn 6-12 yr adult dose.
Childn 7-12 yr 5 mL 2 times daily, 1-6 yr 5 mL once daily, 6 mth-1 yr 2.5 mL once daily.
Syr Adult & childn >5 yr 1-2 tsp once daily. Childn 2-5 yr 1 tsp once daily. Drops Childn 1-3 yr 0.6 mL once daily, <12 mth
0.3 mL once daily.
Apidra is a recombinant human insulin analogue that has been shown to be equipotent to regular human insulin. It has
more rapid onset and a shorter duration of action than regular human insulin.
Apidra should be given shortly (0-15 min) before or soon after meals. It should be used in regimens that include a longer-
acting insulin or basal insulin analogue and can be used with oral hypoglycemic agents. The dosage of Apidra should be
individually adjusted.
Administration: Apidra should be given by SC injection or by continuous SC pump infusion. Apidra should be
administered SC in the abdominal wall, the thigh or upper arm or by continuous infusion in the abdominal wall. As for all
insulins, injection and infusion sites within an injection area (abdomen, thigh or deltoid) should be rotated from one
injection to the next. As for all insulins, the rate of absorption and consequently, the onset and duration of action, may
be affected by the injection site, exercise and other variables.
Subcutaneous injection in the abdominal wall ensures a slightly faster absorption than other injection sites. Care should
be taken to ensure that blood vessel has not been entered. After administration, the site of injection should not be
massaged. Patients must be educated to use proper injection techniques.
Mixing with Insulins: Apidra must not be mixed with any preparation other than Neutral Protamine Hagedorn (NPH)
human insulin. If Apidra is mixed with NPH human insulin, Apidra should be drawn into the syringe first. Injection should
be given immediately after mixing. No data are available on mixing insulin glulisine with insulin preparations other than
NPH human insulin.
Continuous Subcutaneous Infusion Pump: Apidra may be used for Continuous Subcutaneous Insulin Infusion (CSII) in
pump systems suitable for insulin.
Special Populations: Renal Impairment: The pharmacokinetic properties of insulin glulisine are generally maintained in
patients with renal impairment. However, insulin requirements may be reduced in the presence of renal impairment (see
Hepatic Impairment: The pharmacokinetic properties of insulin glulisine have not been investigated in patients with
decreased liver function. In patients with hepatic impairment, insulin requirements may be diminished due to reduced
capacity for gluconeogenesis and reduced insulin metabolism.
Elderly: Limited pharmacokinetic data are available in elderly patients with diabetes mellitus. Deterioration of renal
function may lead to a decrease in insulin requirements.
Children and Adolescents: There is no adequate clinical information on the use of Apidra in children and adolescents.
Apply 2-3 times daily.

Initially 75 mg twice daily. May be increased to 150 mg twice daily at 3-7 daily interval. Max: 300 mg twice daily.
Usual Recommended Initial Maintenance Dose: 150 mg once daily, with or without food. Aprovel, at a dose of 150 mg
once daily generally provides a better 24-hr blood pressure control than 75 mg. However, initiation of therapy with 75
mg could be considered, particularly in haemodialysed patients and in the elderly >75 years.
In patients insufficiently controlled with 150 mg once daily, the dose can be increased to 300 mg or other
antihypertensive agents can be added. In particular, the addition of a diuretic eg, hydrochlorothiazide has been shown to
have an additive effect with Aprovel (see Interactions).
Hypertensive Type 2 Diabetic Patients: Therapy should be initiated at irbesartan 150 mg once daily and titrated up to 300
mg once daily as the preferred maintenance dose for treatment of renal disease.
The demonstration of renal benefit of Aprovel in hypertensive type 2 diabetic patients is based on studies where
irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see
Intravascular Volume Depletion: Volume- and/or sodium-depletion should be corrected prior to administration of
Aprovel.
Children: The safety and efficacy of Aprovel have not been established in children.
Elderly: Although considerations should be given to initiating therapy with 75 mg in patients >75 years, dosage
adjustment is not usually necessary for the elderly.
Renal Impairment: No dosage adjustment is necessary in patients with impaired renal function. A lower starting dose (75
mg) should be considered for patients undergoing haemodialysis.
Hepatic Impairment: No dosage adjustment is necessary in patients with mild to moderate hepatic impairment. There is
no clinical experience in patients with severe hepatic impairment.
Adult 100-150 mg daily. Milder cases & childn >14 yr 75-100 mg daily. Daily dose should be given in 2-3 divided doses.
2 tabs a day.
Adult 250-500 mg. Childn up to 10 yr 125 mg. To be taken 3 times daily.
Adult & childn >12 yr 2 tab/tsp after stool (max 12 tab/tsp daily), 6-12 yr 1 tab/tsp after stool (max 6 tab/tsp daily).
Arcoxia is administered orally. It may be taken with or without food. Recommended Dose: Arthritis/Osteoarthritis: 60 mg
once daily. Analgesia/Acute Pain Associated with Dental Surgery: 120 mg once daily. Arcoxia 120 mg should be used only
for the acute symptomatic period.
Chronic Musculoskeletal Pain: 60 mg once daily.
Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not
been studied. Therefore, the dose for each indication is the maximum recommended dose.
Hepatic Insufficiency: In patients with mild hepatic insufficiency (Child-Pugh score 5-6), a dose of 60 mg once daily
should not be exceeded. In patients with moderate hepatic insufficiency (Child-Pugh score 7-9), the dose should be
reduced; a dose of 60 mg every other day should not be exceeded. There are no clinical or pharmacokinetic data in
patients with severe hepatic insufficiency (Child-Pugh score >9). (See Precautions.)
Renal Insufficiency: In patients with advanced renal disease (CrCl <30 mL/min), treatment with Arcoxia is not
recommended. No dosage adjustment is necessary for patients with lesser degrees of renal insufficiency (CrCl =30
mL/min). (See Precautions.)
Elderly, Gender, Race: No dosage adjustment in Arcoxia is necessary.
Acute Hemorrhoid: 6 tablets daily for 4 days, then 4 tablets daily for the next 3 days.
Chronic Hemorrhoid and Venous Insufficiency: 2 tablets daily for 2 months.
Dilute 4 mL in 1L of 5% dextrose soln or 5% dextrose-NaCl soln. Initially 2-3 mL/min via IV infusion. Maintenance: 0.5-1
mL/min.
Adult 400 mg 3-4 times daily. Analgesia 200-400 mg 3-4 times daily.
Adult & childn >12 yr 1 tab 3 times daily, childn 6-12 yr 1 tab twice daily (morning & evening). Max duration of therapy: 3
wk.
5 mg daily, may be increased to 10 mg/day following 1 mth clinical assessment.
Adult & elderly Mild to moderate Alzheimer's disease Initially 5 mg/day in the evening (prior to retiring). Dose can be
increased to 10 mg/day after at least 1 mth of clinical assessment of treatment at 5 mg/day. Max: 10 mg/day. Severe
Alzheimer's disease 10 mg/day, only after daily dose of 5 mg for 4-6 wk. If not tolerated, reduce to 5 mg.
OA 7.5 mg once daily, may be increased to 15 mg once daily. RA 15 mg once daily, may be reduced to 7.5 mg once daily.
Patient w/ kidney failure Max: 7.5 mg once daily.
Adults Including the Elderly: 1 tab to be taken orally once a day.
Patients with Advanced Breast Cancer: Arimidex should be continued until tumor progression.
Children: Not recommended for use in children.
Renal Impairment: No dose change is recommended in patients with mild or moderate renal impairment.
Hepatic Impairment: No dose change is recommended in patients with mild hepatic disease.
Starting and target dose: 10 or 15 mg once daily.

Adults: Prevention of Venous Thromboembolic Events (VTE): Orthopaedic and Abdominal Surgery: Recommended Dose:
2.5 mg once daily, administered postoperatively by SC injection.
The timing of the 1st dose should be no earlier than 6 hrs following surgical closure and only after haemostasis has been
established (see Precautions).
Treatment should be continued until the risk of venous thromboembolism has diminished, usually until the patient is
ambulant, at least 5-9 days after surgery. Experience shows that in patients undergoing hip fracture surgery, the risk of
VTE continues beyond 9 days after surgery. In these patients, the use of prolonged prophylaxis with Arixtra should be
considered for up to an additional 24 days (see Clinical Studies under Actions).
Patients at Risk of Thromboembolic Complications: Recommended Dose: 2.5 mg once daily administered by SC injection.
A treatment duration of 6-14 days has been clinically studied in medical patients (see Clinical Studies under Actions).
Treatment of DVT & PE: The recommended dose of Arixtra to be administrated by SC inj daily is 5 mg for body weight
<50 kg, 7.5 mg for body weight 50-100 kg, 10 mg for body weight >100 kg. Treatment should be continued for at least 5
days and until adequate oral anticoagulant is established (International Normalized Ratio 2-3). Concomitant treatment
with vitamin K antagonist should be initiated as soon as possible, usually within 72 hrs. The usual duration of Arixtra
treatment is 5-9 days (see Clinical Studies under Actions).
Treatment of Unstable Angina/Non-ST Segment Elevation Myocardial Infection (UA/NSTEMI): Recommended Dose: 2.5
mg once daily, administered by SC injection. Treatment should be initiated as soon as possible following diagnosis and
continued for up to 8 days or until hospital discharge.
If a patient is to undergo percutaneous coronary intervention (PCI), while on Arixtra, unfractionated heparin (UFH) as per
standard practice should be administered during PCI, taking into account the patient's potential risk of bleeding,
including the time since the last dose of Arixtra (see Precautions).
The timing of restarting Arixtra SC after sheath removal should be based on clinical judgment. In the UA/NSTEMI clinical
trial, treatment with Arixtra was restarted no earlier than 2 hrs after sheath removal.
In patients who are to undergo coronary artery bypass graft (CABG) surgery, Arixtra, where possible, should not be given
during the 24 hrs before surgery and may be restarted 48 hrs postoperatively.
Treatment of ST Segment Elevation Myocardial Infarction (STEMI): Recommended Dose: 2.5 mg once daily. The1st dose
of Arixtra is administered IV and subsequent doses are administered by SC injection. Treatment should be initiated as
soon as possible following diagnosis and continued for up to 8 days or until hospital discharge if that occurs earlier.
If a patient is to undergo non-primary PCI while on Arixtra, UFH as per local practice should be administered during PCI,
taking into account the patient's potential risk of bleeding, including the time since the last dose of Arixtra (see
Precautions).
The timing of restarting Arixtra SC after sheath removal should be based on clinical judgment. In the pivotal STEMI
clinical trial, treatment with Arixtra was restarted no earlier than 3 hrs after sheath removal.
In patients who are to undergo CABG surgery, Arixtra where possible, should not be given during the 24 hrs before
surgery and may be restarted 48 hrs postoperatively.
Special Populations: Children: The safety and efficacy of Arixtra in patients <17 years has not been established.
Elderly =75 years: Arixtra should be used with caution in elderly patients as renal function decreases with age (see Renal
Impairment
Parkinsonismas1st follows
day: 1and
mg.Precautions).
2nd day: 2 mgIn w/
patients undergoing
further increase ofsurgery, the timing
2 mg daily of the
at 3-5 days 1st dose
interval, upoftoArixtra
6-10 mgrequires
daily in 3-
4 divided doses. Some patients may require total dose of 12-15 mg daily. Drug-induced parkinsonism 5-15 mg daily,
advisable to initiate therapy w/ single 1 mg dose. Patient >65 yr Smaller doses required.
Patients w/ normal kidney function Acute exacerbation of chronic bronchitis 500 mg/day for 7 days. Community-
acquired pneumonia 500 mg/day for 7-14 days. Acute maxillary sinusitis 500 mg/day for 10-14 days. Skin infections 500
mg/day for 7-10 days. Complicated UTI 250 mg/day for 10 days. Acute pyelonephritis 250 mg/day for 10 days. Patient w/
CrCl 20-49 mL/min Initially 500 mg followed by 250 mg/day, CrCl 10-19 mL/min Initially 500 mg followed by 250 mg/48
hr; Haemodialysis Initially 500 mg, followed by 250 mg/2 days; CAPD Initially 250 mg, followed by 250 mg/2 days.
1 cap daily.
25 mg once daily until tumour progression is evident.

1 drop in each eye once daily.
Adult 75 mg once daily. Unstable angina 300 mg, then reduce to 75 mg once daily.
Tab Initially 1200 mg daily. Maintenance: 600-800 mg daily. To be taken in 3-4 divided doses. Susp Adult 2 tsp 3-4 times
daily. Childn 8-12 yr 2 tsp, 3-7 yr 1 tsp, 1-2 yr tsp. All doses to be taken 3-4 times daily.
Adult 1 tab 3-4 times daily.

1-2 cap daily.
Childn >6 yr 1 tbsp twice daily; <6 yr -1 tbsp twice daily.
Dose is adjusted according to the individual need.

In general, individual capacity to metabolize glucose is around 500 mg/kg body weight/hr.
Adult & childn >14 yr Initially 500 mg, followed by 250 mg 6 hrly.
Adult 1-2 tab 3-4 times daily. Childn -1 tab up to 2 times daily.
Adult 0.5- 2 g daily IV/IM.
1 tab once daily.

1 caplet daily.
1 FC caplet once daily.
1 cap daily.
Tab Adult 2-4 mg, childn 6-12 yr 2 mg, 2-6 yr 1-2 mg. Syr Adult 5-10 mL, childn 6-12 yr 5 mL, 2-6 yr 2.5-5 mL. All doses
are to be taken 3-4 times daily.
1 cap daily.
1 softcap daily.
Anxiety 0.25-0.5 mg 3 times daily. Geriatric patients or in the presence of debilitating disease 0.25 mg 2-3 times daily.
Adult 50 mcg twice daily. Childn >6 yr 25 mcg (or 5 mL syr) twice daily; <6 yr 1.125 mcg or 0.2-0.25 mg/kg body wt twice
daily.
Usual dose: 10 mg once daily. Range: 10-80 mg once daily. Primary hypercholesterolemia & combined or mixed
hyperlipidemia 10 mg daily for 2 wk & up to 4 wk for max response. Homozygous familial hypercholesterolemia 80 mg.
Heterozygous familial hypercholesterolemia in ped patients 10-17 yr 10 mg daily. Max: 20 mg daily. Dose adjustment
should be made at =4 wk intervals.
Apply to affected area 3 times daily & massage gently into the skin.
Initially 10 mg once daily at range of 10-80 mg once daily. Primary hypercholesterolemia & combined (mixed)
hyperlipidemia 10 mg once daily for 2 wk & up to 4 wk for max response. Homozygous familial hypercholesterolemia 80
mg. Heterozygous familial hypercholesterolemia Childn 10-17 yr Recommended starting dose: 10 mg daily. Max: 20 mg
daily. Adjust dose at =4 wkly intervals.
General: Before instituting therapy with atorvastatin, an attempt should be made to control hypercholesterolemia with
appropriate diet, exercise and weight reduction in obese patients and to treat underlying medical problems. The patients
should continue on a standard cholesterol-lowering diet during treatment with atorvastatin.
Usual Starting Dose: 10 mg once daily. Dosage Range: 10-80 mg once daily.
Dosage may be given any time of the day, with or without food. Starting and maintenance dosage should be
individualized according to baseline LDL-C levels, the goal of therapy and patients response. After initiation and/or upon
titration of atorvastatin, lipid levels should be analyzed within 2-4 weeks and dosage adjusted accordingly.
Primary Hypercholesterolemia and Combined (Mixed) Hyperlipidemia: The majority of patients are controlled with
atorvastatin 10 mg once daily. A therapeutic response is evident within 2 weeks and the maximum response is usually
achieved within 4 weeks. The response is maintained during chronic therapy.
Homozygous Familial Hypercholesterolemia: In a compassionate-use study of patients with homozygous familial
hypercholesterolemia, most patients responded to 80 mg of atorvastatin.
Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10-17 years): Recommended Starting Dose: 10
mg/day. Maximum Recommended Dose: 20 mg/day (doses >20 mg have not been studied in this population). Doses
should be individualized according to the recommended goal of therapy (see Indications and Pharmacodynamics under
Actions). Adjustment should be made at intervals of =4 weeks.
Hepatic Insufficiency (see Contraindications and Precautions).
Renal Insufficiency: Renal disease has no influence on the plasma concentrations or on the LDL-C of atorvastatin. Thus,
no adjustment of the dose is required.
Children: Treatment experience in a pediatric population is limited to doses of atorvastatin up to 80 mg/day for 1 year in
patients with homozygous FH. No clinical or biochemical abnormalities were reported in these patients.
Elderly: No differences in safety, efficacy or lipid treatment goal attainment were observed between elderly patients and
the overall population (see Actions).
The Following Treatment Guidelines may be Used to Establish Treatment Goals (see Table 1):
After the LDL-C goal has been achieved, if the TG is still =200 mg/dL, non HDL-C (total-C minus HDL-C) becomes a
secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category. (See Table
2.)
European Atherosclerosis Society (EAS)/Treatment Goals for Lipid Management: For patients with established coronary
heart disease or other patients at increased risk of ischemic events, the treatment goal is LDL-C <3 mmol/L (or <115
mg/dL) and total cholesterol <5 mmol/L (or <190 mg/dL).
Customary Local Treatment Guidelines (include local guidelines as necessary).
RA 15 mg daily, may be reduced to 7.5 mg daily. OA 7.5 mg daily, may be increased to 15 mg daily. Max: 15 mg/day.
Initially, 7.5 mg daily for patients w/ increased risk of adverse reactions.
Metered-Dose Inhaler/Metered-Aerosol: The dosage should be adapted to the individual requirements. Unless
otherwise prescribed, the following dosages are recommended: Adults and Children =12 years: 2 metered doses (puffs) 4
times daily.
Since a requirement for increasing doses suggests that additional therapeutic modalities may be needed, a total daily
dose of 12 puffs should generally not be exceeded.
If therapy does not produce a significant improvement or if the patient's condition gets worse, medical advice must be
sought in order to determine a new plan of treatment. In the case of acute or rapidly worsening dyspnoea (difficulty in
breathing), a doctor should be consulted immediately.
For acute exacerbations of chronic obstructive pulmonary disease, treatment with Atrovent inhalation solution or unit
dose vials may be indicated.
Because of insufficient information in children, Atrovent metered-aerosol should only be used on medical advice and
under the supervision of an adult.
Inhalation Solution: The dosage should be adapted to the individual requirements of the patient. Patients should also be
kept under medical supervision during treatment. Unless otherwise prescribed, the following doses are recommended:
Adults (Including the Elderly) and Adolescents >14 years: 0.4-2 mL (8-40 drops=0.1-0.5 mg) 3-4 times daily. Children 6-14
years: 0.4-1 mL (8-20 drops=0.1-0.25 mg) 3-4 times daily.
The recommended dose is to be diluted with physiological saline to a final volume of 3-4 mL and nebulised and inhaled
until the solution is consumed. The solution should be rediluted each time before use; any residual diluted solution
should be discarded.
Dosage may be dependent upon the mode of inhalation and the quality of nebulisation. In the case of particle sizes up
to 5 micrometer or with assisted ventilation, dose levels may be reduced to approximately 0.4 mL (8 drops=0.1 mg). The
duration of inhalation can be controlled by the dilution volume.
The dose may be repeated after intervals of at least 4 hrs, if required.
Daily doses exceeding 2 mg should be given under medical supervision.
Patients should be advised to consult a physician or the nearest hospital immediately in the case of acute or rapidly
worsening dyspnoea (difficulty in breathing) if additional inhalations do not produce an adequate improvement. Where
wall oxygen is available, the solution is best administered at a flow rate of 6-8 L/min.
Atrovent inhalation solution is suitable for concurrent inhalation with secretomucolytics and Berotec inhalation
solutions.
Administration: The correct operation of the metered aerosol apparatus is essential for successful therapy.
Depress the valve twice before the apparatus is used for the 1st time.
Before each use, the following rules should be observed: Remove protective cap. Breathe out deeply. Hold the metered
aerosol and close lips over the mouthpiece. The arrow and the base of the container should be pointing upwards.
Breathe in as deeply as possible, pressing the base of the container firmly at the same time; this releases 1 metered
dose. Hold breath for a few seconds, then remove mouthpiece from the mouth and breathe out. The same action should
be repeated for a 2nd inhalation. Replace the protective cap after use.
After not using the metered aerosol for 3 days, the valve has to be actuated once.
The container is not transparent. It is not therefore possible to see when it is empty. The aerosol will deliver 200 doses.
Dosages depends on the age, weight and renal function of the patient and the severity of the infection.
Dosages are expressed throughout in terms of amoxicillin-clavulanate content except when doses are stated in terms of
an individual component.
Adults: Mild to Moderate Infections: 250/125 mg 3 times daily, or 500/125 mg 2 or 3 times daily, or 875/125 mg twice
daily.
Severe Infections (Including Chronic and Recurrent Infections of Urinary Tract and Lower Respiratory Tract): 2 times
250/125 mg 3 times daily, or 1-2 times 500/125 mg 3 times daily, or 875/125 mg 3 times daily.
Two (2) amoxicillin-clavulanate 250/125 mg tablets should not be substituted for 1 amoxicillin-clavulanate 500/125 mg
tablet, since they are not equivalent.
Children: Dosage should be expressed in terms of the age of the child and either in mg/kg/day or mL of suspension/dose
or equivalent for other presentations.
Children Weighing =40 kg: Dosed according to adult recommendations.
Children up to 12 years: Lower Dose: Skin and Soft Tissue and Recurrent Tonsillitis: 20/5 to 40/10 mg/kg/day. Higher
Dose: Otitis Media, Sinusitis, Lower Respiratory Tract and Urinary Tract Infections: 40/10 to 60/15 mg/kg/day. Doses
should be taken 3 times daily.
No clinical data are available on doses of these formulations >40/10 mg/kg/day 3 times daily.
There are no clinical data for the 7:1 (amoxicillin-clavulanate ratio) formulation for patients <2 months. Dosing
recommendation in this population therefore cannot be made.
Premature: No dosage recommendation can be made for this category.
Elderly: No adjustment needed as for adults. If there is evidence of renal impairment, dose should be adjusted as for
renally impaired adults.
Renal Impairment: Dosage adjustments are based on the maximum recommended level of amoxicillin.
Hemodialysis: Adults: 1 time 500/125 mg or 2 times 250/125 mg every 24 hours plus 1 dose during dialysis to be
repeated at the end of dialysis (as serum concentrations of both amoxicillin and clavulanic acid are decreased)+.
Note: +The 875/125-mg presentations should only be used in patients with a creatinine clearance of >30 mL/min.
Children: 15/3.75 mg/kg/day given as a single daily dose.
Prior to hemodialysis, one additional dose of 15/3.75 mg/kg should be administered. In order to restore circulating drug
levels, another dose of 15/3.75 mg/kg should be administered after hemodialysis.
Hepatic Impairment: Dose with caution; monitor hepatic function at regular intervals. There are insufficient data on
which to based a dosage recommendations.
Administration: To minimize potential gastrointestinal intolerance, administer at the start of a meal.
The absorption of amoxicillin-clavulanate is optimized when taken at the start of a meal.
Treatment should not be extended >14 days without review.
Therapy can be started parenterally and continued with oral preparation.
After cleansing the face, apply thoroughly over the face affected by acne; only by then, loose powd may be applied.
For full therapeutic benefit, regular scheduled usage is recommended. Onset of action has been observed as early as 8
hrs after initial administration. It may take several days of treatment to achieve maximum benefit and the patient should
be informed that their symptoms will improve with continuous regular use. The duration of treatment should be
restricted to the period that corresponds to allergenic exposure.
Adults and Adolescents =12 years: The recommended starting dosage is 2 sprays (27.5 mcg/spray) in each nostril once
daily (total daily dose: 110 mcg). Once adequate control of symptoms is achieved, dose reduction to 1 spray in each
nostril once daily (total daily dose: 55 mcg) may be effective for maintenance. The dose should be titrated to the lowest
dose at which effective control of symptoms is maintained.
Children 6-11 years: The recommended starting dosage is 1 spray (27.5 mcg/spray) in each nostril once daily (total daily
dose: 55 mcg). Patients not adequately responding to 1 spray in each nostril once daily (total daily dose: 55 mcg) may
use 2 sprays in each nostril once daily (total daily dose: 110 mcg). Once adequate control of symptoms is achieved, dose
reduction to 1 spray in each nostril once daily (total daily dose: 55 mcg) is recommended.
Children <6 years: The experience in children <6 years is limited. Safety in efficacy in this group has not been well
established.
Elderly: No dosage adjustment is required. (See Pharmacokinetics under Actions.)
Renal Impairment: No dosage adjustment is required. (See Pharmacokinetics under Actions.)
Hepatic Impairment: No dosage adjustment is required in patients with mild to moderate hepatic impairment. There are
no data in patients with severe hepatic impairment (see Pharmacokinetics under Actions and Precautions).
Administration: Avamys nasal spray is for administration by the intranasal route only.
The intranasal device should be shaken before use. The device is primed by pressing the mist release button for at least 6
spray actuations (until a fine mist is seen), whilst holding the device upright. The device should be cleansed after each
use and the cap replaced.
Adult 1-2 sachet daily. May be given before or during cancer treatment (surgery, radio- & chemotherapy).
1-2 sachet daily.
Adult & childn >6 yr 5 mg once daily.

Avodart can be administered alone or in combination with the a-blocker tamsulosin (0.4 mg).
Recommended Dose: 1 cap (0.5 mg) taken orally once daily.
Although an improvement may be observed at an early stage, it can take up to 6 months before a response to the
treatment can be achieved. No dose adjustment is necessary in the elderly.
Renal Impairment: The effect of renal impairment on dutasteride pharmacokinetics has not been studied. No adjustment
in dosage is anticipated for patients with renal impairment (see Pharmacokinetics under Actions).
Hepatic Impairment: The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied, and
therefore, should be used with caution in patients with mild to moderate hepatic impairment (see Pharmacokinetics
under Actions and Precautions). In patients with hepatic impairment, the use of dutasteride is contraindicated.
Administration: Avodart capsule should be swallowed whole and not chewed or opened as contact with the capsule
contents may result in irritation of the oropharyngeal mucosa. Avodart may be taken with or without food.
Adult 1 caplet 1-2 times daily.
1 licap once daily.
1 cap once daily.
1 cap once daily.
Adult & elderly 2 tsp once daily. Childn <12 yr 0.1 mg/kg body wt.
Adult 4 mg. Childn >12 yr 2-4 mg, 6-12 yr 2 mg, 2-6 yr 1-2 mg. To be taken 3-4 times daily.
In women of reproductive age, therapy should begin during menstruation. A sensitive test (eg, -subunit test if available)
capable of determining early pregnancy is recommended immediately prior to start of therapy to ensure the patient is
not pregnant. A nonhormonal method of contraception should be recommended.
Endometriosis: 200-600 mg daily in 2 divided doses. Initially 200 mg, if necessary dose may be increased to 600 mg daily.
Continue therapy uninterrupted for 3-6 months, which may be extended to 9 months.
Menorrhagia: 200 mg daily for 12 weeks. An occasional patient may need up to 400 mg daily.
Fibrocystic Breast Disease: Start with 50 mg daily, then the dose can be increased up to 100 mg daily in 2 divided doses,
depending on the severity of symptoms and the patient's response. Therapy should begin during menstruation.
Otherwise, appropriate test should be performed to ensure that the patient is not pregnant while on therapy with Azol
200.
Adult Mild to moderate infection in pulmonary disease, pneumonia, pharyngitis, tonsillitis, skin & soft tissue infections
Day 1: 500 mg as a single dose, Days 2-5: 250 mg once daily. Total dose of 1 g. Non-gonococcal urethritis & cervicitis 1 g
as a single dose.
Cap Upper & lower resp tract, mild & moderate skin infections 500 mg as single dose on the 1st day followed by single
dose of 250 mg for 2.5 days. Non-complicated urethritis & non-gonorrheal cervicitis caused by Chlamydia trachomatis 1
g as single dose. Syr Adult 500 mg/day for 3 days. Alternative dose: For 5 days administration: 1st day: 500 mg/day, 2nd-
5th day: 250 mg/day. Childn 10 mg/kg/day for 3 days. Alternative dose: For 5 days administration: 1st day: 10 mg/kg/day,
2nd-5th day: 5 mg/kg/day.
Initial treatment & prophylaxis: A single dose of 15 mg/kg/day ethambutol w/ 300 mg/day INH. Repeat treatment after
2-mth initial phase: A single dose of 25 mg/kg/day ethambutol w/ 300 mg/day INH.
15-25 mg/kg as single dose 24 hrly.

Tab Adult & childn >30 kg 375-750 mg twice daily. Childn <30 kg 25-50 mg/kg/day in 2 divided dose. Uncomplicated
gonorrhoea 2.25 g as a single dose + probenecid 1 g concomitantly. Inj Adult 1.5-12 g/day in divided doses every 6-8 hr
up to a max of 4 g/day of sulbactam. Childn, infant & neonates 150 mg/kg/day in divided doses every 6-8 hr. Prophylaxis
of surgical infections 1.5-3 g upon induction of anesth. May be repeated every 6-8 hr.
UTI 250 mg twice daily. May be increased to 500 mg twice daily in severe infections. Resp tract, bone & joint, skin & soft
tissue infections 500 mg twice daily, may be increased to 750 mg twice daily. GIT infections 500 mg twice daily. Acute
gonorrhoea 250 mg as a single dose. Acute osteomyelitis 750 mg twice daily.
Complicated upper & lower UTI, skin & soft tissue infections 1 g. Lower resp tract infections 1 or 2 g.
Bacteraemia/septicaemia & infections in neutropenic patients 2 g. All doses are given 12 hrly.
Adult & childn Apply up to 3 times daily for up to 10 days.

Adults, Children and the Elderly: Apply to the affected area up to 3 times daily, for up to 10 days depending on the
response.
Hepatic and Renal Impairment: No dosage adjustment is necessary.
Administration: Cream: A small quantity of cream should be applied to the affected area with a piece of clean cotton
wool or gauze swab. The treated area may be covered by a dressing.
Ointment: The treated area may be covered with a dressing or occluded if desired.
Epilepsy Adult & childn >12 yr Initially 200 mg 2 times daily. Dosage may be increased at intervals of 1 wk until 200 mg 3-
4 times daily. Childn 12-15 yr Max: 1,000 mg/day, >15 yr Max: 1,200 mg/day. Adult 1,600 mg/day. Maintenance 800-
1,200 mg/day. Childn 6-12 yr Initially 100 mg 2 times daily, increased w/ interval 1 wk to 3-4 times daily until the
optimum dosage is reached. Maintenance 400-800 mg/day. Trigeminal neuralgia Initially 100 mg 2 times daily. Dosage
may be increased to 200 mg 2 times daily until free of pain. Max: 1,200 mg/day. Maintenance: 400-800 mg/day.
Childn 7-12 yr 10 mL, 2-6 yr 5 mL. All doses are to be taken 3 times daily.
Corneal ulcer 1st day: 2 drops every 15 min for 1st 6 hr then 2 drops every 30 min for remainder of the day. 2nd day: 2
drops hrly. 3rd-14th day 2 drops 4 hrly. Conjunctivitis 1-2 drops 2 hrly for 2 days & 1-2 drops 4 hrly for next 5 days.
Oral UTI Mild/moderate: 250 mg twice daily. Severe infections: 500 mg twice daily. Resp tract, skin & soft tissues, bone &
joints infections Mild/moderate: 500 mg twice daily. More severe complications: 750 mg twice daily. GIT infections 500
mg twice daily. Acute osteomyelitis Dosage should not be <750 mg twice daily. IV infusion Uncomplicated renal infection,
lower & upper UTI 100 mg twice daily. Other infections 200 mg twice daily. Acute gonorrhoea & uncomplicated cystitis in
women 100 mg as a single dose in women.
Recommended Dosage: Compensated Liver Disease: Adults and Adolescents =16 years: Chronic Hepatitis B Virus
Infection in Nucleoside-Treatment-Naive: 0.5 mg once daily with or without food.
History of Hepatitis B Viremia while Receiving Lamivudine or Known Lamivudine Resistance Mutations: 1 mg once daily
administered on an empty stomach (at least 2 hrs after a meal and 2 hrs before the next meal).
Decompensated Liver Disease: Adults: 1 mg once daily administered on an empty stomach (at least 2 hrs after a meal
and 2 hrs before the next meal).
Renal Impairment: In subjects with renal impairment, the apparent oral clearance of entecavir decreased as creatinine
clearance decreased. Dosage adjustment is recommended for patients with creatinine clearance <50 mL/min, including
patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), as shown in Table 10. The once-daily
dosing regimens are preferred. (See Table 10.)
Hepatic Impairment: No dosage adjustment is necessary for patients with hepatic impairment.
Duration of Treatment: The optimal duration of treatment with Baraclude for patients with chronic hepatitis B infection
and the relationship between treatment and long-term outcome eg, cirrhosis and hepatocellular carcinoma are
unknown.
Adult Monotherapy Initially 300 mg/day. Maintenance: 600-1,200 mg/day. Polytherapy Initially 300 mg/day.
Maintenance: 900-3,000 mg/day. Childn >5 yr Mono- or polytherapy 10 mg/kg/day. Maintenance: 30 mg/kg/day. Dose
may be increased by 5-10 mg/kg/day if seizures remain uncontrolled.
Adult 2-4 g daily 12 hrly. May be increased up to 8 g daily in severe or refractory infections. Max daily dose: 4 g. Childn
40-80 mg/kg/day in divided doses every 6-12 hr. May be increased up to 160 mg/kg/day in severe or refractory
administered in 2-4 equally divided doses. Neonate May be given in the 1st wk of life 12 hrly. Max: 80 mg/kg/day.
Acute or chronic infection 1-2 cap daily. Supportive treatment of cancer 2 cap 3 times daily.
Reconstitution: 3 scoops to 90 mL water.

Reconstitution: To make 1 glass, add 3 spoonful into 180 mL of water. To be taken 2 glass/day.
Gastric ulcer & gastritis Adult 1 tab 3 times daily in the morning, in the evening & before bedtime.
Tab 1 or more tab daily. Syr 1 tsp once daily.
Consciousness due to head injury or brain surgery 100-500 mg IM/IV 1-2 times daily. Consciousness disturbances in
acute cerebral infarction stage 1,000 mg IV once daily for 2 consecutive wk. Hemiplegia after cerebral apoplexy 1,000 mg
IV once daily for 4 consecutive wk, continue for 4 wk if patient shows clinical improvement.
Adult 1-2 caplet daily. Childn 1 caplet daily.
1 caplet daily.
Childn 1 mL once daily.
2.5 g IV infusion (corresponding to 50 mL/kg/day). Infusion rate: 2-5 mL/kg/hr or 2-5 drops/kg/min (60 drops=1g0.1 g).
Apply 1-2 times daily. Nipple sore May be applied directly to the nipple after breastfeeding.
Tab Adult & childn >12 yr 1 tab 2-3 times daily. Childn 6-12 yr tab 2-3 times daily. Syr Adult & childn >12 yr 10 mL 2-3
times daily. Childn 6-12 yr 5 mL 2-3 times daily.
Apply to wound & repeat as necessary.

1 effervescent tab daily.
The dosage should be adapted to the individual's requirements. Unless otherwise prescribed, the following dosages are
recommended for adults and children >6 years: Acute Asthma Episodes: 2 actuations are sufficient for prompt
symptomatic relief in many cases. In more severe cases, if breathing has not noticeably improved after 5 min, 2 further
actuations may be taken. If an attack has not been relieved by 4 actuations, further actuations may be required. In these
cases, patients should consult the physician or go to the nearest hospital immediately.
Intermittent and Long-Term Treatment: (In asthma, Berodual metered dose aerosol should be used only on an as needed
basis) 1-2 actuations for each administration, up to a maximum of 8 actuations/day (average of 1-2 actuations 3 times
daily).
In children, Berodual metered aerosol should only be used upon medical advice and under the supervision of an adult.
Patients should be instructed in the correct administration of the metered aerosol to ensure successful therapy.
Administration: Before first time use of the metered-dose aerosol, the following rules should be observed: Remove
protective cap and depress the valve twice.
Before each use of the metered dose aerosol, the following rules should be observed: Remove protective cap (if the
metered aerosol has not been used for >3 days, the valve has to be actuated once). Breathe out deeply. Hold the inhaler
between the thumb and forefinger and close lips over the mouthpiece. The arrow and the base of the container should
be pointing upwards. Breathe in as deeply as possible, pressing the base of the container firmly at the same time, this
releases 1-metered-dose. Hold breath for a few secs, then remove the mouthpiece from the mouth and breathe out. The
same action should be repeated for a second inhalation. Replace the protective cap after use.
The container is under pressure and should by no account be opened by force or exposed to temperatures exceeding
50C. As the container is not transparent, it is impossible to see when the contents are used up, the inhaler will deliver
200 or, if available, 300 doses. When these have all been used, the container may still appear to contain a small amount
of fluid.
The inhaler should, however, be replaced to get the right amount of treatment.
The approximate amount of treatment in your inhaler can be checked as follows: Shaking the container will show if there
is any remaining fluid.
Alternatively, remove the canister from the plastic mouthpiece and put into a container of water. The contents can be
estimated by observing its position in the water. Clean your inhaler at least once a week. It is important to keep the
mouthpiece of your inhaler clean to ensure that medicine does not build up and block the spray. For cleaning, first take
off the dust cap and remove the canister from the inhaler. Rinse with warm water through the inhaler until no
medication build-up and/or dirt is visible. After cleaning, shake out the inhaler and let it air-dry without using any
heating system. Once the mouthpiece is dry, replace the canister and the dust can.
Metered Aerosol: Acute Asthma Episodes: 1 puff is sufficient for prompt symptomatic relief in many cases. If breathing
has not noticeably improved after 5 min, a 2nd dose may be taken.
If an attack has not been relieved by 2 puffs, further puffs may be required. In these cases, patients should consult the
doctor or the nearest hospital immediately.
Prophylaxis of Exercise-Induced Asthma: 1-2 puffs for each administration, up to a maximum of 8 puffs/day.
Bronchial Asthma and Other Conditions with Reversible Airways Narrowing: If repeated dosing is required, 1-2 puffs for
each administration, up to a maximum of 8 puffs/day.
Administration: The correct operation of the metered aerosol is essential for successful therapy.
Depress the valve twice before the apparatus is used for the 1st time.
Before each use, the following rules should be observed: Remove protective cap. Breathe out deeply. Hold the metered
aerosol and close lips over the mouthpiece. The arrow and the base of the container should be pointing upwards.
Breathe in as deeply as possible, pressing the base of the container firmly at the same time, this releases 1 metered
dose. Hold breath for a few seconds, then remove the mouthpiece from the mouth and breathe out. If a 2nd inhalation
is required, the same action should be repeated. Replace the protective cap after use. After not using the metered
aerosol for 3 days, the valve has to be actuated once.
The container is not transparent. It is, therefore, not possible to see when it is empty. The metered-dose aerosol will
deliver 200 doses. When these have all been used, the metered-aerosol may still appear to contain a small amount of
fluid. The metered-dose aerosol should, however, be replaced because it may not get the right amount of treatment.
The amount of treatment in the metered aerosol can be checked as follows: Remove the metered aerosol from the
plastic mouthpiece and put the metered-aerosol into a container of water.
Clean the metered aerosol at least once a week. It is important to keep the mouthpiece of the metered-aerosol clean to
ensure that medicine does not build up and block the spray.
For cleaning, first take off the dust cap and remove the canister from the inhaler. Rinse warm water through the metered
aerosol until no medication build-up and/or dirt is visible. After cleaning, shake the metered aerosol and let it air-dry
without using any heating system. Once the mouthpiece is dry, replace the canister and the dust cap.
Warning: The plastic mouthpiece has been specially designed for use with Berotec 100 mcg to ensure in getting the right
amount of the medicine. The mouthpiece must never be used with any other metered aerosol nor must Berotec 100
mcg be used with any mouthpiece other than the one supplied.
The container is under pressure and should by no account be opened by force or exposed to temperatures above 50C.
Inhalation Solution: (20 drops=1 mL) (1 drop=50 mcg fenoterol HBr).
The dosage should be adapted to the individual requirements of the patient; patients should also be kept under medical
supervision during treatment.
Unless otherwise prescribed, the following doses are recommended:
Adults (Including the Elderly) and Adolescent >12 years: Acute Asthma Episodes: 0.5 mL (10 drops=0.5 mg fenoterol HBr)
are sufficient for immediate symptomatic relief in many cases.
In severe cases eg, in most patients admitted to the emergency room, higher doses between 1 and 1.25 mL (20-25
drops=1-1.25 mg fenoterol HBr) may be required.
For
Tab particular severedaily.
1 tab 2-3 times cases, up to 2 mL
Dispersible (40
tab drops=2
Adult mg2-3
1-2 tab fenoterol HBr) may
times daily. be6-12
Childn administered
yr 1 tab 3under
times medical
daily, 1-6supervision.
yr tab 3
times daily.
Adult 25 mg 3 times daily, if required 100 mg daily, childn >6 yr 50-100 mg daily divided into 3-4 doses, <6 yr 50 mg daily
divided into 3-4 doses. Sedative Adult 50-100 mg. Childn 0.6 mg/kg/day.
Mild or moderate UTI 250 twice daily. Severe UTI, chonic prostatitis, GIT infections 500 mg twice daily. Mild or moderate
resp tract, bone, joint, skin & soft tissue infections 250-500 mg twice daily. Severe resp tract, bone, joint, skin & soft
tissue infections 500-750 mg twice daily. Acute gonorrhoeae 250 mg as a single dose. Acute osteomyelitis Not <750 mg
twice daily.
1-2 drops 4-6 times daily.
Duodenal ulcer & recurrent gastric ulcer 30 mg once daily for 4-8 wk. Reflux/erosive oesophagitis 30 mg once daily for 8
wk.
Initially 1-2 drops/hr during the day & every 2 hr at night. Reduce to 1 drop 4 hrly & then to 1 drop 3-4 times daily.
Tab Adult & childn =12 yr 10 mg daily. Syr Adult & childn >12 yr 10 mL once daily. Childn 6-12 yr 10 mL once daily or 5 mL
12 hrly, 2-6 yr 5 mL once daily or 2.5 mL 12 hrly. Drops Adult & childn >12 yr 1 mL once daily. Childn 6-12 yr 1 mL once
daily or 0.5 mL 12 hrly, 2-6 yr 0.5 mL once daily or 0.25 mL hrly.
Adults: 24-48 mg per day in divided doses.

8-mg Tablet: 1-2 tablets 3 times daily.
24-mg Tablet: 1 tablet 2 times/day.
The dosage should be individually adapted according to the response.
Improvement can sometimes only be observed after a couple of weeks of treatment. The best results are sometimes
obtained after a few months. There are indications that treatment from onset of the disease prevents the progression of
the disease and/or the loss of hearing in later phases of the disease.
Children: Betaserc is not recommended for use in children below 18 years due to insufficient data on safety and efficacy.
Elderly: No dose adjustment is required in elderly.
Renal Impairment: No dose adjustment is required in renally impaired patients.
Hepatic Impaiment: No dose adjustment is required in hepatically impaired patients.
1 caplet 3 times daily.

Adult 1-2 tab 3 times daily.
Apply 2-3 times daily until acute phase is over, then apply once daily.
Adult & childn >12 yr 1-2 g IV once daily. Max: 4 g daily. Peri-op infection prophylaxis 1 g as a single dose -2 hr pre-op.
Infant & childn <12 yr 50-75 mg/kg/day in 2 divided doses. Max: 4 g daily. Meningits 100 mg/kg/day in 2 divided doses.
Adult 1 tsp 3 times daily. Childn 6-12 yr 1 tsp 2 times daily, 1-6 yr 1 tsp once daily, 6 mth-1 yr tsp once daily.
Adult 1 caplet daily.

Tab 1 tab 3 times daily. Retard tab 1 tab daily.
Trichomoniasis Adult 2 g daily in a single dose or 500 mg twice daily for 7 days. To prevent re-infection, the partner
should be treated simultaneously w/ the same dose. Childn 15 mg/kg/day in 3 divided doses for 7-10 days. Intestinal
amoebiasis Adult 750 mg 3 times daily for 5-10 days. Hepatic amoebiasis 500-750 mg 3 times daily for 5-10 days. Childn
35-50 mg/kg/day in 3 times daily for 10 days. Giardiasis Adult 2 g once daily for 3 days or 250-500 mg 3 times daily for 5-
7 days. Childn 15 mg/kg in 3 divided doses for 5-7 days. Anaerobe infection Adult 7.5 mg/kg 6 hrly, (Max: 4 g daily) for 7-
10 days.
Adult 2-3 tab. Up to 6 tab may be taken for complete evacuation of the colon. Childn 1-2 tab.
Pharyngitis/tonsillitis 250 mg 12 hrly for 10 days. Acute maxillary sinusitis 500 mg 12 hrly for 14 days. Lower resp tract
infections 250-500 mg 12 hrly for 7-14 days. Uncomplicated skin & skin structure 250 mg 12 hrly for 7-14 days.
Adult 2-4 g daily IM/IV at 12 hr intervals. Severe infections 6-12 g daily in 2-4 divided doses.
1-3 softcap 3 times/day.
Childn 6 mth to 5 yr 1 tab once daily for 10 days. Infant 2-6 mth tab once daily for 10 days.
After the skin has been cleansed, apply thinly 2 or 3 times a day.
10,000 IU via IM/IV inj depends on severity.
2-4 tab daily.

Tab Adult 1 tab once daily. Inj Adult Severe deficiencies: 1 amp IM daily until acute symptoms subside, then 1 amp 2-3
times wkly. Mild deficiencies: 1 amp IM 2-3 times wkly.
Adult Serious infection 150-300 mg 6 hrly. More severe infection 300-450 mg 6 hrly. Childn Serious infection 8-16
mg/kg/day in 3-4 divided doses. More severe infection 16-20 mg/kg/day in 3-4 divided doses.
1-2 tab daily.

Adult 1 tsp 3 times daily. Childn 7-12 yr 1 tsp twice daily; 1-6 yr 1 tsp once daily.
Adult 1-2 tab 3 times daily. Childn 7-12 yr 10-15 mL, 2-6 yr 5-10 mL. Infant 2.5-5 mL. To be taken 3-4 times daily.
Adult & childn >6 yr 1 effervescent tab/day as recommended by doctors.
Apply a few amount thoroughly over the face & neck.

Cream Apply a thin layer on the wound twice daily or as needed. Gauze pad Cover wound w/ sterile gauze pad & a sterile
bandage.
1 cap daily.
The dose should be individualised according to the patient profile (see Precautions) and blood pressure response.
Hypertension: Bioprexum may be used in monotherapy or in combination with other classes of antihypertensive therapy.
Recommended Dose: 5 mg once daily in the morning.
Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt-
and/or volume-depletion, cardiac decompensation or severe hypertension) may experience an excessive drop in blood
pressure following the initial dose. A starting dose of 2.5 mg is recommended in such patients and the initiation of
treatment should take place under medical supervision. The dose may be increased to 10 mg once daily after 1 month of
treatment.
Symptomatic hypotension may occur following initiation of therapy with Bioprexum; this is more likely in patients who
are being treated concurrently with diuretics. Caution is therefore recommended since these patients may be volume-
and/or salt-depleted.
If possible, the diuretic should be discontinued 2-3 days before beginning therapy with Bioprexum (see Precautions).
Hypertensive Patients in Whom the Diuretic Cannot be Discontinued: Therapy with Bioprexum should be initiated with a
2.5-mg dose. Renal function and serum potassium should be monitored. The subsequent dosage of Bioprexum should
be adjusted according to blood pressure response. If required, diuretic therapy may be resumed.
Elderly: Treatment should be initiated at a dose of 2.5 mg which may be progressively increased to 5 mg after 1 month,
then to 10 mg if necessary depending on renal function.
Symptomatic Heart Failure: It is recommended that Bioprexum, generally associated with a nonpotassium-sparing
diuretic and/or digoxin and/or a -blocker, be introduced under close medical supervision with a recommended starting
dose of 2.5 mg taken in the morning. This dose may be increased after 2 weeks to 5 mg once daily if tolerated. The dose
adjustment should be based on the clinical response of the individual patient.
In severe heart failure and in other patients considered to be at high risk (patients with impaired renal function and a
tendency to have electrolyte disturbances, patients receiving simultaneous treatment with diuretics and/or treatment
with vasodilating agents), treatment should be initiated under careful supervision (see Precautions).
Patients at high risk of symptomatic hypotension eg, patients with salt depletion with or without hyponatraemia,
patients with hypovolaemia or patients who have been receiving vigorous diuretic therapy, should have these conditions
corrected, if possible, prior to therapy with Bioprexum. Blood pressure, renal function and serum potassium should be
monitored closely, both before and during treatment with Bioprexum (see Precautions).
Stable Coronary Artery Disease: Initially 5 mg once daily for 2 weeks, then increased to 10 mg once daily, depending on
renal function and provided that the 5 mg dose is well tolerated.
Elderly: Elderly patients should receive 2.5 mg once daily for 1 week, then 5 mg once daily the next week, before
increasing the dose up to 10 mg once daily depending on renal function. The dose should be increased only if the
previous lower dose is well tolerated.
Renal Impairment: Dosage in patients with renal impairment should be based on creatinine clearance (CrCl).
CrCl =60 mL/min: 5 mg/day, >30 to <60 mL/min: 2.5 mg/day, >15 to <30 mL/min: 2.5 mg every other day.
Haemodialysed Patients* (CrCl <15 mL/min): 2.5 mg on the day of dialysis.
*Dialysis clearance of perindoprilat is 70 mL/min. For patients on haemodialysis, the dose should be taken after dialysis.
Hepatic Impairment: No dosage adjustment is necessary in patients with hepatic impairment (see Pharmacokinetics
1 tab/day as a single dose, preferably to be taken in the morning and before a meal.
When possible, individual dose titration with the components is recommended.
Elderly: Treatment should be initiated after considering blood pressure response and renal function (see Precautions).
Renal Impairment: In severe renal impairment (CrCl <30 mL/min), treatment is contraindicated (see Contraindications).
In patients with moderate renal impairment (CrCl 30-60 mL/min), it is recommended to start treatment with the
adequate dosage of the free combination (see Precautions).
In patients with CrCl =60 mL/min, no dose modification is required. Usual medical follow-up will include frequent
monitoring of creatinine and potassium.
Hepatic Impairment: In severe hepatic impairment, treatment is contraindicated (see Contraindications).
In patients with moderate hepatic impairment, no dose modification is required (see Pharmacokinetics under Actions
and Precautions).
Children and Adolescents: Bioprexum Plus should not be used in children and adolescents as the efficacy and tolerability
of perindopril in children and adolescents, alone or in combination, have not been established.
Cream Apply twice daily. Forte cream Apply once or twice daily.
1 softcap daily.
1 tab 3 times daily.

1 cap daily.
1 dose of 1,500 IU via IM inj.
Depends on severity. Infusion 1st dose of 2% v/v at rate of 40-80 drop/min then repeat dose after 6 hr. If needed, doses
may be given 24 hrly to max of 80-100 mL. Childn Same dose as adult.
Childn >4 yr 1-3 tsp daily, =4 yr 1 tsp daily.
Adult, childn & infant >2 wk 50 mg/kg/day in 3-4 divided doses, =2 wk & premature infant 25 mg/kg/day in 4 divided
doses.
Gently massage into skin w/ fingertips using slow circular motion w/ a few pressure points. Apply morning & night.
Apply small dabs to the entire face & neck twice daily, preferably in the morning & night for optimum result. Allow to
penetrate the skin for 5 min before applying make-up.
1 tab daily. Mild case: 1 tab daily, severe case: 2 tab daily.
Rub on the affected area.
Instill 2-3 drops 3-4 times daily.
1-2 drops to the affected eye 1-2 hrly for 2-3 days, decrease to 1-2 drops 3-4 times daily.
Uterine involution 1 tab 3 times daily for 3-4 days. Control of uterine bleeding in emergency state 0.2 mg IV.
Subinvolution, puerperium & lochiometral bleeding 1-2 tab 3 times daily or 0.5-1 mL IM. Caesarean section 1 mL IM or
0.5-1 mL IV following baby delivery.
Total dose: 300-400 mg. Twice a wk in average cases, should be adjusted according to patient's condition in the range
from once a day to once a wk. Pleural effusion 30-60 mg dissolved in 50-100 mL saline soln to be instilled via needle or
catheter used for aspiration.
Anovulatory infertility 1 tab daily for 5 days starting on the 5th day of the menstrual cycle. If no ovulation occurs, a 2nd
course of 1 tab twice daily for 5 days may be given. Oligospermia 1 tab daily for 40-90 days.
Emergency treatment of acute HTN during surgery 0.01-0.02% IV drip infusion (equiv 0.1-0.2 mg/mL) at a starting rate of
2-10 mcg /kg/min until the desired BP value is reached. Rapid BP reduction 10-30 mcg/kg/min IV inj. Hypertensive
emergency 0.01-0.02% IV drip infusion (equiv 0.1-0.2 mg/mL) at a rate of 0.5 mcg/kg/min until the desired BP value is
reached.
Hypertension: The recommended dose of Blopress is 4 mg once daily. The dose should be titrated according to response
up to 16 mg once daily. The maximum antihypertensive effect is attained within 4 weeks after initiation of treatment.
Children: The safety and efficacy of Blopress have not been established in children.
Elderly: No dosage adjustment is necessary for patients up to 75 year. In patients >75 years, an initial dose of 2 mg once
daily is recommended. The dose may be titrated up according to response.
Impaired Renal Function: No dosage adjustment is necessary in patients with mild renal impairment. In patients with
moderate to severe renal impairment, an initial dose 2 mg once daily is recommended. The dose may be titrated up
according to response.
Impaired Hepatic Function: An initial dose of 2 mg once daily is recommended in patients with mild to moderate hepatic
impairment. The dose may be titrated up according to response. There is no experience in patients with severe hepatic
impairment.
Concomitant Therapy: Blopress may be administered with other antihypertensive agents.
Heart Failure: The usual recommended initial dose of Blopress is 4 mg once daily. Up-titration to the target dose of 32
mg once daily or the highest tolerated dose is done by doubling the dose at intervals of at least 2 weeks.
Special Patient Populations: No initial dose adjustment is necessary for elderly patients or in patients with intravascular
volume depletion, renal impairment or mild to moderate hepatic impairment.
Concomitant Therapy: Blopress can be administered with other heart failure treatment, including ACE-inhibitors, beta-
blockers, diuretics and digitalis or a combination of these medicinal products.
Administration: Blopress should be taken once daily with or without food.
One tab daily, with or without food.
Children: Safety and effectiveness in pediatric patients have not been established.
Elderly: Before treatment with Blopress Plus tablet, the treatment should start with 2 mg of candesartan cilexetil
monotherapy for elderly people =75 years or 4 mg of candesartan cilexetil monotherapy for elderly people <75 years.
Patients with Renal Impairment: The usual regimen of therapy with Blopress Plus may be followed as long as the
patient's creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred
than thiazides, so Blopress Plus is not recommended.
Patients with Hepatic Impairment: Thiazide diuretics should be used with caution in patients with hepatic impairment.
Therefore, care should be exercised with the dosing of Blopress Plus.
1 tab once daily. Adult Recommended dose: Initially 12.5 mg once daily for the 1st 2 days. Thereafter, 25 mg once daily.
May be subsequently increased at intervals of at least 2 wk up to the recommended max daily dose of 50 mg once daily
or in divided doses (twice daily).
Reconstitution: 1 level scoop (4.3 g) to 30 mL water.


Metastatic bone disease 6 mg IV every 3-4 wk infused over 1-2 hr. Moderate tumour-induced hypercalcemia 2 mg.
Severe 4 mg as a single dose.
Chronic renal failure & osteoporosis Adult 0.5-1 mcg once daily. Hypoparathyroidism & other diseases associated w/
abnormal vit D metabolism Adult 1-4 mcg once daily. The dose may be adjusted according to patient's age, severity of
symptoms & type of disease.
1-2 caplet 3 times daily.
Ointment: Spread 2-5 g on a piece of gauze or lint sheet and apply to the afflicted areas. Change the gauze or lint sheet
2-3 times daily.
Children: Borraginol-N ointment may be applied by rubbing-in.
Suppository: Remove wrapper and insert 1 suppository intrarectally, 3 times daily (morning, afternoon and evening). In
severe cases, also use another suppository before retiring.
Ointment: Spread 2-5 g on a piece of gauze or lint sheet and apply to the afflicted areas. Change the gauze or lint sheet
2-3 times daily.
Children: Borraginol-S may be applied by rubbing-in.
Suppository: Remove wrapper and insert 1 supp intrarectally twice daily (morning and evening). In severe cases, also use
another suppository before retiring.
Strabismus For vertical muscles & horizontal strabismus of <20 prism diopters: 1.25-2.5 units in any 1 muscle. For
horizontal strabismus of 20-50 prism diopters: 2.5-5 units in any 1 muscle. For persistent VII nerve palsy of =1 mth: 1.25-
2.5 units in the medial rectus muscle. Max: 25 units as single inj for any muscle. Blepharospasm Initially 1.25-2.5 units
into the medial & lateral pre-tarsal orbicularis oculi of the upper lid & into the lateral pre-tarsal orbicularis oculi of the
lower lid. Glabellar lines 0.1 mL of reconstituted soln into each of 5 sites, 2 in each corrugator muscle & 1 in the procerus
muscle. Total dose: 20 units.
Unconsciousness due to head injury or brain surgery 500 mg drip or IV 1-2 times daily. Unconsciousness in acute cerebral
infarction 1,000 mg IV once daily continuously for 2 wk. Post-apoplectic hemiplegia 1,000 mg IV once daily continuously
for 4 wk. Continue treatment for additional 4 wk if there is tendency of recovery. Tab/caplet/powd 1,000-2,000 mg daily
in divided doses. O-dis tab 500 mg 2 times daily.
Unconsciousness due to head injury or brain surgery 100-500 mg IV drip or IM 1-2 times daily. Unconsciousness in acute
cerebral infarct 1000 mg IV once daily continuously for 2 wk. Post-apoplectic hemiplegia 1000 mg once daily by oral or IV
inj.
Childn =4 yr 1 tsp 3 times daily, <4 yr 1 tsp daily.
Mild to moderate disease 1-2 drops 4 hrly. Severe infections 2 drops hrly until improvement, reduce prior to
discontinuation.
1-2 drops 4-6 hrly. During initial 24-48 hr, dosage may be increased to 1-2 drops 2 hrly.
Recommended initial dose: Anovulation 75-150 IU daily for at least 7 days. Controlled ovarian hyperstimulation 150-225
IU daily for the 1st 5 days of treatment.
Apply thinly into the affected area 2-4 times daily.
Apply on the affected area 1-2 times daily.
Adult 3-4 tab daily. Elderly & debilitated Initially 1-2 tab daily, increase gradually to the effective dose.
Cerebral circulatory disorders & equilibrium disturbances 1 caplet 3 times daily. Peripheral circulatory disorders 2 caplet
3 times daily.
Childn & infant >1 mth Nasal spray 1 spray/day in each nostril. Nasal drops 1-2 drops into each nostril.
Breast cancer Recommended dose: 100 mg/m2 IV over 1 hr 3 wkly. 1st-line treatment: 75 mg/m2 in combination w/
doxorubicin 50 mg/m2. Non-small cell lung cancer Failure of prior platinum-based chemotherapy Recommended dose:
75 mg/m2 IV over 1 hr 3 wkly. Chemotherapy-naive patient Recommended dose: 75 mg/m2 IV over 1 hr immediately
followed by cisplatin 75 mg/m2 over 30-60 min 3 wkly. Ovarian cancer Recommended dose: 100 mg/m2 as 1 hr infusion
3 wkly.
Adults: Tablet: 1-2 tab 2-3 times daily. In most patients, the optimum single dose is 2 tab. In patients being unusually
sensitive to sympathomimetic amines, it is advisable to initiate treatment with 1 tab 2-3 times daily. A total dose of 15
mg in a 24-hr period should not be exceeded.
Injection: Bronchospasm: Intravenous Injection: Adults: 0.25-0.5 mg (0.5-1 ml) is injected slowly intravenously. The
solution for injection is diluted with sterile physiological saline up to 10 ml and is given slowly intravenously during 5
minutes. The dose may have to be repeated with short intervals (a few hours). The dose should not exceed 2 mg in 24
hours.
Intravenous Infusion: Adults: 1-2 mg (2-4 ml) is given during a 24 hour interval as a continuous infusion. An initial loading
dose up to 0.10 mg (0.2 ml) can be given over 10 minutes.
Children: Up to 25 g/kg bw (0.05 ml/kg bw) is given during a 24 hour interval as a continuous infusion. An initial loading
dose up to 1.5 g/kg bw (0.003 ml/kg bw) can be given over 10 minutes.
Subcutaneous Injection: Adults: 1-2 mg (2-4) ml) is given during a 24 hour interval, split into at least 4 occasions.
Children: Up to 25 g/kg bw (0.05 ml/kg bw) is given during a 24 hour interval, split into at least 4 occasions.
Respules: Inhaled bronchodilators should, as initial therapy, be used as required rather than regularly.
BRICASMA solution for nebulization is to be used in nebulizers with or without assisted breathing in acute or subacute
disorders where conventional inhalers prove unsatisfactory and in maintenance therapy in severe broncho-obstructive
conditions.
Dosage should be individual.
Body Weight >25 kg: 5 mg (1 single dose unit, 2 ml) is inhaled 2 up to 4 times in a 24 h period.
Terbuhaler: Dosage of inhaled terbutaline via BRICASMA TURBUHALER should be individualized.
BRICASMA TURBUHALER should, as initially therapy, be used as required rather than regularly.
Adult and children over 12 years: 0.25 mg-0.50 mg as required or, when used as regular maintenance therapy, every 6
hours. In severe cases the single dose may be increased to 1.5 mg. The total dose in 24 hours should not exceed 2 mg.
Children 7-12 years: 0.25 mg-0.5 mg as required or, when used as regular maintenance therapy, every 6 hours. In severe
cases the single dose may be increased to 1.0 mg. The total dose in 24 hours should not exceed 2 mg.
The medication from BRICASMA TURBUHALER is delivered to the lung as patient inhales and therefore it is important to
instruct the patient to breathe in forcefully and deeply through the mouthpiece. When prescribing BRICASMA
TURBUHALER to young children it is necessary to ascertain that they can follow the instructions for use.
The patient may not taste or feel any medication when using BRICASMA TURBUHALER due to the small amount of drug
dispensed.
Administration: Injection: The dose may be given intravenously or subcutaneously. BRICASMA for injection, 1 ml
ampoule, is intended for subcutaneous and intravenous injection. Dosage should be individual.
Terbuhaler: Instruction for correct use of TURBUHALER.
TURBUHALER is inspiratory flow-driven which means that, when the patient inhales through the mouthpiece, the
substance will follow the inspired air into the airways.
NOTE: It is important to instruct the patient: To breathe in forcefully and deeply through the mouthpiece to ensure that
an optimal dose is delivered to the lungs; never to breathe out through the mouthpiece.
The patient may not taste or feel any medication when using TURBUHALER due to the small amount of drug dispensed.
Initiate BRILINTA treatment with a 180 mg (two 90 mg tablets) loading dose and continue treatment with 90 mg twice
daily.
After the initial loading dose of aspirin (usually 325 mg), use Brilinta with a daily maintenance dose of aspirin 75-100 mg.
ACS patients who have received a loading dose of clopidogrel may be started on BRILINTA.
A patient who misses a dose of BRILINTA should take one 90 mg tablet (their next dose) at its scheduled time.
Administration: BRILINTA can be administered with or without food. For patients who are unable to swallow the tablets
whole, Brilinta tablets (90 mg and 2 x 90 mg) can be crushed to a fine powder and mixed in half a glass of water and
drunk immediately. The glass should be rinsed with a further half glass of water and the contents drunk. The mixture can
also be administered via a nasogastric tube (CH8 or greater). It is important to flush the nasogastric tube through with
water after administration of the mixture.
Adult & childn >12 yr 1-2 g once daily depending on type & severity of infection. Max: 4 g daily. Uncomplicated
gonococcal infection 250 mg IM as a single dose. Childn <12 yr & infant For serious infection other than meningitis 50-75
mg/kg daily in equally divided doses 12 hrly. Max: 2 g/day. Meningitis 100 mg/kg daily in divided doses 12 hrly w/ or w/o
a loading dose of 75 mg/kg. Max: 4 g/day. Preop use (surgical prophylaxis) 1 g as a single dose -2 hr before surgery. To
be administered by IV, IM or short IV infusion.
Brochifar Adult & childn >12 yr 1 caplet 3-4 times daily, 6-12 yr caplet 3-4 times daily. Brochifar Plus Adult 1 caplet 3
times daily. Childn 6-12 yr caplet 3 times daily.
Caplet & Plus tab Adult & childn >10 yr 1 tab 3 times daily; childn 5-10 yr tab 3 times daily; 2-5 yr tab twice daily (for
Bromifar caplet) or 3 times daily (for Bromifar Plus tab). Syr Adult & childn >12 yr 10 mL 3 times daily; childn 6-12 yr 5 mL
3 times daily.
Adult 1 tab 3 times daily. In long-term therapy, the dose may be reduced to twice daily. Childn 1.2-1.6 mg/kg/day.
1 cap daily for 10 days/mth for 3 mth.

Susp: Adult: To Relieve Pain: 3-4 times of 10 ml a day. Children: To Relieve Fever and Pain: See table.
Forte tab: Initially 1,200-1,800 mg daily in 3 divided doses. Rheumatic arthritis and osteoarthritis Max dose of 2,400
mg/day in acute exacerbation and may be reduced to max of 1,800 mg/day in stable condition.
1 cap 3 times daily. Duration of administration: 8 wk.
Adult 1 cap or 3 tsp. Childn 6-12 yr 1 tsp. All doses to be taken 3 times daily.
HTN 5 mg once daily. Max: 10 mg/day. Chronic stable or vasospastic angina 5-10 mg daily. Fragile, elderly or patients w/
impaired liver function Initially 2.5 mg once daily.
Apply thinly in the affected area 2-3 times daily at night.
Rub gently on the affected skin 3-4 times daily.
Adult & childn =20 kg 250-500 mg. Childn <20 kg 20-40 mg/kg. All doses to be taken 8 hrly. Severe infection Dosage may
be doubled. Acute gonorrhea 2-3 g as a single dose.
Adult & childn =12 yr 1 tab 3-4 times daily. Max: 12 mg/day. Childn 6-12 yr Max: 6 mg/day in 3-4 divided doses. Childn 2-
6 yr Max: 3 mg/hr in 3-4 divided doses.
Bufect tab Adult & childn 8-12 yr 1 tab, 3-7 yr tab, 1-2 yr tab. All doses to be taken 3-4 times daily. Bufect oral susp
Adult 2 tsp 3-4 times daily. Bufect Forte oral susp Adult 1 tsp 3-4 times daily. Childn Relief of pain & reduction of fever 20
mg/kg in divided doses.
Lumbar epidural abdominal, pelvic & lower limb surgery including caesarean section 5 mg/mL (75-150 g). Thoracic
epidural upper abdominal & thoracic surgery 2.5 mg/mL (12.5-37.5 g) or 5 mg/mL (25-50 g). Caudal epidural 2.5 mg/mL
(37.5-100 g) or 5 mg/mL (75-125 g). Other blocks local inflitration 2.5 mg/mL (12.5-150 g) or 5 mg/mL (25-150 g).
Intercostal (per segment) 2.5 mg/mL (10-20 g) or 5 mg/mL (15-25 g). Brachial plexus 5 mg/mL (100-150 g). Sciatic 3 in 1
(femoral, obturator & lateral cutaneous) 5 mg/mL (50-100 g). Pudendal 2.5-5 mg/mL (7.5-100 g). Caudal epidural post-op
pain management 2.5 mg/mL (50-75 mg bolus). Lumbar epidural bolus & continuous (including labour pain
management) 2.5-5 mg/mL (15-60 mg bolus followed by 12.5-18.75 mg/hr. Thoracic epidural continuous infusion for
post-op pain management 1.25 mg/mL (6.25-12.5 mg/hr).
After cleansing & debriding of the wound, the cream is applied w/ a sterile glove to the burned surface 1-2 times daily to
a 2 mm thickness. Therapy is continue until satisfactory healing has occurred or until the burned site is ready for grafting.
General Considerations: Caduet is a combination product targeting concomitant cardiovascular conditions,
hypertension/angina and dyslipidemia.
The dosage range for Caduet is 5/10 mg to a maximum dose of 10/80 mg once daily. The starting dose and maintenance
dose should be individualized on the basis of both effectiveness and tolerance for each individual component in the
treatment of hypertension/angina and dyslipidemia. Current treatment guidelines should be consulted to establish
treatment goals for patients based on their baseline characteristics. Doses may be taken at any time of the day with or
without food.
As a component of multiple-risk factor intervention, Caduet should be used in addition to non-pharmacological
measures including an appropriate diet, exercise and weight reduction in obese patients, smoking cessation, and to treat
underlying medical problems when the response to these measures have been inadequate.
Following initiation and/or titration of Caduet, lipid levels should be analyzed and blood pressure be measured within 2-
4 weeks, and dosage of amlodipine and atorvastatin components should be adjusted accordingly. Titration for blood
pressure response may proceed more rapidly if clinically warranted.
Initial Therapy: Caduet may be used to initiate treatment in patients with hyperlipidemia and with either hypertension or
angina. The recommended starting dose of Caduet should be based on the appropriate combination of
recommendations for the amlodipine and atorvastatin components considered separately. The maximum dose of the
amlodipine component of Caduet is 10 mg once daily. The maximum dose of the atorvastatin component of Caduet is 80
mg once daily.
If titrated dose is required, atorvastatin can be added separately to the combination of Caduet.
Substitution Therapy: Caduet may be substituted for its individually titrated components. Patients may be given the
equivalent dose of Caduet or a dose of Caduet with increased amounts of amlodipine, atorvastatin or both for additional
antianginal effects, blood pressure- or lipid-lowering effect.
Caduet may be used to provide additional therapy for patients already on one of its components. As initial therapy for
one indication and continuation of treatment of the other, the recommended starting dose of Caduet should be selected
based on continuation of the component being used previously and on the recommended starting dose for the
component being added.
Concomitant Medication: The amlodipine component of Caduet has been safely co-administered with thiazide diuretics,
a- and -blockers, ACE inhibitors, long-acting nitrates and with sublingual nitroglycerin. Caduet has also been safely
administered with the aforementioned medicines.
The atorvastatin component of Caduet may be used in combination with a bile acid-binding resin for additive effect on
lipid-lowering. The combination of HMG-CoA reductase inhibitors and fibrates should generally be avoided (see
Precautions and Interactions).
Special Populations and Special Considerations for Dosing: Primary Hypercholesterolemia and Combined (Mixed)
Hyperlipidemia (Atorvastatin Studies): The majority of patients are controlled with atorvastatin 10 mg once daily. A
therapeutic response is evident within 2 weeks and the maximum response is usually achieved within 4 weeks. The
response is maintained during chronic therapy.
Homozygous Familial Hypercholesterolemia (FH) (Atorvastatin Studies): In a compassionate-use study of patients with
homozygous FH, most patients responded to atorvastatin 80 mg with a >15% reduction in LDL-C (18-45%).
1-3 caplet daily.
Apply 2 times daily.

1 caplet twice daily.
5-10 mg 3 times daily.
Pregnant & lactating women 1 tab once daily.
1 cap daily.
Chew 1-2 tab twice daily.
1 tab daily.
Adult 1 tsp twice daily. Childn 6-12 yr 1 tsp 1-2 times daily; 1-6 yr 1 tsp once daily; 6 mth-1 yr tsp once daily.
Caplet Adult 1 caplet 1-2 times daily. Adolescent & childn >8 yr caplet 1-2 times daily. Susp Childn 1-3 tsp once daily.
Pregnancy & lactation 2 cap daily. Menopausal period & elderly 2-3 cap daily.
1-2 caplet daily.
Childn >4 yr 1 tsp 1-2 times daily; <4 yr 1 tsp once daily.
1 caplet 1-3 times daily.
Adult 1 caplet daily. Childn >6 yr caplet daily.

HTN 5 mg once daily. Max: 10 mg. Patients w/ liver dysfunction, elderly & infants Initially 2.5 mg once daily. Chronic
stable or vasospastic (Prinzmetal's) angina 5-10 mg.
CalSource: Children 4-12 years: 6-9 measuring spoons (30-45 mL) daily in divided doses; up to 3 years: 2-5 measuring
spoons (10-15 mL) daily in divided doses.
In severe calcium deficiency states, up to 75 mL may be necessary.
Fast-growing children may require adult doses.
CalSource Forte: The effervescent tab should be dissolved in a glass of water.
Adults: The usual daily dose is 1-2 tabs covering at least 70% of recommended dietary allowance.
In severe cases, up to 4 effervescent tabs may be required during the first few weeks of therapy.
CalSource Plus Vitamin C: Adults and Children of School Age: 1 effervescent tab daily.
Children 3-7 years: -1 tab effervescent tab daily.
CalSource Junior Strength: Children: 2 tab daily.
CalSource Junior Growth: >3 years: 2 tabs daily. 1-3 years: 1 tab/day.
Adults: 1 tablet daily.

Administration: To be taken with water after meals or consult a physician before use. Do not exceed suggested doses.
Adults: 1 tablet daily with water.
Administration: To be taken with water after meals or consult a physician before use. Do not exceed suggested doses.
1 tab daily.
Adult 1-2 caplet daily.
1 tab once daily.

Dosage: Strictly follow the recommended dosage unless directed otherwise by the physician.
Adults: Monotherapy (For Previously Treated Patient): Recommended Dosage: 350 mg/m2 administered as an IV
infusion over a 30- to 90-min period every 3 weeks.
Combination Therapy (For Previously Untreated Patients): Safety and efficacy of Campto in combination with 5-
fluorouracil (5-FU) and folinic acid (FA) have been assessed with the following schedule. Recommended Dosage: 180
mg/m2 administered once every 2 weeks as an IV infusion over a 30- to 90-min period, followed by infusion with folinic
acid and 5-fluorouracil.
Dosage Adjustment: Campto should be administered after appropriate recovery of all adverse events to grade 0 or 1 NCI-
CTC grading (National Cancer Institute Common Toxicity Criteria) and when treatment-related diarrhea is fully resolved.
At the start of a subsequent infusion of therapy, the dose of Campto, and 5-FU when applicable, should be decreased
according to the worst grade of adverse events observed in the prior infusion. Treatment should be delayed by 1-2 weeks
to allow recovery from treatment-related adverse events. With the following adverse events, a dose reduction of 15-20%
should be applied for Campto and/or 5-FU when applicable: Hematological toxicity, neutropenia grade 4, febrile
neutropenia, (neutropenia grade 3-4 and fever grade 2-4), thrombocytopenia and leukopenia (grade 4),
nonhematological toxicity (grade 3-4).
Treatment Duration: Treatment with Campto should be continued until there is an objective progression of the disease
or an unacceptable toxicity.
Special Populations: Elderly: No specific pharmacokinetic study have been performed in the elderly. However, the dose
should be chosen carefully in this population due to their greater frequency or decreased biological functions. This
population should require more intensive surveillance.
Patients with Impaired Hepatic Function: Monotherapy: In patients with hyperbilirubinemia and prothrombin >50%, the
clearance of irinotecan is decreased and therefore, the risk of hematotoxicity is increased. Thus, frequent monitoring of
complete blood counts should be conducted in this patient population. In patients with bilirubin up to 1.5 times the
upper limit of the normal range (ULN), the recommended dosage of Campto is 350 mg/m2. In patients with bilirubin
ranging from 1.5-3 times the ULN, the recommended dosage of Campto is 200 mg/m2. Patients with bilirubin >3 times
the ULN should not be treated with Campto (see Contraindications and Precautions).
No data are available in patients with hepatic impairment treated with Campto in combination.
Patients with Impaired Renal Function: Campto is not recommended for use in patients with impaired renal function, as
studies in this population have not been conducted.
Administration: Preparation for IV Infusion Administration: As with any other injectable drugs, the Campto solution must
be prepared aseptically. If any precipitate is observed in the vials or after reconstitution, it should be discarded according
to standard procedures for cytotoxic agents. Aseptically withdraw the required amount of Campto solution from the vial
with a calibrated syringe and inject into a 250-mL infusion bag or bottle containing either 0.9% sodium chloride solution
or 5% dextrose solution. The infusion should then be thoroughly mixed by manual rotation.
Campto solution for infusion should be infused into a peripheral or central vein. Campto should not be delivered as an IV
bolus or IV infusion <30 min or >90 min.
HTN Initially 4 mg once daily; max: 16 mg/day. Patients w/ moderate & severe renal impairment & mild to moderate
hepatic impairment Initially 2 mg once daily. Heart failure Usual recommended initial dose: 4 mg once daily, may be up-
titrated to target dose 32 mg or to the highest tolerated dose by doubling the dose w/ at least 2-wk interval.
Adult 1-6 mL. Childn 1-2 mL. To be taken 4 times daily.
HTN Initially 4 mg daily. Max: 16 mg daily. Elderly (>75 yr) & patients w/ moderate to severe impaired kidney function &
mild to moderate impaired liver function Initially 2 mg once daily. Heart failure 4 mg daily, may be increased to 32 mg or
to the highest tolerated dose by doubling the dose w/ at least 2-wk interval.
Adult 1 tab once daily.
Apply in the affected skin 2-3 times daily.

Canesten SD 1 vag tab as a single dose, preferably in the evening. Canesten VT 1 vag tab in the evening for 6 consecutive
days or 2 vag tab in the evening for 3 consecutive days.
Adult 250-500 mg 3-4 times daily. Childn 50 mg/kg/day in 3-4 divided doses. Premature & newborn infant <2 wk 25
mg/kg/day in 4 divided doses.
Adult & elderly Recommended dose: 30 mg once daily. Duration of therapy: Duodenal ulcer & reflux esophagitis 4 wk;
benign gastric ulcer 8 wk. Hepatic & renal impairment Max dose: 30 mg daily.
Adult 50 mg as needed 1 hr before sexual activity. May be taken anywhere from 4 to hr before sexual activity. Dose
may be increased to a max of 100 mg or decreased to 25 mg. Max dosing frequency is once daily.
Adult Pneumonia, UTI, gynecological infections eg, endometritis, skin & skin structure infections 500 mg IV 8 hrly.
Nosocomial pneumonia, peritonitis, septicemia, presumed infections in neutropenic patients 1 g IV 8 hrly. Meningitis 2 g
IV 8 hrly. Renal impairment: CrCl 26-50 mL/min 1 unit dose 12 hrly, 10-25 mL/min -1 unit dose 12 hrly, <10 mL/min -1
unit dose 24 hrly. Childn >3 mth up to 12 yr 10-20 mg/kg 8 hrly depending on type & severity of infection, susceptibility
of the pathogen & condition of the patient. >50 kg Same as adult dose. Meningitis 40 mg/kg 8 hrly.
Adult Mild to moderate UTI 500 mg-1 g IM/IV. Mild to moderate infections except UTI 1 g IM/IV. Severe infections
including skin & skin structure infections 2 g IV. Doses are given 12 hrly. Very severe or life-threatening infections 2 g IV 8
hrly. IV doses should be given approx over 30 min. Childn 2 mth-<16 yr w/ =40 kg body wt Pneumonia, UTI, skin & skin
structure infections; empiric therapy for febrile neutropenia 50 mg/kg body wt/dose 12 hrly for 7-10 days. Febrile
neutropenic patient 50 mg/kg body wt/dose 8 hrly for 7-10 days.
FC caplet Adult & childn =12 yr 10 mg daily during the evening meal. Childn 6-12 yr 10 mg daily either as single dose or
as divided doses 5 mg ( caplet) in the morning & in the evening. Patient w/ renal insufficiency Reduce to of the usual
recommended dose. Syr Adult & childn >6 yr 10 mL once daily. Childn 2-6 yr 2.5 mL once daily. May be increased to a
max of 5 mL/day given as 2.5 mL every 12 hr. Childn 6 mth to <2 yr 2.5 mL once daily. Drops Childn 2-6 yr 0.25 mL once
daily. May be increased to a max of 0.5 mL/day, given as 0.25 mL 12 hrly. Childn 6 mth to <2 yr 0.25 mL once daily.
Complicated upper & lower UTI, skin & soft tissue infections 1 g, may be increased to 2 g in very severe cases. Lower resp
tract infections 1-2 g. Infections in neutropenic patient, bacteremia/septicemia 2 g. All doses should be given 12 hrly.
1-2 FC caplet 3 times daily.

Caplet Adult & childn >12 yr Mild to moderate infections: 250 mg 3 times daily. Severe infections: 500 mg 3 times daily.
Childn Usual recommended dose: 25 mg/kg/day 8 hrly in divided doses. Dental infections Adult & childn >12 yr 250 mg 3
times daily for 5 days. Renal impairment: Moderate (CrCl 10-30 mL/min) 250-500 mg 12 hrly. Severe (CrCl <10 mL/min)
Max: 250 mg tab 12 hrly. Dry syr 1-6 yr 5 mL. Childn <1 yr 2.5 mL. Forte dry syr Childn >6 yr 5 mL. Doses of syr should be
taken 3 times daily.
Infections Adult & childn >12 yr 1.2 g inj 8 hrly. Childn 3 mth-12 yr 30 mg/kg 8 hrly. In more serious infections, increase
frequency to 6 hrly. Childn 0-3 mth 30 mg/kg 8 hrly. In more serious infections, increase frequency to 8 hrly. Surgical
prophylaxis 1.2 g inj given after the induction of anesth. Operations where there is a high risk of infections eg, colorectal
surgery, may require 3-4 times daily.
Adult w/ normal renal function 400 mg/m2 IV over 15-60 min. Combination w/ other myelosuppresive agent requires
dosage adjustment; or use target AUC of 5-7 mg/mL.min for single agent, or 4-6 mg/mLmin for combination therapy.
Recommended dose: 60-75 mg/m2 as single IV administration for 21 days. Alternative dose: 20 mg/m2 wkly or 30
mg/m2 each successive days repeated every 4 wk to decrease toxicity. In combination w/ other myelosuppressive drugs
30-40 mg/m2 every 3-4 wk. In combination w/ non-myelosuppressive drugs 60-75 mg/m2 every 3-4 wk.
The dosage is based on the desired effect and on how the patient tolerates Cardace. Therapy is usually long-term. The
physician determines the duration of treatment individually for each patients.
Treatment of Hypertension: Recommended Initial Dose: 2.5 mg once daily. Depending on the response, the dose may be
increased. Any increase should be implemented by doubling the dose at intervals of 2-3 weeks. Usual Maintenance
Dose: 2.5-5 mg daily. Maximum Dose: 10 mg daily.
Renal Impairment: Creatinine Clearance (CrCl) 20-50 mL/min/1.73 m2 Body Surface Area: Initial Dose: Generally, 1.25
mg. Maximum Daily Dose: 5 mg. When CrCl cannot be measured, it can be calculated based on the serum creatinine
level using the following formula (Cockcroft's equation):
In patients with incompletely corrected fluid or salt deficiency, those with severe hypertension, as well as in those for
whom a hypotensive reaction would constitute a particular risk (eg, patients with haemodynamically relevant stenoses
of the coronary arteries or of the blood vessels supplying the brain) and in the elderly, a reduced initial dose of 1.25 mg
daily must be considered.
Patients Pretreated with a Diuretic: Discontinuing the diuretic for at least 2-3 days or longer, depending on the duration
of action of the diuretic, before starting treatment with Cardace, or at least reducing the diuretic dose shoud be
considered. The physician will decide in each individual case whether such discontinuation or dose reduction is possible
and how long it should last. The initial dose in such patients is generally Cardace 1.25 mg.
Hepatic Impairment: Response to treatment may be either increased or decreased. Therefore, treatment must be
initiated only under close medical supervision. Maximum Daily Dose: 2.5 mg.
Treatment of Congestive Heart Failure: Recommended Initial Dose: 1.25 mg once daily. Depending on the response, the
dose may be increased. Any increase should be implemented by doubling the dose at intervals of 1-2 weeks. Maximum
Daily Dose: 10 mg.
The required daily dose, if =25 mg may be taken as a single dose or in 2 separate doses.
In impaired liver or renal function and in patients pretreated with a diuretic, dosage recommendations for Cardace are
identical to those given previously in the treatment of hypertension. The recommendations given there in conjunction
with diuretic pretreatment also apply.
Treatment After Myocardial Infarction: Recommended Initial Dose: 5 mg daily, divided into 2 single doses of 2.5 mg each,
1 in the morning and 1 in the evening. If this dose is not well tolerated, 1.25 mg should be taken twice daily over 2 days.
In either event depending on the response, the dose may then be increased. Any increase should be implemented by
doubling the dose at intervals of 1-3 days. As treatment progresses, the total daily dose may be taken as a single dose.
Maximum Daily Dose: 10 mg.
Sufficient experience is still lacking in the treatment of patients with severe heart failure (NYHA IV) immediately after
myocardial infarction. Treatment, if nevertheless given, should be started with 1.25 mg once daily and increased only
with particular caution.
In patients with impaired liver or renal function, with incompletely corrected fluid or salt deficiency, or with severe
hypertension, and in those for whom a hypotensive reaction would constitute a particular risk (eg, patients with
haemodynamically relevant stenoses of the coronary arteries or of the blood vessels supplying the brain), as well as in
those pretreated with a diuretic and in the elderly, the recommendations are identical to those given prevoiusly in
HTN Initially 5 mg daily may be increased up to 7.5 mg/day w/ max 10 mg/day. Chronic stable or vasospastic angina 5-10
mg. Elderly & hepatically impaired 2.5 mg daily.
1 softcap daily.
Rate of infusion: 2.5-10 mcg/kg/min which may be increased up to 40 mcg/kg/min. Dose adjustment depends on heart
rate & rhythm, BP & diuresis.
5 mg once daily. Max: 10 mg/day. Patients w/ hepatic insufficiency, elderly Initially 2.5 mg.
Adult 1 tab twice daily, if necessary 1 tab up to 3 times daily. Max: 120 mg/day.
Hypertension: Full Dosage Range: 1-16 mg daily. It is recommended that therapy be initiated at 1 mg given once daily for
1 or 2 weeks. The dosage may then be increased to 2 mg once daily for an additional 1 or 2 weeks. If necessary, the daily
dosage should then be increased gradually at similar intervals to 4 mg, 8 mg and a maximum of 16 mg as determined by
patient's response to achieve the desired reduction in blood pressure. The usual dose is 2-4 mg once daily.
Benign Prostatic Hyperplasia: Initial Dosage: 1 mg given once daily. Depending on the individual patient's urodynamics
and BPH symptomatology, dosage may then be increased to 2 mg and thereafter to 4 mg and up to the maximum
recommended dose of 8 mg. The recommended titration interval is 1-2 weeks. The usual recommended dose is 2-4 mg
once daily.
Elderly: Normal adult dosage is recommended.
Children: The safety and efficacy of Cardura in childrena have not been established.
Renally Impaired Patients: Since the pharmacokinetics of Cardura is unchanged in patients with renal insufficiency, and
there is no evidence that Cardura aggravates existing renal dysfunction, the usual dosages may be used in these patients.
Hepatically Impaired Patients: See Precautions.
1 softcap once daily.
Adult Pneumonia, UTI, endometritis, gynecological infections, skin & soft tissue infections 500 mg IV 8 hrly. Nosocomial
pneumonia, peritonitis, infections in patient w/ neutropenia, septicemia 1 g IV 8 hrly. Meningitis 2 g IV 8 hrly. Childn 3
mth-12 yr 10-20 mg/kg 8 hrly. Childn >50 kg Adult dose. Meningitis 40 mg/kg 3 times daily.
Essential HTN Adult Initially 25 mg/day, then increased to 100 mg/day as a single dose or in 2 divided doses. Childn 1-2
mg/kg body wt/day in 2 divided doses. Severe HTN 100 mg/day. May be increased at 2 wkly intervals up to 400 mg/day.
Cardiac edema Adult 50-100 mg/day as a single or divided doses. Childn 1 mg/kg body wt 3 times daily. Edema due to
hepatic cirrhosis w/ or w/out ascites Adult 300-600 mg/day. Edema due to nephrotic syndrome Adult 100-200 mg/day.
Idiopathic edema 100 mg/day. Edema in childn 3.3 mg/kg in either divided dose or as a single dose. Diagnosis &
treatment of primary aldosteronism 400 mg/day for 3-4 wk for long test. For short test, 400 mg/day for 4 days.
Emergency treatment of acute HTN crisis during surgery 2-10 mcg/kg/min IV drip infusion until desired BP value is
reached & adjusted thereafter w/ monitoring to maintain BP. For rapid BP reduction 10-30 mcg/kg IV inj. Hypertensive
emergencies 0.5-6 mcg/kg/min IV drip infusion at rate of 0.5 mcg/kg/min until desired BP value is reached & adjusted
thereafter w/ monitoring to maintain BP.
Adult 1 caplet 1-3 times daily.

Adult 1 cap twice daily.
1 effervescent tab once daily.
Adult Males Including the Elderly: Casodex 50 mg/Casodex 150 mg: 1 tab once a day.
Casodex 50 mg: Should be started at least 3 days before commencing treatment with an LHRH analogue, or at the same
time as surgical castration.
Casodex 150 mg: Should be taken continuously for at least 2 years or until disease progression.
Renal Impairment: No dosage adjustment is necessary for patients with renal impairment.
Hepatic Impairment: No dosage adjustment is necessary for patients with mild hepatic impairment. Increased
accumulation may occur in patients with moderate to severe hepatic impairment (see Precautions).
The dosage should be adjusted to the patient's condition and started from the lowest effective dose.
Adults: The recommended initial daily dosage is 100-150 mg. The daily dosage should generally be divided in 2-3 doses.
Dosage should not exceed 150 mg/day (for pain management and osteoarthritis), 225 mg/day (for rheumatoid arthritis)
and 125 mg/day (for ankylosing spondylitis).
Migraine: Initial dose of 50 mg should be taken at the 1st sign of an impending attack. In cases where pain relief within 2
hrs after the 1st dose is not sufficient, a further dose of 50 mg may be taken. If needed, further doses of 50 mg may be
taken at intervals of 4-6 hrs, not exceeding a total dose of 200 mg/day.
Children: Cataflam/Cataflam D is not recommended for use in children.
Administration: Cataflam sugar-coated tablets should be swallowed whole with liquid, preferably before meals and must
not be divided or chewed.
Cataflam D should be dissolved in water.
Treatment of hypertension requires regular medical supervision.
The dose of Catapres must be adjusted according to the patient's individual blood pressure response.
Tablet: As an initial daily dose in mild to moderate forms of hypertension, 0.075-0.15 mg daily are sufficient in most
cases.
After a period of 2-4 weeks, the dose may be increased if necessary until desired response is achieved.
Usually, doses >0.6 mg/day do not result in a further marked drop in blood pressure.
In severe hypertension, it might be necessary to increase the single dose further to 0.3 mg; this could be repeated up to
3 times daily (0.9 mg).
Ampoule: SC or IM injection of an ampoule containing Catapres 0.15 mg should only be carried out in patients in a lying
position.
A dosage of 0.2 mcg/kg/min is recommended for IV infusion. The rate of infusion should not exceed 0.5 mcg/kg/min to
avoid transient blood pressure increase. No more than 0.15 mg should be used per infusion.
If necessary, ampoules can be administered parenterally up to 4 times daily.
1 tab daily.
Administration: Cavit D3 should be taken with meal.
Adult 1-2 mL 4 times daily. Infant & childn 1 mL 3-4 times daily. Prophylaxis 1 mL once daily.
1 tab daily.
1 tab daily.
Adult 2-4 g daily 12 hrly. Max daily dose: 4 g. Childn 40-80 mg/kg/day 6-12 hrly. Max daily dose: 160 mg/kg/day. Neonate
To be given 12 hrly. Max daily dose: 80 mg/kg/day.
Apply twice daily, may be used by itself or in combination w/ other dermatological treatments.
Adult Cedocard 5 tab Angina acute attack 1 tab. Prophylaxis: 1-2 tab 3-4 times daily. Prevention of nocturnal attacks 1-2
tab before sleep. Cedocard 10 tab 1-3 tab 4 times daily. Cedocard 20 tab Prevention of expected attack or of nocturnal
angina 1 tab. General dose: 30-160 mg/day, taken 3-4 times daily. CHF Initially tab. Effective dose: 40-160 mg daily, in
severe cases up to 240 mg daily. Cedocard IV infusion 2-10 mg/hr. Cedocard Retard tab 1 tab 2 times daily.
Adult Usual dose: 50-100 mg twice daily. Renal impairment CrCl >60 mL/min Standard dose, 21-60 mL/min 75% of the
standard dose, <20 mL/min 50% of the standard dose. Uncomplicated gonorrhea 400 mg as single dose. Childn >30 kg
Recommended daily dose: 50-100 mg twice daily. Childn =30 kg 1.5-3 mg/kg body wt twice daily. More severe or
intractable infections Up to 6 mg/kg daily in divided doses as twice daily.
Adult & childn >12 yr Usual dose: 1 g 2 times daily (12 hrly), may be increased to max 12 g in severe cases. Gonorrhoea 1
g IM as a single dose. Uncomplicated infection 1 g IM/IV 12 hrly. Moderate to severe infection 1-2 g IM/IV 8 hrly. High-
level infection 2 g IV 6-8 hrly.
Cap Adult & childn =30 kg 100 mg 1-2 times daily, may be increased to 200 mg 2 times daily in severe infections. Dry syr
Childn 1.5-3 mg/kg body wt 2 times daily, may be increased to 6 mg/kg body wt 2 times daily in severe infection.
Adult 1-2 g daily in 2 divided doses. Cystitis 1-2 g daily as a single dose or in 2 divided doses. Other UTI 2 g daily in 2
divided doses. Skin & soft tissue infections 1 g daily as a single dose or in 2 divided doses. Upper & lower resp tract
infections 1 g daily. The dose may be increased up to 2 g daily in severe infections in 2 divided doses. Pharyngitis &
tonsillitis caused by group A -haemolytic streptococci 1 g daily in divided doses for 10 days. Childn 25-50 mg/kg/day in
2 divided doses.
Adult 1 g in 2 equally divided doses, may be increased to 1.5-3 g in 3 divided doses. Childn 20-40 mg/kg in 2 equally
divided doses, may be increased to 100 mg/kg in =3 equally divided doses.
Adult & childn =30 kg 50-100 mg twice daily, may be increased up to 200 mg twice daily. Childn 1.5-3 mg/kg twice daily.
Adult 0.5 g IM/IV in 2-4 divided doses, may be increased to 4 g/day. Childn =6 mth 40-80 mg/kg/day IV in 2-4 divided
doses, may be increased to 120 mg/kg/day.
Adult Mild to moderate UTI 500 mg-1 g IV/IM 12 hrly. Mild to moderate infections except UTI 1 g IV/IM 12 hrly. Severe
infections 2 g IV 12 hrly. Very severe to life-threatening infections 2 g IV 8 hrly. Paed patient 2 mth-16 yr up to 40 kg
Pneumonia & empiric therapy for febrile neutropic patient 50 mg/kg/dose 12 hrly (or 8 hrly in neutropenic patient) for
7-10 days.
2-4 g/day administered 12 hrly.
Overdosage Administration
Symptoms: Limited data are available on the consequences of May be taken with or without food.
ingestion of acute overdoses in humans. No fatalities
occurred, and the patients recovered. No specific signs or
symptoms have been identified following such overdose.
Treatment: If overdosage occurs, the patient should be
monitored and standard supportive treatment applied as
required. Since lamivudine is dialyzable, continuous
hemodialysis could be used in the treatment of overdosage,
although this has not been studied.
Administration of lamivudine at very high dose levels in acute May be taken with or without food.
animal studies did not result in any organ toxicity. Limited
data are available on the consequences of ingestion of acute
overdoses in humans. No fatalities occurred and the patients
recovered. No specific signs or symptoms have been
identified following such overdose.
If overdosage occurs, the patient should be monitored, and
standard supportive treatment applied as required. Since
lamivudine is dialyzable, continuous hemodialysis could be
used in the treatment of overdosage, although this has not
been studied.
May be taken with or without food.
Symptoms: Reports indicate that the ingestion of large Filmtab/Granule dry syr: May be taken with
amounts of clarithromycin can be expected to produce or without food.; XL filmtab: Should be
gastrointestinal symptoms. One patient who had a history of taken with food: Must be taken w/ meals.
bipolar disorder ingested clarithromycin 8 g and showed Swallow whole, do not chew/crush.
altered mental status, paranoid behavior, hypokalemia and
hypoxemia.
Treatment: Allergic reactions accompanying overdosage
should be treated by the prompt elimination of unabsorbed
drug and supportive measures. As with other macrolides,
clarithromycin serum are not expected to be appreciably
affected by hemodialysis or peritoneal dialysis.
Treatment should be symptomatic and supportive eg, May be taken with or without food.
adequate airway maintenance, cardiovascular monitoring and
close medical supervision. Activated charcoal reduces serum
concentration.
Treatment should be symptomatic and supportive eg, May be taken with or without food.
adequate airway maintenance, cardiovascular monitoring and
close medical supervision. Activated charcoal reduces serum
concentration.
MedDRA terminology has been used to classify the adverse May be taken with or without food.
events.
Human Experience: A total of 76 cases of deliberate or
accidental overdosage with aripiprazole have been reported
worldwide. These include overdoses with aripiprazole alone
and in combination with other substances. No fatality was
reported from these cases. Of the 44 cases with known
outcome, 33 recovered without sequelae and 1 recovered
with sequelae (mydriasis and feeling abnormal). The largest
known acute ingestion with a known outcome involved 1080
mg of aripiprazole (36 times the maximum recommended
daily dose) in a patient who fully recovered. Included in the
76 cases are 10 cases of deliberate or accidental overdosage
in children (=12 years) involving aripiprazole ingestions up to
195 mg with no fatalities.
Symptoms: Common adverse events (reported in at least 5%
of all overdose cases) reported with aripiprazole overdosage
(alone or in combination with other substances) include
vomiting, somnolence and tremor. Other clinically important
signs and symptoms observed in =1 patients with aripiprazole
overdoses (alone or with other substances) include acidosis,
aggression, increased aspartate aminotransferase, atrial
fibrillation, bradycardia, coma, confusional state, convulsion,
increased blood creatine phosphokinase, depressed level of
consciousness, hypertension, hypokalaemia, hypotension,
lethargy, loss of consciousness, prolonged QRS complex,
prolonged QT, aspiration pneumonia, respiratory arrest, status
epilepticus and tachycardia.
Treatment: No specific information is available on the
treatment of overdose with aripiprazole. An
electrocardiogram should be obtained in case of overdosage
and, if QTc interval prolongation is present, cardiac
monitoring should be instituted. Otherwise, management of
overdose should concentrate on supportive therapy,
maintaining an adequate airway, oxygenation and ventilation,
and management of symptoms. Close medical supervision
and monitoring should continue until the patient recovers.
Charcoal: In the event of an overdose of Abilify, an early
May be taken with or without food: May be

taken w/ food or milk to reduce GI
discomfort.
Limited information exists with regard to the effects of Should be taken on an empty stomach:
overdosage of ACCOLATE in humans. Take at least 1 hr before or 2 hr after meals.
Management should be supportive. Removal of excess
medication by gastric lavage may be helpful.
Should be taken with food: Dissolve 1 tab in

a glass of water (200 mL). Take after
evening meal.

taken w/ meals to reduce GI discomfort.

given w/o regard to meals. Best taken at
the start of meals for better absorption &
to reduce GI discomfort.
Should be taken with food.
Should be taken with food: Take w/ meals.
Should be taken on an empty stomach:

Take 15 min before meals.
Should be taken on an empty stomach.

Should be taken with food: Take

immediately before or during breakfast, or
the 1st main meal of the day. Do not skip
meals.
May be taken with or without food: Side
effects eg, sleepiness/drowsiness may be
reduced if taken immediately after meals.
Symptoms: Drowsiness, lethargy, dizziness, ataxia, weakness, May be taken with or without food.
hypotonicity, respiratory depression, dryness of the skin and
mucous membranes, tachycardia, hypertension, hyperpyrexia,
hyperactivity, irritability, convulsions and difficulty with
micturition.
Treatment: Necessary measures should be taken to maintain
and support respiration and control convulsions. Gastric
lavage should be performed up to 3 hrs after ingestion, if
indicated. Catheterisation of the bladder may be necessary. If
desired, the elimination of pseudoephedrine can be
accelerated by acid diuresis or by dialysis.

The relative fibrin specificity not withstanding a clinically
significant reduction in fibrinogen and other blood
coagulation components may occur after overdosage. In most
cases, it is sufficient to await the physiological regeneration of
these factors after the Actilyse therapy has been terminated.
If however, severe bleeding results, the infusion of fresh
frozen plasma or fresh blood is recommended and if
necessary, synthetic antifibrinolytics may be administered.
Take w/ a full glass of plain water at least
30 min before the 1st
food/drink/medication of the day & remain
in sitting/upright position for at least 30
min. Swallow whole, do not chew/crush.
One case of overdosage with Actos has been reported. A May be taken with or without food.
patient took 120 mg daily for 4 days, then 180 mg daily for 7
days. The patient did not report any clinical symptoms.
Hypoglycaemia may occur in concomitant administration with
sulfonylurea or insulin.
Symptomatic and general supportive measures should be
taken in case of overdosage.
Pioglitazone Hydrochloride: During controlled clinical trials, 1 Should be taken with food.
case of overdosage with pioglitazone was reported. A male
patient took 120 mg daily for 4 days, then 180 mg daily for 7
days. The patient denied any clinical symptoms during this
period.
In the event of overdosage, appropriate supportive treatment
should be initiated according to patient's clinical signs and
symptoms.
Metformin Hydrochloride: Overdosage of metformin
hydrochloride has occurred, including ingestion of amounts
>50 g. Hypoglycemia was reported in approximately 10% of
cases, but no causal association with metformin
hydrochloride has been established. Lactic acidosis has been
reported in approximately 32% of metformin overdosage
cases (see Metformin Hydrochloride under Warnings).
Metformin is dialyzable with a clearance of up to 170 mL/min
under good hemodynamic conditions. Therefore,
hemodialysis may be useful for removal of accumulated
metformin from patients in whom metformin overdosage is
suspected.
There are no specific overdose definitions for insulins. Should be taken with food: Administer 30
However, hypoglycemia may develop over sequential stages, min before meals. Administration should be
if too high doses relative to the patient's requirements are followed by a meal/snack containing
administered: carbohydrates w/in 30 min.
Mild hypoglycemic episodes can be treated by oral
administration of glucose or sugary products. It is therefore
recommended that the diabetic patient constantly carries
some sugar-containing products.
Severe hypoglycemic episodes, where the patient has become
unconscious, can be treated with glucagon (0.5-1 mg) given
IM or SC by a person who has received appropriate
instruction or glucose given IV by a medical professional.
Glucose must be given IV if the patient does not respond to
glucagon within 10-15 min. Upon regaining consciousness,
administration of oral carbohydrate is recommended for the
patient in order to prevent relapse.
Should be taken with food: Take during or
after meals.
Information regarding acute overdosage is limited to May be taken with or without food.
experience from clinical trials conducted during the
development of Aerius. In a dose-ranging trial, at doses of 10
and 20 mg/day, somnolence was reported.
Single-daily doses of 45 mg were given to normal male and
female volunteers for 10 days. All ECGs obtained in this study
were manually read in a blinded fashion by a cardiologist. In
Aerius-treated subjects, there was an increase in mean heart
rate of 9.2 bpm relative to placebo. The QT interval was
corrected for heart rate (QTc) by both the Bazett and
Fridericia methods.
Using the QTc (Bazett), there was a mean increase of 8.1 msec
in Aerius-treated subjects relative to placebo.
Using QTc (Fridericia), there was a mean increase of 0.4 msec
in Aerius-treated subjects relative to placebo. No clinically
relevant adverse events were reported.
In the event of overdose, consider standard measures to
remove any unabsorbed drug. Symptomatic and supportive
treatment is recommended.
Based on a multiple-dose clinical trial in adults and
adolescents, in which up to 45 mg of desloratadine was
administered (9 times the clinical dose), no clinically relevant
effects were observed.
Desloratadine and 3-hydroxydesloratadine are not eliminated
by hemodialysis; it is not known if it is eliminated by
peritoneal dialysis.
Lethality occurred in rats at oral doses of =250 mg/kg
(estimated desloratadine and desloratadine metabolite
exposures were approximately 120 times the AUC in humans
at the recommended daily oral dose). The oral median lethal
dose in mice was 353 mg/kg (estimated desloratadine
exposures were approximately 290 times the human daily
oral dose on a mg/m2 basis). No deaths occurred at oral
doses up to 250 mg/kg in monkeys (estimated desloratadine
exposures were approximately 810 times the human daily
oral dose on a mg/m2 basis).
May be taken with or without food:
Swallow whole. Do not chew/break/crush.
May be taken with or without food: Avoid
antacids or supplements containing Fe or
Zn w/in 2 hr before or after ofloxacin.
Ensure adequate hydration.
Take 30 min before meals. Swallow whole,
do not chew/crush.
Should be taken with food: To be taken

after meals.

Swallow whole, do not chew/crush.

Should be taken with food: Take after meals

& before bedtime.
Should be taken with food: Take w/ meals.

Reported symptoms of overdose include neutropenia,
anaemia, thrombocytopenia, mucositis, sensory
polyneuropathy and rash. Anticipated complications of
overdose include bone marrow suppression as manifested by
neutropenia, thrombocytopenia and anaemia. In addition,
infection with or without fever, diarrhoea, and/or mucositis
may be seen.
In the event of suspected overdose, patients should be
monitored with blood counts and should receive supportive
therapy as necessary. The use of calcium folinate/folinic acid
should be considered.
Should be taken with food: Take after
meals.

Take w/ a full glass of plain water at least
hr before the 1st food/drink/medication of
the day & remain in sitting/upright position
for at least hr. Swallow whole, do not
chew/crush.



taken w/ meals if GI upset occurs.

immediately before the 1st main meal of
the day. Do not skip meals.

Symptoms: Accidental or intentional overdose may cause Should be taken with food: Take
severe and prolonged hypoglycaemia which may be life- immediately before the 1st main meal of
threatening. the day. Do not skip meals. Swallow whole,
Treatment: In case of overdosage with glimepiride, a do not chew/crush.
physician must be notified immediately. At the 1st signs of
hypoglycaemia, the patient must immediately take sugar,
preferably glucose, unless a physician has already started
care.
Since hypoglycaemia and its clinical symptoms may recur
after apparent clinical recovery (even after several days), close
and continued medical supervision and possibly referral to a
hospital are indicated. In particular, significant overdosage
and severe reactions eg, with unconsciousness or other
neurological dysfunctions, are emergency cases and require
immediate care and hospitalization.
If hypoglycaemic coma is diagnosed or suspected, intravenous
infusion of a 20% glucose solution (adults: 40-100 mL) is
indicated. Alternatively, IV, SC or IM administration of
glucagons (adults: 0.5-1 mg) may be considered. In infants,
glucose must be dosed very carefully and close monitoring of
blood glucose is required to minimize the risk of potentially
severe hyperglycaemia. Other symptomatic therapy (eg,
anticonvulsants) should be administered as necessary. After
acute glucose replacement has been completed, it is usually
necessary to give an IV glucose infusion in lower
concentration so as to ensure that hypoglycaemia does not
recur. The patient's blood glucose level should be carefully
monitored for at least 24 hrs. In severe cases with a
protracted course, hypoglycaemia, or the danger of slipping
back into hypoglycaemia, may persist for several days.
In cases of acute intake of large amounts of glimepiride,
detoxification (eg, by gastric lavage and administration of
medicinal charcoal) is indicated.
Because Amaryl M includes glimepiride, overdosage can Should be taken with food: Take
produce hypoglycemia. Mild hypoglycemia without loss of immediately before or together w/ meals.
consciousness or neurological findings should be treated
aggressively with oral glucose and adjustments in drug
dosage and/or meal patterns. Close monitoring should
continue until the physician is assured that the patient is out
of danger. Severe hypoglycemic reactions with coma, seizure
or other neurological impairment occur infrequently, but
constitute medical emergencies requiring immediate
hospitalization. If hypoglycemic coma is diagnosed or
suspected, the patient should be given a rapid IV injection of
concentrated (50%) glucose solution. This should be followed
by a continuous infusion of a more dilute (10%) glucose
solution at a rate that maintain the blood glucose at a level
>100 mg/dL. Patients should be closely monitored for a
minimum of 24-48 hrs, because hypoglycemia may recur after
apparent clinical recovery.
Because Amaryl M includes metformin, lactic acidosis may
occur. Hypoglycemia has not been seen with ingestion of up
to 85 g of metformin HCl. Metformin is dialyzable with a
clearance of up to 170 mL/min under good hemodynamic
conditions. Therefore, hemodialysis may be useful for
removal of accumulated drug from patients in whom
metformin overdosage is suspected.

Take 1 hr before or 2 hr after meals.
In humans, experiences with intentional overdose is limited. May be taken with or without food.
Gastric lavage may be worthwhile in some cases. Available
data suggest that gross overdosage could result in excessive
peripheral vasodilatation with subsequent marked and
probably prolonged systemic hypotension. Clinically
significant hypotension due to amlodipine overdosage calls
for active cardiovascular support including frequent
monitoring of cardiac and respiratory function, elevation of
extremities and attention to circulating fluid volume and urine
output. A vasoconstrictor may be helpful in restoring vascular
tone and blood pressure, provided that there is no
contraindication to its use.
Calcium gluconate IV may be beneficial in reversing the
effects of calcium channel blockade. Since amlodipine is
highly protein bound, dialysis is not likely to be of benefit.
taken w/ meals for better absorption & to
reduce GI discomfort.

meals.
Swallow whole, do not break/chew.

Take before meals.


taken before, during or after meals.
Swallow whole w/ liqd. Do not chew.
Should be taken with food: Take at meal

times.
immediately before the 1st main meal of
the day. Do not skip meals.
Take at least hr before or 2 hr after
meals.


Take before meals. Dissolve tab in a glass of
water prior to taking. Do not chew/divide.

taken w/ meals for better absorption or if
GI discomfort occurs.
Hypoglycemia may occur as a result of an excess of insulin Should be taken with food: Administer w/in
activity relative to food intake and energy expenditure. 15 min before a meal or immediately after
There are no specific data available concerning overdose with a meal.
insulin glulisine. However, hypoglycemia may develop over
sequential stages: Mild hypoglycemia episodes can be treated
by oral administration of glucose or sugary products. It is
therefore recommended that the diabetic patient constantly
carries sugar lumps, sweets, biscuits or sugary fruit juice.
Severe hypoglycemia episodes, where the patient has
become unconscious, can be treated by glucagon (0.5-1 mg)
given IM or SC by a person who has received appropriate
instruction, or by glucose given IV by a medical professional.
Glucose must also be given IV, if the patient does not respond
to glucagon within 10-15 min. Upon regaining consciousness,
administration of oral carbohydrate is recommended for the
patient in order to prevent relapse.
After an injection of glucagon, the patient should be
monitored in a hospital in order to find the reason for this
severe hypoglycemia and prevent other similar episodes.
Experience in adults exposed to doses of up to 900 mg daily May be taken with or without food.
for 8 weeks revealed no toxicity. The most likely
manifestations of overdosage are expected to be hypotension
and tachycardia; bradycardia might also occur from
overdosage. No specific information is available on the
treatment of overdosage with Aprovel.
The patient should be closely monitored and the treatment
should be symptomatic and supportive. Suggested measures
include induction of emesis and/or gastric lavage. Activated
charcoal may be useful in the treatment of overdosage.
Irbesartan is not removed by haemodialysis.
immediately before meals.


No overdoses of Arcoxia were reported during clinical trials. May be taken with or without food.
In clinical studies, administration of Arcoxia at single doses up
to 500 mg and multiple doses up to 150 mg/day for 21 days
did not result in significant toxicity.
In the event of an overdose, it is reasonable to employ the
usual supportive measures eg, removing unabsorbed material
from the gastrointestinal tract, employing clinical monitoring,
and instituting supportive therapy, if required.
Etoricoxib is not dialyzable by hemodialysis; it is not known
whether etoricoxib is dialyzable by peritoneal dialysis.
Should be taken with food: Take at meal

times.
May be taken with or without food: Place

orodispersible tab on tongue, allow to
disintegrate before swallowing w/ or w/o
water.

taken w/ meals if GI discomfort occurs.
There is limited clinical experience of overdosage. In animal May be taken with or without food:
studies, anastrozole demonstrated low acute toxicity. Clinical Swallow whole, do not chew/crush.
trials have been conducted with various dosages of Arimidex,
up to 60 mg in a single dose given to healthy male volunteers
and up to 10 mg daily given to postmenopausal women with
advanced breast cancer; these dosages were well tolerated. A
single dose of Arimidex that results in life-threatening
symptoms has not been established. There is no specific
antidote to overdosage and treatment must be symptomatic.
In the management of an overdose, consideration should be
given to the possibility that multiple agents may have been
taken. Vomiting may be induced if the patient is alert. Dialysis
may be helpful because Arimidex is not highly protein-bound.
General supportive care, including frequent monitoring of
vital signs and close observation of the patient, is indicated.

Symptoms: Arixtra doses above the recommended regimen
may lead to an increased risk of bleeding.
Treatment: Overdose associated with bleeding complications
should lead to treatment discontinuation and search for the
primary cause. Initiation of appropriate therapy which may
include surgical haemostasis, blood replacements, fresh
plasma transfusion, plasmapheresis should be considered.
Should be taken with food: Best taken w/

meals. Take before meals if dry mouth
occurs, after meals if drooling/nausea
occurs. Take at the same time each day.
May be taken with or without food: Ensure

adequate fluid intake.
Should be taken with food: Take after a

meal.

immediately after meals.



Should be taken with food: Take after meal.

meals.


excessive consumption (>1 L/day) of
grapefruit juice.

There is no specific treatment for atorvastatin overdosage.
Should an overdosage occur, the patient should be treated
symptomatically and supportive measure instituted, as
required. Due to extensive drug binding to plasma proteins,
hemodialysis is not expected to significantly enhance
atorvastatin clearance.
taken w/ meals if GI discomfort occurs.
No symptoms specific to overdosage have been encountered.

In view of the wide therapeutic range and topical
administration of Atrovent metered-aerosol, no serious
anticholinergic symptoms are to be expected. Minor systemic
manifestations of anticholinergic action, including dry mouth,
visual accommodation disturbances and increases of heart
rate may occur.
Symptoms: Gastrointestinal symptoms and disturbance of the May be taken with or without food: May be
fluid and electrolyte balances may be evident. given w/o regard to meals. Best taken at
Amoxicillin crystalluria, in some cases leading to renal failure, the start of meals for better absorption &
has been observed (see Precautions). to reduce GI discomfort.
Treatment: Gastrointestinal symptoms may be treated
symptomatically, with attention to the water/electrolyte
balance. Amoxicillin-clavulanate can be removed from the
circulations by hemodialysis.
Children: A prospective study of 51 pediatric patients at a
poison control centre suggested that overdosages of <250
mg/kg of amoxicillin are not associated with significant
clinical symptoms and do not require gastric emptying.
Drug Abuse and Dependence: Drug dependency, addiction
and recreational abuse have not been reported as a problem
with this compound.
Symptoms: In a bioavailability study, intranasal doses of up to
24 times the recommended daily adult dose were studied
over 3 days with no adverse systemic effects observed (see
Treatment: Acute overdose is unlikely to require any therapy
other than observation.
Take 2 hr before & after food, drugs,
supplement, vit & minerals.

Swallow whole w/ liqd.
In volunteer studies, single doses of dutasteride up to 40 May be taken with or without food:
mg/day (80 times the therapeutic dose) for 7 days have been Swallow whole, do not chew/crush.
administered without significant safety concerns. In clinical
studies, doses of 5 mg daily have been administered to
patients for 6 months with no additional adverse effects to
those seen at therapeutic doses of 0.5 mg.
There is no specific antidote for dutasteride; therefore, in
cases of suspected overdosage, symptomatic and supportive
treatment should be given as appropriate.
May be taken with or without food: Take

before or after meals.

meals.

meals.
Not reported in humans. LD50 could not be determined in May be taken with or without food: Take
animals but Azol was found not to cause death after single consistently either always w/ or always w/o
doses from 5000 mg/kg in rabbits and dogs to 16,000 mg/kg meals.
in rats and mice.
Symptoms: Overdosage could reflect the adverse reactions
seen with Azol (eg, nausea, indigestion and edema).
Treatment: General supportive measures; give diuretics if
edema occurs.
Cap: Should be taken on an empty

stomach: Take 1 hr before or 2 hr after
meals. Syr: May be taken with or without
food: May be taken w/ meals to reduce GI
discomfort.


taken w/ meals to minimise GI discomfort.
Do not take w/ antacids, Fe or dairy
products.
Not applicable.
Should be taken with food: Avoid grapefruit

juice.

taken w/ meals to minimise GI discomfort.
Do not take w/ antacids, Fe or dairy
products.
There is limited experience of entecavir overdosage reported Should be taken on an empty stomach:
in patients. Healthy subjects who received single entecavir Take on an empty stomach at least 2 hr
doses up to 40 mg or multiple doses up to 20 mg/day for up after a meal & 2 hr before the next meal.
to 14 days had no increase in or unexpected adverse events.
If overdose occurs, the patient must be monitored for
evidence of toxicity, and standard supportive treatment
applied as necessary.
Following a single 1-mg dose of entecavir, a 4-hr hemodialysis
session removed approximately 13% of the entecavir dose.



Symptoms: The effects of overdosage are expected to be
primarily related to fenoterol.
The expected symptoms are those of excessive -adrenergic
stimulation, the most prominent being tachycardia,
palpitation, tremor, hypertension, hypotension, widening of
the pulse pressure, anginal pain, arrhythmias and flushing.
Metabolic acidosis has also been observed with fenoterol
when applied in doses higher than recommended for the
approved indications of Berodual. Expected symptoms of
overdosage with ipratropium bromide (eg, dry mouth, visual
accommodation disorder) are mild because the systemic
availability of inhaled ipatropium is very low.
Treatment: Administration of sedatives and tranquilizers, or in
severe cases, intensive care treatment.
Beta-receptor blockers, preferably 1-selective, are suitable
as specific antidotes; however, a possible increase in
bronchial obstruction must be taken into account and the
dose should be adjusted carefully in patients suffering from
bronchial asthma or COPD because of the risk of precipitating
severe bronchospasm, which may be fatal.
Symptoms: Expected symptoms are those of excessive -
adrenergic stimulation, including exaggeration of the known
pharmacologic reactions ie, any of the symptoms listed under
Adverse Effects, the most prominent being tachycardia,
palpitation, tremor, hypertension, hypotension, widening of
the pulse pressure, anginal pain, arrhythmias and flushing.
Metabolic acidosis has also been observed with fenoterol
when applied in doses higher than recommended for the
approved indications of Berotec.
Treatment: Administration of sedatives, tranquilizers and in
severe cases, intensive therapy.
Beta-receptor blockers, preferably 1-selective, are suitable
as specific antidotes; however, a possible increase in
bronchial obstruction must be taken into account and the
dose should be adjusted carefully in patients suffering from
bronchial asthma.

Take before meals.
A few overdose cases have been reported. Some patients Should be taken with food.
experienced mild to moderate symptoms with doses up to
640 mg (e.g. nausea, somnolence, abdominal pain).
More serious complications (e.g. convulsion, pulmonary or
cardiac complications) were observed in cases of intentional
overdose of betahistine especially in combination with other
overdosed drugs.
Treatment of overdose should include standard supportive
measures.

Take hr before meals.

Should be taken with food: Retard tab:

Take on an empty stomach for rapid effect.
Do not take w/in 1 hr of antacids, milk or
other dairy products.

Dissolve tab in a glass of water (=200 mL).


Swallow whole w/ a full glass of water & in
an upright position.

Should be taken on an empty stomach: Tab

should be dissolved in a glass of water.
Best taken between meals. May be taken
w/ meals to reduce GI discomfort.
Symptoms: Limited data are available for overdosage in Should be taken on an empty stomach:
humans. Symptoms associated with overdosage of ACE Take before meals.
inhibitors may include hypotension, circulatory shock,
electrolyte disturbances, renal failure, hyperventilation,
tachycardia, palpitations, bradycardia, dizziness, anxiety and
cough.
Treatment: The recommended treatment of overdosage is IV
infusion of 0.9% sodium chloride 9 mg/mL solution. If
hypotension occurs, the patient should be placed in the shock
position. If available, treatment with angiotensin II infusion
and/or IV catecholamines may also be considered. Perindopril
may be removed from the general circulation by
haemodialysis (see Precautions). Pacemaker therapy is
indicated for therapy-resistant bradycardia. Vital signs, serum
electrolytes and creatinine concentrations should be
monitored continuously.
Symptoms: The most likely adverse reaction in cases of Should be taken on an empty stomach:
overdose is hypotension, sometimes associated with nausea, Take before meals.
vomiting, cramps, dizziness, sleepiness, mental confusion,
oliguria which may progress to anuria (due to hypovolemia).
Salt and water disturbances (low sodium and potassium
levels) may occur.
Treatment: The first measures to be taken consist of rapidly
eliminating the product(s) ingested by gastric lavage and/or
administration of activated charcoal, then restoring fluid and
electrolyte balance in a specialized center until they return to
normal.
If marked hypotension occurs, this can be treated by placing
the patient in a supine position with the head lowered. If
necessary an IV infusion of isotonic saline may be given or any
other method of volemic expansion may be used.
Perindoprilat, the active form of perindopril, can be dialysed
(see Pharmacokinetics under Actions).

Should be taken with food: Take during or
after meals.

before or after meals.

Symptoms: Based on pharmacological considerations, the May be taken with or without food.
main manifestation of an overdose is likely to be symptomatic
hypotension and dizziness. In individual case reports of
overdose (of up to 672 mg candesartan cilexetil), patient
recovery was uneventful.
Management: If symptomatic hypotension should occur,
symptomatic treatment should be instituted and vital signs
monitored. The patient should be placed supine with the legs
elevated. If this is not sufficient, plasma volume should be
increased by infusion of, e.g. isotonic saline solution.
Sympathomimetic drugs may be administered if the
previously mentioned measures are not sufficient.
Blopress is not removed by haemodialysis.
Symptoms: Based on pharmacological considerations, the May be taken with or without food.
main manifestation of an overdose of candesartan cilexetil is
likely to be symptomatic hypotension and dizziness. In 2 case
reports of overdose (candesartan cilexetil 160 and 432 mg),
patient recovery was uneventful.
The main manifestation of an overdose of
hydrochlorothiazide is acute loss of fluid and electrolytes.
Symptoms eg, dizziness, hypotension, thirst, tachycardia,
ventricular arrhythmias, sedation/impairment of
consciousness and muscle cramps can also be observed.
Management: No specific information is available on the
treatment of overdosage with Blopress Plus. The following
measures are, however, suggested in case of overdosage.
When indicated, induction of vomiting or gastric lavage
should be considered. If symptomatic hypotension should
occur, symptomatic treatment should be instituted and vital
signs monitored. The patient should be placed supine with
the legs elevated. If it is not sufficient, plasma volume should
be increased by infusion of isotonic saline solution. Serum
electrolyte and acid balance should be checked and
corrected, if needed. Sympathomimetic drugs may be
administered if the previously mentioned measures are not
sufficient.
Candesartan cannot be removed by haemodialysis. It is not
known to what extent hydrochlorothiazide is removed by
haemodialysis.

Should be taken with food: Take w/ or
between meals. O-dis tab: Dissolve
completely in the oral cavity.

w/ or between meals.

Take before meals & bedtime.

meals.
Too frequent administration, as with other sympathomimetic May be taken with or without food.
agents, may cause nausea, headaches, changes in blood
pressure, anxiety, tension, insomnia, tremor. The symptoms
and sign are those characteristic of excessive sympathetic
stimulation.
Symptoms: Headache, anxiety, tremor, nausea, tonic muscle
cramps, palpitation, tachycardia and cardiac arrhythmia. A fall
in blood pressure sometimes occurs.
Laboratory Findings: Hyperglycaemia and lactacidosis
sometimes occur. 2-agonists may cause hypokalemia as a
result of redistribution of potassium.
Treatment: Usually no treatment is required.
If it can be suspected that significant amounts of terbutaline
sulphate have been swallowed, the following measures
should be considered: Gastric lavage, activated charcoal.
Determine acid-base balance, blood sugar and electrolytes.
Monitor heart rate and rhythm and blood pressure. Metabolic
changes should be corrected. A cardio-selective -blocker
(e.g. metoprolol) is recommended for the treatment of
arrhythmias causing a hemodynamic deterioration. The -
blocker should be used with care because of the possibility of
inducing bronchial obstruction.
If the 2-mediated reduction in peripheral vascular resistance
significantly contributes to the fall in blood pressure, a
volume expander should be given.
Mild and Moderate Cases: Reduce the dose. Then increase
the dose more slowly if the broncholytic effect is insufficient.
Turbuhaler: There is a potential for progressive accumulation
of dry powder in the mouthpiece of the Bricasma Turbuhaler
that could be released if dropped (for example, see table)
towards the end of inhaler life. To minimize unnecessary
systemic exposure to terbutaline, the patients should be
advised to, when possible, rinse their mouth after each use.
There is currently no known treatment to reverse the effects May be taken with or without food: For
of BRILINTA and ticagrelor is not expected to be dialyzable. patients w/ swallowing difficulties, the tab
Treatment of overdose should follow local standard medical may be crushed to a fine powd & mixed in
practice. Bleeding is the expected pharmacologic effect of a glass of water & drunk immediately.
overdosing. If bleeding occurs, appropriate supportive Rinse the glass w/ glass of water & drink.
measures should be taken. Other effects of overdose may The mixture may also be administered via a
include gastrointestinal effects (nausea, vomiting, diarrhea) or nasogastric tube.
ventricular pauses. Monitor the electrocardiogram (ECG).
Should be taken on an empty stomach: For

childn w/ swallowing difficulties, cap may
be opened & poured into a drink (fruit
juice, milk).
Take 30 min before meals.



There is no information on overdosage with May be taken with or without food.
amlodipine/atorvastatin in humans.
Due to amlodipine's and atorvastatin's extensive drug-binding
to plasma proteins, hemodialysis is not expected to
significantly enhance amlodipine/atorvastatin clearance (see
Renal Insufficiency under Pharmacokinetics under Actions).
Symptoms: Additional data on amlodipine ingestion suggest
that gross overdosage could result in excessive peripheral
vasodilatation and possibly reflex tachycardia. Marked and
probably prolonged systemic hypotension up to and including
shock with fatal outcome have been reported.
Treatment: Administration of activated charcoal to healthy
volunteers immediately or up to 2 hrs after ingestion of
amlodipine 10 mg has been shown to significantly decrease
amlodipine absorption. Gastric lavage may be worthwhile in
some cases. Clinically significant hypotension due to
amlodipine overdosage calls for active cardiovascular support
including frequent monitoring of cardiac and respiratory
function, elevation of extremities, and attention to circulating
fluid volume and urine output. A vasoconstrictor may be
helpful in restoring vascular tone and blood pressure,
provided that there is no contraindication to its use.
Intravenous calcium gluconate may be beneficial in reversing
the effects of calcium-channel blockade.
Additional data on atorvastatin ingestion, suggest that there is
no specific treatment for atorvastatin overdosage. Should an
overdose occur, the patient should be treated
symptomatically and supportive measures instituted as
required.

grapefruit juice.
Should be taken with food: Take after meal.

Should be taken with food: Dissolve tab in a

glass of water (=200 mL).


w/ meals for better absorption. Avoid
taking w/ large amount of fibre-rich food.

Acute overdosage has not been reported. It would be May be taken with or without food: Take
expected to cause gastrointestinal disturbances but not to before or after meals.
result in hypercalcaemia, except in patients treated with an
excessive dose of vitamin D.
Should be taken with food: To be taken w/

water after meals.
Should be taken with food: To be taken
after meals.

Single doses of up to irinotecan 750 mg/m2 have been given
to patients with various cancers. The adverse events in these
patients were similar to those reported with the
recommended dosages and regimens. There have been
reports of overdosage at doses up to approximately twice the
recommended therapeutic dose, which may be fatal. The
most significant adverse reactions reported were severe
neutropenia and severe diarrhea. There is no known antidote
for Campto. Maximum supportive care should be instituted to
prevent dehydration due to diarrhea and to treat any
infectious complications.

May be taken with or without food: Swish
& hold in mouth for as long as possible
before swallowing.


Take before or 1 hr after meals.


Symptoms: Overdosage may cause excessive peripheral May be taken with or without food.
vasodilatation (with marked hypotension, shock), bradycardia,
electrolyte disturbances and renal failure.
Treatment: Primary Detoxification eg, gastric lavage,
administration of adsorbents and sodium sulfate (if possible
during the 1st 30 min). In case of hypotension, administration
of a1-adrenergic agonists (eg, norepinephrine, dopamine)
and angiotensin II (angiotensinamide) must be considered in
addition to volume and salt substitution.


Should overdosage lead to hypotension, the patient should be May be taken with or without food.
immediately placed in a supine, head-down position. Other
supportive measures should be performed if thought
appropriate in individual cases. Since Cardura is highly protein
bound, dialysis is not indicated.

There is no human experience of overdosage. There is no May be taken with or without food.
specific antidote; treatment should be symptomatic. Dialysis
may not be helpful since bicalutamide is highly protein bound
and is not recovered unchanged in the urine. General
supportive care, including frequent monitoring of vital signs,
is indicated.
Symptoms: There is no typical clinical picture resulting from Should be taken with food: Take before
diclofenac overdosage. Overdosage can cause symptoms eg, meals.
vomiting, gastrointestinal (GI) haemorrhage, diarrhoea,
dizziness, tinnitus or convulsions. In the event of significant
poisoning, acute renal failure and liver damage are possible.
Treatment: Management of acute poisoning with NSAIDs,
including diclofenac, consists essentially of supportive and
symptomatic measures. Supportive measures and
symptomatic treatment should be given for complications eg,
hypotension, renal failure, convulsions, GI irritation and
respiratory depression.
Specific measures eg, forced diuresis, dialysis, or
haemoperfusion are probably of no help in eliminating
NSAIDs, including diclofenac, due to high protein-binding and
extensive metabolism.
Activated charcoal may be considered after ingestion of a
potentially toxic overdose and gastric decontamination (eg,
vomiting, gastric lavage) after ingestion of a potentially life-
threatening overdose.
Symptoms: Clonidine has a wide therapeutic range. May be taken with or without food.
Manifestations of intoxication are due to generalised
sympathetic depression and include pupillary constriction,
lethargy, bradycardia, hypotension, hypothermia, coma,
apnea. Paradoxic hypertension caused by stimulation of
peripheral a1-receptors may occur.
Treatment: In most cases, symptomatic therapy is sufficient.
Gastric lavage is only worthwhile if it guarantees that the part
taken which has not yet been absorbed, can be removed.
Tolazoline is indicated as a specific antidote (tolazoline 10 mg
IV or 50 mg oral neutralises the effect of Catapres 600 mcg).
Should be taken with food: Dissolve 1

effervescent tab in a glass of water.


Take hr before meals. Retard tab:

taken w/ food or milk to reduce GI
discomfort.

Contraindications
The use of lamivudine is contraindicated in

patients with known hypersensitivity to
lamivudine or to any ingredient of 3TC.
Patients with known hypersensitivity to
lamivudine or to any ingredient of 3TC-HBV.
Warnings An exacerbation of hepatitis has been
observed in a small percentage of patients in
clinical trials when 3TC-HBV was stopped. When
stopping treatment with 3TC-HBV (eg, due to
pregnancy, creatinine clearance falling <30
mL/min or other reason), patients should be
monitored carefully. This exacerbation of
hepatitis could potentially be more severe in
patients with decompensated liver disease. If an
exacerbation of hepatitis occurs, consideration
should be given to restarting treatment with 3TC-
HBV.
Lamivudine is renally cleared and dose reduction
is necessary for renally impaired patients with a
creatinine clearance of <30 mL/min. There is
currently no formulation available to allow
appropriate dosing of these patients. For
patients whose renal function declines to a
creatinine clearance of <30 mL/min while on
treatment, the physician will need to consider
the risk/benefit to the patient of increased
serum lamivudine levels by continuing
treatment, and the risk of an exacerbation of
hepatitis occurring if treatment is stopped.
Use in pregnancy: There is little data on the use
of 3TC-HBV in pregnancy. 3TC-HBV should be
used during pregnancy only if the potential
benefits outweigh the risks. Administration of
3TC-HBV is not recommended during the first 3
months of pregnancy.
Use in children: There is no clinical efficacy or
pharmacokinetic data available to support the
use of 3TC-HBV in patients with hepatitis B <16
years.
Known anaphylactic or severe systemic response

to Ig (human); patients w/ selective IgA
deficiencies.
Hypersensitivity.
Hypersensitivity to dihydropyridine.

macrolide antibiotic drugs.
Patients receiving terfenadine therapy who have
preexisting cardiac abnormalities (arrhythmia,
bradycardia, QT interval prolongation, ischaemic
heart disease, congestive heart failure, etc) or
electrolyte disturbances (see Precautions).
Abbotic XL: As the dose cannot be reduced from
500 mg once daily, clarithromycin MR is
contraindicated in patients with creatinine
clearance <30 mL/min. Clarithromycin 500-mg
immediate-release tablets may be utilized in this
patient population.
Concomitant administration of clarithromycin
with any of the following drugs is
contraindicated: Cisapride, pimozide and
terfenadine and astemizole (see Interactions).
Warnings Pseudomembranous colitis has been
reported with nearly all antibacterial agents,
including macrolides and may range in severity
from mild to life-threatening.
Therefore, it is important to consider this
diagnosis in patients who present with diarrhea
subsequent to the administration of antibacterial
agents. Treatment with antibacterial agents
alters the normal flora of the colon and may
permit overgrowth of Clostridium difficile which
is the primary cause of "antibiotic-associated
colitis". After the diagnosis, pseudomembranous
colitis usually respond to discontinuation of the
drug alone. In moderate to severe cases,
consideration should be given to management
with fluids and electrolytes, protein
supplementation and treatment with an
antibacterial drug effective against Clostridium
difficile.
Use in pregnancy: Clarithromycin should not be
used in pregnant women, except in clinical
Hypesensitivity to aripiprazole.
Hypersensitivity to aripiprazole.
aripiprazole.
Warnings Increased Mortality in Elderly Patients
with Dementia-Related Psychosis: Elderly
patients with dementia-related psychosis treated
with atypical antipsychotic drugs are at an
increased risk of death compared to placebo.
Analyses of 17 placebo-controlled trials (modal
duration of 10 weeks) in these patients revealed
a risk of death in the drug-treated patients of
between 1.6-1.7 times that seen in placebo-
treated patients. Over the course of a typical 10-
week controlled trial, the rate of death in drug-
treated patients was about 4.5%, compared to a
rate of about 2.6% in the placebo group.
Although the causes of death were varied, most
of the deaths appeared to be either
cardiovascular (eg, heart failure, sudden death)
or infectious (eg, pneumonia) in nature. Abilify is
not approved for the treatment of patients with
dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): A
potentially fatal symptom complex sometimes
referred to as Neuroleptic Malignant Syndrome
(NMS) has been reported in association with
administration of antipsychotic drugs, including
aripiprazole. Two possible cases of NMS occurred
during aripiprazole treatment in the
premarketing worldwide clinical database.
Clinical manifestations of NMS are hyperpyrexia,
muscle rigidity, altered mental status, and
evidence of autonomic instability (irregular pulse
or blood pressure, tachycardia, diaphoresis and
cardiac dysrhythmia). Additional signs may
include elevated creatine phosphokinase,
myoglobinuria (rhabdomyolysis) and acute renal
failure.
The diagnostic evaluation
Hypersensitivity of patients with this
to cephalosporins.
Hypersensitivity.
ACCOLATE should not be given to patients who
have previously experienced hypersensitivity to
the product or any of its ingredients.
ACCOLATE is contraindicated in patients with
hepatic impairment or cirrhosis; it has not been
studied in patients with hepatitis or in long term
studies of patients with cirrhosis.
ACCOLATE is contraindicated in children under
12 years of age until safety information is
available.
Hypersensitivity. Infections due to nonsensitive

organism against fusidic acid especially
Pseudomonas aeruginosa.
Hypersensitivity.
Acute alcohol intoxication, hypnotics, centrally-

acting analgesics, opioids or psychotropic drugs.
Hypersensitivity.
Hypersensitivity.
Hypersensitivity.
Hypersensitivity to penicillins.
Hypocalcemia. Pregnancy & lactation.

Hypersensitivity.
Pregnancy & lactation.
Organic disease eg, gastric or intestinal bleeding,

mechanical obstruction or GI perforation.
Known hypersensitivity or co-medication w/

other bisphosphonates; moderate to severe
renal failure. Pregnancy & lactation. Childn.
Active liver disease or unexplained persistent
serum transaminases elevation =3 x ULN;
myopathy. Pregnancy, women of childbearing
potential & lactation.
Severe HTN. Pregnancy.
Hypersensitivity to other sulphonylureas or

sulphonamides, insulin-dependent diabetes,
diabetic coma, ketoacidosis, severe renal or
hepatic function disorders. Pregnancy &
lactation.
Hypersensitivity. Chronic inflammatory bowel

disease &/or bowel obstruction. Bilirubin level >3
times the ULN. Severe bone marrow failure.
WHO performance status >2. Pregnancy &
lactation.
Hypersensitivity to cephalosphorins & penicillins.
Hypersensitivity to benzodiazepines. Acute

narrow-angle glaucoma, myasthenia gravis, acute
pulmonary insufficiency, phobia & chronic
obsessive psychosis. Childn & premature infants.
Individuals who have previously exhibited
intolerance to Actifed or to pseudoephedrine or
triprolidine; patients with severe hypertension or
severe coronary artery disease; patients who are
taking or have taken MAOIs within the preceding
2 weeks. The concomitant use of
pseudoephedrine and this type of product may
occasionally cause a rise in blood pressure.
Sensitivity to other sympathomimetic agents (eg,

ephedrine, phenylpropanolamine,
phenylephrine).
Severe hypertension. Receiving monoamine
oxidase inhibitors (MAOIs) therapy. Heart
disease, diabetes mellitus.
Sensitivity to other sympathomimetic agents (eg,

ephedrine, phenylpropanolamine,
phenylephrine).
Severe hypertension, or receiving monoamine
oxidase inhibitor (MAOI) therapy.
The following contraindications apply in general.
As with all thrombolytic agents, Actilyse should
not be used in cases where there is a high risk of
haemorrhage eg, significant bleeding disorder at
present or within the past 6 months, known
haemorrhagic diathesis; patients receiving oral
anticoagulants eg, warfarin sodium (INR >1.3);
any history of central nervous system damage
(ie, neoplasm, aneurysm, intracranial or spinal
surgery); history, evidence or suspicion of
intracranial haemorrhage including sub-
arachnoid haemorrhage; severe uncontrolled
arterial hypertension; major surgery or
significant trauma in the past 3 months (this
includes any trauma associated with the current
acute myocardial infarction), recent trauma of
the head or cranium; prolonged or traumatic
cardiopulmonary resuscitation (>2 min),
obstetrical delivery within the past 10 days,
recent puncture of a noncompressible blood
vessel (eg, subclavian or jugular vein puncture);
severe hepatic dysfunction, including hepatic
failure, cirrhosis, portal hypertension
(oesophageal varices) and active hepatitis;
haemorrhagic retinopathy eg, in diabetes (vision
disturbances may indicate haemorrhagic
retinopathy) or other haemorrhagic ophthalmic
conditions; bacterial endocarditis and
pericarditis; acute pancreatitis; documented
ulcerative gastrointestinal disease during the last
3 months; arterial aneurysms, arterial/venous
malformations; neoplasm with increased
bleeding risk; hypersensitivity to alteplase or to
any of the excipients of Actilyse.
The following contraindications apply where
Actilyse is indicated: Acute Myocardial Infarction
and Pulmonary Embolism: History of stroke.
Acute Ischaemic Stroke: Symptoms of ischaemic
Hypocalcemia, inability to stand/sit upright for at
least 30 min.
Hypersensitivity to carboplatin or other

platinum-containing compds or mannitol. Severe
preexisting renal impairment (glomerular
filtration rate <30 mL/min), severe
myelosuppression, bleeding tumors & other
significant hemorrhages. Pregnancy & lactation.
Known hypersensitivity to pioglitazone or to any

of the excipients of Actos. Cardiac failure or
history of cardiac failure (NYHA stages I to IV).
Hepatic impairment. Diabetic ketoacidosis.
Current bladder cancer or a history of a bladder
cancer
Hypersensitivity to the pioglitazone
hydrochloride and metformin hydrochloride or to
any of the excipients of Actosmet.
Cardiac failure or history of cardiac failure (NYHA
stages I to IV); acute or chronic disease which
may cause tissue hypoxia eg, cardiac or
respiratory failure, recents myocardial infarction,
shock; hepatic impairment; acute alcohol
intoxication, alcoholism; diabetic ketoacidosis or
diabetic pre-coma; renal failure or renal
dysfunction (creatinine clearance <60 mL/min).
Acute conditions with the potential to alter renal
function eg, dehydration, severe infection, shock,
intravascular administration of iodinated contrast
agents (see Warning and Precautions). Current
bladder cancer or a history of bladder cancer.
Use in pregnancy: Pregnancy Category C: No
preclinical or clinical data on exposed
pregnancies or lactation are available.
Risk Related to Pioglitazone: There are no
adequate human data from the use of
pioglitazone in pregnant women. Animal studies
have not shown teratogenic effects but have
shown foetoxicity related to the pharmacologic
action (see Toxicology under Actions).
Risk Related to Metformin: Animal studies have
not revealed teratogenic effects. Small clinical
trials have not revealed metformin to have
malformative effects.
However, Actosmet should not be used during
pregnancy and in women of childbearing age not
using contraceptive measures. If a patient wishes
to become pregnant or if a pregnancy occurs,
treatment with Actosmet should be
discontinued.
Both pioglitazone and metformin have been
shown to be present in the milk of lactating rats.
It is not known whether breast-feeding will lead
Hypersensitivity to human insulin or any of the
excipients of Actrapid HM/Penfill. Hypoglycemia.
Hypersensitivity to Acuatim.
Patients with history of hypersensitivity to any of
the ingredients of Adant Dispo.
Infection or skin disease at the injection site.
Fe accumulation, disorders in Fe utilization.
Hypersensitivity. Tuberculous or syphilitic

processes in the area to be treated; virus
diseases (eg, varicella, herpes zoster), rosacea,
perioral dermatitis & postvaccination skin
reactions in the area to be treated. Pregnancy
(1st trimester) & lactation.
Hypersensitivity to desloratadine or to any of the
ingredients of Aerius, or to loratadine.
Hypersensitivity to loratadine or to any of the
excipients of Aerius D-12.
Due to its pseudoephedrine component, Aerius
D-12 tablets are contraindicated in patients with
narrow-angle glaucoma or urinary retention and
in patients receiving monoamine oxidase (MAO)
inhibitor therapy or within 14 days of stopping
such treatment. It is also contraindicated in
patients with severe hypertension, severe
coronary artery disease and in those who have
shown hypersensitivity to components of Aerius
D-12 tablet, to adrenergic agents or to other
drugs of similar chemical structures.
A history of haemorrhagic stroke or with risk
factors which could increase the risk of
haemorrhagic stroke. This is due to the a-
mimetic activity of pseudoephedrine in
combination with other vasoconstrictors eg,
bromocriptine, pergolide, lisuride, cabergoline,
ergotamine, dihydroergotamine or any other
decongestant drug used as nasal decongestant,
either by oral route or by nasal route
(phenylpropanolamine, phenylephrine,
ephedrine, oxymetazoline, naphazoline).
Hypersensitivity.
Active pathological bleeding eg, peptic ulcer,

intracranial hemorrhage. Severe liver
impairment. Lactation.
Hypersensitivity to ofloxacin & quinolone
derivatives. Pregnant & nursing women.
Prepubertal childn.
Hypersensitivity.
Hypersensitivity to paracetamol, ibuprofen, or
other NSAIDs. Severe & active peptic ulcer.
Patients in whom acetosal or other NSAIDs
induce symptoms of asthma, rhinitis, or urticaria.
3rd trimester of pregnancy.
History of allergy to albumin. Cardiac failure,

pulmonary edema, severe anemia.
Hypoproteinemic states associated w/ chronic
cirrhosis, malabsorption, protein-losing
enteropathies, pancreatic insufficiencies or
undernutrition. Chronic nephrosis.
CHF; renal insufficiency; chronic anemia. Allergic
or anaphylactic type reactions to albumin.
Severe anemia or cardiac failure.

HTN, stroke, palpitations, insomnia.
Patients on or w/ in 14 days after MAOI therapy

discontinuation; narrow-angle glaucoma, urinary
retention, severe HTN, severe coronary artery
disease, hyperthyroidism.
Hypersensitivity to piperidine derivatives. Childn.

Peptic ulcer, fungal infection.
Systemic fungal infections. Active gastric ulcer,

ocular herpes simplex. Patients receiving MAOIs.
Neoneates, premature infants.
Hypersensitivity. Rare hereditary problems of

fructose intolerance, glucose-galactose
malabsorption or sucrase-isomaltase
insufficiency.
Hypersensitivity. Bacterial, viral, fungal, ocular TB

or purulent eye infections. Glaucoma or herpatic
keratitis. Do not use w/ contact lenses.
Hypersensitivity to pemetrexed or to any of the
excipients of Alimta.
Concomitant yellow fever vaccine (see
Interactions).
Use in lactation: It is not known whether
pemetrexed is excreted in human milk and
adverse reactions on the suckling child cannot be
excluded. Breastfeeding must be discontinued
during pemetrexed therapy.
Hyperthyroidism; HTN, coronary disease. Avoid
use w/in 2 wk of MAOI.
Esophageal abnormalities eg, stricture &
achalasia, inability to stand or sit upright for at
least 30 min, hypocalcemia, renal impairment.
Pregnancy & lactation. Childn.
Acute narrow-angle glaucoma. Myasthenia
gravis, acute pulmonary insufficiency, phobia &
psychosis, childn & premature infants.
Hypersensitivity to benzodiazepines.
Hypersensitivity to aspirin & NSAIDs. Patients w/

history of bronchial asthma, allergic reactions,
urticaria or rhinitis; gastroduodenal ulcer.
Hypersensitivity.
Acute narrow-angle glaucoma.
Abnormal liver condition.
Hypersensitivity to piperadine derivatives.
Type 1 DM, diabetic ketoacidosis, diabetic

precoma, coma; severe renal impairment &
hepatic dysfunction. Pregnancy, lactation.
Amaryl is not suitable for the treatment of
insulin-dependent (type I) diabetes mellitus (eg,
for the treatment of diabetics with a history of
ketoacidosis), diabetic ketoacidosis or diabetic
precoma or coma.
Amaryl must not be used in patients
hypersensitive to glimepiride, other
sulfonylureas other sulfonamides or any of the
excipients of Amaryl (see Description).
No experience has been gained concerning the
use of Amaryl in patients with severe impairment
of liver function and in dialysis patients. In
patients with severe impairment of renal or
hepatic function, a changeover to insulin is
indicated, not least to achieve optimal metabolic
control.
Use in Pregnancy & Lactation: To avoid risk of
harm to the child, Amaryl must not be taken
during pregnancy; a changeover to insulin is
necessary. Patients planning a pregnancy must
inform their physician, and should changeover to
insulin.
Ingestion of glimepiride with breast milk may
harm the child. Therefore, Amaryl must not be
taken by breastfeeding women and a changeover
to insulin or discontinuation of breastfeeding is
necessary.
Known hypersensitivity to any of the excipients
of Amaryl M, sulfonylureas, sulfonamides or
biguanide.
Insulin-dependent (type I) diabetes (eg, diabetics
with a history of ketonemia), diabetic ketonemia,
diabetic coma or precoma, acute or chronic
metabolic acidosis.
There is no experience in patients with severe
hepatic dysfunction or hemodialysis. In case of
severe hepatic or renal function disorders, a
change over to insulin is required to achieve
adequate control of blood glucose.
Patients susceptible or with a history of lactic
acidosis, renal disease or dysfunction [eg, as
suggested by serum creatinine levels =1.5 mg/dL
(males), =1.4 mg/dL (females) or abnormal
creatinine clearance], which may also result from
conditions eg, cardiovascular collapse (shock),
acute myocardial infarction and septicemia.
Amaryl M should be temporarily discontinued in
patients being administered with iodinated
contrast materials IV, because use of such
products may result in acute alteration of renal
function.
Severe infections, before and after surgery,
serious trauma.
Malnourished, starving or debilitated patients, or
patients with pituitary or adrenal insufficiency.
Hepatic dysfunction, severe lung dysfunction,
other conditions likely to be with hypoxemia,
excessive alcohol intake, dehydration, GI
disturbances including diarrhea and vomiting.
Congestive heart failure requiring pharmacologic
treatment.
Use in Pregnancy & Lactation: Amaryl M must
not be taken during pregnancy. Otherwise there
is risk of harm to the child. Pregnant patient or
patient planning to
Hypersensitivity a pregnancy
penicillins.must inform the
Known hypersensitivity to dihydropyridines.
Hypercalcemia.
Patients with hepatic coma or a risk of hepatic

coma (because of inadequate amino acid
metabolism, the patient's clinical condition may
be worsened. Patients with severe renal disorder
or azotemia (the amounts of water and
electrolytes tend to be excessive and the
patient's clinical condition may be worsened.
Urea and other amino acid metabolites may be
retained, which may worsen the patient's clinical
condition). Patient's with congestive cardiac
failure (an increase in the circulating blood
volume may worsen the patient's clinical
condition). Patients with severe acidosis
(hyperlactacidemia, etc) (the patient's clinical
condition may be worsened). Patients with
abnormal electrolyte metabolism: Patients with
hyperpotassemia (oliguria, Addison's disease,
etc), patients with hyperphosphatemia
(hypoparathyroidism, etc), patients with
hypermagnesemia (hypothyroidism, etc),
patients with hypercalcemia (administration may
worsen the patient's clinical condition). Patients
with reduced urine output due to obstructive
uropathy (overload of water and electrolytes
may worsen the patient's clinical condition).
Patients with abnormal amino acid metabolism.
Since the infused amino acids are not adequately
metabolized, the patient's clinical condition may
be worsened.
Patients with severe renal disorder (the amount
of water tends to be excessive and the patient's
clinical condition may be worsened. Urea and
other amino acid metabolites may be retained,
which may worsen the patient's clinical
condition) and patients with abnormal amino
acid metabolism (since the infused amino acids
are not adequately metabolized, the patient's
clinical condition may be worsened).
In patients w/ inborn errors of amino acids

metabolism; hepatic coma & untreated anuria,
manifest cardiac insufficiency, hypokalaemia &
hyperhydration.
Hypersensitivity to one of the components of
Aminovel 600. Hepatic coma, congestive heart
failure, severe acidosis and renal failure.
Hypersensitivity to amikacin & other

aminoglycosides.
Patients with hepatic coma or a risk of hepatic
coma, severely impaired renal function or a risk
of hypernatremia, and abnormal amino acid
metabolism.
Risk of hepatic coma, hyperammonemia,

inherited abnormal amino acid metabolism,
severe renal disorder or azotemia.
Hypersensitivity to dihydropyridines.
Systemic fungal infections, TB, corticosteroid

hypersensitivity.
Systemic fungal infections, TB, corticosteroid

hypersensitivity.
BP <100 mmHg, acute psychosis. Pregnancy &
lactation. Infant 1st mth birth.
Hypersensitivity to opioids, acute intoxication w/
alcohol, hypnotics, narcotics, centrally acting
analgesics, opioids, psychotropics; patients
receiving MAOIs or w/in 2 wk of w/drawal;
severe hepatic impairment; epilepsy not
controlled by treatment. Pregnancy & lactation.
Hypersensitivity to cephalosporins.
Known hypersensitivity to macrolides.

Concomitant therapy w/ vasoconstrictive ergot
alkaloids.
Known hypersensitivity to cephalosporins.

Pernicious anemia.
Hypersentivity to benzodiazepines. History of

acute narrow-angle glaucoma. Premature infant.
Intrathecal or epidural administration.
Hypersensitivity. Stenosis of the renal artery

(bilateral/unilateral) in the single-kidney
patients; low BP or labile circulatory conditions.
Pregnancy.
Hypersensitivity. Not for initial treatment of

unstable angina or MI. Pre-hospital phase or
during 1st days of hospitalization. Lactation.
Type 1 DM, diabetic ketoacidosis, diabetic
precoma, coma; severe renal impairment &
hepatic dysfunction. Pregnancy & lactation.
Hemorrhage, CHF. Pregnancy.
Hyperthyroidism, HTN, coronary disease; MAOI;
nephropathy.
Hypersensitivity. Active gastric or intestinal ulcer,

bleeding or perforation, severe hepatic, renal &
cardiac failure; asthma, urticaria or allergy to
aspirin or other NSAIDs, Periop pain in CABG
surgery. Pregnancy (last trimester) & lactation.
Hypersensitivity.
Hypersensitivity to insulin glulisine or to any of
the exipients of Apidra.
Hypoglycaemia.
Herpes simplex, varicella, skin TB, dermatitis

caused by syphilis & skin ulcer. Treatment of the
eye.
Herpes simplex, varicella, skin TB, dermatitis

caused by syphilis & skin ulcer. Treatment of the
eye. Hypersensitivity to neomycin.
Hypersensitivity to any component of Aprovel
(see Description).
Second and third trimester of pregnancy (see
Precautions).
Lactation (see Precautions).
Fertility: Irbesartan had no effect upon fertility of
treated rats and their offspring up to the dose
levels inducing the first signs of parental toxicity
(see Pharmacology: Toxicology: Preclinical Safety
Data under Actions).
Use in Pregnancy: The use of AIIRAs is not
recommended during the first trimester of
pregnancy (see Precautions). The use of AIIRAs is
contraindicated during the second and third
trimesters of pregnancy (see Precautions).
Epidemiological evidence regarding the risk of
teratogenicity following exposure to ACE
inhibitors during the first trimester of pregnancy
has not been conclusive; however, a small
increase in risk cannot be excluded. Whilst there
is no controlled epidemiological data on the risk
with Angiotensin II Receptor Antagonists
(AIIRAs), similar risks may exist for this class of
drugs. Unless continued AIIRA therapy is
considered essential, patients planning
pregnancy should be changed to alternative
antihypertensive treatments which have an
established safety profile for use in pregnancy.
When pregnancy is diagnosed, treatment with
AIIRAs should be stopped immediately, and, if
appropriate, alternative therapy should be
started.
Exposure to AIIRA therapy during the second and
third trimesters is known to induce human
fetotoxicity (decreased renal function,
oligohydramnios, skull ossification retardation)
and neonatal toxicity (renal failure, hypotension,
hyperkalaemia) (see Pharmacology:
Gastric ulcer. Asthma, urticaria or acute rhinitis
precipitated by ASA/prostaglandin synthetase
inhibitors. Lactation. Childn <14 yr.
Only a history of hypersensitivity to sulbutiamine

constitutes a contraindication.
Hypersensitivity to penicillins. Infectious
mononucleosis.
Constipation.
Patients with hypersensitivity to any component
of Arcoxia; congestive heart failure (NYHA II-IV);
established ischemic heart disease, peripheral
arterial disease and/or cerebrovascular disease
[including patients who have recently undergone
coronary artery bypass graft (CABG) surgery or
angioplasty].
Warnings Cardiovascular Effects: Cardiovascular
Thrombotic Events: Clinical trials of several COX-2
selective and nonselective NSAIDs up to 3 years
duration have shown an increased risk of serious
cardiovascular (CV) thrombotic events,
myocardial infarction (MI), and stroke, which can
be fatal. All NSAIDs, both COX-2 selective and
nonselective, may have a similar risk. Patients
with known CV disease or risk factors for CV
disease may be at greater risk. To minimize the
potential risk for an adverse CV event in patients
treated with an NSAID, the lowest effective dose
should be used for the shortest duration
possible. Physicians and patients should remain
alert for the development of such events, even in
the absence of previous CV symptoms. Patients
should be informed about the signs and/or
symptoms of serious CV events and the steps to
take if they occur.
There is no consistent evidence that concurrent
use of aspirin mitigates the increased risk of
serious CV thrombotic events associated with
NSAID use. The concurrent use of aspirin and an
NSAID does increase the risk of serious GI
events.
Two large, controlled, clinical trials of a COX-2
selective NSAID for the treatment of pain in the
first 10-14 days following CABG surgery found an
increased incidence of MI and stroke (see
Contraindications).
Hypertension: NSAIDs, including Arcoxia, can
Hypontension due to uncorrected hypovolemia.
Concomitant w/ cyclopropane & halothane
anesth.
Peptic ulceration. Patient in whom aspirin or

other NSAIDs induce the symptoms of asthma,
rhinitis or urticaria. 3rd trimester pregnancy.
Vaccinia, varicella, skin TB, fungal & viral

infections.
Hypersensitivity. Increased bleeding tendency;

patients on anticoagulation therapy; severe liver
& kidney disease.
Hypersensitivity to piperidine derivatives.
GI & cerebrovascular bleeding, asthma, active

peptic ulcer, nondialyzed severe kidney
insufficiency, severe liver insufficiency, other
bleeding disorders. Pregnancy & lactation. Childn
<15 yr.
Known hypersensitivity to anastrozole or to any
of the excipients of Arimidex; premenopausal
women; patients with severe renal impairment
(CrCl <20 mL/min); patients with moderate or
severe hepatic disease. Co-administration with
oestrogen-containing therapies.
Concurrent tamoxifen therapy (see Interactions).
Use in pregnancy & lactation: Arimidex is
contraindicated in pregnant or lactating women.
Hypersensitivity.
Known hypersensitivity to fondaparinux or to any
of the excipients of Arixtra. Clinically active
significant bleeding; acute bacterial endocarditis;
severe renal impairment (CrCl <20 mL/min).
Closed-angle glaucoma, paralytic ileus, prostatic

hypertrophy.
Hypersensitivity to quinolones or any other

component of Armolev. Epilepsy. Childn during
growth period. Pregnancy & lactation.
Hypersensitivity. Pre-menopausal women.
Inadequately controlled cardiac insufficiency,
sinus bradycardia, AV block or cardiogenic shock;
symptoms or history of bronchial asthma &
bronchospasm or severe chronic pulmonary
obstruction.
Active pathological bleeding, peptic ulcer,

intracranial hemorrhage, severe liver
impairment. Lactation.
Hypersensitivity to ibuprofen or other NSAIDs.

Patients who exhibit asthma, rhinitis & dyspnea,
nasal polyp, angioedema, bronchospastic
reactions due to aspirin, severe & active peptic
ulcer (gastric & duodenal ulcer), last trimester of
pregnancy.
Liver dysfunction; asthma, rhinitis & urticaria due

to acetosal or other NSAIDs. Severe & active
peptic ulcer (gastric & duodenal ulcers). End
trimester of pregnancy.
Do not give to patients with congestive heart
failure, renal impairment, pulmonary edema
caused by sodium retention and
hyperproteinemia. Do not give to patients with
hypernatremia, hyperchloremia and
hyperhydration.
GI ulcer, asthma, kidney disease.

Hyperthyroidism, HTN & CV disease, closed-
angle glaucoma, prostatic enlargement. Peptic
ulcer. Concomitant use of MAOI.
Hypersensitivity.
Bleeding disorders, asthma, active peptic ulcer.

Acute narrow-angle glaucoma. Myasthenia
gravis, acute pulmonary insufficiency, phobia &
psychosis, childn & premature infants.
Hypersensitivity to benzodiazepines.
Hypersensitivity.

serum transaminases elevation =3 x ULN.
Pregnancy, women of childbearing potential &
lactation.
Hypersensitivity. Active liver disease or

unexplained persistent serum transaminases
elevation =3 x ULN. Pregnancy, women of
childbearing potential & lactation.
Hypersensitivity to any component of Atorwin.
elevations of serum transaminases exceeding 3
times the upper limit of normal, or who are:
Childbearing potential who are not using
adequate contraceptive measures. Atorvastatin
should be administered to woman of
childbearing age only when such patients are
highly unlikely to conceive and have been
informed of the potential hazards to the fetus.
Use in pregnancy & lactation: Atorvastatin is
contraindicated in pregnancy. Women of
childbearing potential should use adequate
contraceptive measures. Atorvastatin should be
administered to women of childbearing age only
when such patients are highly unlikely to
conceive and have been informed of the
potential hazards to the fetus.
Atorvastatin is contraindicated while
breastfeeding. It is not knows whether this drug
is excreted in human milk. Because of the
potential for adverse reactions in nursing infants,
women taking atorvastatin should not
breastfeed.
Active gastric ulcer, severe liver insufficiency,
asthma, nasal polyp, angioedema or urticaria
caused by ASA or other NSAIDs. Childn &
adolescents <15 yr. Pregnancy & lactation.
Patients with known hypersensitivity to atropine

or its derivative or to any component of
Atrovent.
Patients who are hypersensitive to -lactam
antibiotics eg, penicillin and cephalosporins.
Previous history of amoxicillin-clavulanate-
associated jaundice or hepatic dysfunction.
Patients with hypersensitivity to any of the
ingredients of Avamys nasal spray.
Phenylketonuria. Pregnant w/ high phenylalanine
levels.
Hypersensitivity; severe renal impairment (CrCl

<10 mL/min).
Patients with hypersensitivity to dutasteride,
other 5a-reductase inhibitors or to any of the
excipients of Avodart.
Patients with severe hepatic impairment.
Women, children and adolescents.
Use in pregnancy & lactation: Dutasteride is
contraindicated for use by women. Dutasteride
has not been studied in women because
preclinical data suggest that the suppression of
circulating levels of dihydrotestosterone may
inhibit the development of the external genital
organs in a male fetus carried by a woman
exposed to dutasteride.
It is not known whether dutasteride is excreted
in breast milk.
HTN, myocardial insufficiency, hyperthyroidism,
diabetic & CV disorders. Hypersensitivity to
salbutamol sulfate.
Known hypersensitivity to danazol or to any of

the components of Azol. Undiagnosed abnormal
genital bleeding; markedly impaired liver
function; past jaundice with oral contraceptives;
undiagnosed ovarian/uterine masses; pelvic
infection; neoplasia of primary or secondary
sexual organs; hypertension world health
organization (WHO) II or worse; renal or cardiac
edema; porphyria (Azol can induce ALA
synthetase activity and hence porphyrin
metabolism).
Use in pregnancy & lactation: Anabolic steroids
and other substances with androgenic effects
may have a virilising effect on the female fetus
and should be avoided during pregnancy.
Pregnancy should be excluded before
commencing therapy and treatment should be
commenced during menstruation. A
nonhormonal method of contraception should
be recommended. If a patient becomes pregnant
during treatment, administration of Azol should
be discontinued and the patient should be
apprised of the potential risk to the fetus. If a
patient has become pregnant during treatment,
cease taking Azol and consult the physician.
Exposure to Azol in utero may result in
androgenic effects on the female fetus; reports
to date comprise clitoral hypertrophy, labial
fusion, urogenital sinus defect, vaginal atresia
and ambiguous genitalia.
It is known if Azol is excreted in breast milk or
whether it has a harmful effect on the newborn.
Therefore, it is not recommended for use in
nursing mothers.
Warnings Thromboembolism, thrombotic and
thrombophlebitic events including sagittal sinus
thrombosis and life-threatening or fatal strokes
have been reported.
Hypersensitivity to azithromycin, erythromycin &
other macrolide antibiotics. Pregnancy &
lactation.
Hypersensitivity to erythromycin or macrolides.
Optic neuritis. INH-induced liver disease. Childn

<13 yr.
Optic neuritis, childn <13 yr.

Hypersensitivity. Pregnancy & lactation. Childn,

adolescents.
Cream: History of hypersensitivity to any of the
constituents of Bactroban cream.
Ointment: Hypersensitivity to Bactroban or other
ointments containing polyethylene glycol and
any of its constituents.
AV block, history of bone marrow depression.

Concomitant use w/ MAOIs.
Patients on MAOIs 2 wk prior to treatment.
Hypersensitivity to ciprofloxacin or other

quinolones.
Childn & juvenile before end of growth phase.

Hypersensitivity to entecavir or to any of the
components of Baraclude.
Warnings Lactic acidosis and severe
hepatomegaly with steatosis, including fatal
cases, have been reported with the use of
nucleoside analogues alone in combination with
antiretrovirals.
A majority of these cases have been in woman.
Obesity and prolonged nucleoside exposure may
be risk factors. Particular caution should be
exercised when administering nucleoside
analogues to any patient with known risk factors
for liver disease; however, cases have also been
reported in patients with no known risk factors.
Lactic Acidosis with Baraclude should be
suspended in any patient who develops clinical
or laboratory findings suggestive of lactic
acidosis or pronounced hepatotoxicity (which
may include hepatomegaly and steatosis even in
the absence of marked transaminase elevations).
Severe Acute Exacerbations of Hepatitis B:
Severe acute exacerbations of hepatitis B have
been reported in patients who have discontinued
anti-hepatitis B therapy, including entecavir.
Hepatic function should be monitored closely
with both clinical and laboratory follow-up for at
least several months in patients who discontinue
anti-hepatitis B therapy. If appropriate, initiation
of anti-hepatitis B therapy may be warranted.
Patients Co-Infected with HIV and HBV:
Baraclude has not been evaluated in HIV/HBV co-
infected patients who were not simultaneously
receiving effective HIV treatment. Limited clinical
experience suggests there is a potential for the
development of resistance to HIV nucleoside
reverse transcriptase inhibitors if Baraclude is
used to treat chronic HBV infection in patients
with HIV infection that is not being treated (see
AV block. Bone marrow depression or acute

intermittent porphyria. Impaired renal function.
Hypersensitivity to penicillins, sulbactam,

cefoperazone or any of the cephalosporins.
Autoimmune diseases.
Amino acid metabolism disturbance,
hyperkalemia, advanced hepatic insufficiency,
renal insufficiency due to kidney defects &
hyperhydration.
Hypersensitivity. Haemophilia.
Arterial & strong venous bleeding. Known
hypersensitivity to bovine proteins.
Hypertrophic obstructive cardiomyopathy,
tachyarrhythmia.
Hypersensitivity to fenoterol hydrobromide,
atropine-like substances or inactive ingredients
of Berodual.
Hypertrophic obstructive cardiomyopathy,
tachyarrhythmia. Hypersensitivity to fenoterol
HBr or inactive ingredients of the metered
aerosol.
Hypersensitivity. Pregnancy & lactation. Childn
<12 yr.
Hypersensitivity to aminoglycosides, viral or
fungal infections of the eye.
Bacterial, viral or fungal infections of the eye,

ocular TB, acute purulent eye infections,
glaucoma. Do not use w/ contact lenses.
Lactation.
Hypersensitivity to the active substance or to any

of the excipients. Betaserc should not be given to
pregnant women and lactation.
Phaeochromocytoma. Children less than 12
years.

Viral diseases of the skin, skin TB, acute purulent
infection of bacterial, fungal origin.
Liver diseases (except fatty liver), gallbladder
diseases w/ or without cholelithiasis. Severe
renal dysfunction (serum creatinine >6 mg/100
mL or 530 micromole/L for Bezalip or >1.6
mg/100 mL or 136 micromole/L for Bezalip
Retard). Pregnancy, lactation. Nephrotic
syndrome.
Acute surgical abdominal conditions, ileus

intestinal obstruction, appendicitis.
Hypersensitivity.
Hypersensitivity to Zn.
Hypersensitivity to equine antisera.

Hypersensitivity to clindamycin & lincomycin.
Diarrhea.
Hypersensitivity.
Hypersensitivity. Patients w/ kidney failure, AV
block, unless the patients are using pacemaker.
Hypersensitivity.
Hemochromatosis, hemosiderosis, anemia not

caused by Fe deficiency. Repeated blood
transfusion.
Known hypersensitivity to perindopril, to any of
the excipients of Bioprexum or to any other ACE
inhibitor; history of angioedema associated with
previous ACE inhibitor therapy; hereditary or
idiopathic angioedema; 2nd and 3rd trimesters
of pregnancy (see Use in pregnancy & lactation
under Precautions).
Due to the lack of sufficient therapeutic
experience, Bioprexum Plus should not be used
in dialysis patients and patients with untreated
decompensated heart failure.
Perindopril: Hypersensitivity to perindopril or
any other ACE inhibitor. History of angioedema
(Quincke's edema) associated with previous ACE
inhibitor therapy. Hereditary/idiopathic
angioedema. 2nd and 3rd trimesters of
pregnancy (see Use in pregnancy & lactation
under Precautions).
Indapamide: Hypersensitivity to indapamide or
to any other sulphonamides. Severe renal
impairment (CrCl <30 mL/min). Hepatic
encephalopathy. Severe hepatic impairment.
Hypokalemia. As a general rule, indapamide is
inadvisable in combination with non-
antiarrhythmic agents causing Torsades de
pointes (see Interactions). Lactation (see Use in
pregnancy & lactation under Precautions).
Warnings Perindopril and Indapamide: Lithium:
The combination of lithium and the combination
of perindopril and indapamide is usually not
recommended (see Interactions).
Perindopril: Neutropenia/Agranulocytosis:
Neutropenia/agranulocytosis, thrombocytopenia
and anemia have been reported in patients
receiving ACE inhibitors. In patients with normal
renal function and no other complicating factors,
neutropenia occurs rarely. Perindopril should be
used with extreme caution in patients with
collagen vascular disease, immunosuppressant
therapy, treatment with allopurinol or
procainamide, or a combination of these
complicating factors, especially if there is
preexisting impaired renal function. Some of
these patients developed serious infections
which in a few instances did not respond to
Hypersensitivity to equine antisera.
Hypersenstivity to equine antisera.
Severe hepatic & renal dysfunction,

hypersensitivity.
Acute heart failure or during episodes of heart
failure decompensation requiring IV inotropic
therapy, cardiogenic shock, 2nd or 3rd degree AV
block, sick sinus syndrome, SA block, bradycardia
(<80 bpm), hypotension (systolic BP <100
mmHg), severe bronchial asthma or COPD, late
stages of peripheral arterial occlusive disease,
Raynaud's syndrome, untreated
phaeochromocytoma, metabolic acidosis.
Lactation.
Otitis externa w/ perforated membrane of the
ear.
Acute herpes simplex & other viral diseases of

cornea & conjunctiva, ocular TB, fungal diseases
& acute purulent infections, trachoma.
Hypersensitivity. 1st & 2nd stage of labor before

crowning of the head, toxemia, HTN. Lactation.
Acute pulmonary infection or greatly reduced

lung function. Pregnancy & lactation.
Abnormal uterine bleeding, ovarian

enlargement, thyroid or adrenal dysfunction.
Liver disease or history of liver dysfunction,
organic intracranial lesion (eg, pituitary tumor).
Suspected incomplete hemostasis following

intracranial hemorrhage; elevated intracranial
pressure at the acute stage of cerebral stroke.
Hypersensitivity to any component of Blopress.
Severe hepatic and/or cholestasis. Pregnancy
and lactation.
Hypersensitivity to the active ingredients of
Blopress Plus or sulfonamide-derived drugs (eg,
hydrochlorothiazide) or to any of its excipients.
Pregnancy and lactation; severe renal
impairment (creatinine clearance <30
mL/min/1.73 m2 body surface area); severe
hepatic impairment and or cholestasis; refractory
hypokalemia and hypercalcemia; gout.
Warnings Fetal/Neonatal Morbidity and
Mortality: Drugs that act directly on the renin-
angiotensin system can cause fetal and neonatal
morbidity and death when administered to
pregnant women. Several dozen cases have been
reported in the world literature in patients who
were taking angiotensin-converting enzyme
inhibitors. Post-marketing experience has
identified reports of fetal and neonatal toxicity in
babies born to women treated with candesartan
cilexetil during pregnancy.
Because candesartan cilexetil is a component of
Blopress Plus, Blopress Plus should be
discontinued as soon as possible when
pregnancy is detected.
The use of drugs that act directly on the renin-
angiotensin system during the 2nd and 3rd
trimesters of pregnancy has been associated
with fetal and neonatal injury, including
hypotension, neonatal skull hypoplasia, anuria,
reversible or irreversible renal failure and death.
Oligohydramnios in this setting has been
associated with fetal limb contractures,
craniofacial deformation and hypoplastic lung
development.
Prematurity, intrauterine growth retardation and
patent ductus arteriosus have also been
reported, although it is not clear whether these
occurrences were due to exposure to the drug.
These adverse
Bronchial asthmaeffects do notbronchospastic
or related appear to have
conditions including severe hypotension, severe
sinus bradycardia, 2nd- & 3rd-degree AV block;
patients w/ NYHA class IV decompensated heart
failure requiring IV inotropic support; COPD w/ a
bronchospatic component; clinically manifested
liver dysfunction; cardiogenic & hypovolaemic
shock.
Hypersensitivity to ibandronate, other
bisphosphonates. Pregnancy & lactation. Childn.
Hypercalcemia, metastatic calcification.

Hypersensitivity.
Hypersensitivity.
Hypersensitivity; epithelial herpes simplex

keratitis (dendritic keratitis), vaccinia, varicella &
many other viral diseases of the cornea &
conjunctiva; mycobacterial eye infection, fungal
diseases of ocular structures.
Hypersensitivity to highly purified urofollitropin.
Pituitary or hypothalamic gland tumor; ovarian,
uterine or mammary carcinoma. Gynecological
hemorrhage of unknown aetiology. Pregnancy &
lactation.
Hypersensitivity. Primary infections of the skin

due to bacterial, fungal or viral. Rosacea, acne,
perioral dermatitis, anogenital pruritus. Childn
<2 yr.
Dermatoses in childn <1 yr. Skin disorders due to

acute infections, TB, herpes simplex, virus,
varicella.
Prostatic hypertrophy & glaucoma.

Hypersensitivy to docetaxel or to other drugs
formulated w/ polysorbate 8. Neutrophil counts
<1500 cells/mm3. Severe liver impairment.
Hypersensitivity to terbutaline or to
sympathomimetic amines, or to any of the
components of Bricasma.
Hypersensitivity (eg, angioedema) to ticagrelor
or to any of the components of Brilinta (see
Adverse Reactions).
History of Intracranial Hemorrhage: Patients with
a history of intracranial hemorrhage (ICH)
because of a high risk of recurrent ICH in this
population (see Pharmacology:
Pharmacodynamics: Clinical Studies under
Actions).
Active Bleeding: Patients with active pathological
bleeding eg, peptic ulcer or intracranial
hemorrhage (see Warnings, Precautions and
Adverse Reactions).
Severe Hepatic Impairment: Patients with severe
hepatic impairment because of a probable
increase in exposure and it has not been studied
in these patients. Severe hepatic impairment
increases the risk of bleeding because of
reduced synthesis of coagulation proteins (see
Warnings Bleeding Risk: Brilinta, like other
antiplatelet agents, can cause significant,
sometimes fatal, bleeding.
Do not use Brilinta in patients with active
pathological bleeding or a history of intracranial
hemorrhage.
Do not start Brilinta in patients planned to
undergo urgent coronary artery bypass graft
surgery (CABG). When possible, discontinue
Brilinta at least 5 days prior to any surgery.
Suspect bleeding in any patient who is
hypotensive and has recently undergone
coronary angiography, percutaneous coronary
intervention (PCI), CABG or other surgical
procedures in the setting of Brilinta.
If possible, manage bleeding without
discontinuing Brilinta. Stopping Brilinta increases
the risk of subsequent
Hypersensitivity CV events.
to cephalosporins.
Sensitivity to other sympathomimetic agents,

severe HTN, cardiac disorders, DM, severe liver
dysfunction.
Hypersensitivity.
BRUFEN tablet is contraindicated in patients with
severe and active ulcus pepticum (gastric and
duodenal ulceration), history of hypersensitivity
to ibuprofen and other nonsteroidal anti-
inflammatory drugs, polyps in the nose,
angioedema and patients who develop asthma
symptoms, rhinitis or urticaria when taking
acetylsalicylic acid or other nonsteroidal anti-
inflammatory drugs. Last trimester in pregnancy.
Local infections of the intestine, infants & young
childn, severe disorders of liver function.
Gastric ulcer.
Hypersensitivity to dihydropiridine.
Hypersensitivity.
Hypersensitivity to diclofenac, salicylic acid,

other NSAIDs, isopropanol or propylene glycol.
Patients in whom acetylsalicylic acid (aspirin) or
other NSAIDs induce asthma, urticaria or acute
rhinitis.
Hypersensitivity to penicillins. Infectious

mononucleosis.
Hypersensitivity. Newborn babies, patients under

MAOIs treatment.
Hypersensitivity to other NSAIDs; peptic
ulceration, patients in whom aspirin or other
NSAIDs induce the symptoms of asthma, rhinitis
or urticaria. 3rd trimester of pregnancy. Childn
<7 kg (tab).
Hypersensitivity to amide type local anaesth or

Na metabisulfite in adrenaline-containing soln.
Uncorrected hypotension. Presence of infection
in the region the proposed inj &/or septicaemia.
Obstet paracervical block, IV regional anaesth
(Bier's block) & all IV infusions.
Meningitis, tumors, poliomyelitis & cranial

hemorrhage; active TB or metastatic lesions in
vertebral column; septicemia; pernicious anemia
w/ subacute combined degeneration of spinal
cord; pyrogenic skin infection at/or adjacent to
puncture site; cardiogenic or hypovolemic shock;
coagulation disorders or ongoing anticoagulant
treatment.
Hypercalcemia, hypervitaminosis D, severe renal
failure.
Known hypersensitivity to dihydropyridines,
amlodipine, atorvastatin or any component of
Caduet.
elevations of serum transaminases exceeding 3
times the upper limit of normal. Or who are
pregnant, breastfeeding or of childbearing
potential not using adequate contraceptive
measures. Caduet should be administered to
women of childbearing age only when such
patients are highly unlikely to conceive and have
been informed of the potential hazards to the
fetus.
Use in pregnancy & lactation: Caduet is
contraindicated in pregnancy due to the
atorvastatin component. Women of childbearing
potential should use adequate contraceptive
measures. Caduet should be administered to
women of childbearing age only when such
patients are highly unlikely to conceive and have
been informed of the potential hazards to the
fetus.
Caduet is contraindicated while breastfeeding
due to the atorvastatin component. It is not
known whether atorvastatin is excreted in
human milk. Because of the potential for adverse
reactions in nursing infants, women taking
Caduet should not breastfeed.
Safety of amlodipine in human pregnancy or
lactation has not been established. Amlodipine
does not demonstrate toxicity in animal
reproductive studies other than to delay
parturition and prolong labor in rates at a dose
level 50 times the maximum recommended dose
in humans.
Viral & tuberculous skin lesions, fungal skin

infection, rosacea.
Pregnancy, lactation.
Hypercalcemia & hypercalciuria, renal calculi,

severe renal failure.
Hypercalcaemia & hypercalciuria, renal calculi,
severe renal failure.
Hypervitaminosis D, hypercalcaemia,
hypercalciuria, end-stage renal failure.
Hypercalcaemia, hypercalciuria, severe renal

insufficiency.
Hypercalcemia, severe hypercalciuria.

Severe hypercalcemia, hypercalciuria & renal
insufficiency.
Hypersensitivity to colostrum-containing
products.
Fiber-rich products intake.
Severe hypercalcemia & hypercalciuria, severe

renal insufficiency.
Known sensitivity to dihydropyridines.
Hypersensitivity to the drug, hypercalcaemia (eg,

in hyperparathyroidism, vitamin D overdosage,
decalcifying tumours eg, plasmocytoma, bone
metastases); severe renal failure; severe
hypercalciuria; galactosaemia.
Hypersensitivity to calcium carbonate and

cholecalciferol or to any of the contents of
Caltrate 600 +D.
Patients with impaired kidney function. Children
<18 years.
Hypersensitivity to calcium carbonate,
cholecalciferol or to any of the contents of
Caltrate 600 Plus.
Patients with impaired kidney function. Children
<18 years.
Hypervitaminosis D, hypercalcemia,
hypercalciuria, severe kidney dysfunction.
Severe hypercalcemia & hypercalciuria. Severe

renal insufficiency.
Patients with a chronic inflammatory bowel
disease and/or bowel obstruction (see
Precautions); history of severe hypersensitivity
reactions to irinotecan HCl trihydrate or to one of
the excipients of Campto; bilirubin >3 times the
ULN (see Precautions); severe bone marrow
failure. Patients presenting a risk factor,
particularly those with a WHO performance
status >2.
Use in pregnancy: Irinotecan is teratogenic in rats
and rabbits (see Preclinical Safety Data in
Toxicology under Actions). Irinotecan may cause
fetal harm when administered to a pregnant
woman. There are no adequate and well-
controlled studies of irinotecan in pregnant
women.
If Campto is used during pregnancy or if the
patient becomes pregnant while receiving
Campto, the patient should be apprised of the
potential hazard to the fetus. Women of
childbearing potential should be advised to avoid
becoming pregnant while receiving treatment
with irinotecan.
Use in lactation: In rats, radioactivity appeared in
the milk within 5 min of IV administration of
radiolabeled irinotecan and was concentrated up
to 65-fold at 4 hrs after administration relative to
plasma concentrations. Because many drugs are
excreted in human milk and because of the
potential for adverse reactions in nursing infants,
breastfeeding must be discontinued for the
duration of Campto therapy.
Severe hepatic impairment &/or cholestasis. 2nd

& 3rd trimester of pregnancy, lactation.
Hypersensitivity. Severe liver damage &/or
cholestasis. Pregnancy & lactation.
Hypersensitivity.
Canesten SD Hypersensitivity.
Hypersensitivity. Severe hepatic & renal

impairment. Not for bacterial infection
prevention; trivial & laryngeal infections & flu
treatment.
Hypersensitivity.
Hypersensitivity. Patients who are using organic

nitrates, either regularly &/or intermittently.
Women. Newborn & childn.
Hypersensitivity.
Hypersensitivity to cephalosporins, penicillins or

other -lactams.
Hypersensitivity to cetirizine or hydroxizine.

Lactation.
Hypersensitivity. Pregnancy & lactation.
HTN, hypokalemia, renal impairment & edema.

Hypersensitivity to penicillin; neonates whose
mothers are hypersensitive to penicillins or its
derivatives; history of cholestatic jaundice
(hepatic dysfunction).
Hypersensitivity; neonate whose mother is

hypersensitive to penicillin or its derivatives;
patient w/ cholestasic jaundice history (hepatic
impairment) that is related to penicillin or co-
amoxiclav usage.
Severe myelosuppression, preexisting severe
renal impairment, history of allergic reactions to
platinum-containing compds or mannitol,
pregnancy & lactation, bleeding.
Hypersensitivity to hydroxybenzoate.
Myelosuppression due to antitumor therapy or
radiotherapy. Patients w/ preexisting heart
disease, who received previous treatment w/
complete cumulative doses of doxorubicin HCl or
daunorubicin. Pregnancy.
Known hypersensitivity to ramipril, to any other
ACE inhibitor or to any of the excipients of
Cardace (see Description).
History of angioneurotic oedema (risk of
precipitating angioneurotic oedema; see also
Adverse Reactions).
Blood flow reducing and narrowing
(haemodynamically relevant stenosis) of the
renal artery, bilateral or unilateral in the single
kidney (risk of fall in blood pressure and renal
failure).
Patients with low blood pressure or labile
circulatory condition (risk of fall in blood
pressure and renal failure).
Since severe rapid-onset and allergy-like
(anaphylactoid) hypersensitivity reactions may
occur, treatment with ACE inhibitors in
conjunction with extracorporeal treatments
leading to contact of blood with negatively
charged surfaces must be avoided. This latter
include dialysis or haemofiltration with certain
high-flux membranes (eg, polyacrylonitril
membranes) and low-density lipoprotein
apheresis with dextran sulfate.
Use in Pregnancy & Lactation: Cardace must not
be taken during pregnancy. Therefore, pregnancy
must be excluded before starting treatment.
Pregnancy must be avoided where treatment
with ACE inhibitors is indispensable.
If a pregnancy is planned, treatment with ACE
inhibitors must be discontinued ie, replaced by
another form of treatment.
If pregnancy occurs during treatment,
medication with Cardace must be substituted as
soon as possible with a treatment regimen which
excluded ACE inhibitors. Otherwise, there is a
risk of harm to the fetus. Whether the exposure
is limited to the 1st 3 months of pregnancy,
Obstructive cardiomyopathy; idiopathic
hypertropic subaortic stenosis.
Hypotensive conditions & hypovolaemia;

hypertrophic obstructive cardiomyopathy, aortic
stenosis, cardiac tamponade, constrictive
pericarditis, mitral stenosis; marked anaemia,
head trauma, cerebral haemorrhage, closed-
angle glaucoma. Co-administration w/ sildenafil.
Patients with a known hypersensitivity to
quinazolines, doxazosin or to any of the inert
ingredients of Cardura.
Severe renal impairment, hyperkalemia.
Hyponatremia, pregnancy & lactation, Addison's
disease, peptic ulcer, anuria.
Suspected incomplete hemostasis following

intracranial hemmorhage; elevated intracranial
pressure at acute stage of cerebral stroke.
Bleeding disorder.
Patients who have shown a hypersensitivity

reaction to bicalutamide or any of the excipients
of Casodex. Co-administration of terfenadine,
astemizole or cisapride with Casodex (see
Interactions).
Use in pregnancy & lactation: Casodex is
contraindicated in females and must not be
given to pregnant women or nursing mothers.
Use in children: Casodex is contraindicated in
children.
Known hypersensitivity to diclofenac or to any of
the excipients of Cataflam/Cataflam D.
Active gastric or intestinal ulcer, bleeding or
perforation; severe hepatic, renal and cardiac
failure (see Warnings and Precautions).
Patients who have experienced asthma, urticaria
or allergic type reactions after taking aspirin or
other NSAIDs. Severe, rarely fatal, anaphylactic-
like reactions to NSAIDs have been reported in
such patients (see Warnings).
Cataflam/Cataflam D is contraindicated in the
treatment of peri-operative pain in the setting of
coronary artery bypass graft (CABG) surgery (see
Warnings).
Last trimester of pregnancy (see Use in
pregnancy & lactation under Precautions).
Warnings Cardiovascular Effects: Cardiovascular
Thrombotic Events: Clinical trials of several
cyclooxygenase-2 (COX-2) selective and
nonselective NSAIDs of up to 3 years in duration
have shown an increased risk of serious
cardiovascular (CV) thrombotic events,
myocardial infarction and stroke, which can be
fatal. All NSAIDs, both COX-2 selective and
nonselective, may have a similar risk. Patients
with known CV disease or risk factors for CV
disease may be at greater risk. To minimize the
potential risk for an adverse CV event in patients
treated with an NSAID, the lowest effective dose
should be used for the shortest duration
possible. Physicians and patients should remain
alert for the development of such events, even in
the absence of previous CV symptoms. Patients
should be informed about the signs and/or
symptoms of serious CV events and the steps to
take if they occur.
There is no consistent evidence that concurrent
use of aspirin mitigates the increased risk of
Patients with known hypersensitivity to the
clonidine HCl or other components of Catapres.
Patients with severe bradyarrhythmia resulting
from either sick sinus syndrome or AV block of
2nd or 3rd degree.
Hypercalcemia, hypervitaminosis D, severe renal
failure.
Patients w/ hypercalcemia, hypervitaminosis w/

vit D, renal disease or hypercalciuria (w/ or w/o
kidney stone), phenylketonuria.
Hypersensitivity to penicillin, sulbactam,

cefoperazone, or cephalosporins.
Hypopigmentation.
Marked anaemia, hypotension, cardiogenic
shock. Avoid sildenafil, tadalafil, vardenafil.
History of shock or hypersensitivity.

History of shock or hypersensitivity.
Hypersensitivity. History of shock.

History of shock.
History of shock & hypersensitivity to lidocaine &

anilide-type local anesth.
Hypersensitivity to cephalosporins, penicillins &

other -lactam antibiotics.
Hypersensitivity.
Special Precautions
Lamivudine is not recommended for use as monotherapy.

Patients should be advised that current antiretroviral therapy, including lamivudine, has not been proven to prevent the ris
transmission of HIV to others through sexual contact or blood contamination. Appropriate precautions should continue to b
employed.
Patients receiving 3TC or any other antiretroviral therapy may continue to develop opportunistic infections and other
complications of HIV infection, and therefore they should remain under close clinical observation by physicians experience
the treatment of patients with associated HIV diseases
Renal Impairment: Lamivudine plasma concentrations (AUC) are increased in patients with moderate to severe renal
impairment due to decreased clearance. The dose should therefore be adjusted (see Dosage & Administration).
Pancreatitis: Pancreatitis has been observed in some patients receiving lamivudine. However it is unclear whether this was
due to treatment with the medicinal product or to the underlying HIV disease. Pancreatitis must be considered whenever a
patient develops abdominal pain, nausea, vomiting or elevated biochemical markers.
Discontinue use of lamivudine until diagnosis of pancreatitis is excluded.
Lactic Acidosis/Severe Hepatomegaly with Steatosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal
cases, have been reported with the use of antiretroviral nucleoside analogues either alone or in combination, including
lamivudine. A majority of these cases have been in women.
Clinical features which may be indicative of the development of lactic acidosis include generalized weakness, anorexia, and
sudden unexplained weight loss, gastrointestinal symptoms and respiratory symptoms (dyspnea and tachypnea).
Caution should be exercised when administering lamivudine to any patient and particularly to those with known risk factor
for liver disease. Treatment with lamivudine should be suspended in any patient who develops clinical or laboratory finding
suggestive of lactic acidosis or hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marke
transaminase elevations).
Fat Redistribution: Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement (buffal
hump), peripheral wasting, facial wasting, breast enlargement, elevated serum lipid and blood glucose levels have been
observed either separately or together in some patients receiving combination antiretroviral therapy (see Adverse Reaction
Whilst all members of the PI and NRTI classes of medicinal products have been associated with one or more of these speci
adverse events, linked to a general syndrome commonly referred to as lipodystrophy, data indicate that there are difference
in the risk between individual members of the respective therapeutic classes.
In addition, the lipodystrophy syndrome has a multifactorial etiology; with for example HIV disease status, older age and
duration of antiretroviral treatment all playing important, possibly synergistic roles.
The long-term consequences of these events are currently unknown.
Clinical examination should include evaluation for physical signs of fat redistribution. Consideration should be given to the
measurement of serum lipids and blood glucose. Lipid disorders should be managed as clinically appropriate.
Immune Reconstitution Syndrome: In HIV-infected patients with severe immune deficiency at the time of initiation of
antiretroviral therapy (ART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise and
cause serious clinical conditions, or aggravation of symptoms. Typically, such reactions have been observed within the first
few weeks or months of initiation of ART. Relevant examples are cytomegalovirus retinitis, generalized and/or focal
mycobacterial infections and Pneumocystis jiroveci (P. carinii) pneumonia. Any inflammatory symptoms must be evaluated
Patients who are HIV-positive, co-infected with hepatitis B virus and are receiving treatment with lamivudine in combinatio
with other antiretroviral agents for HIV, should continue treatment with the regimen prescribed for HIV infection (150 mg
twice daily). These patients are also at risk of an exacerbation of their hepatitis if their lamivudine treatment for HIV is
discontinued.
The clinical and virological status of patients should be monitored regularly during treatment by a physician experienced in
the management of hepatitis B infection.
There is no information available on maternal-fetal transmission of hepatitis B virus in pregnant mothers receiving treatme
with 3TC-HBV. The standard recommended procedures for hepatitis B virus immunization in infants should still be followed
Patients should be advised that therapy with 3TC-HBV has not been proven to prevent the risk of transmission of hepatitis
virus to others, through sexual contact or blood contamination. Appropriate precautions should still be taken.
The efficacy of lamivudine in hepatitis B patients co-infected with hepatitis C and D is unknown.
Effects on the Ability to Drive or Operate Machinery: There have been no studies to investigate the effect of lamivudine on
driving performance or the ability to operate machinery. Further, a detrimental effect on such activities would not be
predicted from the pharmacology of the drug. Nevertheless, the clinical status of the patient and the adverse event profile
3TC-HBV should be borne in mind when considering the patient's ability to drive or operate machinery.
Use in pregnancy & lactation: Reproductive studies in animals have not shown evidence of teratogenicity and showed no
effect on male or female fertility. There was some evidence of early embryo lethality when administered to pregnant rabbi
at exposure levels of 2 or 3 times those achieved in humans at therapeutic doses. Studies in lactating rats showed that
following oral administration, levels of lamivudine in milk were generally higher than those measured in plasma.
Although animal reproductive studies are not always predictive of the human response, lamivudine should be used during
pregnancy only if the potential benefits outweigh the risks. Administration of 3TC-HBV during the first 3 months of pregnan
is not recommended.
In clinical study, lamivudine has proven to be safe and well tolerated in HIV-infected pregnant women at doses up to 300 m
twice daily, administered from week 38 of pregnancy.
Lamivudine was shown to cross the placenta with a maternal/neonate serum concentration ratio of about 1 established at
birth. The presence of lamivudine in amniotic fluid was also established.
There is no safety information available on infant breastfed by mothers treated with 3TC-HBV. In breast milk samples taken
the 1st week postpartum, lamivudine was present overall in similar concentrations to those seen in serum (range 1-8
mcg/mL). Ingestion of lamivudine via this route would not provide concentrations sufficient to provide antiviral (HBV)
protection.
Breastfeeding should not be discouraged unless the potential risk to the baby is considered to outweigh the benefit of
treatment with lamivudine to the mother.
Administer only via IV route. When large or frequently repeated doses are required, patients of blood groups A, B or AB
should be monitored for signs of progressive anemia. Pregnancy.
Anaphylactic reaction.
Impaired liver function. CHF. Pregnancy & lactation.
Clarithromycin is principally excreted by the liver and kidney. Therefore, caution should be exercised in administering this
antibiotic to patients with impaired hepatic function. Caution should also be exercised when administering clarithromycin t
patients with moderate to severe renal impairment. Clarithromycin may be administered without dosage adjustment to
patients with hepatic impairment and normal renal function. However, in the presence of severe renal impairment with or
without coexisting hepatic impairment, decreased dosage or prolonged dosing intervals may be appropriate.
Prolonged or repeated use of clarithromycin may result in an overgrowth of nonsusceptible bacteria or fungi. If superinfecti
occurs, clarithromycin should be discontinued and appropriate therapy instituted. Attention should also be paid to the
possibility of cross-resistance between clarithromycin and other macrolide drugs, as well as lincomycin and clindamycin.
A pharmacokinetic study demonstrated that the concomitant administration of ritonavir 200 mg every 8 hrs and
clarithromycin 500 mg every 12 hrs resulted in a marked inhibition of the metabolism of clarithromycin. The clarithromycin
Cmax increased by 31%, Cmin increased 182% and AUC increased by 77% with concomitant administration of ritonavir. An
essentially complete inhibition of the formation of 14-(R)-hydroxy clarithromycin was noted. Because of the large therapeu
window for clarithromycin, no dosage reduction should be necessary in patients with normal renal function. However, for
patients with renal impairment, the following dosage adjustment should be reduced by 50%. For patients with creatinine
clearance 30-60 mL/min, the dose of clarithromycin should be decreased by 75%. Doses of clarithromycin >1 g/day should
be co-administered with ritonavir.
Carcinogenicity, Mutagenicity & Impairment of Fertility: The following in vitro mutagenicity test have been conducted with
clarithromycin: Salmonella/mammalian microsome test, bacterial-induced mutation frequency tests, in vitro chromosome
aberration test, rat hepatocyte DNA synthesis assay, mouse dominant lethal study, mouse lymphoma assay and mouse
micronucleus test.
All tests had negative results except the in vitro chromosome aberration test, which was weakly positive in one test and
negative in another.
In addition, a bacterial reverse mutation test (Ames test) has been performed on clarithromycin metabolites with negative
results.
Fertility and reproduction studies have shown that daily doses of 150-160 mg/kg/day to male and female rats caused no
adverse effects on the estrous cycle, fertility, parturition or number and viability of offspring. Plasma levels in rats after 150
mg/kg/day were 2 times the human serum levels.
In the 150 mg/kg/day monkey studies, plasma levels were 3 times the human serum levels. When given orally at 150
mg/kg/day, clarithromycin was shown to produce embryonic loss in monkeys. This effect has been attributed to marked
maternal toxicity of the drug at this high dose.
In rabbits, in utero fetal loss occurred at an IV dose of 33 mg/m2, which is 17 times less than the maximum proposed huma
oral daily dose of 618 mg/m2. Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Use in pregnancy: Teratogenic Effects: Pregnancy Category C: Four teratogenicity studies in rats (3 with oral doses and 1 wit
IV doses up to 160 mg/kg/day administered during the period of major organogenesis) and 2 in rabbits (at oral doses up to
125 mg/kg/day or IV doses of 30 mg/kg/day administered during gestation days 6-18) failed to demonstrate any teratogeni
from clarithromycin. Two additional oral studies in a different rat strain at similar doses and similar conditions demonstrate
low incidence of cardiovascular anomalies at doses of 150 mg/kg/day administered during gestation days 6-15. Plasma leve
after 150 mg/kg/day were 2 times the human serum levels. Four studies in mice revealed a variable incidence of cleft palat
Clinical improvement may take several days to some weeks. Monitoring the patient throughout this period is recommende
Reduce dose or discontinue if signs or symptoms of tardive dyskinesia appear. Discontinue if patient develops signs and
symptoms indicative of neuroleptic malignant syndrome. Caution in patients with a history of seizure.
Effects on the Ability to Drive or Operate Machinery: Until individual patient response is established, caution is advised whe
driving or operating machines.
Use in pregnancy & lactation: Do not use in pregnancy unless the benefit outweighs the risk.
Breastfeeding is not advised during treatment.
Clinical improvement may take several days to some weeks. Monitoring of the patient throughout this period is
recommended. Reduce dose or discontinue if signs or symptoms of tardive dyskinesia appear. Discontinue if patient develo
signs and symptoms indicative of neuroleptic malignant syndrome. Caution in patients with a history of seizure.
Effects on the Ability to Drive or Operate Machinery: Until individual patient response is established, caution is advised whe
driving or operating machines.
Use in pregnancy & lactation: Do not use in pregnancy unless the benefit outweighs the risk.
Breastfeeding is not advised during treatment.
General: Orthostatic Hypotension: Aripiprazole may be associated with orthostatic hypotension, perhaps due to its a1-
adernergic receptor antagonism. The incidence of orthostatic hypotension-associated events from 5 short-term, placebo-
controlled trials in schizophrenia (n=926) on Abilify included: Orthostatic hypotension (placebo 1%, aripiprazole 1.9%),
orthostatic lightheadedness (placebo 1%, aripiprazole 0.9%), and syncope (placebo 1%, aripiprazole 0.6%). The incidence o
orthostatic hypotension-associated events from short-term, placebo-controlled trials in bipolar mania (n=597) on Abilify
included: Orthostatic hypotension (placebo 0%, aripiprazole 0.7%), orthostatic lightheadedness (placebo 0.5%, aripiprazole
0.5%), and syncope (placebo 0.9%, aripiprazole 0.5%).
The incidence of a significant orthostatic change in blood pressure (defined as a decrease of at least 30 mm Hg in systolic
blood pressure when changing from a supine to standing position) for aripiprazole was not statistically different from place
(in schizophrenia: 14% among aripiprazole-treated patients and 12% among placebo-treated patients and in bipolar mania:
3% among aripiprazole-treated patients and 2% among placebo-treated patients).
Aripiprazole should be used with caution in patients with known cardiovascular disease (history of myocardial infarction or
ischemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions which would
predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications).
Seizure: Seizures occurred in 0.1% (1/926) of aripiprazole-treated patients with schizophrenia in short-term, placebo-
controlled trials. In short-term, placebo-controlled clinical trials of patients with bipolar mania, 0.3% (2/597) of aripiprazole
treated patients and 0.2% (1/436) of placebo-treated patients experienced seizures. As with other antipsychotic drugs,
aripiprazole should be used cautiously in patients with a history of seizures or with conditions that lower the seizure thresh
eg, Alzheimer's dementia. Conditions that lower the seizure threshold may be more prevalent in a population of >65 years.
Potential for Cognitive and Motor Impairment: In short-term, placebo-controlled trials of schizophrenia, somnolence was
reported in 11% of patients on Abilify compared to 8% of patients on placebo; somnolence led to discontinuation in 0.1%
(1/926) of patients with schizophrenia on Abilify in short-term, placebo-controlled trials. In short-term, placebo-controlled
trials of bipolar mania, somnolence was reported in 14% of patients on Abilify compared to 7% of patients on placebo, but
not lead to discontinuation of any patients with bipolar mania. Despite the relatively modest increased incidence of
somnolence compared to placebo, Abilify, like other antipsychotics, may have the potential to impair judgment, thinking or
motor skills. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are
reasonably certain that therapy with Abilify does not affect them adversely.
Body Temperature Regulation: Disruption of the body's ability to reduce core body temperature has been attributed to
antipsychotic agents. Appropriate care is advised when prescribing aripiprazole for patients who will be experiencing
conditions which may contribute to an elevation in core body temperature eg, exercising strenuously, exposure to extreme
heat, receiving concomitant medication with anticholinergic activity or being subject to dehydration.
Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia
a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer's dementia.
Aripiprazole and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia (see Use i
Patients with Concomitant Illness as follows).
Suicide: The possibility of a suicide attempt is inherent in psychotic illnesses and bipolar disorder, and close supervision of
high-risk patients should accompany drug therapy. Prescriptions for Abilify should be written for the smallest quantity
consistent
Monitor renalwithfunction
good patient
duringmanagement
concomitantin order to reduce
treatment the risk of overdose.
w/ aminoglycocides. Pregnancy & lactation.
History of hypersensitivity to other cephem antibiotics & penicillins; allergy eg, bronchial asthma, rash, urticaria; serious re
dysfunction; poor oral nutrition, receiving parenteral nutrition, debility. Periodic monitoring of renal function is
recommended. Pregnancy & lactation. Childn <6 mth, elderly.
ACCOLATE should be taken regularly to achieve benefit, even during symptom free periods.
ACCOLATE therapy should normally be continued during acute exacerbations of asthma.
ACCOLATE does not allow a reduction in existing steroid treatment.
As with inhaled steroids and cromones (disodium cromoglycate, nedocromil sodium), ACCOLATE is not indicated for use in
reversal of bronchospasm in acute asthma attacks.
ACCOLATE has not been evaluated in the treatment of labile (brittle) or unstable asthma.
Rarely, patients with asthma on anti-leukotriene medications, including ACCOLATE, may present with systemic eosinophilia
eosinophilic pneumonia or with clinical features of systemic vasculitis, consistent with Churg-Strauss syndrome. Presentatio
may involve various body systems including vasculitic rash, worsening pulmonary symptoms, cardiac complications or
neuropathy. These events have usually, but not always, been associated with reductions and/or withdrawal of steroid thera
The possibility that leukotriene-receptor antagonists, including ACCOLATE may be associated with emergence of Churg-
Strauss syndrome can neither be excluded nor established. If a patient develops an eosinophilic condition or a Churg-Strau
syndrome-type illness, ACCOLATE should be stopped, a rechallenge test should not be performed and treatment should no
be restarted.
Elevations in serum transaminases can occur during treatment with ACCOLATE. These are usually asymptomatic and transie
but could represent early evidence of hepatotoxicity, and have been very rarely associated with more severe hepatocellula
injury, fulminant hepatitis and liver failure, some of which resulted in a fatal outcome. Extremely rarely, case of fulminant
hepatitis and liver failure has been reported in patient in whom no previous clinical sign or symptoms of liver dysfunction
were reported.
If clinical symptoms or signs suggestive of liver dysfunction occur (e.g. anorexia, nausea, vomiting, upper right quadrant pa
fatigue, lethargy, flu-like symptoms, enlarged liver, pruritus and jaundice), ACCOLATE should be discontinued. The serum
transaminases, in particular serum ALT, should be measured immediately and the patient managed accordingly.
Physicians may consider the value of routine liver function testing. Periodic serum transaminase testing has not been prove
to prevent serious injury but is generally believed that early detection of drug-induced hepatic injury along with immediate
withdrawal of the suspect drug may enhance the likelihood of recovery. If liver function testing shows evidence of
hepatotoxicity, ACCOLATE should be discontinued immediately and the patient managed accordingly.
Patients in whom ACCOLATE was withdrawn because of hepatotoxicity cause should not be re-exposed to ACCOLATE.
Effects on Ability to Drive and Use Machines: There is no evidence that ACCOLATE affects the ability to drive and use
machinery.
Use In Pregnancy & Lactation The safety of ACCOLATE in human pregnancy has not been established. In animal studies,
zafirlukast did not have any apparent effect on fertility and did not appear to have any teratogenic or selective toxic effect o
the foetus. The potential risks should be weighed against the benefits of continuing therapy during pregnancy and ACCOLA
should be used during pregnancy only if clearly needed.
Zafirlukast is excreted in human breast milk. ACCOLATE should not be administered to mothers who are breast-feeding.
Avoid contact w/ eyes. May increase the risk of sensitization & bacterial resistance. If possible, avoid use during the last mt
of pregnancy. May cause kernicterus in babies during the 1st mth of age.
Pregnancy, neonates, lactation, intravascular vol depletion.
Administer after food intake in patients with gastritis. Not recommended for DM patients until blood glucose level is
controlled at normal level.
Renal impairment. Pregnancy & lactation.
Anaphylactic reactions. Patients w/ bronchial asthma or w/ a history of asthma. Monitor coagulation factors in case of liver
transplantation. May interfere w/ the determination of salicylates & plasma, & urinary ketones. Pregnancy & lactation. Chil
Renal dysfunction. Elderly w/ creatinine clearance disturbance. Pregnancy & lactation.
Do not apply to mucous membrane. Not for prevention of recurrent herpes simplex infection. Pregnancy & lactation, childn
Babies born of mother hypersensitive to penicillins. Previous hypersensitivity reactions to cephalosporins or to other
allergens. Superinfections. Pregnancy, lactation.
Ensure appropriate hydration prior to administration esp in elderly & in patients on diuretics. Adequate Ca & vit D intake pr
to Aclasta therapy in patients w/ preexisting hypocalcemia & for 10 days following Aclasta in patients w/ Paget's disease of
bone. Should not be used in severe renal impairment (CrCl <35 mL/min); monitor serum creatinine. Dental examination pri
to treatment in patients w/ cancer, under chemotherapy or corticosteroids, w/ poor oral hygiene; avoid invasive dental
procedures for those who develop osteonecrosis of the jaw. 5-mg dose must be administered over at least 15 min.
Pregnancy & lactation. Childn <12 yr.
Arrhythmias, ventricular tachycardia, ventricular fibrillation, Torsade de pointes, QT interval prolongation; history of heart
disease including serious ventricular arrhythmia, ischaemic heart disease, CHF, renal impairment, hypocalcaemia,
hypomagnesemia, resp disorders.
Renal insufficiency; patient w/ concomitant risk factors eg, cancer, chemotherapy, radiotherapy, corticosteroids, poor oral
hygiene. Monitor hydration status, renal function & serum Ca. Avoid invasive dental procedures.
Perform liver function test prior to initiation 12 wk after treatment initiation, during dose evaluation & periodically thereaft
Alcohol consumption or history of liver disease. Promptly report unexplained muscle pain, tenderness or weakness, especi
if accompanied w/ malaise or fever. Discontinue use in case of markedly elevated CPK levels, diagnosed or suspected
myopathy or w/ risk factor to development of renal failure secondary to rhabdomyolysis.
Impaired hepatic & renal function. Heart failure. Lactation. Elderly.
Regular hepatic & hematological monitoring; undernutrition, irregular meal times, missed meals, diet alteration, imbalance
between physical exertion & carbohydrate intake, alcohol consumption; impaired renal function, serious liver dysfunction,
endocrine system disorders affecting carbohydrate metabolism; galactose intolerance, Lapp-lactase deficiency or glucose-
galactose malabsorption. Childn.
WHO performance status = 2. Patients may have cholinergic symptoms. Extravasation may occur. Discontinue if neutropeni
fever occurs or if the absolute neutrophil count drops <1000/mm3. Late diarrhea (generally occurs >8 hr after administratio
of irinotecan) can be prolonged, may lead to dehydration, electrolyte imbalance or sepsis & may be life-threatening. Patien
must not be treated w/ irinotecan until resolution of the bowel obstruction. Nausea & vomiting can be severe & usually
occurs during or shortly after infusion. Increase in serum creatinine or BUN. Monitor patients w/ risk factors for resp
symptoms before & during therapy. Unsuitable in hereditary fructose intolerance. Increased risk of myelosuppression for
patients who have previously received pelvic/abdominal irradiation & patients w/ gastric cancer. May impair ability to drive
operate machinery. Renal & hepatic insufficiency. Elderly.
History of anaphylactic shock & diarrhea. Monitor blood count during prolonged treatment. Hepatic & renal dysfunction.
Pregnancy & lactation. Hyperbiliruminemic neonates especially prematures.
Chronic renal & hepatic disorders, resp disorder, muscle weakness, history of drug or alcohol abuse, marked personality
disorders, chronic pulmonary insufficiency. May cause dependence. Avoid single dose treatment in depression or combined
anxiety-depression. Avoid long-term therapy. May affect the ability to drive or operate machinery. Pregnancy & lactation.
Recommended dosage should not be exceeded.
Not recommended for children <2 years, pregnancy, lactation except by physician's advise. Discontinue therapy when
insomnia, palpitation or dizziness occur.
Although there are no objective data, users of Actifed should avoid the concomitant use of alcohol or other centrally-acting
sedatives.
Although pseudoephedrine has virtually no pressor effects in normotensive patients, Actifed should be used with caution i
patients taking antihypertensive agents, tricyclic antidepressants or other sympathomimetic agents eg, decongestants,
appetite suppressants and amphetamine-like psychostimulants. The effects of a single dose on the blood pressure of these
patients should be observed before recommending repeated or unsupervised treatment.
As with other sympathomimetic agents, Actifed should be used with caution in patients with hypertension, heart diseases,
diabetes, hyperthyroidism, elevated intraocular pressure and prostatic enlargement.
There have been no specific studies of Actifed in patients with hepatic and/or renal dysfunction. Caution should be exercise
in the presence of severe renal or hepatic impairment.
Effects on the Ability to Drive or Operate Machinery: Actifed may cause drowsiness and impair performance in tests of
auditory vigilance. Patients should not drive or operate machinery until they have determined their own response.
Carcinogenicity, Mutagenicity & Impairment of Fertility: There is insufficient information available to determine whether
triprolidine and pseudoephedrine have mutagenic or carcinogenic potential.
No studies have been conducted in animals to determine whether triprolidine or pseudoephedrine have the potential to
impair fertility. Systemic administration of pseudoephedrine in rats up to 7 times the human daily dosage in females and 35
times the human daily dosage in males did not impair fertility nor alter foetal morphological development and survival. The
is no information on the effect of Actifed on human fertility.
Use in pregnancy & lactation: Although pseudoephedrine and triprolidine have been in widespread use for many years, the
are no specific data on their use during pregnancy. Caution should therefore be exercised by balancing the potential benefi
treatment against any possible hazards to the developing foetus.
Pseudoephedrine and triprolidine are excreted in breast milk in small amounts but the effect of this on breastfed infants is
known. It has been estimated that 0.5-0.7% of a single dose of pseudoephedrine ingested by a mother will be excreted in t
breast milk over 24 hrs.
Because of the higher than usual risks from antihistamines and sympathomimetic amines for infants generally and for
newborn and premature infants in particular, a decision should be made whether to discontinue nursing or to discontinue
Actifed.
Use in the elderly: There have been no specific studies of Actifed in the elderly. Experience has indicated that normal adult
dosage is appropriate, although it may be advisable to monitor renal and/or hepatic function; if there is serious impairmen
then caution should be exercised.
Severe hypertension, over weight. Discontinue treatment if insomnia, palpitation and dizziness occur. Impaired liver and
kidney function, glaucoma, prostate hypertrophy, hyperthyroid.
Concomitant use with other central nervous system (CNS) suppressants. Caution is recommended in pregnancy and lactatio
and in the elderly.
Dextromethorphan: Debility and hypoxia. May cause respiratory depression and CNS depression in large dose usage or in
patients with impaired respiratory function (eg, asthma, emphysema).
Effects on the Ability to Drive or Operate Machinery: May impair ability to drive or operate machinery.
Use in children: Not recommended for children <2 years.
Hypertension, over weight, impaired liver and kidney function, glaucoma, prostate hypertrophy, hyperthyroid, heart diseas
diabetes mellitus.
Concomitant use with other central nervous system suppressants. Discontinue treatment if insomnia, palpitation and
dizziness occur.
Caution is recommended in pregnancy and lactation and in the elderly.
Effects on the Ability to Drive or Operate Machinery: May impair ability to drive or operate machinery.
Use in children: Not recommended for children <2 years.
Actilyse should be used by physicians experienced in the use of thrombolytic treatment and with facilities to monitor the u
As with other thrombolytics, it is recommended that when Actilyse is administered, standard resuscitation equipment and
medication be available in all circumstances.
General: Bleeding: The most common complication encountered during Actilyse therapy is bleeding. The concomitant use o
heparin anticoagulant may contribute to bleeding. As fibrin is lysed during Actilyse therapy, bleeding from recent puncture
sites may occur. Therefore, thrombolytic therapy requires careful attention to all possible bleeding sites (including those
following catheter insertion, arterial and venous puncture cut down and needle puncture). The use of rigid catheters, IM
injections and non-essential handling of the patient should be avoided during treatment with Actilyse.
Should serious bleeding occur, in particular cerebral haemorrhage, the fibrinolytic therapy must be discontinued and
concomitant heparin administration should be terminated immediately. Administration of protamine should be considered
heparin has been administered within 4 hrs before the onset of bleeding. In the few patients who fail to respond to these
conservative measures, judicious use of transfusion products may be indicated. Transfusion of cryoprecipitate, fresh frozen
plasma and platelets should be considered with clinical and laboratory re-assessment after each administration. A target
fibrinogen level of 1 g/L is desirable with cryoprecipitate infusion. Antifibrinolytic agents should also be considered.
A dose >100 mg of Actilyse should not be given in acute myocardial infarction as well as pulmonary embolism and 90 mg in
acute ischaemic stroke because it has been associated with an increase in intracranial bleeding.
No sustained antibody formation to the recombinant human tissue-type plasminogen activator molecule has been observe
after treatment. There is no systemic experience with re-administration of Actilyse. If an anaphylactoid reaction occurs, the
infusion should be discontinued and appropriate treatment should be initiated. Monitoring is recommended particularly fo
patients receiving angiotensin-converting enzyme (ACE) inhibitors concomitantly (see Adverse Reactions). As with all
thrombolytics, the use of Actilyse therapy has to be carefully evaluated in order to balance the potential risks of bleeding w
expected benefits under the following conditions: Recent IM injection or small recent traumas eg, biopsies, puncture of ma
vessels, cardiac massage for resuscitation; conditions with an increased risk of haemorrhage which are not mentioned und
Contraindications.
For the treatment of acute myocardial infarction and acute pulmonary embolism, caution should be exercised in patients w
systolic blood pressure >160 mmHg; advanced age, which may increase the risk of intracerebral haemorrhage. As the
therapeutic benefit is also increased in elderly patients, the risk-benefit evaluation should be carried out carefully.
For the treatment of acute myocardial infarction, the following precautions apply:
Arrhythmias: Coronary thrombolysis may result in arrhythmia associated with reperfusion.
Glycoprotein IIb/IIIa Antagonists: There is no experience with the use of GP IIb/IIIa antagonists within the first 24 hrs after
start of treatment.
Thromboembolism: The use of thrombolytics can increase the risk of thromboembolic events in patients with left heart
thrombus eg, mitral stenosis or atrial fibrillation.
For the treatment of acute ischaemic stroke, the following precautions apply:
Treatment must be performed only by a physician trained and experienced in neurological care. Compared to other
indications, patients with acute ischaemic stroke treated with Actilyse have a markedly increased risk of intracranial
haemorrhage as the bleeding occurs predominantly into the infarcted area. This applies in particular in the following cases
situations listed in Contraindications and in all general situations involving a high risk of haemorrhage; small asymptomatic
Treat hypocalcaemia & other disturbances of bone & mineral metabolism before starting therapy. Maintain adequate Ca &
D intake. Severe renal impairment, preexisting GI disease. Pregnancy & lactation.
Monitor blood counts & renal function before start of treatment.
Fluid Retention and Cardiac Failure: Actos can cause fluid retention, which may exacerbate or precipitate heart failure, whe
treating patients who have at least one risk factor for development of congestive heart failure (eg, prior myocardial infarcti
or symptomatic coronary artery disease ), physicians should start with the lowest available dose and increase the dose
gradually. Patients should be observed for signs and symptoms of heart failure, particularly those with reduced cardiac
reserve. Actos should be discontinued if any deterioration in cardiac status occurs. There have been cases of cardiac failure
reported from the market when Actos was used in combination with insulin. Therefore, Actos is contraindicated in
combination with insulin. There also have been case of cardiac failure reported from the market when Actos was used in
patients with a history of cardiac failure. Since NSAID and Actos are associated with fluid retention, concomitant
administration may increase the risk of oedema.
Monitoring of Liver Function: There have been rare reports of hepatocellular dysfunction during post-marketing experience
is recommended, therefore, that patients treated with Actos undergo periodic monitoring of liver enzymes. Liver enzymes
should be checked prior to the initiation of therapy with Actos in all patients. Therapy with Actos should not be initiated in
patients with increased baseline liver enzyme levels (ALT >2.5 x ULN) or with any other evidence of liver disease.
Following initiation of therapy with Actos, it is recommended that liver enzymes be monitored periodically based on clinica
judgement. If ALT levels are increased to 3 x ULN during Actos therapy, liver enzyme levels should be reassessed as soon as
possible. If ALT levels remain >3 x ULN, therapy should be discontinued. If any patient develops symptoms suggesting hepa
dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/or dark urine, liver
enzymes should be checked. The decision whether to continue the patient on therapy with Actos should be guided by
judgement pending laboratory evaluations. If jaundice is observed, drug therapy should be discontinued.
Weight Gain: In clinical trials with Actos, there was evidence of dose-related weight gain, therefore weight should be closel
monitored. Part of the treatment of diabetes is dietary control. Patients should be advised to adhere strictly to a caloric-
controlled diet.
Haematology: There was a 4% relative reduction in haemoglobin and 4.1% in haematocrit during therapy with Actos,
consistent with haemodilution. Similar changes were seen in metformin (haemoglobin 3-4% and haematocrit 3.6-4.1%
relative reduction) and to lesser extent sulfonylurea (haemoglobin 1-2% and haematocrit 1-3.2% relative reduction) treated
pastients in comparative controlled trials with Actos.
Hypoglycaemia: As the consequences of increased insulin sensitivity, patients receiving pioglitazone in dual or triple oral
therapy with sulfonylurea may be at risk for dose-related hypoglycaemia and reduction in the dose of sulfonylurea may be
necessary.
Eye Disorders: Post-marketing reports of new onset or worsening diabetic macular edema with decreased visual acuity hav
been reported with thiazolidinediones, including pioglitazone. Many of these patients reported concurrent peripheral edem
It is unclear whether or not there is a direct association between pioglitazone and macular edema but prescribers should b
alert to the possibility of macular edema, if patients report disturbances in visual acuity; an appropriate ophtamological
referral should be considered.
Others: As a consequence of enhancing insulin action, Actos treatment in patients with polycystic ovarian syndrome may
result in resumption of ovulation. These patients may be at risk of pregnancy. Patients should be aware of the risk of
pregnancy and if a patient wishes to become pregnant or if pregnancy occurs, the treatment should be discontinued.
Use in pregnancy & lactation: There are no adequate human data to determine the safety of pioglitazone during pregnancy
Lactic Acidosis: Lactic acidosis is a very rare, but serious, metabolic complication that can occur due to metformin
accumulation. Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with
significant renal failure. The incidence of lactic acidosis can and should be reduced by assessing also other associated risk
factors eg, poorly controlled diabetes, ketosis, plolonged fasting, excessive alcohol intake, hepatic insufficiency and any
condition associated with hypoxia.
Diagnosis: Lactic acidosis is characterized by acidotic dyspnoea, abdominal pain and hypothermia followed by coma.
Diagnostic laboratory findings are decreased blood pH, plasma lactate levels >5mmol/L, and an increased anion gap and
lactate/pyruvate ratio. If metabolic acidosis is suspected, treatment with the medicinal product should be discontinued and
the patient hospitalised immediately (see Overdosage).
Renal Function: As metformin is excreted by the kidney, serum creatinine concentrations should be determined regularly at
least once a year in patients with normal renal function or at least 2-4 times a year in patients with serum creatinine levels
the upper limits of normal and in elderly subjects.
Decreased renal function in elderly patients is frequent and asymptomatic. Special caution should be exercised in situation
where renal function may become impaired ie, when initiating antihypertensive therapy or diuretic therapy and when starti
treatment with a NSAID.
Surgery: As Actosmet contains metformin hydrochloride, the treatment should be discontinued 48 hrs before elective surge
with general anaesthesia and should not be usually resumed earlier than 48 hrs afterwards.
Administration of Iodinated Contrast Agent: The intravascular administration of iodinated contrast agents in radiological ca
lead discontinued prior to, or at the time of the test and not reinstituted until 48 hrs afterwards and only after renal functio
has been re-evaluated and found to be normal.
Polycystic Ovarian Syndrome: As a consequence of enhancing insulin action, pioglitazone treatment in patients with polycy
ovarian syndrome may result in resumption of ovulation. These patients may be at risk of pregnancy. Patients should be aw
of the risk of pregnancy and if a patient wishes to become pregnant or if pregnancy occurs, the treatment should be
discontinued.
Bladder Cancer: Risk factors for bladder cancer should be assessed before initiating pioglitazone treatment (risks include ag
smoking history, exposure to some occupational or chemotherapy agents eg, cyclophosphamide or prior radiation treatme
in the pelvic region).
Any macroscopic haematuria should be investigated before starting pioglitazone therapy. Patients should be advised to
promptly seek the attention of the physician if macroscopic haematuria or other symptoms eg, dysuria or urinary urgency
develop during treatment.
Patients who received pioglitazone more than 1 year, should be evaluated periodically for bladder cancer risk by urinalysis.
Information for Patients: Patients should be instructed regarding the importance of adhering to dietary instructions, a regu
exercise program, and regular testing of blood glucose and HbA1c. During periods of stress eg, fever, trauma, infection or
surgery, medication requirements may change, and patients should be reminded to seek medical advice promptly.
The risks of lactic acidosis, its symptoms and conditions that predispose to its development, as noted should be explained t
patients. Patients should be advised to discontinue Actosmet immediately and to promptly notify the healthcare profession
if unexplained hyperventilation, myalgia, malaise, unusual somnolence or other nonspecific symptoms occur.
Gastrointestinal symptoms are common during initiation of metformin treatment and may occur during initiation of Actosm
Inadequate dosage or discontinuation of treatment, especially in type 1 diabetes (insulin-dependent diabetes mellitus), ma
lead to hyperglycemia.
The 1st symptoms of hyperglycemia usually set in gradually, over a period of hours or days. They include nausea, vomiting,
drowsiness, flushed dry skin, dry mouth, increased frequency of urination, thirst and loss of appetite as well as acetone odo
of the breath.
In type 1 diabetes, untreated hyperglycemic events lead to diabetic ketoacidosis, which is potentially lethal.
Hypoglycemia may occur if the insulin dose is too high in relation to the insulin requirement. Omission of a meal or
unplanned, strenuous physical exercise may lead to hypoglycemia. Patients whose blood glucose control has greatly improv
eg, by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycemia and should b
advised accordingly.
Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
Renal or hepatic impairment may reduce insulin requirement.
Adjustment of dosage may also be necessary if patients increase their physical activities or change their usual diet.
When patients are transferred between different types of insulin products, the early warning symptoms of hypoglycemia m
change or become less pronounced than those experienced with their previous insulin. Transferring a patient to another ty
or brand of insulin should be done under medical supervision. Changes in strength, brand, type, species (animal, human,
human insulin analogue) and/or method of manufacture may result in the need for a change in dosage.
If an adjustment is needed, it may be done with the 1st dose or during the 1st few weeks or months.
As with any insulin therapy, injection site reactions may occur and include pain, redness, hives, inflammation, bruise, swelli
and itching. Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions.
Reactions usually resolve in a few days to a few weeks. On certain cases, injection site reactions may require discontinuatio
of Actrapid HM/Penfill.
Before traveling between different time zones, the patient should be advised to consult the physician, since this may mean
that the patient has to take insulin and meals at different times.
Due to the risk of precipitation in some pump catheters, Actrapid HM/Penfill should not be used in insulin pumps for
continuous SC insulin infusion.
Actrapid contains metacresol which may cause allergic reactions.
Effects on the Ability to Drive or Operate Machinery: The patient's ability to concentrate and react may be impaired as a re
of hypoglycemia. This may constitute a risk in situations where these abilities are of special importance (eg, driving a car or
operating machinery).
Patients should be advised to take precautions to avoid hypoglycemia while driving. This is particularly important in those w
have reduced or absent awareness of the warning signs of hypoglycemia or have frequent episodes of hypoglycemia. The
advisability of driving should be considered in these circumstances.
Use in Pregnancy & Lactation: There are no restrictions on the treatment of diabetes with insulin during pregnancy, as insu
does not pass the placental barrier.
If untreated during pregnancy, diabetes mellitus constitutes a risk in intrauterine development. Diabetes therapy must
therefore be continued during pregnancy. Both hypoglycemia and hyperglycemia, which can occur in inadequately controll
diabetes therapy, increase the risk of malformations and death in utero. Intensified blood glucose control and monitoring o
As a rule, susceptibility testing should be performed prior to actual use of Acuatim to estimate nadifloxacin susceptibility. T
minimize the chance that resistant microorganisms will develop as a result of therapy, the treatment duration should be th
shortest possible.
General: Antibacterial agent should be reserved for treatment of acne vulgaris with secondary bacterial infections.
Important Precautions: Acuatim cream should be discontinued if the desired therapeutic effect is not achieved at the
recommended dose within 4 weeks for the treatment of acne vulgaris. It should not be continued in acne patients after
inflamed lesions disappear.
Others: Photosensitivity has been reported in patients taking orally synthetic quinolone antibacterial agents.
No evidence of nadifloxacin-induced mutagenesis was seen in a reverse mutation assay with bacterial systems and gene
mutation and chromosomal aberration assays with cultured Chinese hamster cells. A chromosome aberration assay was
positive with cultured human peripheral blood lymphocytes, but an in vivo micronucleus assay was negative in mice. S(-)-
nadifloxacin was positive in both chromosomal aberration and micronucleus assays. Other new quinolones have been
reported to be clastogenic.
Use in pregnancy & lactation: The safety of Acuatim for use during pregnancy has not been established. (Clinical experienc
those subjects is insufficient.)
Use in children: The safety of Acuatim in premature babies, newborns and infants has not been established. (Clinical
experience in those subjects is insufficient.)
In case inflammation of the joint in arthrosis deformans of the knee is conspicuous, and considering that the use of sodium
hyaluronate may cause exacerbation of inflammatory symptoms of the affected part, it is desired that treatment be given
after such inflammatory symptoms have been eliminated.
Occasionally, local pain occurs after the use of sodium hyaluronate, therefore, necessary measures should be taken eg,
instruction of how to rest the affected part after application of sodium hyaluronate.
If the injection should leak outside the articular cavity, it may cause pain, therefore, it should be administered accurately in
the cavity of the joint.
Administer with care in patients with history of hypersensitivity to some other drug, with liver impairment or a history of su
impairment.
The safety and effectiveness of the use of joints other than the knee have not been established.
Use with caution when injecting into patients who are allergic to avian proteins, feathers and egg products.
Remove joint effusion, if present, before injecting sodium hyaluronate.
Use in pregnancy & lactation: In animal experiment (rabbit), teratogenicity is not observed, however, safety of sodium
hyaluronate in pregnant women has not yet been established, therefore, it should be administered carefully in women who
are or possibly are pregnant.
In animal experiment (rat), it is recognized that sodium hyaluronate can pass into breast milk.
The safety and effectiveness of sodium hyaluronate have not yet been established in pregnant and lactating women.
Use in children: As safety of sodium hyaluronate in children has not yet been established, administration should be carefull
made only if such treatment is unavoidable.
Use in the elderly: Administer with caution in elderly patients because their physiological function is generally declining.
Side Effects Rarely: <0.1%; occasionally: 0.1% to <5%; no limitation: >5% or frequency not clear.
Severe: Shock: Symptoms of shock occur rarely, however, when there are abnormalities recognized after adequate
observation, Adant Dispo should be discontinued and the patient given appropriate treatment.
Others: Hypersensitivity: Eruption eg, urticaria, etc and itching occur rarely, however, if such symptoms should occur, Adant
Dispo should be discontinued and the patient should be given appropriate treatment.
Joints Under Treatment: Occasionally, pain (mainly transient pain after administration of sodium hyaluronate), swelling, rar
edema, rash, flush, hot sensation and local pain may occur.
Additional, specific therapy required in bacterial &/or fungal infections. Avoid contact w/ eyes. Avoid extensive application
large areas of the body. Glaucoma may develop after large-dosed or extensive application over a prolonged period, occlusiv
dressing techniques or application to the skin around the eyes. Childn. Elderly.
Aerius syrup should be used with caution in patients with severe renal insufficiency.
Aerius syrup contains sucrose and sorbitol, thus, patients with rare hereditary problems of fructose intolerance, glucose-
galactose malabsorption or sucrose-isomaltose insufficiency should not take Aerius syrup.
Drug Abuse and Dependence: There is no information to indicate that abuse or dependency occurs with Aerius.
Information for Patients: Patients should be instructed to use Aerius tablets as directed. As there are no food effects on
bioavailability, patients can be instructed that Aerius tablets may be taken without regard to meals. Patients should be advi
not to increase the dose or the dosing frequency as studies have not demonstrated increased effectiveness at higher doses
and somnolence may occur.
Effects on the Ability to Drive or Operate Machinery: No effects on the ability to drive and use machines have been observe
Carcinogenicity, Mutagenicity & Impairment of Fertility: The carcinogenic potential of desloratadine was assessed using
loratadine studies. In an 18-month study in mice and a 2-year study in rats, loratadine was administered in the diet at dose
up to 40 mg/kg/day in mice (estimated desloratadine and desloratadine metabolite exposures were approximately 3 times
AUC in humans at the recommended daily oral dose) and 25 mg/kg/day in rats (estimated desloratadine and desloratadine
metabolite exposures were approximately 30 times the AUC in humans at the recommended daily oral dose). Male mice gi
loratadine 40 mg/kg/day had a significantly higher incidence of hepatocellular tumors (combined adenomas and carcinom
than concurrent controls. In rats, a significantly higher incidence of hepatocellular tumors (combined adenomas and
carcinomas) was observed in males given 10 mg/kg/day and in males and females given 25 mg/kg/day. The estimated
desloratadine and desloratadine metabolite exposures of rats given loratadine 10 mg/kg were approximately 7 times the A
in humans at the recommended daily oral dose. The clinical significance of these findings during long-term use of
desloratadine is not known. In genotoxicity studies with desloratadine, there was no evidence of genotoxic potential in a
reverse mutation assay (Salmonella/E. coli mammalian microsome bacterial mutagenicity assay) or in 2 assays for
chromosomal aberrations (human peripheral blood lymphocyte clastogenicity assay and mouse bone marrow micronucleu
assay).
There was no effect on female fertility in rats at desloratadine doses up to 24 mg/kg/day (estimated desloratadine and
desloratadine metabolite exposures were approximately 130 times the AUC in humans at the recommended daily oral dose
A male-specific decrease in fertility, demonstrated by reduced female conception rates, decreased sperm numbers and
motility, and histopathologic testicular changes occurred at an oral desloratadine dose of 12 mg/kg in rats (estimated
desloratadine exposures were approximately 45 times the AUC in humans at the recommended daily oral dose).
Desloratadine had no effect on fertility in rats at an oral dose of 3 mg/kg/day (estimated desloratadine and desloratadine
metabolite exposures were approximately 8 times the AUC in humans at the recommended daily oral dose).
Use in pregnancy: Pregnancy Category C: Desloratadine was not teratogenic in rats at doses up to 48 mg/kg/day (estimated
desloratadine and desloratadine metabolite exposures were approximately 210 times the AUC in humans at the
recommended daily oral dose) or in rabbits at doses up to 60 mg/kg/day (estimated desloratadine exposures were
approximately 230 times the AUC in humans at the recommended daily oral dose). In a separate study, an increase in pre-
implantation loss and a decreased number of implantations and fetuses were noted in female rats at 24 mg/kg (estimated
desloratadine and desloratadine metabolite exposures were approximately 120 times the AUC in humans at the
recommended daily oral dose).
Reduced body weight and slow righting reflex were reported in pups at doses of =9 mg/kg/day (estimated desloratadine an
Patients should be informed that the treatment should be discontinued in case of hypertension, tachycardia, palpitations o
cardiac arrhythmias, nausea or any other neurological sign (eg, headache or increased headache).
Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may be
produced by sympathomimetic amines. These effects may be more likely to occur in children, elderly patients or in cases o
overdose.
Caution should be exercised in patients receiving digitalis, patients with cardiac arrhythmias, hypertension and with history
myocardial infarction, diabetes mellitus, bladder neck obstruction or positive anamnesis of bronchospasm.
Use with caution in patients with stenosing peptic ulcer, pyloroduodenal and vesical cervix obstruction.
Patients being treated with other sympathomimetics including decongestants, anorexogenics or amphetamine-type
psychostimulants, antihypertensive agents, tricyclic antidepressants and other antihistamines.
Patients suffering from migraine who are currently being treated with ergot alkaloid vasoconstrictors. Pseudoephedrine
sulfate carries the risk of abuse. Increased doses may ultimately produce toxicity. Continuous use can lead to tolerance
resulting in an increased risk of overdosing. Depression may follow rapid withdrawal.
Perioperative acute hypertension can occur if volatile halogenated anaesthetics are used during treatment with indirect
sympathomimetic agents. Therefore, if surgery is scheduled, it is preferable to discontinue treatment 24 hrs before
anesthesia.
Athletes should be informed that treatment with pseudoephedrine could lead to positive doping test.
The administration of Aerius D-12 should be discontinued at least 48 hrs before skin tests since antihistamines may prevent
reduce the other.
Use in pregnancy & lactation: There have been no reproduction studies conducted with the combination of desloratadine a
pseudoephedrine. There are no adequate and well-controlled studies in pregnant women.
Desloratadine and pseudoephedrine both pass into breast milk, therefore, a decision should be made whether to discontin
nursing or to discontinue Aerius D-12 tab taking into account the importance of the drug to the mother.
Discontinue if hypersensitivity reactions occur.

Avoid excessive dose. Do not use for >3 days. Patients undergoing MAOI treatment, HTN, DM, hyperthyroid, coronary hear
disease, glaucoma. Childn <6 yr (nasal spray).
Patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions; moderate hepatic
disease who may have bleeding diatheses; renal impairment. Acute ischaemic stroke (<7 days). Patients w/ rare hereditary
problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Pregnancy.
Reduced renal function.
Possibility of lesions or erosions of cartilage in wt bearing joints & other signs of arthropathy.
Avoid a high dose.
Avoid high doses.
A history of upper GI disorders (peptic ulcer). Impaired kidney function. Heart diseases, HTN, or other conditions causing fl
retention. Blood coagulation disorders. Asthma. SLE. Concomitant use w/ acetosal or other drugs which contain paracetam
& ibuprofen, or warfarin anticoagulants. Pregnancy & lactation.
Patients requiring Na restriction. Patients w/ cardiac failure, renal insufficiency or chronic anemia at special risk of developi
circulatory overload, dehydration. Monitor BP, MI, serum K, platelet count & prothrombin times. Pregnancy.
IV route only. Monitor central venous pressure, blood coagulation parameters & hematocrit during treatment. Potency of
heart failure. Pregnancy & lactation. Elderly.
Low cardiac reserve or w/o albumin deficiency, HTN. Childn. Pregnancy.

Impaired hepatic or renal function, prostatic hypertrophy, hyperthyroidism, glaucoma, cardiac disorders, DM, hypoxia,
debilitated. May impair ability to drive or operate machinery. Pregnancy & lactation. Childn <2 yr.
Glaucoma, peptic ulcer stenosis, pyloroduodenal obstruction, CV disease, prostatic hypertrophy, HTN, increased IOP or DM
Elderly.
Sinus syndrome or other supraventricular cardiac conditions; history of ulcer disease, asthma or obstructive pulmonary
disease. Concurrent treatment w/ NSAIDs. Pregnancy & lactation. May impair ability to drive or operate machinery.
HTN, DM, chronic renal failure, infectious disease, osteoporosis.
Prolonged use may cause posterior subcapsular cataract, glaucoma & increase secondary fungal & viral ocular infections;
suppress body resistance to infections. Avoid abrupt w/drawal. Patients w/ history of psychotic disorder, HTN, gastric ulcer,
diabetes, osteoporosis, fresh diverticulitis & intestinal anastomosis, myasthenia gravis, narrow-angle glaucoma,
pyloroduodenal obstruction, prostate hypertrophy, renal insufficiency. May impair ability to drive or operate machinery.
Severe renal insufficiency. Pregnancy & lactation. Childn <1 yr.
Patients under warfarin therapy. Pregnancy & lactation. Childn.

Pemetrexed can suppress bone marrow function as manifested by neutropenia, thrombocytopenia and anaemia (or
pancytopenia) (see Adverse Reactions). Myelosuppression is usually the dose-limiting toxicity. Patients should be monitore
for myelosuppression during therapy and pemetrexed should not be given to patients until absolute neutrophil count (ANC
returns to =1,500 cells/mm3 and platelet count returns to =100,000 cells/mm3. Dose reductions for subsequent cycles are
based on nadir ANC, platelet count and maximum non-haematologic toxicity seen from the previous cycle (see Dosage &
Administration).
Less toxicity and reduction in Grade 3/4 haematologic and non-haematologic toxicities eg, neutropenia, febrile neutropenia
and infection with Grade 3/4 neutropenia were reported when pre-treatment with folic acid and vitamin B12 was
administered. Therefore all patients treated with pemetrexed must be instructed to take folic acid and vitamin B12 as a
prophylactic measure to reduce treatment-related toxicity (see Dosage & Administration).
Skin reactions have been reported in patients not pre-treated with a corticosteroid. Pre-treatment with dexamethasone (or
equivalent) can reduce the incidence and severity of skin reactions (see Dosage & Administration).
An insufficient number of patients has been studied with CrCl of <45 mL/min. Therefore, the use of pemetrexed in patients
with CrCl of <45 mL/min is not recommended (see Dosage & Administration).
Patients with mild to moderate renal insufficiency (CrCl 45-79 mL/min) should avoid taking nonsteroidal anti-inflammatory
drugs (NSAIDs) eg, ibuprofen, aspirin (>1.3 g daily) for 2 days before, on the day of and 2 days following pemetrexed
administration (see Interactions).
In patients with mild to moderate renal insufficiency eligible for pemetrexed therapy NSAIDs with long elimination t shou
be interrupted for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see
Interactions).
Serious renal events, including acute renal failure, have been reported with pemetrexed alone or in association with other
chemotherapeutic agents. Many of the patients in whom these occurred had underlying risk factors for the development o
renal events including dehydration or preexisting hypertension or diabetes.
The effect of third space fluid, eg pleural effusion or ascites, on pemetrexed is not fully defined. A phase 2 study of
pemetrexed in 31 solid tumour patients with stable 3rd space fluid demonstrated no difference in pemetrexed dose
normalized plasma concentrations or clearance compared to patients without 3rd space fluid collections. Thus, drainage of
3rd space fluid collection prior to pemetrexed treatment should be considered, but may not be necessary.
Due to the gastrointestinal toxicity of pemetrexed given in combination with cisplatin, severe dehydration has been observe
Therefore, patients should receive adequate antiemetic treatment and appropriate hydration prior to and/or after receiving
treatment.
Serious cardiovascular events, including myocardial infarction and cerebrovascular events have been uncommonly reported
during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent. Most of the patie
in whom these events have been observed had preexisting cardiovascular risk factors (see Adverse Reactions).
Immunodepressed status is common in cancer patients. As a result, concomitant use of live attenuated vaccines is not
recommended (see Contraindications and Interactions).
Cases of radiation pneumonitis have been reported in patients treated with radiation either prior, during or subsequent to
their pemetrexed therapy. Particular attention should be paid to these patients and caution exercised with use of other
radiosensitising agents.
Alinamin-F: Ampoule: Sometimes, anaphylactic shock may occur.
Cardiac disease; diabetes; glaucoma; pregnancy. May impair ability to drive or operate machinery.
Inspect dressing frequently. Not to be used with oxidising agents eg, hypochlorite soln or hydrogen peroxide.
Dysphagia, esophageal diseases, gastritis, duodenitis, ulcers, renal insufficiency.
Sick-sinus syndrome, supraventricular cardiac conductions, history of ulcer disease, asthma or obstructive pulmonary disea
Discontinue gradually over a min of 1 wk. May affect ability to drive or operate machinery. Pregnancy & lactation. Childn <1
yr.
Avoid single dose treatment in depression or combined anxiety-depression. Pregnancy & lactation, chronic renal & liver
disorders, resp disorder, atrophy & patients who are prone to abuse drugs. Childn <10 yr, geriatric & debilitated patients.
Avoid long-term treatment. May impair ability to drive or operate machinery.
Renal insufficiency & gastric hyperacidity disturbances. Pregnancy & lactation.
Renal insufficiency.
May impair the process of granulocytic defense cells (macrophages, leukocytes) phagocyte lipid emulsions in the presence
pneumonia &/or sepsis. Monitor arterial blood gases, inspired oxygen fraction & ventilatory change to ensure appropriate
adjustments. Episodes of bradycardia & decreased oxygen saturation may occur during the dosing procedure.
Abuse-prone individuals. Renal or hepatic dysfunction. Patients whose primary diagnosis is schizophrenia. Depressed or
suicidal patients. Pregnancy, lactation. Childn <18 yr. Avoid abrupt discontinuation. May affect ability to drive or operate
machinery.
Diabetes.
Sick sinus syndrome, conduction defects, asthma, COPD, pregnancy, lactation. Patients receiving NSAIDs.
Regular monitoring of glucose levels in blood & urine. Milder or absent symptoms of hypoglycaemia eg in patients w/
autonomic neuropathy or taking -blockers, clonidine, reserpine, guanethidine or other sympatholytics. Temporary
changeover to insulin in exceptional stress situations (trauma, surgery, febrile infections).
To achieve optimal control of blood sugar, a correct diet, regular and sufficient physical exercise and if necessary, reduction
body weight are just as important as regular intake of Amaryl. Clinical signs of hyperglycaemia are increased urinary
frequency, intense thirst, dryness of the mouth and dry skin.
When starting treatment, the patient must be informed about the effects and risks of Amaryl and about its role in conjuncti
with dietary measures and physical exercise; the importance of adequate cooperation must also be stressed.
In the initial weeks of treatment, the risk of hypoglycaemia may be increased and necessitates especially careful monitorin
Factors favouring hypoglycaemia include: Unwillingness or (more commonly in older patients) incapacity of the patient to
cooperate; undernutrition, irregular mealtimes or skipped meals; imbalance between physical exertion and carbohydrate
intake; alterations of diet; consumption of alcohol, especially in combination with skipped meals; impaired renal function;
severe impairment of liver function; overdosage with Amaryl; certain uncompensated disorders of the endocrine system
affecting carbohydrate metabolism or counter-regulation of hypoglycaemia (eg, in certain disorders of thyroid function and
anterior pituitary or adrenocortical insufficiency); concurrent administration of certain other medicines (see Interactions).
The physician must be informed about such factors and about hypoglycaemic episodes, since these require particularly car
monitoring.
If such risk factors for hypoglycaemia are present, it may be necessary to adjust the dosage of Amaryl or the entire therapy
This also applies whenever illness occurs during therapy or the patient's lifestyle changes.
Those symptoms of hypoglycaemia which reflect the body's adrenergic counter-regulation (see Adverse Reactions) may be
milder or absent in those situations where hypoglycaemia develops gradually in the elderly and in patients with a certain ty
of nervous disease (autonomic neuropathy) or those receiving concurrent treatment with -blockers, clonidine, reserpine,
guanethidine or other sympatholytic drugs.
Hypoglycaemia can almost always be promptly controlled by immediate intake of sugar eg, in the form of glucose, sugar cu
or sugar-sweetened beverages. Patients should always carry at least 20 g of glucose with them for this purpose (food or
beverages containing artificial sweeteners eg, diet foods or drinks, are ineffective in controlling hypoglycaemia). They may
require the assistance of other persons to avoid complications.
It is known from other sulfonylureas that, despite initially successful countermeasures, hypoglycaemia may recur. Therefore
continued close observation is necessary. Severe hypoglycaemia requires, in addition, immediate treatment and follow-up
a physician and, in some circumstances, hospitalization.
If treated by different physicians (eg, upon admission to hospital after an accident, illness while on holiday), the patients m
inform them of their diabetic condition and previous treatment.
In exceptionally stressful situations (eg, trauma, surgery, infections with fever), blood sugar control may deteriorate and a
temporary change to insulin may be necessary.
During treatment with Amaryl, fasting glucose levels in blood and urine must be checked regularly, as should, additionally,
proportion of glycosylated haemoglobin. Usually every 3-6 months to more precisely assess long-term glycaemic control.
Effects on the Ability to Drive or Operate Machinery: Alertness and reactions may be impaired due to hypo- or
hyperglycaemia, especially when beginning or after altering treatment or when Amaryl is not taken regularly. Such
impairment may for example, affect the ability to operate a vehicle or machinery.
Use in Children: Safety and effectiveness in paediatric patients have not been established.
Adequate blood glucose levels should be maintained concomitantly by diet and exercise, if necessary by weight loss as wel
by taking Amaryl M regularly. Clinical signs of not adequately controlled blood glucose levels include oliguria, thirst, dipsia,
skin, etc.
Patients should be informed of the potential risks and advantage of Amaryl M. They should also be informed about the
importance of adherence to dietary instructions and of a regular exercise program. It should be emphasized that patient's
positive cooperation is important.
Hypoglycemia can almost always be promptly controlled by immediate intake of carbohydrates (glucose or sugar eg, lump
sugar, fruit juice and tea including sugar, etc). Patients should carry approximately at least 20 g of sugar for this. Others help
may be necessary to avoid complications. Artificial sweeteners have no effect.
It is known from other sulfonylureas that, despite initially successful countermeasures, hypoglycemia may recur. Patients
must, therefore, remain under close observation. Severe hypoglycemia further requires immediate treatment and follow-u
by a physician in some circumstances, inpatient hospital care.
If a patient receives a treatment from other physician or pharmacist (eg, hospitalization, accident, needed to see a doctor,
etc), he should inform him of his current diabetic situation and previous treatment.
In exceptional stress-situations (eg, trauma, surgery, febrile infections) blood glucose regulation may deteriorate and a
temporary change to insulin may be necessary to maintain good metabolic control.
The dosage of Amaryl M must be the lowest. Treatment requires regular monitoring of glucose levels in blood and urine. (I
addition, determination of the proportion of glycosylated hemoglobin is recommended.) The effectiveness of therapy shou
be assessed and if not satisfactory, switch to another therapy should be promptly made.
Alertness and reactions may be impaired due to hypo- or hyperglycemia, especially when beginning or after altering
treatment or when Amaryl M is not taken regularly. This may affect the ability to drive or to operate machinery.
Monitoring of Renal Function: Amaryl M is known to be substantially excreted by the kidney, and the risk of metformin
accumulation and lactic acidosis increases with the degree of impairment of renal function. Thus, patients with serum
creatinine levels above the upper limit of normal for their age should not receive this drug. In patients with advanced age,
Amaryl M should be carefully titrated to establish the minimum dose for adequate glycemic effect, because aging is
associated with reduced renal function. In elderly patients, renal function should be monitored regularly and generally,
Amaryl M should not be titrated to the maximum dose.
Use of Concomitant Medications that may Affect Renal Function or Metformin Disposition: Concomitant medication(s) that
may affect renal function or result in significant hemodynamic change or may interfere with the disposition of Amaryl M eg
cationic drugs that are eliminated by renal tubular secretion, should be used with caution.
Radiologic studies involving the use of intravascular iodinated contrast materials (eg, IV urogram, IV cholangiography,
angiography and computed tomography (CT) scans with contrast materials): Intravascular contrast studies iodinated materi
can lead to acute alteration of renal function and have been associated with lactic acidosis in patients receiving this drug (s
Contraindications). Therefore, in patients in whom any such study is planned, Amaryl M should be discontinued at the time
or prior to the procedure, and withheld for 48 hrs, subsequent to the procedure and reinstituted only after renal function h
been re-evaluated and found to be normal.
Hypoxic States: Cardiovascular collapse (shock) from whatever cause, acute congestive heart failure, acute myocardial
infarction and other
Hypersensitivity conditions characterized
to cephalosporins. by hypoxemia
Renal impairment. have been
Prolonged associated
treatment with
requires lactic acidosis
assessment and may
of renal, also&cause p
hepatic
hematopoietic function.
Hepatic Impairment: As with all calcium antagonists, amlodipine half-life is prolonged in patients with impaired liver functio
and dosage recommendations have not been established. Amcor should therefore be administered with caution in these
patients.
Renal Failure: Amlodipine is extensively metabolized to inactive metabolites with 10% excreted as unchanged drug in the
urine. Changes in amlodipine plasma concentrations are not correlated with the degree of renal impairment. Amlodipine m
be used in such patients at normal doses. Amlodipine is not dialyzable.
Congestive Heart Failure: In general, calcium-channel blockers should be used with caution in patients with heart failure.
Use in pregnancy & lactation: Safety of amlodipine in human pregnancy or lactation has not been established. Amlodipine
does not demonstrate toxicity in animal reproductive studies other than to delay parturition and prolong labor in rats at a
dose level 50 times the maximum recommended dose in humans. Accordingly, use in pregnancy and lactation is
recommended only when there is no safer alternative and when the disease itself carries greater risk for the mother and
fetus.
Use in the elderly: The time to reach peak plasma concentrations of amlodipine is similar in elderly and younger subjects.
Amlodipine clearance tends to be decreased with resulting increases in area under the curve (AUC) and elimination half-life
elderly patients. Increases in AUC and elimination half-life in patients with congestive heart failure were as expected for the
patient age group studied. Amlodipine, used at a similar doses in elderly or younger patients, is equally well tolerated.
Therefore, normal dosage regimens are recommended.
Ensure adequate calorie intake (35-40 kCal/kg/day). Monitor serum Ca level periodically. Pregnancy & lactation. Childn.
Careful administration of Aminofluid should be observed in the following patients: Patients with hepatic disorder (water an
electrolyte metabolism may be worsened).
Patients with renal disorder (since the patients have reduced water and electrolyte control, the solution should be
administered with care).
Patients with cardiovascular dysfunction (an increase in the circulating blood volume may worsen the patient's clinical
condition).
Patients with acidosis (the patient's clinical condition may be worsened).
Patients with diabetes mellitus (inhibited uptake of glucose into the tissues may cause hyperglycemia, which may worsen th
patient's clinical condition).
Important Precaution: Aminofluid contains amino acids 15 g (nitrogen 2.35 g) and 150 kCal in 500 mL. However, daily calor
requirements cannot be met by only administering this solution as the sole source of nutrition. Thus, this solution should b
used for short-term nutrition therapy.
When used as a nutritional supplement in patients whose oral intake is inadequate, the solution should be used based on t
overall assessment of the patient's nutritional requirements and oral intake.
When this solution is used alone postoperatively, its use shoud be limited to 3-5 days and oral/enteral nutrition or other
regimens should be started as soon as it is feasible to do so.
Use in pregnancy & lactation: The safety in pregnant women has not been established. Aminofluid should be used in pregn
women and women who may possibly be pregnant only if the therapeutic benefits outweigh the possible risks associated
with treatment.
Use in children: The safety in children has not been established (no clinical experience).
Use in the elderly: Since elderly patients often have reduced physiological function and associated hepatic, renal or cardiac
dysfunction, it is advisable to take such measures as reducing the dose by decreasing the infusion rate under careful
supervision.
Careful administration in patients with severe acidosis and congestive heart failure.
Use with electrolyte solution and administration of the solution in large doses require careful supervision of electrolyte
balance.
Use in children: The safety of Aminoleban Infusion in children has not been established.
Careful checking should be done for urine volume not less than 60-70 mL/hr and re-examination of dosage schedule is
necessary when the volume falls below the level.
Caution For Usage Take special care in handling instruments for injection as these preparations are liable to propagate
microorganisms.
Use immediately after breaking the seal and do not use the remaining solution.
Patients w/ impaired kidney function. Adjust or discontinue use if renal impairment, vestibular or hearing disturbances occ
Prolonged use. Pregnancy & lactation.
Acetic acid is formulated in an amount of about 120 mEq/L. Concomitant use of the solution with electrolyte solutions and
administration of the solution in large doses require careful supervision of electrolyte balance.
Administer by slow infusion.
Careful Administration: Patients with severe acidosis, congestive heart failure and hyponatremia.
Use in children: The safe use of Amiparen in immature infants, newborns and infants has not yet been established.
Cerebrovascular dysfunction, hepatic disorder or GI bleeding, severe acidosis or electrolyte imbalance or abdominal acid-b
balance. Pregnancy. Childn. Elderly.
Liver dysfunction, kidney failure. Pregnancy & lactation. Elderly.
Check for urine vol not <60-70 mL/hr & re-examine dosage schedule when vol falls below the level.
Periodically assess renal, hepatic & haematopoietic functions during prolonged therapy. Maintain adequate fluid intake &
urinary output during high-dose treatment. Check indwelling catheters regularly for patency. Pregnancy & lactation.
HTN, ocular herpes simplex, cirrhosis, hypothyroidism, nonspecific ulcerative colitis, DM.
HTN, ocular herpes simplex, cirrhosis, hypothyroidism, nonspecific ulcerative colitis, DM.
Lactation.
Hepatic & renal dysfunction, severely depressed patients, blood disorders.
Moderate or severe renal/resp insufficiency, moderate or severe hepatic impairment, patients susceptible to seizure, opioid
dependence, cranial trauma, convulsive disorder, biliary tract disorder, under altered state of conciousness, resp center
problem. May affect ability to drive or operate machinery. Childn <16 yr.
Anaphylactic reaction to penicillins; concurrent treatment w/ potent diuretics. Renal dysfunction.
Hepatic impairment. Pregnancy & lactation. Childn <4 yr.
Hypersensitivity to penicillins, renal impairment & colitis, prolonged use, superinfections. Pregnancy & lactation.
Moderate or severe renal impairment, severe hepatic dysfunction, prolonged use. Pregnancy (especially 1st trimester) &
lactation.
Avoid contact w/ eyes or mucous membranes. Burning sensation or efflorescence, chickenpox or morbilli. Childn. Prolonge
use may cause skin irritation.
Should not be used as monotherapy for megaloblastic anemia associated w/ vit B12 deficiency.
Elderly or debilitated patients w/ chronic renal failure, CHF. Impaired hepatic function, myasthenia gravis. May affect ability
drive or operate machinery at least 12 hr after IV administration. Pregnancy & lactation. Infant & neonate. Childn <18 yr.
Angioedema unrelated to ACE inhibitor therapy; CHF w/ or w/o associated renal insufficiency.
Hypersensitivity to penicillins. Severe renal impairment. Pregnancy, lactation.
Renal failure (CrCl <15 mL/min), severe hepatic failure. Pregnancy.

Regular monitoring of glucose levels in blood & urine. Milder or absent symptoms of hypoglycaemia in patients w/ autonom
neuropathy or taking -blockers, clonidine, reserpine, guanethidine & other sympatholytics. Temporary change over to insu
in exceptional stress situations eg, trauma, surgery, febrile inj.
Menstruation, tendency for bleeding or hemorrhagic diathesis, hepatic or severe renal impairment. Patients on
anticoagulants, antithrombotics or antiplatelet agents, prostaglandin E1 or its derivatives.
Controlled epilepsy, renal & hepatic impairment, acute cardiac failure, may impair ability to drive or operate machinery.
Cardiac disease, diabetes; glaucoma; impaired kidney or liver function; pregnancy; may impair ability to drive or operate
machinery. Childn <6 yr.
CV thrombotic events, HTN, CHF, prior history of ulcer disease or GI bleeding & toxicity, impaired renal function, heart failu
liver dysfunction, taking diuretics & ACE inhibitors. Monitor renal function & blood count. Concomitant use w/ systemic
NSAIDs including COX-2 selective inhibitors; rare hereditary problems of fructose intolerance, glucose-galactose
malabsorption or sucrose-isomaltase insufficiency; ulcerative colitis or Crohn's disease; impaired hepatic function; hepatic
porphyria. May impair female fertility. May affect ability to drive or operate machinery. Elderly.
May impair ability to drive or operate machinery.

Transferring a patient to a new type or brand of insulin should be done under strict medical supervision. Changes in strengt
brand [manufacturer, type (regular, NPH, lente, etc), species/animal] and/or method of manufacturing may result in a chan
in dosage.
Concomitant oral antidiabetic treatment may need to be adjusted. The use of inadequate dosages or discontinuation of
treatment, especially in insulin-dependent diabetic, may lead to hyperglycemia and diabetic ketoacidosis, conditions which
are potentially lethal.
Hypoglycemia: The time of occurrence of hypoglycemia depends on the action profile of the insulins used and may, therefo
change when the treatment regimen is changed. Conditions which may make the early warning symptoms of hypoglycemia
different or less pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease, medicina
products eg, -blockers or after transfer from animal-source insulin to human insulin. Adjustment of dosage may also be
necessary if patients undertake increased physical activiy or change their usual meal plan. Exercise taken immediately after
meal may increase the risk of hypoglycemia. When compared with soluble human insulin, if hypoglycemia occurs after an
injection with rapid-acting analogues, it may occur earlier. Uncorrected hypoglycemic or hyperglycemic reactions can cause
loss of consciousness, coma or death. Insulin requirements may be altered during illness or emotional disturbances.
Effects on the Ability to Drive or Operate Machinery: The patient's ability to concentrate and react may be impaired as a re
of hypoglycemia or hyperglycemia or for example, as a result of visual impairment.
This may constitute a risk in situations where these abilities are of special importance (eg, driving a car or operating
machinery). Patients should be advised to take precautions to avoid hypoglycemia whilst driving. This is particularly import
in those who have reduced or absent awareness of the warning symptoms of hypoglycemia or have frequent episodes of
hypoglycemia. The advisability of driving should be considered in these circumstances.
Use in Pregnancy: There are no adequate data on the use of insulin glulisine in pregnant women. Animal reproduction stud
have not revealed any differences between insulin glulisine and human insulin regarding pregnancy, embryonal/fetal
development, parturition or postnatal development.
Preclinical data did not reveal toxicity findings other than those linked to the blood glucose-lowering pharmacodynamic
activity (hypoglycemia), different from regular human insulin or of clinical relevance for humans. Caution should be exercis
when prescribing to pregnant women.
Careful monitoring of glucose control is essential. It is essential for patients with pre-existing or gestational diabetes to
maintain good metabolic control throughout pregnancy. Insulin requirement may decrease during the 1st trimester and
generally increase during the 2nd and 3rd trimesters.
Immediately after delivery, insulin requirements decline rapidly.
Use in Lactation: It is unknown whether insulin glulisine is excreted in human milk, but in general, insulin does not pass into
breast milk and is not absorbed after oral administration. Breastfeeding mothers may require adjustments in insulin dose a
diet.
Treatment of large areas of the skin for prolonged periods.
Treatment of large areas of the skin for prolonged periods.

Rare hereditary problems of galactose intolerance Lapp lactase deficiencies, glucose-galactose malabsorption. May affect t
ability to drive or operate the machinery. Pregnancy & lactation. Childn <12 yr. Elderly >65 yr.
Intravascular Volume Depletion: Symptomatic hypotension, especially after the 1st dose, may occur in patients who are
volume- and/or sodium-depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditio
should be corrected before the administration of Aprovel.
Renovascular Hypertension: There is an increased risk of severe hypotension and renal insufficiency when patients with
bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with drugs that affect the
renin-angiotensin-aldosterone system. While this is not documented with Aprovel, a similar effect should be anticipated wi
angiotensin II receptor antagonists.
Renal Impairment and Kidney Transplantation: When Aprovel is used in patients with impaired renal function, a periodic
monitoring of potassium and creatinine serum levels is recommended. There is no experience regarding the administration
Aprovel in patients with a recent kidney transplantation.
Hypertensive Patients with Type 2 Diabetes and Renal Disease: The effects of irbesartan both on renal and cardiovascular
events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal
disease. In particular, they appeared less favourable in women and non-white subjects (see Pharmacology under Actions).
Hyperkalemia: As with other drugs that affect the renin-angiotensin-aldosterone system, hyperkalemia may occur during th
treatment with Aprovel, especially in the presence of renal impairment, overt protenuria due to diabetic renal disease and
heart failure. Close monitoring of serum potassium in patients at risk is recommended (see Interactions).
Lithium: The combination of lithium and Aprovel is not recommended (see Interactions).
Aortic and Mitral Valve Stenosis, Obstructive Hypertrophic Cardiomyopathy: As with other vasodilators, special caution is
indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Primary Aldosteronism: Patients with primary aldosteronism generally will not respond to antihypertensive drugs acting
through inhibition of the renin-angiotensin-aldosterone system. Therefore, the use of Aprovel is not recommended.
General: In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin
aldosterone system (eg, patients with severe congestive heart failure or underlying renal disease, including renal artery
stenosis), treatment with ACE inhibitors or angiotensin II receptor antagonists that affect this system has been associated w
acute hypotension, azotaemia, oliguria or rarely, acute renal failure. As with any antihypertensive agent, excessive blood
pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial
infarction or stroke.
As observed for ACE inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering
blood pressure in Black people than in non-Blacks, possibly because of higher prevalence of low-renin states in the Black
hypertensive population (see Pharmacology under Actions).
Lactose: Aprovel contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficien
or glucose-galactose malabsorption should not take this medicinal product.
Effects on the Ability to Drive or Operate Machinery: The effects of irbesartan on the ability to drive and use machines has
been studied, but based on its pharmacodynamic properties, irbesartan is unlikely to affect this ability. When driving vehicl
or operating machines, it should be taken into account that dizziness or weariness may occur during treatment.
Use in Pregnancy: Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. Unless continued
AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive
treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with
GI disorders, severe hepatic impairment; impaired cardiac or renal function; patients treated w/ diuretics; extracellular vol
depletion. Pregnancy. Elderly.
Use in pregnancy: No fetal toxicity or malformation has been reported. However, follow-up of women exposed to
sulbutiamine during pregnancy is insufficient to exclude such a risk. Therefore, as a precautionary measure, it is preferable
to use this drug during pregnancy.
Use in lactation: In the absence of data concerning the diffusion into breast milk, breastfeeding is not recommended during
treatment.
Hypersensitivity to cephalosporins. Renal impairment.
Childn <6 yr.

Clinical trial suggests that the selective COX-2 inhibitor class of drugs may be associated with an increased risk of thromboti
events (especially MI and stroke), relative to placebo and some NSAIDs (naproxen). As the cardiovascular risks of selective
COX-2 inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective
daily dose should be used. The patients need symptomatic relief and response to therapy should be re-evaluated periodica
Patients with significant risk factors for cardiovascular events (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking
peripheral arterial disease should only be treated with etoricoxib after careful consideration.
Selective COX-2 inhibitors are not a substitute for aspirin for cardiovascular prophylaxis because of their lack of effect on
platelets. Because etoricoxib does not inhibit platelet aggregation, antiplatelet therapies should not be discontinued.
There is a further increase in the risk of GI adverse effects (GI ulceration or other GI complications) for etoricoxib, other
selective COX-2 inhibitors and NSAIDs, when taken concomitantly with acetylsalicylic acid (even at low doses). The relative
differences in gastrointestinal safety between selective COX-2 inhibitors + acetylsalicylic acid vs NSAIDs + acetylsalicylic acid
has not been adequately evaluated in long term clinical trials.
In patients with advanced renal disease, treatment with Arcoxia is not recommended. Clinical experience in patients with
estimated CrCl of <30 mL/min is very limited. If therapy with Arcoxia must be initiated in such patients, close monitoring of
the patient's renal function is advisable.
Renal prostaglandins may play a compensatory role in the maintenance of renal perfusion. Therefore, under conditions of
compromised renal perfusion, administration of Arcoxia may cause a reduction in prostaglandin formation and secondarily,
renal blood flow and thereby impair renal function. Patients at greatest risk of this response are those with preexisting
significantly impaired renal function, uncompensated heart failure or cirrhosis. Monitoring of renal function in such patient
should be considered. As with other drugs known to inhibit prostaglandin synthesis, discontinuation of therapy with Arcoxi
would be expected to be followed by recovery to the pre-treatment state.
Caution should be used when initiating treatment with Arcoxia in patients with considerable dehydration. It is advisable to
rehydrate patients prior to starting therapy with Arcoxia.
As with other drugs known to inhibit prostaglandin synthesis, fluid retention, edema and hypertension have been observed
some patients taking Arcoxia. The possibility of fluid retention, edema or hypertension should be taken into consideration
when Arcoxia is used in patients with preexisting edema, hypertension or heart failure.
Etoricoxib may be associated with more frequent and severe hypertension than some other NSAIDs and selective COX-2
inhibitors, particularly at high doses. Therefore, special attention should be paid to blood pressure monitoring during
treatment with etoricoxib. If blood pressure rises significantly, alternative treatment should be considered.
Caution should be exercised in patients with a medical history of ischemic heart disease because of the pharmacodynamic
profile of COX-2 selective inhibitors noted previously.
Physicians should be aware that individual patients may develop upper GI ulcer complications irrespective of treatment. In
clinical studies, the risk of endoscopically detected upper GI ulcers was lower in patients treated with Arcoxia 120 mg once
daily than in patients treated with nonselective NSAIDs. While the risk of endoscopically detected ulcers was lower in patie
treated with Arcoxia 120 mg than in patients treated with placebo. Upper GI ulcer complications have occurred in patients
treated with Arcoxia. Independent of treatment, patients with a prior history of GI perforation, ulcers and bleeding (PUB) a
patients >65 years are known to be at a higher risk for a PUB.
Elevations
Lactation. of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (approximately =3 times the upper li
May cause a variety type of allergic reactions, including anaphylaxis or asthma in patients w/ sensitivity.
Avoid use w/ occlusive dressing & intensive prolonged treatment, superinfection may occur. Pregnancy & lactation. Childn
yr.
Discontinue if hypersensitivity reactions occur. Pregnancy.
Sick sinus syndrome, supraventricular cardiac conduction conditions; history of ulcer disease, asthma or obstructive
pulmonary disease.
Underlying cardiac condition abnormalities, history of ulcer disease or those receiving concurrent NSAIDs, history of asthm
or obstructive pulmonary disease. May impair ability to drive or operate machinery. Pregnancy & lactation.
History of upper GI diseases, liver or kidney dysfunction, CHF, hypovolemia, dehydration, receiving anticoagulants or diureti
therapy.
The menopause should be defined biochemically [luteinizing-hormone (LH), follicle stimulating hormone (FSH) and/or
estradiol levels] in any patient where there is doubt about hormonal status. There are no data available for the use of
Arimidex with luteinizing hormone releasing hormone (LHRH) analogues. This combination should not be used outside clin
trials.
There are no data to support the safe use of Arimidex in patients with moderate or severe hepatic impairment, or patients
with severe impairment of renal function (CrCl <20 mL/min).
As Arimidex lowers circulating estrogen levels, it may cause a reduction in bone mineral density with a possible consequen
increase risk of fractures. This possible increased risk should be managed according to treatment guidelines for managing
bone health in postmenopausal women.
Women with osteoporosis or at risk of osteoporosis should have their bone mineral density formally assessed by bone
densitometry at the commencement of treatment and at regular intervals thereafter. Treatment or prophylaxis for
osteoporosis should be initiated as appropriate and carefully monitored.
Arimidex contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp-lactase deficiency or gluco
galactose malabsorption should not take Arimidex.
Effects on the Ability to Drive or Operate Machinery: Arimidex is unlikely to impair the ability of patients to drive and opera
machinery. However, asthenia and somnolence have been reported with the use of Arimidex and caution should be observ
when driving or operating machinery while such symptoms persist.
Use in children: Arimidex is not recommended for use in children as safety and efficacy have not been established in this
group of patients.
Orthostatic hypotension, CV disease (history of MI or ischemic heart disease, heart failure or conduction abnormalities),
cerebrovascular disease, dehydration & hypovolemia. Seizure, alzheimer's disease. May impair judgement, thinking.
Reduction of core body temp. Dysphagia. Heat exposure & dehydration. Neuroleptic malignant syndrome (NMS). Tardive
dyskinesia. May impair ability to drive or operate machinery. Pregnancy & lactation. Childn. Elderly.
Route of Administration: Arixtra must not be administered IM (see Dosage & Administration).
Percutaneous Coronary Intervention (PCI) and Risk of Guiding Catheter Thrombus: In STEMI patients undergoing primary P
for reperfusion, the use of Arixtra prior to and during PCI is not recommended. Similarly, in UA/NSTEMI patients with life-
threatening conditions that require urgent revascularization, the use of Arixtra prior to and during PCI is not recommended
These are patients with refractory or recurrent angina associated with dynamic ST deviation, heart failure, life-threatening
arrhythmias or haemodynamic instability. In UA/NSTEMI and STEMI patients undergoing non-primary PCI, the use of Arixtr
as the sole anticoagulant during PCI is not recommended, therefore UFH should be used according to local practice (see
Dosage & Administration).
There are limited data on the use of UFH during non-primary PCI in patients treated with Arixtra (see Clinical Studies under
Actions).
In those patients who underwent non-primary PCI 6-24 hrs after the last dose of Arixtra, the median dose of UFH was 8000
and the incidence of major bleeding was 2% (2/98). In those patients who underwent non-primary PCI <6 hrs after the last
dose of Arixtra, the median dose of UFH was 5000 IU and the incidence of major bleeding was 4.1% (2/49).
Clinical trials have shown a low but increased risk of guiding catheter thrombus in patients treated with Arixtra for
anticoagulation during PCI compared to control. Incidences in non-primary PCI in UA/NSTEMI were 1% versus 0.3% (Arixtra
enoxaparin) and in primary PCI in STEMI were 1.2% versus 0% (Arixtra vs control).
Haemorrhage: Arixtra, like other anticoagulants should be used with caution in conditions with an increased risk of
hemorrhage (eg, congenital or acquired bleeding disorders, active ulcerative gastrointestinal disease, recent intracranial
hemorrhage; shortly after brain, spinal or ophthalmic surgery).
Agents that may enhance the risk of hemorrhage should not be administered concomitantly with fondaparinux. These agen
include desirudin, fibrinolytic agents, GPIIb/IIIa receptor antagonists, heparin, heparinoids or Low Molecular Weight Hepar
(LMWH). Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogre
and NSAIDs should be used with caution. If co-administration is essential, close monitoring is necessary.
Prevention of VTE: Other medicinal products enhancing the risk of haemorrhage, with the exception of vitamin K antagonis
used concomitantly for treatment of VTE, should not be administered with Arixtra. If co-administration is essential, close
monitoring is recommended (see Interactions).
Prevention of VTE Following Surgery (Timing of 1st Arixtra Injection): The timing of the 1st injection requires strict adheren
The 1st dose should be given no earlier than 6 hrs following surgical closure and only after haemostasis has been establishe
Administration before 6 hrs has been associated with an increased risk of major bleeding. Patient groups at particular risk a
those =75 years, body weight of <50 kg or renal impairment with CrCl <50 mL/min.
Treatment of UA/NSTEMI and STEMI: Arixtra should be used with caution in patients who are being treated concomitantly
with other medicinal products that increase the risk of haemorrhage (eg, GPIIb/IIIa inhibitors or thrombolytics).
Spinal/Epidural Anaesthesia/Spinal Puncture: Epidural or spinal haematomas that may result in long-term or permanent
paralysis can occur with the use of anticoagulants and spinal/epidural anaesthesia or spinal puncture. The risk of these rare
events may be higher with postoperative use of indwelling epidural catheters or the concomitant use of other medicinal
products affecting haemostasis.
Low Body Weight: Patients with body weight <50 kg are at increased risk of bleeding. Elimination of Arixtra decreases with
weight decrease.
Tachycardia, Arixtra should
thyrotoxicosis, be used with caution
MI, hyperpyrexia, renal & in thesedisease.
hepatic patientsChildn.
(see Dosage & Administration).
Elderly.
Known or suspected CNS disorders. Renal insufficiency, diabetes, childn.

Not for women w/ premenopausal endocrine status. Postmenopausal status ascertained by assessment of LH, FSH &
oestradiol levels. Assess bone mineral density in women w/ osteoporosis or at risk of osteoporosis. Consider routine
assessment of 25 hydroxy vit D levels prior to start of aromatase inhibitor treatment. Reduction in bone mineral density.
Hepatic or renal impairment. May impair ability to drive or operate machinery. Childn.
In combination w/ other ophth soln, instil as last w/ an interval of at least 10 min following instillation of other ophth soln.
Patients at risk of increased bleeding from trauma, surgery or other pathological conditions. Moderate hepatic disease,
bleeding diatheses; renal impairment.
Hepatic or renal impairment. Patients w/ SLE. Asthma. History of upper GI diseases. Peptic ulcer. History of heart failure. CV
diseases, HTN, other diseases which can cause fluid retention. Bleeding disorders. Elderly. Pregnancy & lactation. Childn <1
History of upper GI disease (peptic ulcer), kidney dysfunction, blood coagulation disorders, heart failure, HTN, other diseas
which lead to fluid retention, SLE. Lactation. Childn <12 yr.
Clinical evaluation eg, periodical monitoring of serum ionogram, water and acid-base balance should be done in long-term
use. Caution should be taken when administering to children, elderly, hypertensive patients and pregnancy toxemia. Do no
administer together with blood transfusion as it may cause precipitation.
Patients in whom aspirin & other NSAIDs precipitate symptoms of bronchospasm, allergic rhinitis or urticaria. Pregnancy.
Childn <14 yr.
Patients w/ hypoxemia, renal & hepatic disorder. Pregnancy, lactation. Childn & elderly.
Esophageal passage disturbance. Penicillin allergy. Pregnancy, lactation.
Dyspepsia, renal or hepatic dysfunction, porphyria. Pregnancy, lactation, childn.

Concomitant use w/ iron prep. Pregnancy & lactation. Childn.
Thyrotoxicosis, HTN, CV dysfunction, hyperthyroidism & DM. Pregnancy & lactation. Childn <2 yr.
Avoid single-dose treatment in depression or combined anxiety-depression. Chronic renal & liver disorders, resp disorder,
atrophy & patients who are prone to abuse drugs. Childn <10 yr, geriatric & debilitated patients. Avoid long-term treatmen
May impair ability to drive or operate machinery. Pregnancy & lactation.
Hyperthyroidism, HTN, heart disease, DM. Pregnancy & lactation. Elderly, childn.
Perform liver function test prior initiation, 12 wk after, during evaluation of dose & periodically thereafter; patient w/ diffus
myalgias, muscle tenderness or weakness &/or marked elevation of CPK. Promptly report unexplained muscle pain,
tenderness or weakness, especially if accompanied w/ malaise or fever. Discontinue use in case of markedly elevated CPK
levels, diagnosed or suspected myopathy or w/ risk factor to development of renal failure secondary to rhabdomyolysis.
Hypersensitivity to shea butter or any of the components. Avoid contact w/ eyes.
Perform liver function test prior to initiation, 12 wk after treatment initiation, during dose evaluation & periodically thereaft
Alcohol consumption, active or history of liver disease, unexplained persistent transaminases elevation; diffuse myalgia,
muscle tenderness or weakness &/or marked CPK elevation. Discontinue use in case of markedly elevated CPK levels,
diagnosed or suspected myopathy or w/ risk factor predisposing to development of renal failure secondary to rhabdomyoly
Hepatic Effects: As with other lipid-lowering agents of the same class, moderate [>3 x upper limit of normal (ULN)] elevatio
of serum transaminases have been reported following therapy with atorvastatin. Liver function was monitored during pre-
marketing as well as post-marketing clinical studies of atorvastatin given at doses of 10, 20, 40, and 80 mg.
Persistent increases in serum transaminases (>3 x ULN on =2 occasions) occurred in 0.7% of patients who received
atorvastatin in these clinical trials. The incidence of these abnormalities was 0.2%, 0.2%, 0.6%, and 2.3% for 10, 20, 40 and
mg respectively. One (1) patient in clinical trials developed jaundice.
Increases in liver function tests (LFT) in other patients were not associated with jaundice or other clinical signs or symptom
When the dosage of atorvastatin was reduced or drug treatment interrupted or discontinued, transaminase levels returned
pretreatment levels. Most patients continued treatment on a reduced dose of atorvastatin without sequelae. LFT elevation
continued treatment with a reduced dose of atorvastatin.
Liver function tests should be performed before the initiation of treatment and periodically thereafter. Patients who develo
any signs or symptoms suggesting liver injury should have liver function test performed. Patients who develop increased
transaminase levels should be monitored until the abnormality (ies) resolve(s). Should an increase in ALT or AST of >3 time
the ULN persist, reduction of dose or withdrawal of atorvastatin is recommended.
Atorvastatin can cause an elevation in transaminases (see Adverse Reactions).
Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol and/or have a history o
liver disease. Active liver disease or unexplained persistent transaminase elevations are contraindications to the use of
atorvastatin (see Contraindications).
Skeletal Muscle Effects-Myalgia has been reported in atorvastatin-treated patients (see Adverse Reactions). Myopathy, defi
as muscle aching or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values >10 x ULN, sho
be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of CPK.
Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompani
by malaise of fever. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is
diagnosed or suspected.
The risk of myopathy during treatment with drugs in this class is increased with concurrent administration of cyclosporine,
fibric acid derivatives, erythromycin, niacin or azole antifungals. Many of these drugs inhibit cytochrome P-450 and 3A4
metabolism and/or drug-transport. Atorvastatin is biotransformed by CYP 3A4. Physicians considering combined therapy w
atorvastatin and fibric acid derivatives, erythromycin, immunosuppressive drugs, azole antifungals or lipid-lowering doses o
niacin should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and
symptoms of muscle pain, tenderness or weakness, particularly during the initial months of therapy and during any period
upward dosage titration of either drug. Periodic creatine phosphokinase (CPK) determinations may be considered in such
situations, but there is no assurance that such monitoring will prevent the occurrence of severe myopathy (see Interactions
Atorvastatin may cause an elevation of CPK (see Adverse Reactions).
As with other drugs in this class, rare cases of rhabdomyolysis with acute renal failure, secondary to myoglobinuria has bee
reported.
Atorvastatin therapy should be temporarily withheld or discontinued in any patient with an acute, serious condition
suggestive of a myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyol
(eg, severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders and
History of upper GI diseases; patients receiving antihemostatic therapy or diuretic. Discontinue if peptic ulcer or GI bleedin
occurs. Patients w/ dehydration, CHF, liver cirrhosis, nephrotic syndrome, kidney diseases. Post-op patients w/ tendency of
hypovolemia. Debilitated patients & elderly.
Atrovent 0.025% inhalant solution contains the (antimicrobial) preservative benzalkonium chloride and the stabiliser disodi
edetate. It has been shown that these components may cause bronchoconstriction in some patients.
Atrovent should be used with caution in patients predisposed to narrow-angle glaucoma or with prostatic hyperplasia or
bladder-neck obstruction.
Patients with cystic fibrosis may be more prone to gastrointestinal motility disturbances.
Immediate hypersensitivity reactions may occur after administration of Atrovent as demonstrated by rare cases of urticaria
angioedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis.
Ocular Complications: There have been isolated reports of ocular complications (ie, mydriasis, increased intraocular pressu
narrow-angle glaucoma, eye pain) when aerosolised ipratropium bromide either alone or in combination with an adrenerg
2-agonist has come into contact with the eyes. Thus, patients must be instructed in the correct administration of Atrovent
metered aerosol.
Eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival conges
and corneal edema may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop,
treatment with miotic drops should be initiated and specialist advice sought immediately.
Patients must be instructed of the correct administration of Atrovent solution for inhalation. Care must be taken not to allo
the solution or mist to enter into the eyes. It is recommended that the nebulised solution is administered via a mouth piece
this is not available and a nebuliser mask is used, it must fit properly. Patients who may be predisposed to glaucoma should
warned specifically to protect their eyes.
Use in pregnancy & lactation: The safety of Atrovent during human pregnancy has not been established. The benefits of us
Atrovent during a confirmed or suspected pregnancy must be weighed against possible hazards to the unborn child.
Preclinical studies have shown no embryotoxic or teratogenic effects following inhalation or intranasal application at doses
considerably higher than those recommended in man.
It is not known whether Atrovent is excreted in breast milk. Although lipid-insoluble quaternary cations pass into breast mi
it is unlikely that Atrovent would reach the infant to an important extent, when administered by inhalation. However, becau
many drugs are excreted in breast milk, caution should be exercised when Atrovent is administered to nursing mothers.
Use in children: Safety and effectiveness in children <12 years have not been established.
Side Effects The most frequent nonrespiratory adverse events reported in clinical trials were GI motility disorders (eg,
constipation, diarrhea and vomiting), dryness of the mouth and headache.
Further, the following side effects have been observed with Atrovent: Increased heart rate, palpitations, supraventricular
tachycardia and atrial fibrillation, ocular accommodation disturbances, nausea and urinary retention. These side effects hav
been reversible. The risk of urinary retention may be increased in patients with preexisting outflow tract obstruction.
Ocular side effects have been reported (see Precautions).
As with other inhaled therapy including bronchodilators, cough, local irritation and inhalation-induced bronchoconstriction
have been observed.
Allergic-type reactions eg, skin rash, angioedema of the tongue, lips and face, urticaria (including giant urticaria),
laryngospasm and anaphylactic reactions have been reported, with positive rechallenge in some cases.
Before initiating therapy with amoxicillin-clavulanate, careful enquiry should be made concerning previous hypersensitivity
reactions to penicillin, cephalosporins or other allergens.
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therap
These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity. If an allergic reaction occu
amoxicillin-clavulanate therapy should be discontinued and appropriate alternative therapy instituted. Serious anaphylacto
reactions require immediate emergency treatment with adrenaline. Oxygen IV steroids and airway management, including
intubation may also be required.
Amoxicillin-clavulanate should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform r
has been associated with this condition following the use of amoxicillin.
Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.
In general, amoxicillin-clavulanate is well tolerated and possesses the characteristic low toxicity of the penicillin group of
antibiotics. Periodic assessment of organ system functions, including renal, hepatic and hematopoietic function is advisable
during prolonged therapy.
Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin-clavulanate. Appropriate
monitoring should be undertaken when anticoagulants are prescribed concomitantly.
Changes in liver function tests have been observed in some patients receiving Augmentin. The clinical significance of these
changes is uncertain but Augmentin should be used with caution in patients with evidence of hepatic dysfunction.
In patients with renal impairment, dosage should be adjusted according to the degree of implement (see Renal Impairmen
under Dosage & Administration).
In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy.
During the administration of high doses of amoxicillin. It is advisable to maintain adequate fluid intake and urinary output i
order to reduce the possibility of amoxicillin crystalluria (see Overdosage).
Amoxicillin-clavulanate suspensions, contains aspartame, which is a source of phenylalanine; and so should be used with
caution in patients with phenylketonuria.
Erythematous rashes have been associated with glandular fever in patients receiving amoxicillin. Augmentin should be
avoided if glandular fever is suspected.
Cholestatic jaundice, which may be severe, but is usually reversible, has been reported rarely, signs and symptoms may not
become apparent for several weeks after treatment has ceased.
Effects on the Ability to Drive or Operate Machinery: Adverse effects on the ability to drive or operate machinery have not
been observed.
Use in pregnancy: Reproduction studies in animals (mice and rats at doses up to 10 times the human dose) with orally and
parenterally administered Augmentin have shown no teratogenic effects. In a single study in women with preterm, prematu
rupture of the fetal membrane (pPROM), it was reported that prophylactic treatment with amoxicillin-clavulanate may be
associated with an increased risk of necrotizing enterocolitis in neonates. As with all medicines, use should be avoided in
pregnancy, unless considered essential by the physician.
Use in lactation: Amoxicillin-clavulanate may be administered during the period of lactation. With the exception of the risk
sensitization, associated with the excretion of trace quantities in breast milk, there are no known detrimental effects for th
breastfed infant.
Fluticasone furoate undergoes extensive first-pass metabolism by the liver enzyme CYP3A4, therefore the pharmacokinetic
fluticasone furoate in patients with severe liver disease may be altered (see Pharmacokinetics under Actions and Interactio
Based on data with another glucocorticoid metabolized by CYP3A4, co-administration with ritonavir is not recommended
because of the potential risk of increased systemic exposure to fluticasone furoate (see Pharmacokinetics under Actions an
Interactions).
Systemic effects of nasal corticosteroid may occur, particularly at high doses prescribed for prolonged periods. These effect
vary between patients and different corticosteroids. Treatment with higher than the recommended doses of nasal
corticosteroids may result in clinically significant adrenal suppression. If there is evidence for higher than recommended do
being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Fluticasone furoate 110 mcg once daily was not associated with hypothalamic-pituitary-adrenal (HPA) axis suppression in
adult, adolescent or pediatric subjects. However, the dose of intranasal fluticasone furoate should be reduced to the lowes
dose at which effective control of the symptoms of rhinitis is maintained. As with all intranasal corticosteroids, the total
systemic burden of corticosteroids should be considered whenever other forms of corticosteroid treatment are prescribed
concurrently.
Growth retardation has been reported in children receiving some nasal corticosteroids at licensed doses. It is recommende
that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is
slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid if possible, to the lowest dos
which effective control of symptoms is maintained.
In addition, consideration should be given to referring the patient to a pediatric specialist. If there is any reason to believe t
adrenal function is impaired, care must be taken when transferring patients from systemic steroid treatment to fluticasone
furoate.
Nasal or inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Therefore, close monitoring i
warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma and/or cataracts
Avamys nasal spray contains benzalkonium chloride. It may cause irritation of the nasal mucosa.
Effects on the Ability to Drive or Operate Machinery: Based on the pharmacology of fluticasone furoate and other intranasa
administered steroids, there is no reason to expect an effect on the ability to drive or to operate machinery with Avamys na
spray.
Impairment of Fertility: There are no data in humans (see Toxicology under Actions).
Use in pregnancy & lactation: Adequate data are not available regarding the use of Avamys nasal spray during pregnancy an
lactation in humans. Avamys nasal spray should be used in pregnancy only if the benefits to the mother outweigh the
potential risks to the fetus.
Following intranasal administration of fluticasone furoate at the maximum recommended human dose (110 mcg/day), plas
fluticasone furoate concentrations were typically non-quantifiable and therefore potential for reproductive toxicity is expec
to be very low (see Toxicology under Actions).
The excretion of fluticasone furoate into human breast milk has not been investigated. Administration of fluticasone furoat
women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible
risk to the child.
Prolonged use (>4 wk).
Patients w/ hereditary problems of galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. May
affect ability to drive or operate machinery. Pregnancy & lactation. Childn <6 yr.
Combination therapy should be prescribed after careful benefit risk assessment due to the potential increased risk of adve
events and after consideration of alternative treatment options including monotherapies (see Dosage & Administration).
In two 4-year clinical studies, the incidence of cardiac failure (a composite term of reported events, primarily cardiac failure
and congestive cardiac failure) was higher among subjects taking the combination of Avodart and an a-blocker, primarily
tamsulosin, than it was among subjects not taking the combination. In these two trials, the incidence of cardiac failure was
low (=1%) and variable between the studies. No imbalance was observed in the incidence of cardiovascular adverse events
overall in either trial. No causal relationship between Avodart (alone or in combination with an alpha blocker) and cardiac
failure has been established (See Clinical Studies under Actions).
Digital rectal examination, as well as other evaluations for prostate cancer, must be performed on patients with BPH prior t
initiating therapy with Avodart and periodically thereafter.
Dutasteride is absorbed through the skin; therefore, women, children and adolescents must avoid contact with leaking
capsules (see Use in pregnancy & lactation under Contraindication). If contact is made with leaking capsules, the contact ar
should be washed immediately with soap and water.
Dutasteride was not studied in patients with liver disease. Caution should be used in the administration of dutasteride to
patients with mild to moderate hepatic impairment (see Dosage & Administration, Contraindications, and Pharmacokinetic
under Actions).
Serum prostate-specific antigen (PSA) concentration is an important component in the detection of prostate cancer. Genera
a total serum PSA concentration >4 ng/mL (Hybritech) requires further evaluation and consideration of prostate biopsy.
Physicians should be aware that a baseline PSA <4 ng/mL in patients taking Avodart does not exclude a diagnosis of prostat
cancer. Avodart causes a decrease in serum PSA levels by approximately 50% after 6 months, in patients with BPH, even in
presence of prostate cancer. Although there may be individual variation, the reduction in PSA by approximately 50% is
predictable as it was observed over the entire range of baseline PSA values (1.5-10 ng/mL). Therefore, to interpret an isolat
PSA value in a man treated with Avodart for =6 months, PSA values should be doubled for comparison with normal ranges
untreated men. This adjustment preserves the sensitivity and specificity of the PSA assay and maintains its ability to detect
prostate cancer.
Any sustained increases in PSA levels while on Avodart should be carefully evaluated, including consideration of non-
compliance to therapy with Avodart.
Total serum PSA levels return to baseline within 6 months of discontinuing treatment.
The ratio of free to total PSA remains constant even under the influence of Avodart. If clinicians elect to use percent-free PS
as an aid in the detection of prostate cancer in men undergoing Avodart therapy, no adjustment to its value is necessary.
Effects on the Ability to Drive or Operate Machinery: Based on the pharmacokinetic and pharmacodynamic properties of
dutasteride, treatment would not be expected to interfere with the ability to drive or operate machinery.
Impairment of Fertility: The effects of dutasteride 0.5 mg/day on semen characteristics were evaluated in normal volunteer
18-52 years (n=27 dutasteride, n=23 placebo) throughout 52 weeks of treatment and 24 weeks of post-treatment follow-up
At 52 weeks, the mean percent reduction from baseline in total sperm count, semen volume and sperm motility were 23%
26% and 18%, respectively, in the dutasteride group when adjusted for changes from baseline in the placebo group. Sperm
concentration and morphology were unaffected. After 24 weeks of follow-up, the mean percentage change in total sperm
count in the dutasteride group remained 23% lower than baseline. While mean values for all semen parameters at all time

Thyrotoxicosis, 1st trimester of pregnancy. Avoid co-administration w/ -blockers.
Fluid retention may be produced to such a degree as to necessitate the use of diuretics. However, in some cases, fluid
retention may be controlled by restriction of salt intake. Patients with conditions which may be influenced by fluid retentio
eg, epilepsy, migraine or cardiac or renal dysfunction, require careful observation.
Androgenic/anabolic effects may be seen in female patients eg, acne, oily skin, decreased breast size, vaginitis, clitoral
hypertrophy, hot flushes, hirsutism, deepening of the voice and weight gain (up to 6.5 kg). Patients should be advised to
report signs eg, voice changes or hirsutism promptly, as these effects may persist even when drug administration has been
stopped. Testicular atrophy may occur rarely in male patients. Semen quantity and quality should be checked regularly,
especially in adolescents.
Since hepatic dysfunction manifested by modest increases in serum transaminase levels and/or jaundice has been reported
patients treated with Azol, periodic liver function tests should be performed (see Warnings). Administration of Azol has bee
reported to cause exacerbation of the manifestations of acute intermittent porphyria (see Contraindications).
Use in pregnancy: In female patients, ovulation and menses may cease. Use of Azol during pregnancy may damage the fetu
and that if pregnancy is suspected, it should be stopped and a physician consulted. A nonhormonal method of contraceptio
should be recommended. Therapy should begin during menstruation.
Use in children: Safety and efficacy in children has not been established.
Side Effects In general, the side effects associated with Azol therapy are attributable to the pharmacological activity of the
drug; these effects reflect Azol's weak androgenic and anabolic activity, and/or the gonadal suppression which results from
therapy. Incidence rates are indicated for more common reactions.
Androgenic/Anabolic Effects: Weight gain (4%), acne (13%), seborrhoea (2%), mild hirsutism (5%), edema (6%) and hair loss
Voice change (3%), which may take the form of hoarseness, sore throat or of instability or deepening of the pitch, may occu
and may persist after cessation of therapy. Hypertrophy of the clitoris is rare.
Endocrine: Menstrual disturbances in the form of spotting, alteration of the timing of the cycle and amenorrhoea. Althoug
cyclical bleeding and ovulation usually return within 60-90 days after discontinuation of Azol, persistent amenorrhoea has
occasionally been reported. Flushing (6%), sweating (3%), vaginal dryness and irritation (4%) and changes in breast size, ma
reflect lowering of oestrogen. Nervousness and emotional lability have been reported. Abnormalities in semen volume,
viscosity, sperm count and motility may occur in males receiving long-term therapy. Testicular atrophy may occur rarely.
Hepatic Impairment: Hepatic dysfunction, as evidenced by elevated serum enzymes and/or jaundice, has been reported in
patients receiving a daily dosage of Azol >400 mg. Serious hepatic toxicity including cholestatic jaundice, peliosis hepatitis a
hepatic adenoma have been reported (see Warnings and Precautions).
Biochemical: Alteration in values of laboratory tests may occur during Azol therapy, including: Creatinine phosphokinase (C
glucose tolerance, glucagon, thyroid binding globulin, sex hormone binding globulin, other plasma proteins, raised aspartat
transaminase (AST), decreased protein bind iodine (PBI), depressed serum T4, blunted cyclical surges of luteinizing hormon
(LH), raised total cholesterol, reduced high-density lipoprotein (HDL) cholesterol (see Warnings).
The following reactions have also been reported: Allergic: Urticaria, pruritus and rarely, nasal congestion.
Dermatological: Rashes (3%) (maculopapular, vesicular, papular, purpuric, petechial) and rarely sun sensitivity, Stevens-
Johnson syndrome.
Gastrointestinal: Nausea (2%), vomiting, constipation, indigestion, gastroenteritis and rarely pancreatitis.
Genitourinary: Haematuria.
Moderate or severe renal or liver impairment. Pregnancy & lactation. Childn <16 yr. Mild to moderate pneumonia.
Moderate or severe kidney impairment, liver disorders. Pregnancy & lactation.
Impaired liver or kidney function, patients taking other hepatotoxic agents. Reduced visual acuity. Gout. Convulsive disorde
DM, chronic alcoholism.
Severe renal impairment; gout, reduced visual acuity. Lactation.

Overgrowth of nonsusceptible organisms. Check periodically for organ system dysfunction eg renal, hepatic & haematopoie
system. Neonates.
CNS disorders, renal impairment.
Monitor renal function during concomitant treatment w/ aminoglycosides. Pregnancy & lactation.
Avoid contact w/ eyes, moderate to severe renal impairment. Prolonged use. Pregnancy, lactation.
Cream: In the rare event of a possible sensitization reaction or severe local irritation occurring with the use of Bactroban
cream, treatment should be discontinued, Bactroban cream should be washed off and appropriate alternative therapy for t
infection should be instituted. As with other antibacterial products, prolonged use may result in overgrowth of nonsuscepti
organisms.
For intranasal use, a separate presentation as Bactroban nasal ointment is available. Avoid contact with eyes.
Ointment: When Bactroban ointment is used on the face, care should be taken to avoid contact with eyes. Polyethylene gly
can be absorbed from open wounds and damaged skin and is excreted by the kidneys.
In common with other polyethylene glycol-based ointments, Bactroban ointment should be used with caution if there is
evidence of moderate or severe renal impairment.
Bactroban ointment is not suitable for ophthalmic or intranasal use.
Effects on the Ability to Drive or Operate Machinery: No adverse effects on the ability to drive or operate machinery have
been observed.
Use in pregnancy: Adequate human and animal data on use during pregnancy are not available. Therefore, there is
inadequate evidence of safety to recommend the use of Bactroban during pregnancy. However, experimental animal studie
have shown that mupirocin has no teratogenic effect.
Mupirocin should only be used in pregnancy when the potential benefits outweigh the potential risks associated with
treatment.
Use in lactation: Cream: Adequate human and animal data on use during lactation are not available. If a cracked nipple is to
be treated, it should be thoroughly washed prior to breastfeeding.
Ointment: Adequate human data on use during lactation is not available.
Severe CV disease, hepatic or renal disorders, elderly patients, history of haematological disorders.
Heart & thyroid disease, HTN, diabetes, difficulty in urination due to enlargement of prostate gland; chronic cough due to
asthma, smoking, emphysema or accompanied by excessive phlegm, fever, drowsiness, debile & hypoxia. Childn <2 yr.
Prolonged use may result in overgrowth of nonsusceptible organisms. Discontinue use at first appearance of skin rash or ot
signs of hypersensitivity reactions.
Known or suspected CNS disorder. Renal impairment.

General: Renal Impairment: Dosage adjustment of Baraclude is recommended for patients with a creatinine clearance <50
mL/min, including patients on hemodialysis or CAPD (see Renal Impairment under Dosage & Administration).
Post-Liver Transplant Recipients: The safety and efficacy of Baraclude in liver transplant recipients are unknown. However, i
small pilot study of entecavir use in HBV-infected liver transplant recipients on a stable dose of cyclosporine A (n=5) or
tacrolimus (n=4), entecavir exposure was approximately 2-fold healthy subjects with normal renal function. Altered renal
function contributed to the increased in entecavir exposure in these subject. The potential of pharmacokinetic interactions
between entecavir and cyclosporine A or tacrolimus was not formally evaluated. Renal function must be carefully monitore
both before and during treatment with Baraclude in liver transplant recipients who have received or are receiving an
immunosupresant that may affect renal function eg, cyclosporine or tacrolimus. (See Pharmacokinetics: Special Population
under Action, and Renal Impairment under Dosage & Administration).
Information for Patients: Patients should remain under the care of a physician while taking Baraclude. The patient should
discuss any new symptoms or concurrent medications with their physician.
Lamivudine-refractory patients receiving the 1-mg daily dose should be advised to take Baraclude on an empty stomach (at
least 2 hrs after a meal and 2 hrs before the next meal).
Patients should be informed that deterioration of liver disease may occur in some cases if treatment is discontinued, and th
the patient should discuss any change in regimen with the physician.
Patient should be offered HIV antibody testing before starting Baraclude therapy. The patient should be informed that if the
patient have HIV infection and are not receiving effective HIV treatment, Baraclude may increase the chance of HIV resistan
to HIV medication (see Patient Co-Infected with HIV and HBV under Warnings).
Patients should be advised that treatment with Baraclude has not been shown to reduce the risk of transmission of HBV to
others through sexual contact or blood contamination (see Labor and Delivery).
Carcinogenicity, Mutagenicity & Impairment of Fertility: Long-term oral carcinogenicity studies of entecavir in mice and rats
were carried out at exposures up to approximately 42 times (mice) and 35 times (rats) those observed in humans at the
highest recommended dose of 1 mg/day. In mouse and rat studies, entecavir was positive for carcinogenic findings.
In mice, lung adenomas were increased in males and females at exposures 3 times and 40 times those in humans. Lung
carcinomas in both male and female mice were increased at exposures 40 times those in humans. Combined lung adenom
and carcinomas were increased in male mice at exposures 3 times and in female mice at exposures 40 times those in huma
Tumor development was preceded by pneumocyte proliferation in the lung, which was not observed in rats, dogs, or monk
administered entecavir, supporting the conclusion that lung tumors in mice may be a species-specific event. Hepatocellular
carcinomas were increased in males and combined liver adenomas and carcinomas were also increased at exposures 42 tim
those in humans. Vascular tumors in female mice (hemangiomas of ovaries and uterus and hemangiosarcomas of spleen)
were increased at exposures 40 times those in humans. In rats, hepatocellular adenomas were increased in females at
exposures 24 times those in humans; combined adenomas and carcinomas were also increased in females at exposures 24
times those in humans. Brain gliomas were induced in both males and females at exposures 35 and 24 times those in huma
Skin fibromas were induced in females at exposures 4 times those in humans.
It is not known how predictive the results of rodent carcinogenicity studies may be for humans.
Entecavir was clastogenic to human lymphocyte cultures. Entecavir was not mutagenic in the Ames bacterial reverse mutati
assay using S. typhimurium and E. coli strains in the presence or absence of metabolic activation, a mammalian-cell gene
Pregnancy, lactation. Monitor serum Na levels & blood counts. Renal, hepatic or cardiac dysfunction. Abrupt discontinuatio
of treatment. Cross-allergy to carbamazepine. Alcohol consumption. Elderly. May affect ability to drive or operate machine
Vit K deficiency in patient w/ poor diet, malabsorption states (cystic fibrosis) & prolonged IV alimentation regimen. Monito
prothrombin time & those receiving anticoagulant therapy. Overgrowth of nonsusceptible organism in prolonged use. Perio
monitoring for organ system dysfunction during extended therapy eg, renal, hepatic & hematopoietic system. May impair
ability to drive or operate machinery. Pregnancy & lactation. Childn.
Pregnancy & lactation. Childn. Elderly.
Should be given concomitantly w/ brain pressure-decreasing agent or antihemorrhagic; maintain body temp at low level in
acute & serious situation. Slow IV administration; IM administration only when no side effect & limited in min requirement
avoid repeated inj at same site. Hypersensitivity. Childn, premature, neonates, infant.
Not for patients who are receiving repeated blood transfusion or anemia that are not caused by iron deficiency.
Decompensated cardiac insufficiency; shock, acid-base balance disturbances, pre-renally-induced oliguria. Treat anuria bef
commencing parenteral nutrition. Ensure adequate renal function.
GI disturbances, skin allergy, facial edema, dyspnea, fever.
Patients w/ phenylketonuria & pregnant mother w/ high level of phenylalanine.
When using Berodual metered-dose aerosol HFA for the first time, some patients may notice that the taste is slightly differe
from that of the CFC-containing metered-dose aerosol formulation. Patients should be made aware of this when changing
from one formulation to the other. They should also be told that the formulations have been shown to be interchangeable
all practical purposes and that the difference in taste has no consequences in terms of the safety or the efficacy.
In the case of acute, rapidly worsening dyspnea (difficulty in breathing), a physician should be consulted immediately.
Prolonged Use: In patients with bronchial asthma, Berodual should be used only on an as needed basis. In patients with mi
COPD, on demand treatment (symptom-oriented) may be preferable to use regularly. The addition or the increase of anti-
inflammatory therapy to control airway inflammation and to prevent the deterioration of disease control should be
considered for patients with bronchial asthma and steroid-responsive COPD.
The use of increasing amounts of 2-agonists-containing products eg, Berodual on a regular basis to control symptoms of
bronchial obstruction may suggest declining disease control. If bronchial obstruction deteriorates, it is inappropriate and
possibly hazardous to simply increase the use of 2-agonist-containing products eg, Berodual beyond the recommended do
over extended periods of time. In this situation, the patient's therapy plan and in particular, the adequacy of anti-
inflammatory therapy with inhaled corticosteroids, should be reviewed to prevent potentially life-threatening deterioration
disease control.
Other sympathomimetic bronchodilators should only be used with Berodual under strict medical supervision.
In the following conditions, Berodual should only be used after careful risk-benefit assessment, especially when doses high
than recommended are used: Insufficiently controlled diabetes mellitus, recent myocardial infarction, severe organic heart
vascular disorders, hyperthyroidism and pheochromocytoma.
Cardiovascular effects may be seen with sympathomimetic drugs, including Berodual. There is some evidence from post-
marketing data and published literature of rare occurrences of myocardial ischaemia associated with -agonists. Patients w
underlying severe heart disease (eg, ischaemic heart disease, arrhythmia or severe heart failure) who are receiving Berodu
should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease,
attention should be paid to the assessment of symptoms eg, dyspnoea and chest pain, as they may be of either respiratory
cardiac origin. Potentially serious hypokalemia may result from 2-agonist therapy.
Berodual should be used with caution in patients predisposed to narrow-angled glaucoma, or with preexisting urinary outfl
tract obstruction (eg, prostatic hyperplasia or bladder-neck obstruction).
There have been isolated reports of ocular complications (ie, mydriasis, increased intraocular pressure, narrow-angle
glaucoma, eye pain) when aerosolized ipratropium bromide, either alone or in combination with an adrenergic 2-agonist,
has come in contact with. Thus, patients must be instructed in the correct administration of Berodual metered aerosol.
Eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes from conjunctival
congestion and corneal oedema may be signs of acute narrow-angle glaucoma. Should any combination of these symptom
develop, treatment with miotic drops should be initiated and specialist advice sought immediately.
Patients with cystic fibrosis may be more prone to gastrointestinal motility disturbances.
Immediate hypersensitivity reactions may occur after administration of Berodual as demonstrated by rare cases of urticaria
angiooedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis.
The use of Berodual may lead to positive result with regard to fenoterol in tests for nonclinical substance abuse eg, in the
context of athletic performance enhancement (doping).
Metered-Dose Aerosol: When using the new formulation of Berotec HFA 100 mcg for the first time, some patients may noti
that the taste is different from that of the CFC-containing formulation. Patients should be made aware of this when changin
from one formulation to the other. They should also be told that the formulations have been shown to be interchangeable
all practical purposes and that the difference in taste have no consequences in terms of the safety or the efficacy of the ne
formulation.
Other sympathomimetic bronchodilators should only be used with Berotec HFA 100 mcg/Berotec Solution 0.1% under stric
medical supervision. Anticholinergic bronchodilators may, however, be inhaled at the same time.
In the following conditions, Berotec HFA 100 mcg/Berotec Solution 0.1% should only be used after careful risk/benefit
assessment, especially when doses higher than recommended are used: Insufficiently controlled diabetes mellitus, recent
myocardial infarction, severe organic heart or vascular disorders, hyperthyroidism and phaeochromocytoma.
In the case of acute, rapidly worsening dyspnea (difficulty in breathing), a physician should be consulted immediately.
Prolonged Use: On demand (symptom-oriented) treatment is preferable to regular use. Patients must be evaluated for the
addition or the increase of anti-inflammatory therapy (eg, inhaled corticosteroids) to control airway inflammation and to
prevent long-term lung damage.
If bronchial obstruction deteriorates, it is inappropriate and possibly hazardous to simply increase the use of 2-agonist-
containing drugs eg, Berotec HFA 100 mcg/Berotec Solution 0.1% beyond the recommended dose over extended periods o
time. The use of increasing amounts of 2-agonist-containing products like Berotec HFA 100 mcg/Berotec Solution 0.1% on
regular basis to control symptoms of bronchial obstruction may suggest declining disease control. In this situation, the
patient's therapy plan and, in particular, the adequacy of anti-inflammatory therapy, should be reviewed to prevent
potentially life-threatening deterioration of disease control.
Potentially serious hypokalemia may result from 2-agonist therapy. Particular caution is advised in severe asthma, as this
effect may be potentiated by concomitant treatment with xanthine derivatives, glucocorticosteroids and diuretics.
Additionally, hypoxia may aggravate the effects of hypokalemia on cardiac rhythm. Hypokalaemia may result in an increase
susceptibility to arrhythmias in patients receiving digoxin.
It is recommended that serum potassium levels are monitored in such situations.
Cardiovascular effects may be seen with sympathomimetic drugs, including Berotec. There is some evidence from post-
marketing data and published literature of rare occurrences of myocardial ischaemia associated with -agonists.
Patients with underlying severe heart disease (eg, ischaemic heart disease, arrhythmia or severe heart failure) who are
receiving Berotec should be warned to seek medical advice if they experience chest pain or other symptoms of worsening
heart disease.
Attention should be paid to the assessment of symptoms eg, dyspnoea and chest pain, as they may be of either respiratory
cardiac origin.
Solution 0.1% for Inhalation: Berotec solution for inhalation contains the (antimicrobial) preservative benzalkonium chlorid
and the stabiliser disodium edetate. It has been shown that these components may cause bronchoconstriction in some
patients.
The use of Berotec may lead to positive results on fenoterol in tests for nonclinical substance abuse eg, in the context of
athletic performance enhancement (doping).
Effects on the Ability to Drive or Operate Machinery: No studies on the effect on the ability to drive and use machines have
Avoid operating vehicles.
Discontinue therapy if pain, swelling or inflammation of tendon or tendon rupture occur. Patients w/ impaired kidney
function, epilepsy or history of CNS disorders. Avoid excessive sunlight exposure. May impair ability to drive of operate
machinery. Elderly.
Use of contact lenses, prolonged use. Childn <6 yr. Pregnancy. Discontinue use if eye irritation, sensitivity or superinfection
occurs. May lead to overgrowth of nonsusceptible organisms.
Hepatic disorders. Pregnancy & lactation. Elderly.
Childn. Pregnancy & lactation.

Renal impairment. May impair ability to drive or operate machinery. Pregnancy.
Patients suffering from phaeochromocytoma and patients with bronchial asthma need to be carefully monitored during the
therapy.
Caution should be taken in the treatment of patients with a history of peptic ulcer.
Effects on Ability to Drive and to Use Machines: Betahistine is regarded to have no or negligible effects on the ability to driv
and use machines as no effects potentially influencing this ability were found to be related to betahistine in clinical studies.
Use in Pregnancy: There are no adequate data from the use of betahistine in pregnant women.
Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition and postna
development. The potential risk for humans is unknown. Betahistine should not be used during pregnancy unless clearly
necessary.
Use in Lactation: It is not known whether betahistine is excreted in human milk. There are no animal studies on the excretio
of betahistine in milk. The importance of drug to mother should be weighed against the benefits of nursing and the potenti
risks for the child.
Allergy to seafood.
Peptic ulcer, bronchial asthma, pheochromocytoma.
Pregnancy. Prolonged & extensive use.
Hypersensitivity to penicillins. Pregnancy & lactation.

Childn; patients w/ hypoalbuminemia, total renal failure.
Pregnancy & lactation. Adjust doses in patients w/ liver dysfunction.
Childn, pregnancy.
Pregnancy & lactation. Hepatic impairment.
Renal impairment.
GI disorder (colitis), vit K deficiency. Pregnancy & lactation.

Oral rehydration salts should be given concomitantly w/ Zn supplementation during diarrhea. Nursing mother should conti
or increase frequency of breastfeeding during & after diarrhea.
Perform sensitivity test prior antisera inj.

Patients w/ megaloblastic anemia. May mask subacute symptoms of bone marrow degeneration or true pernicious anemia
Monitor serum K during early phase treatment of pernicious anemia.
Not for upper resp tract infections. History of GI diseases esp colitis. Severe liver & kidney dysfunction. Liver & kidney functi
should be monitored in long-term use. Pregnancy & lactation. Newborn. Elderly.
Renal & hepatic failure.
Avoid direct exposure to sunlight.

Ensure individual use to reduce risk of cross infection.
Black stool.
Stable Coronary Artery Disease: If an episode of unstable angina pectoris (major or not) occurs during the 1st month of
perindopril treatment, a careful appraisal of the benefit/risk should be performed before treatment continuation.
Hypotension: ACE inhibitors may cause a fall in blood pressure. Symptomatic hypotension is seen rarely in uncomplicated
hypertensive patients and is more likely to occur in patients who have been volume-depleted eg, by diuretic therapy, dietar
salt restriction, dialysis, diarrhoea or vomiting, or who have severe renin-dependent hypertension (see Adverse Reactions a
Interactions). In patients with symptomatic heart failure, with or without associated renal insufficiency, symptomatic
hypotension has been observed. This is most likely to occur in those patients with more severe degrees of heart failure, as
reflected by the use of high doses of loop diuretics, hyponatraemia or functional renal impairment. In patients at increased
risk of symptomatic hypotension, initiation of therapy and dose adjustment should be closely monitored (see Dosage &
Administration and Adverse Reactions). Similar considerations apply to patients with ischaemic heart or cerebrovascular
disease in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident.
If hypotension occurs, the patient should be placed in the supine position and if necessary, should receive an IV infusion of
0.9% sodium chloride 9 mg/mL solution. A transient hypotensive response is not a contraindication to further doses, which
can be given usually without difficulty once the blood pressure has increased after volume expansion.
In some patients with congestive heart failure who have normal or low blood pressure, additional lowering of systemic bloo
pressure may occur with Bioprexum.
This effect is anticipated and is usually not a reason to discontinue treatment. If hypotension becomes symptomatic, a
reduction of dose or discontinuation of Bioprexum may be necessary.
Aortic and Mitral Valve Stenosis/Hypertrophic Cardiomyopathy: As with other ACE inhibitors, Bioprexum should be given w
caution to patients with mitral valve stenosis and obstruction in the outflow of the left ventricle eg, aortic stenosis or
hypertrophic cardiomyopathy.
Renal Impairment: In cases of renal impairment (CrCl <60 mL/min), the initial perindopril dosage should be adjusted accord
to the patient's CrCl (see Dosage & Administration) and then as a function of the patient's response to treatment. Routine
monitoring of potassium and creatinine are part of normal medical practice for these patients (see Adverse Reactions).
In patients with symptomatic heart failure, hypotension following the initiation of therapy with ACE inhibitors may lead to
some further impairment in renal function. Acute renal failure, usually reversible, has been reported in this situation.
In some patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, who have been treated wi
ACE inhibitors, increases in blood urea and serum creatinine, usually reversible upon discontinuation of therapy, have been
seen. This is especially likely in patients with renal insufficiency. If renovascular hypertension is also present, there is an
increased risk of severe hypotension and renal insufficiency. In these patients, treatment should be started under close
medical supervision with low doses and careful dose titration. Since treatment with diuretics may be a contributory factor
the above, they should be discontinued and renal function should be monitored during the 1st weeks of Bioprexum therap
Some hypertensive patients with no apparent preexisting renal vascular disease have developed increases in blood urea an
serum creatinine, usually minor and transient, especially when Bioprexum has been given concomitantly with a diuretic. Th
is more likely to occur in patients with preexisting renal impairment. Dosage reduction and/or discontinuation of the diureti
and/or Bioprexum may be required.
Haemodialysis Patients: Anaphylactoid reactions have been reported in patients dialysed with high-flux membranes and
treated concomitantly with an ACE inhibitor. In these patients, consideration should be given to using a different type of
Perindopril and Indapamide: Renal Impairment: In cases of severe renal impairment (CrCl <30 mL/min), treatment is
contraindicated.
In certain hypertensive patients without preexisting apparent renal lesions and for whom renal blood tests show functiona
renal insufficiency, treatment should be stopped and possibly restarted either at a low dose or with 1 constituent only.
In these patients, usual medical follow-up will include frequent monitoring of potassium and creatinine, after 2 weeks of
treatment and then every 2 months during therapeutic stability period. Renal failure has been reported mainly in patients
with severe heart failure or underlying renal failure including renal artery stenosis.
Bioprexum Plus is usually not recommended in case of bilateral renal artery stenosis or a single functioning kidney.
Hypotension and Water and Electrolyte Depletion: There is a risk of sudden hypotension in the presence of preexisting
sodium depletion (particularly in individuals with renal artery stenosis). Therefore systematic testing should be carried out
clinical signs of water and electrolyte depletion, which may occur with an intercurrent episode of diarrhea or vomiting.
Regular monitoring of plasma electrolytes should be carried out in such patients.
Marked hypotension may require the implementation of an IV infusion of isotonic saline.
Transient hypotension is not a contraindication to continuation of treatment. After re-establishment of a satisfactory blood
volume and blood pressure, treatment can be started again either at a reduced dose or with only 1 of the constituents.
Potassium Levels: The combination of perindopril and indapamide does not prevent the onset of hypokalaemia particularly
diabetic patients or in patients with renal failure. As with any antihypertensive agent containing a diuretic, regular monitori
of plasma potassium levels should be carried out.
Bioprexum Plus should not be administered to patients with rare hereditary problems of galactose intolerance, Lapp-lactas
deficiency or glucose-galactose malabsorption.
Perindopril: Cough: A dry cough has been reported with the use of ACE inhibitors. It is characterized by its persistence and
disappearance when treatment is withdrawn. An iatrogenic etiology should be considered in the event of this symptom. If
prescription of an ACE inhibitor is still preferred, continuation of treatment may be considered.
Patients with Known Atherosclerosis: The risk of hypotension exists in all patients but particular care should be taken in
patients with ischaemic heart disease or cerebral circulatory insufficiency, with treatment being started at a low dose.
Renovascular Hypertension: The treatment for renovascular hypertension is revascularization. Nonetheless, ACE inhibitors
be beneficial in patients presenting with renovascular hypertension who are awaiting corrective surgery or when such a
surgery is not possible.
If Bioprexum Plus is prescribed to patients with known or suspected renal artery stenosis, treatment should be started in a
hospital setting at a low dose and renal function and potassium levels should be monitored, since some patients have
developed a functional renal insufficiency which was reversed when treatment was stopped.
Other Populations: In patients with severe cardiac insufficiency (grade IV) or in patients with insulin-dependent diabetes
mellitus (spontaneous tendency to increased levels of potassium), treatment should be started under medical supervision
with a reduced initial dose. Treatment with -blockers in hypertensive patients with coronary insufficiency should not be
stopped, the ACE inhibitor should be added to the -blocker.
Diabetic Patients: The glycaemia levels should be closely monitored in diabetic patients previously treated with oral
antidiabetic drugs or insulin, namely during the 1st month of treatment with an ACE inhibitor.
Ethnic Differences: As with other ACE inhibitors, perindopril is apparently less effective in lowering blood pressure in Black
Avoid use around eyes or on open wounds. Avoid exposure to sunlight. Childn <12 yr. For Bioquin Forte: Pregnancy &
lactation.

Perform sensitivity test prior antisera inj.
Perform sensitivity test prior treatment. Not effective to snake bites caused by snakes from Eastern Indonesia. May be give
patients w/ history of severe asthma who shown symptoms of systemic toxicity.
Premature & newborn infants. Pregnancy & lactation.

Bronchospasm, bronchial asthma, other chronic obstructive lung disease; concomitant treatment w/ inhalational anesth, D
w/ large fluctuations in blood glucose values, strict fasting, ongoing desensitization therapy, 1st degree AV block, Prinzmeta
angina, psoriasis; may mask symptoms of thyrotoxicosis & increase sensitivity to allergens & severity of anaphylactic
reactions. May impair ability to drive or operate machinery. Pregnancy.
Avoid contact w/ eyes & open skin lesions.
Avoid prolonged use >7 days. Not to be applied on open wounds or damaged skin. Infants & small childn. Hypersensitivity
streptomycin (neomycin, paromomycin, kanamycin).
Undiagnosed red eye. Avoid prolonged use >7 days. Not to be applied on open wounds or damaged skin. Infants & small
childn. Hypersensitivity to streptomycins (neomycin, paramomycin, kanamycin).
HTN, sepsis, vascular stricture; heart or kidney impairment. If inverse, methylergometrine is not allowed until the birth ove
twins, then wait until the last baby birth is over.
Renal impairment. Childn.
Possibility of multiple pregnancy.
Hepatic or renal dysfunction, aortic stenosis.

Renal Impairment: As with other agents inhibiting the renin-angiotensin-aldosterone system, changes in renal function may
be anticipated in susceptible patients treated with Blopress.
When Blopress is used in hypertensive patients with renal impairment, periodic monitoring of serum potassium and
creatinine levels is recommended. There is limited experience in patients with very severe or end-stage renal impairment
(Clcreatinine <15 ml/min). In these patients Blopress should be carefully titrated with thorough monitoring of blood pressu
Evaluation of patients with heart failure should include periodic assessments of renal function, especially in elderly patient
75 years or older, and patients with impaired renal function. During dose titration of Blopress, monitoring of serum creatin
and potassium is recommended. Clinical trials in heart failure did not include patients with serum creatinine >265 mol/L (
mg/dl).
Concomitant Therapy with an ACE Inhibitor in Heart Failure: The risk of adverse events, especially renal function impairmen
and hyperkalaemia, may increase when Blopress is used in combination with an ACE inhibitor. Patients with such treatmen
should be monitored regularly and carefully.
Hemodialysis: During dialysis the blood pressure may be particularly sensitive to AT1-receptor blockade as a result of reduc
plasma volume and activation of the renin-angiotensin-aldosterone system. Therefore, Blopress should be carefully titrated
with thorough monitoring of blood pressure in patients on haemodialysis.
Renal Artery Stenosis: Other medicinal products that affect the renin-angiotensin-aldosterone system, i.e. angiotensin
converting enzyme (ACE) inhibitors, may increase blood urea and serum creatinine in patients with bilateral renal artery
stenosis or stenosis of the artery to a solitary kidney. A similar effect may be anticipated with angiotensin II receptor
antagonists.
Kidney Transplantation: There is no experience regarding the administration of Blopress in patients with a recent kidney
transplantation.
Hypotension: Hypotension may occur during treatment with Blopress in heart failure patients. As described for other agent
acting on the renin-angiotensin-aldosterone system, it may also occur in hypertensive patients with intravascular volume
depletion such as those receiving high dose diuretics. Caution should be observed when initiating therapy and correction o
hypovolemia should be attempted.
Anaesthesia and Surgery: Hypotension may occur during anaesthesia and surgery in patients treated with angiotensin II
antagonists due to blockade of the renin-angiotensin system. Very rarely, hypotension may be severe such that it may warr
the use of intravenous fluids and/or vasopressors.
Aortic and Mitral Valve Stenosis (Obstructive Hypertrophic Cardiomyopathy): As with other vasodilators, special caution is
indicated in patients suffering from haemodynamically relevant aortic or mitral valve stenosis, or obstructive hypertrophic
cardiomyopathy.
Primary Hyperaldosteronism: Patients with primary hyperaldosteronism will not generally respond to antihypertensive
medicinal products acting through inhibition of the renin-angiotensin-aldosterone system. Therefore, the use of Blopress is
not recommended.
Hyperkalaemia: Based on experience with the use of other medicinal products that affect the renin-angiotensin-aldosteron
system, concomitant use of Blopress with potassium-sparing diuretics, potassium supplements, salt substitutes containing
potassium, or other medicinal products that may increase potassium levels (e.g. heparin) may lead to increase in serum
potassium in hypertensive patients.
General: Candesartan Cilexetil-Hydrochlorothiazide: In clinical trials of various doses of candesartan cilexetil and
hydrochlorothiazide, the incidence of hypertensive patients who developed hypokalemia (serum 3.5 mEq/L) was 2.5% vs 2.
for placebo; the incidence of hyperkalemia (serum potassium >5.7 mEq/L) was 0.4% vs 1% for placebo. No patient receivin
Blopress Plus 16-12.5 mg was discontinued due to increases or decreases in serum potassium. Overall, the combination of
candesartan cilexetil and hydrochlorothiazide had no clinically significant effect on serum potassium.
Hydrochlorothiazide: Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be
performed at appropriate intervals.
All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance eg, hyponatrem
hypochloremic alkalosis and hypokalemia.
Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving
parenteral fluids. Warning signs or symptoms of fluid and electrolyte imbalance, irrespective of cause, include dryness of
mouth, thirst, weakness, lethargy, drowsiness, restlessness, confusion, seizures, muscle pains or cramps, muscular fatigue,
hypotension, oliguria, tachycardia and gastrointestinal disturbances eg, nausea and vomiting.
Hypokalemia may develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy.
Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Hypokalemia may cause cardiac
arrhythmia and may also sensitize or exaggerate the response of the heart to the toxic effects of digitalis (eg, increased
ventricular irritability).
Although any chloride deficit is generally mild and usually does not require specific treatment except under extraordinary
circumstances (as in liver disease or renal disease), chloride replacement may be required in the treatment of metabolic
alkalosis.
Dilution hyponatraemia may occur in edematous patients in hot weather; appropriate therapy is water restriction, rather th
administration of salts, except in rare instances when the hyponatraemia is life-threatening. In actual salt depletion,
appropriate replacement is the therapy of choice.
Hyperuricaemia may occur or acute gout may be precipitated in certain patients receiving thiazide therapy.
In diabetic patients, dosage adjustment of insulin or oral hypoglycemic agents may be required. Hyperglycemia may occur
with thiazide diuretics. Thus, latent diabetes mellitus may be manifested during thiazide therapy.
The antihypertensive effect of hydrochlorothiazide may be enhanced in the post-sympathectomy patient.
If progressive renal impairment becomes evident, consider with holding or discontinuing diuretic therapy.
Thiazides have been shown to increase the urinary excretion of magnesium which may result in hypomagnesemia.
Thiazides have been shown to decrease the urinary calcium excretion or may impair glucose tolerance.
Thiazides may cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium
metabolism. Marked hypercalcemia may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued
before carrying out tests for parathyroid function.
Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.
Impaired Renal Function: Candesartan Cilexetil: As a consequence of inhibiting the renin-angiotensin-aldosterone system,
changes in renal function may be anticipated in susceptible individuals treated with candesartan cilexetil. In patients whose
renal function may depend upon the activity of the renin-angiotensin-aldosterone system (eg, patients with severe congesti
heart failure),
Laboratory treatment
tests with
should be ACE inhibitors
performed at the and angiotensin
1st symptom receptor
of liver antagonist
dysfunction. has been associated
Discontinue with
if liver injury oliguria and/or
or jaundice is evide
Peripheral vascular disease; spontaneous hypoglycemia or diabetic patients receiving insulin or oral hypoglycemic agents;
heart failure; suspected of having Prinzmetal's (variant) angina; w/ labile or secondary HTN. Abrupt w/drawal may exacerb
symptoms of hypothyroidism or may precipitate thyroid storm. ECG & BP should be monitored when administered orally w
Ca-channel blockers of the verapamil or diltiazem type. Pregnancy & lactation. Childn.
Treat hypocalcemia & other bone & mineral metabolism disturbances prior to therapy. Maintain Ca & vit D level. Intra-arte
or paravenous administration is not recommended. Patients w/ severe hepatic insufficiency. Over hydration should be avoi
in patients w/ the risk of heart failure. Avoid invasive dental procedures. Monitor of kidney function, serum Ca, phosphate
Mg.
Hyperphosphatemia. Monitor Ca levels periodically. Pregnancy. Childn. Elderly.

Peripheral motor neuropathic disease eg amyotrophic lateral sclerosis, motor neuropathy; neuromuscular junctional disord
eg myasthenia gravis or Lambert-Eaton syndrome; preexisting CV disease; VII nerve disorders; inflammatory skin problem a
inj site, marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin.
Administration must not be more frequent than every 3 mthly. Pregnancy & lactation. Childn <12 yr. Elderly.
Acute, severe & progressive consciousness disturbance; concomitant therapy w/ hemostatic or intracranial pressure-relievi
drugs or use of measures to keep body temp low. Avoid high doses in intracranial bleeding. Patients w/ phenylketonuria &
pregnant women w/ high phenylalanine. Pregnancy & lactation. Childn.
Acute, severe & progressive consciousness disturbance; concomitant therapy w/ hemostatic or intracranial pressure-relievi
drugs or use of measures to keep body temp low. Avoid high doses in intracranial bleeding.
Prolonged use, superinfection. Pregnancy, lactation.
Long-term use. Pregnancy & lactation. Childn.

Regularly monitor ovarian response w/ ultrasound, alone or preferably in combination w/ measurement of serum estradiol
levels. Administer 1st inj under direct medical supervision.
Discontinue if irritation occurs. Not for ophth use. Avoid contact w/ eye. Systemic absorption of topical corticosteroid may
cause reversible hypothalmic pituitary adrenal, Cushing's syndrome, hypoglycemia, glycosuria. Long-term use may cause
superinfections. Pregnancy & lactation.
Long-term & prophylactic use; avoid abrupt w/drawal. Avoid contact w/ eyes. Excessive skin damage.
Hepatic disorder, long-term therapy. Pregnancy (1st trimester).
Pregnancy.
History of allergies. Pregnancy & lactation.

All patients should be premedicated w/ oral corticosteroids for 3 days starting 1 day prior to docetaxel therapy. Hepatic
impairment. Contraceptive measures must be taken during & for at least 3 mth after therapy. Avoid contact w/ plasticized P
equipment. Childn <16 yr. Elderly.
If a previously effective dosage regimen no longer gives the same symptomatic relief, the patient should seek medical care
soon as possible as this could be sign of worsening asthma and repeated inhalations of 2-agonists must then not delay
reassessment of the asthma therapy.
As for all 2-agonists, caution should be observed in patients with thyrotoxicosis. Cardiovascular effects may be seen with
sympathomimetic drugs, including Bricasma. There is some evidence from post-marketing data and published literature of
myocardial ischaemia associated with -agonists.
Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are
receiving Bricasma should be warned to seek medical advice if they experience chest pain or other symptoms of worsening
heart disease. Attention should be paid to assessment of symptoms eg, dyspnoea and chest pain, as they may be of either
respiratory or cardiac origin.
Due to the hyperglycemic effect of 2-agonist, additional blood glucose controls are recommended initially in diabetic
patients.
Due to the positive inotropic effect of 2-agonist these drugs should not be used in patients with hypertrophic
cardiomyopathy.
As terbutaline sulphate is largely excreted in urine, caution should be exercised in patients with renal impairment.
Increased tendency to uterine bleeding has been reported in connection with Caesarean section. However, this can be
effectively stopped by propranolol 1-2 mg injected intravenously.
Terbutaline is not indicated and should not be used for the management of preterm labor. Serious adverse reactions have
been reported following administration of terbutaline sulphate to women in labor.
These reports have included transient hypokalemia, pulmonary edema (sometimes after delivery) and hypoglycemia in the
mother and/or neonatal child. Maternal death has been reported with terbutaline sulphate and other drugs of this class.
There have been rare reports of seizures occurring in patients receiving terbutaline, which do not recur when the drug is
discontinued and have not been explained on any other basis.
Terbutaline sulphate is a sympathomimetic amine and such should be used with caution in patients with cardiovascular
disorders (including arrhythmias, coronary insufficiency and hypertension), in patients with hyperthyroidism or diabetes
mellitus, history of seizures, or in patients who are unusually responsive to sympathomimetic amines.
Potentially serious hypokalemia may result from 2-agonist therapy. Particular caution is recommended in acute severe
asthma as the associated risk may be augmented by hypoxia. The hypokalemic effect may be potentiated by concomitant
treatment (see Interactions). It is recommended that serum potassium levels are monitored in such situations. Patients
susceptible to hypokalemia should be monitored because transient early falls in serum potassium levels have been reporte
with -agonist.
Immediate hypersensitivity reactions and exacerbation of bronchospasm have been reported after terbutaline administrati
Lactic acidosis has been reported in association with high therapeutic doses of parenteral and nebulised short-acting beta-
agonist therapy, mainly in patients being treated for an acute asthma exacerbation (see Overdosage and Adverse Reactions
In patients not adequately responding to acute Bricasma therapy, consideration should be given to the presence of lactic
acidosis as a possible contributing factor to ongoing respiratory symptoms.
Tablet: Terbutaline should not be given together with non-selective -blocker.
Respules: The patient's inhalation technique should be checked regularly, and the optimal dose of Bricasma should be
General Risk of Bleeding: Drugs that inhibit platelet function including Brilinta increase the risk of bleeding. Brilinta increase
the overall risk of bleeding (major + minor) to a somewhat greater extent than did clopidogrel. The increase was seen for n
CABG-related bleeding, but not for CABG-related bleeding. Fatal and life-threatening bleeding rates were not increased (se
Adverse Reactions).
In general, risk factors for bleeding include older age, a history of bleeding disorders, performance of percutaneous invasiv
procedures and concomitant use of medications that increase the risk of bleeding [eg, anticoagulant and fibrinolytic therap
higher doses of aspirin, and chronic nonsteroidal anti-inflammatory drugs (NSAIDs)].
When possible, discontinue Brilinta five days prior to surgery. Suspect bleeding in any patient who is hypotensive and has
recently undergone coronary angiography, PCI, CABG, or other surgical procedures, even if the patient does not have any si
of bleeding.
If possible, manage bleeding without discontinuing Brilinta. Stopping Brilinta increases the risk of subsequent cardiovascula
events (see Precautions and Adverse Reactions).
Concomitant Aspirin Maintenance Dose: In PLATO, use of BRILINTA with maintenance doses of aspirin >100 mg decreased t
effectiveness of Brilinta. Therefore, after the initial loading dose of aspirin (usually 325 mg), use Brilinta with a maintenance
dose of aspirin 75-100 mg (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions, and Dosage &
Administration).
Moderate Hepatic Impairment: BRILINTA has not been studied in patients with moderate hepatic impairment. Consider the
risks and benefits of treatment, noting the probable increase in exposure to ticagrelor.
Dyspnea: Dyspnea was reported in 14% of patients treated with BRILINTA and in 8% of patients taking clopidogrel. Dyspnea
was usually mild to moderate in intensity and often resolved during continued treatment. If a patient develops new,
prolonged, or worsened dyspnea during treatment with BRILINTA, exclude underlying diseases that may require treatment
dyspnea is determined to be related to BRILINTA, no specific treatment is required; continue BRILINTA without interruption
In a substudy, 199 patients from PLATO underwent pulmonary function testing irrespective of whether they reported dyspn
There was no significant difference between treatment groups for FEV1. There was no indication of an adverse effect on
pulmonary function assessed after 1 month or after at least 6 months of chronic treatment.
Discontinuation of BRILINTA: Avoid interruption of BRILINTA treatment. If BRILINTA must be temporarily discontinued (eg, t
treat bleeding or for elective surgery), restart it as soon as possible. Discontinuation of BRILINTA will increase the risk of
myocardial infarction, stent thrombosis and death.
Strong Inhibitors of Cytochrome CYP3A: Ticagrelor is metabolized by CYP3A4/5. Avoid use with strong CYP3A inhibitors eg,
atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin a
voriconazole (see Pharmacology under Actions and Interactions).
Cytochrome CYP3A Potent Inducers: Avoid use with potent CYP3A inducers eg, rifampin, dexamethasone, phenytoin,
carbamazepine, and phenobarbital (see Pharmacology under Actions and Interactions).
Hepatic Impairment: BRILINTA has not been studied in the patients with moderate or severe hepatic impairment. Ticagrelo
metabolized by the liver and impaired hepatic function can increase risks for bleeding and other adverse events. Hence,
BRILINTA is contraindicated for use in patients with severe hepatic impairment and its use should be considered carefully in
patients with moderate hepatic impairment. No dosage adjustment is needed in patients with mild hepatic impairment (se
Pharmacology under
Penicillin-sensitive Actions,Pregnancy
patients. Contraindications and Precautions).
& lactation.
HTN, overwt. Liver & kidney dysfunction, glaucoma, prostate hypertrophy, hyperthyroid, urinary retention, alcohol
consumption, resp disorders, debilitated patients, hypoxia. May impair ability to drive or operate machinery. Pregnancy &
lactation. Childn <6 yr. Elderly.
Gastric ulcer. 1st trimester of pregnancy. Bromifar Plus Lactation.
Pregnancy, lactation.
Pregnancy & lactation. Childn <6 mth.

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control
symptoms (see Dosage & Administration). As with other NSAIDs, ibuprofen may mask the signs of infection.
Caution on the use in geriatric use; gastrointestinal bleeding, ulceration and perforation; respiratory disorder; cardiac, rena
and hepatic impairment. BRUFEN has also been reported to be associated with dermatological effects; renal effects;
hematological effects; and aseptic meningitis.
Use In Pregnancy & Lactation While no teratogenic effects have been demonstrated in animal toxicology studies, the use o
ibuprofen during pregnancy should be avoided. In the limited studies so far available, ibuprofen appears in the breast milk
very low concentrations. Ibuprofen is not recommended for use in nursing mothers.
TB, HTN, DM, osteoporosis, peptic ulcer, glaucoma, cataract, family history of diabetes or glaucoma, hepatic impairment.
Hypoxemia, HTN, hepatic failure, chronic resp disease. Pregnancy & lactation. Elderly, infants & childn.
Patients w/ impaired liver function. Pregnancy & lactation. Childn. Elderly.
TB, gastric ulcer, DM. Pregnancy.
Avoid contact w/ open wound (muscle layer), eye or mucous membrane. Avoid concomitant use w/ oral prep to avoid activ
toxicity. Extensive & prolonged use may cause systemic side effects. Pregnancy & lactation.
Hypersensitivity to cephalosporins. Renal impairment. Lymphatic leukemia. Pregnancy & lactation.
Close-angle glaucoma, urinary retention, prostate hyperplasia, pyloroduodenal obstructions, kidney disorders. May impair
ability to drive the vehicle or operate the machinery. Lactation.
History of upper GI diseases (peptic ulceration); heart failure, renal & liver impairment, lupus erythematosus; HTN or other
conditions predisposing to fluid retention; coagulation defect, asthma. 1st & 2nd trimester pregnancy & lactation. Childn <1
yr.
Careful & constant monitoring of CV & resp vital signs & patient's state of consciousness should be accomplished after each
local anaesth inj. Patients w/ impaired CV function. Risk of developing an epidural or spinal haematoma which can result in
long-term or permanent paralysis in patients anti-coagulated or scheduled to be anti-coagulated w/ LMWH or heparinoids.
Frequently monitor for signs & symptoms of neurological impairment. Patients w/ epilepsy, impaired cardiac conduction,
bradycardia, severe shock or digitalis intoxication. Stokes-Adams syndrome or Wolff-Parkinson-White syndrome. Myasthen
gravis. Epidural, caudal & spinal anaesth when there are serious CNS disease. Severe hepatic disease. Reduced plasma prot
conc, hyperthyroidism. Careful monitoring of the fetal heart rate is necessary. Drug sensitivities. May impair ability to drive
operate machinery. Pregnancy other than labour & lactation. Childn <12 yr.
Renal, hepatic & CV function impairment. Pregnancy & lactation.

Increased Angina and/or MI: Rarely, patients particularly those with severe obstructive coronary artery disease have
developed documented increased frequency, duration and/or severity of angina or acute MI on starting calcium-channel
blocker therapy or at the time of dosage increase. The mechanism of this effect has not been elucidated.
Use in Patients with Heart Failure: In a long-term, placebo-controlled study (PRAISE-2) of amlodipine-treated patients with
NYHA III and IV heart failure of non-ischemic etiology, amlodipine was associated with increased reports of pulmonary ede
despite of no significant difference in the incidence of worsening heart failure as compared to placebo (see Pharmacology:
Pharmacodynamics under Actions).
Use in Patients with Impaired Hepatic Function (see also Contraindications): Hepatic Effects: As with other lipid-lowering
agents of the HMG-CoA reductase inhibitor class, moderate [>3 times upper limit of normal (ULN)] elevations of serum
transaminases have been reported following therapy with atorvastatin. Liver function was monitored during pre-marketing
well as post-marketing clinical studies of atorvastatin given at doses of 10, 20, 40 and 80 mg.
Persistent increases in serum transaminases (>3 times ULN on =2 occasions) occurred in 0.7% of patients who received
atorvastatin in these clinical trials. The incidence of these abnormalities was 0.2%, 0.2%, 0.6% and 2.3% for 10, 20, 40 and 8
mg respectively. Increases were generally not associated with jaundice or other clinical signs or symptoms. When the dosa
of atorvastatin was reduced, or drug treatment interrupted or discontinued, transaminase levels returned to pre-treatment
levels. Most patients continued treatment on a reduced dose of atorvastatin without sequelae.
Liver function tests should be performed before the initiation of treatment and periodically thereafter. Patients who develo
any signs or symptoms suggesting liver injury should have liver function tests performed. Patients who develop increased
transaminase levels should be monitored until the abnormality(ies) resolve(s). Should an increase in ALT or AST of >3 times
times the ULN persist, reduction of dose or withdrawal of Caduet is recommended. Atorvastatin can cause an elevation in
transaminases (see Adverse Reactions).
Caduet should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of live
disease. Active liver disease or unexplained persistent transaminase elevations are contraindications to the use of Caduet (
Contraindications).
Skeletal Muscle Effects: Myalgia has been reported in atorvastatin-treated patients (see Adverse Reactions). Myopathy,
defined as muscle aching or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values >10x U
should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of CPK
Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompani
by malaise or fever. Amlodipine/atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or
myopathy is diagnosed or suspected. The risk of myopathy during treatment with HMG-CoA reductase inhibitors is increase
with concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, niacin, or azole antifungals. Many of
these drugs inhibit cytochrome P-450 3A4 metabolism and/or drug transport. CYP3A4 is the primary hepatic isozymes know
to be involved in the biotransformation of atorvastatin. Physicians considering combined therapy with atorvastatin and fibr
acid derivatives, erythromycin, immunosuppressive drugs, azole antifungals or lipid-modifying doses of niacin should carefu
weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain,
tenderness or weakness, particularly during the initial months of therapy and during any periods of upward dosage titratio
of either drug. Therefore, the lower starting and maintenance dose of the atorvastatin component should also be consider
when taken concomitantly with the aforementioned drugs. (See Interactions.) Periodic CPK determinations may be conside
Renal impairment. Do not take w/ fiber rich products.
Prolonged or extensive use. Avoid contact w/ eyes. Pregnancy. Occlusive dressing of large areas of skin. Infected skin lesion
Severe hypotension; close monitoring of dialysis patients w/ malignant HTN; heart failure, severe aortic stenosis, diabetes.
Hypercalcium, DM, patient on Na diet.
Monitor serum Ca conc & kidney function in large doses, impaired renal function, history of renal stones.
Mild hypercalciuria, impaired renal function, history of renal stones.
Renal impairment; patients on levodopa therapy.
Impaired renal function, history of renal stones.
Mild hypercalcemia, DM, patients under low Na diet.

Mild hypercalciuria, mild to moderate renal insufficiency, urinary calculi.
Renal impairment.
Mild hypercalciuria, mild to moderate renal insufficiency, urinary calculi.

Impaired liver function. Pregnancy & lactation. Elderly, childn.
In patients with mild hypercalciuria (exceeding 300 mg = 7.5 mmol/24 hrs), with mild or moderate impairment of renal
function or with a history of urinary concrements, monitoring of calcium excretion in the urine is required. If necessary, the
calcium dose should be reduced or therapy should be discontinued. In patients prone to formation of calculi in the urinary
tract, an increased fluid intake is recommended. High doses of vitamin D should be avoided during calcium therapy, unless
especially indicated. The sugar content of CalSource (0.3 g/mL), CalSource Forte (0.87 g/tablet) and CalSource Vit C (2
g/tablet) should be taken into account in diabetic patients and the sodium content of CalSource Forte (0.27 g/tablet) shoul
be considered in patients requiring low-sodium diet.
Side Effects In rare cases, mild gastrointestinal disturbances may occur. In predisposed patients, prolonged treatment with
high doses of CalSource Plus Vitamin C may promote the formation of calculi in the urinary tract.
Vitamins are taken as supplement when nutritional intake from diet is inadequate.
Consult the physician if currently taking or has recently used prescribed medicines.
Vitamins are taken as supplement when nutritional intake from diet is inadequate.
Consult the physician if currently taking or has recently used prescribed medicines.
Excessive dose may cause diarrhoea & kidney dysfunction. Patients w/ impaired kidney function & receiving levodopa ther
Mild hypercalciuria, mild or moderate renal insufficiency, urinary calculi.

Irinotecan should be administered only under the supervision of a physician who is experienced in the use of cancer
chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and
treatment facilities are readily available.
Irinotecan will only be prescribed in the following cases after the expected benefits have been weighed against the possible
therapeutic risks: In patients presenting a risk factor, particularly those with a WHO performance status of 2; in the few rare
instances where patients are deemed unlikely to observe recommendations regarding management of adverse events (nee
for immediate and prolonged antidiarrheal treatment combined with high fluid intake at onset of delayed diarrhea). Strict
hospital supervision is recommended for such patients.
Cholinergic Symptoms: Patients may have cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation,
diaphoresis, flushing (vasodilation), bradycardia and intestinal hyperperistalsis that can cause abdominal cramping and ear
diarrhea (ie, diarrhea generally occurring during or within 8 hrs of administration of irinotecan). These symptoms which ma
be observed during or shortly after infusion of irinotecan, are thought to be related to the anticholinesterase activity of the
irinotecan parent compound and are expected to occur more frequently with higher irinotecan doses. Therapeutic or
prophylactic administration of 0.25-1 mg of IV or SC atropine should be considered (unless clinically contraindicated) in
patients experiencing cholinergic symptoms.
Extravasation: While irinotecan is not a known vesicant, care should be taken to avoid extravasation and the infusion site
should be monitored for signs of inflammation. Should extravasations occur, flushing the site and application of ice is
recommended.
Hepatic: In clinical studies, National Cancer Institute (NCI) Common Toxicity Criteria grade 3 or 4 liver enzyme abnormalitie
have been observed in <10% of patients. These events typically occur in patients with known hepatic metastases and are n
clearly related to irinotecan.
Hematology: Irinotecan commonly causes neutropenia, leukopenia and anemia, any of which may be severe and therefore
should not be used in patients with severe bone marrow failure. Serious thrombocytopenia is uncommon. In clinical studie
the frequency of NCI grade 3 and 4 neutropenia has been significantly higher in patients who received previous
pelvic/abdominal irradiation than in those who had not received such irradiation. Patients with baseline serum total bilirub
levels of =1 mg/dL also have had a significantly greater likelihood of experiencing first-cycle grade 3 or 4 neutropenia than
those with bilirubin levels that were <1 mg/dL. There were no significant differences in the frequency of grade 3 and 4
neutropenia by age or gender. (See Hepatic Insufficiency as follows.)
Neutropenic fever (concurrent NCI grade 4 neutropenia and =grade 2 fever) occurred in <10% of patients in clinical studies
however, deaths due to sepsis following severe neutropenia have been reported in patients treated with irinotecan.
Neutropenic complications should be managed promptly with antibiotic support. Therapy with irinotecan should be
temporarily discontinued if neutropenic fever occurs or if the absolute neutrophil count drops <1000/mm3. The dose of
irinotecan should be reduced if clinically significant neutropenia occurs.
Patients with Reduced UGT1A1 Activity: The metabolic conversion of irinotecan to the active metabolite SN-38 is mediated
carboxylesterase enzymes and primarily occurs in the liver. SN-38 subsequently undergoes conjugation to form the inactive
glucuronide metabolite SN-38G. This glucuronidation reaction is mediated primarily by uridine diphosphate-glucuronosyl
transferase 1A1 (UGT1A1), which is encoded by the UGT1A1 gene. The UGT1A1 gene is highly polymorphic, resulting in
variable metabolic capacities among individuals. One specific variation of the UGT1A1 gene includes a polymorphism in the
Patients whose vascular tone & renal function depend predominantly on the activity of the renin-angiotensin-aldosterone
system, severe CHF; renal impairment; haemodialysis; unilateral or bilateral renal artery stenosis; patients w/ vol- & salt-
depletion secondary to salt restriction, prolonged diuretic therapy, heart failure or dialysis; surgery/anaesth; aortic & mitra
valve stenosis (obstructive hypertrophic cardiomyopathy); primary hyperaldosteronism; CHF; history of angioedema
associated w/ or unrelated to ACE or angiotensin II receptor therapy; galactose intolerance, Lapp-lactase deficiency or
glucose-galactose malabsorption. Avoid concomitant use w/ ACE inhibitor in heart failure patients & K-sparing diuretics.
Monitor BP, serum creatinine K levels periodically. May affect ability to drive or operate machinery. Childn & adolescents <1
yr. Elderly >75 yr.
Serum K & creatinine level should be examined regularly in patients w/ kidney failure. Patients receiving hemodialysis.
Patients w/ bilateral or unilateral renal artery. Patients using diuretics in high-dose. Patients w/ primary hyperaldosteronism
Patients receiving coumarin (warfarin) anticoagulants, DM. Avoid taking high doses. Pregnancy.
Discontinue if irritation or sensitivity occurs. Pregnancy & lactation.

Canesten SD Do not use if the patients has irregular vag bleeding, abnormal vag bleeding or a blood-stained discharge, vulv
or vag ulcers, blisters or sores, lower abdominal pain, dysuria, redness, irritation or swelling associated w/ the treatment,
fever or chills, nausea or vomiting, diarrhea, foul smelling vag discharge. May reduce effectiveness & safety of latex produc
eg, condoms & diaphragms. Pregnancy (1st trimester). Childn.
Perform periodic hematological test on long-term treatment. Renal impairment. Avoid prolonged use. Pregnancy & lactatio
Hepatic disorders, exclude possibility of malignancy in suspected gastric ulcer. Pregnancy & lactation. Childn. Elderly.
Serious CV events eg, MI, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic
attack. Stroke, life-threathening arryhtmia w/in the last 6 mth, hypotension (BP <90/50), HTN (BP >170/110), cardiac failure
CAD causing unstable angina, retinitis pigmentosa. Patients w/ bleeding disorders & active peptic ulceration. Patients w/
anatomical deformation of the penis eg, angulation, cavernosal fibrosis or Peyronie's disease or in patients who have
conditions which may predispose them to priapism eg, sickle cell anemia, multiple myeloma or leukemia. Combinations w/
other drug for treatment of erectile dysfunction is not recommended. Patients w/ regular &/or intermittent use of organic
nitrates.
Hypersensitivity to -lactams. Do not use for infections due to MRSA. Monitor serum hepatic levels in patients w/ hepatic
disease. Consider diagnosis of pseudomembranous colitis in patients who develop diarrhea. May impair ability to drive &
operate machinery. Pregnancy & lactation. Infant <3 mth.
Impaired renal function (CrCl =50 mL/min); superinfection. Discontinue in case of allergic reactions or mild case of
pseudomembranous colitis. Elderly. Pregnancy & lactation.
May impair ability to drive or operate machinery. Pregnancy. Childn <6 mth.
Cross-sensitivity w/ penicillins; renal impairment. Discontinue in case of neutropenia or if pseudomembranous colitis is

diagnosed. Monitor renal function & blood count during long-term use (>10 days). Childn <12 yr.
Treatment of >4 wk should be under monitoring. Pregnancy & lactation.

Severe hepatic impairment, moderate or severe renal impairment. Avoid prolonged use. Pregnancy & lactation.
Liver impairment; maintain liver function monitoring; renal impairment. Prolonged use may result in overgrowth of
nonsusceptible organisms. Hypersensitivity to penicillin. In high doses administration, fluid intake & urine excretion should
ensure in excessive amount, to reduce the possibility of crystalluria. Patients using catheter should be in closed monitoring
Monitor peripheral blood counts, renal & neurological functions. Carboplatin should not come in contact w/ Al.
Do not inject IM or SC. Reduced dosage in patients w/ hepatic impairment. Perform laboratory test eg SGOT, SGPT, alkaline
phosphate, bilirubin. Severe myelosuppression. Monitor ECG, before & after treatment hematological, blood uric level. It
causes red coloration to urine 1-2 days after administration.
Treatment with Cardace requires regular medical supervision.
If angioneurotic oedema occurs during treatment (see Adverse Reactions), Cardace must be discontinued immediately and
emergency measures must be taken especially if the tongue, glottis or larynx are involved.
Patients with a hyperstimulated rennin-angiotensin system must be treated with particular caution. ACE inhibition puts suc
patients at risk of an acute pronounced fall in blood pressure and deterioration of renal function, especially when an ACE
inhibitor in combination with a diuretic, a medicine that promotes fluid excretion, is given for the 1st time or for the 1st tim
at an increased dose.
Therefore, at the start of treatment with Cardace or after the 1st dose of an additional diuretic, as well as after every 1st
increased dose thereof, blood pressure must be closely monitored until such time as no further acute reduction in blood
pressure is expected.
Significant activation of the rennin-angiotensin system is to be expected eg, patients with severe and particularly malignan
hypertension. The initial phase of treatment requires special medical supervision).
Patients with heart failure particularly if severe or if treated with other potential blood pressure-lowering medicines in seve
heart failure, the initial phase of treatment requires special medical supervision.
Patients with blood flow-reducing (haemodynamically relevant) left-ventricular inflow or outflow impediment (eg, narrowin
of the aortic or mitral valve); patients with blood flow reducing and narrowing (haemodynamically relevant stenosis) of the
renal artery. The initial phase of treatment requires special medical supervision and concomitant treatment with a diuretic
may have to be discontinued.
Patients pretreated with diuretics, where discontinuation or reduction of diuretic dose is not possible, the initial phase of
treatment requires special medical supervision.
Patients in whom fluid or salt deficiency exists or may develop as a result of inadequate fluid or salt intake, or as a result of
diarrhea, vomiting or excessive sweating in cases where salt and fluid replacement is inadequate. Generally, dehydration,
reduced blood volume (hypovolaemia) or salt deficiency should be corrected before initiating treatment in patients with he
failure; however, such corrective action must be carefully weighed against the risk of volume overload. When such conditio
have become clinically relevant, treatment with Cardace must be started or continued only if appropriate steps are taken
concurrently to prevent an excessive fall in blood pressure and deterioration of renal function (see Dosage & Administratio
Also, at particular risk from a pronounced fall in blood pressure are eg, patients with haemodynamically relevant stenoses o
the coronary arteries or of the blood vessels supplying the brain. Such patients require special medical supervision in the
initial phase of treatment as well.
In patients with impaired liver function, response to treatment with Cardace may either be increased or decreased. In
addition, the renin-angiotensin system may be significantly activated; therefore, in patients with severe liver cirrhosis with
oedema and/or ascites; therefore, particular caution must be exercised in treating such patients (see Dosage &
Administration).
Renal function should be monitored, particularly, in the initial weeks of treatment. Particularly, careful monitoring is requir
in patients with heart failure, renovascular disease (including those with haemodynamically relevant unilateral renal artery
stenosis in whom even a small increase in serum creatinine may be indicative of unilateral loss of renal function), in renal
impairment, or in kidney transplant patients.
Serum potassium should be monitored regularly. More frequent monitoring of serum potassium is required in patients with
Hepatic & renal impairment. Pregnancy & lactation.

Severe aortic stenosis, CHF, impaired liver function, heart failure. Pregnancy & lactation.
Not suitable for treating attacks of acute angina pectoris. severe hepatic or renal impairment; hypothyroidism, malnutrition
or hypothermia; recent history of MI. Pregnancy & lactation.
Postural Hypotension/Syncope: As with all a-blockers, a very small percentage of patients have experienced postural
hypotension evidenced by dizziness and weakness, or rarely loss of consciousness (syncope), particularly with the
commencement of therapy (see Dosage & Administration).
When instituting therapy with any effective a-blocker, the patient should be advised how to avoid symptoms resulting from
postural hypotension and what measures to take should they develop. The patient should be cautioned to avoid situations
where injury could result should dizziness or weakness occur during the initiation of doxazosin mesylate therapy.
Use with PDE-5 Inhibitors: Concomitant administration of doxazosin with a PDE-5 inhibitor should be used with caution as i
may lead to symptomatic hypotension in some patients.
Hepatic Impairment: As with any drug wholly metabolized by the liver, Cardura should be administered with caution to
patients with evidence of impaired hepatic function (see Pharmacokinetics under Actions).
Effects on the Ability to Drive or Operate Machinery: The ability to engage in activities eg, operating machinery or a motor
vehicle, may be impaired, especially when initiating therapy.
Use in pregnancy & lactation: Although no teratogenic effects were seen in animal testing, reduced fetal survival was
observed in animals at extremely high doses. These doses were approximately 300 times the maximum human recommen
dose. Animal studies have shown that doxazosin mesylate accumulates in breast milk. As there are no adequate and well-
controlled studies in pregnant or nursing women, the safety of Cardura during pregnancy or lactation has not yet been
established. Accordingly, during pregnancy or lactation, Cardura should be used only when, in the opinion of the physician,
potential benefit outweighs the risk.
Use in children: No experience is available on usage of Cardura in children.
Monotherapy in patients w/ critical illness & known or suspected Pseudomonas aeruginosa infection; cross-allergy to
penicillins & cephalosporins. Monitor transaminase & bilirubin level in patients w/ liver disease. History of GI disease
especially colitis; concomitant use w/ other nephrotoxic drugs. May affect the ability to drive vehicle or operate machinery
Pregnancy & lactation. Childn <3 mth.
Impaired renal function. Elderly.
Patients diagnosed w/ DM. Pregnancy & lactation.
Abrupt w/drawal. Hepatic or renal dysfunction, aortic stenosis. Pregnancy & lactation. Childn. Elderly.
Patients w/ allergy to seafood.

Patients using warfarin. Discontinue use if hypersensitivity reactions occur. Pregnancy & lactation.
Initiation of treatment should be under the direct supervision of a specialist. Bicalutamide is extensively metabolised in the
liver. Data suggest that its elimination may be slower in subjects with severe hepatic impairment and this could lead to
increased accumulation of bicalutamide. Therefore, Casodex should be used with caution in patients with moderate to seve
hepatic impairment.
Periodic liver function testing should be considered due to the possibility of hepatic changes. The majority of changes are
expected to occur within the first 6 months of Casodex therapy.
Severe hepatic changes and hepatic failure have been observed rarely with Casodex and fatal outcomes have been reporte
(see Adverse Reactions). Casodex therapy should be discontinued if changes are severe.
Bicalutamide has been shown to inhibit cytochrome P-450 (CYP3A4), as such, caution should be exercised when co-
administered with drugs metabolised predominantly by CYP3A4 (see Contraindications and Interactions).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose
malabsorption should not take Casodex.
50 mg: A reduction in glucose tolerance has been observed in males receiving LHRH agonist. This may manifest as diabetes
loss of glycaemic control in those with preexisting diabetes. Consideration should therefore, be given to monitoring blood
glucose in patients receiving Casodex in combination with LHRH agonist.
150 mg: For patients who have an objective progression of disease together with elevated PSA, cessation of Casodex thera
should be considered.
Lactose-sensitive patients should be aware that each Casodex 150 mg contains lactose monohydrate 183 mg.
Effects on the Ability to Drive or Operate Machinery: Casodex is unlikely to impair the ability of patients to drive or operate
machinery. However, it should be noted that occasionally somnolence may occur. Any affected patients should exercise
caution.
General: The concomitant use of Cataflam/Cataflam D with systemic NSAIDs including COX-2 selective inhibitors, should be
avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable
effects.
Cataflam tablets contain sucrose and therefore are not recommended for patients with rare hereditary problems of fructos
intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Preexisting Asthma: In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (ie, nasal polyps), chron
obstructive pulmonary diseases or chronic infections of the respiratory tract (especially if linked to allergic rhinitis-like
symptoms), reactions on NSAIDs eg, asthma exacerbations (so-called intolerance to analgesics/analgesics-asthma), Quincke
oedema or urticaria are more frequent than in other patients. Therefore, special precaution is recommended in such patien
(readiness for emergency). This is applicable as well for patients who are allergic to other substances eg, with skin reaction
pruritus or urticaria.
Gastrointestinal Effects: As with all NSAIDs, including diclofenac, close medical surveillance is imperative and particular
caution should be exercised when prescribing Cataflam/Cataflam D in patients with symptoms indicative of GI disorders or
with a history suggestive of gastric or intestinal ulceration, bleeding or perforation (see Adverse Reactions). The risk of GI
bleeding is higher with increasing NSAID doses and in patients with a history of ulcer (particularly if complicated with
haemorrhage or perforation) and in the elderly.
To reduce the risk of GI toxicity in patients with a history of ulcer (particularly if complicated with haemorrhage or perforati
and in the elderly, the treatment should be initiated and maintained at the lowest effective dose.
Combination therapy with protective agents (eg, proton-pump inhibitors or misoprostol) should be considered for these
patients and also for patients requiring concomitant use of medicinal products containing low-dose acetylsalicylic acid
(ASA)/aspirin or other medicinal products likely to increase GI risk.
Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI
bleeding). Caution is recommended in patients receiving concomitant medications which could increase the risk of ulcerati
or bleeding eg, systemic corticosteroids, anticoagulants, antiplatelet agents or selective serotonin re-uptake inhibitors (see
Interactions).
Close medical surveillance and caution should also be exercised in patients with ulcerative colitis or Crohn's disease, as the
condition may be exacerbated (see Adverse Reactions).
Hepatic Effects: Close medical surveillance is required when prescribing Cataflam/Cataflam D to patients with impaired
hepatic function, as their condition may be exacerbated.
As with other NSAIDs, including diclofenac, values of 1 or more liver enzymes may increase. During prolonged treatment w
Cataflam/Cataflam D, regular monitoring of hepatic function is indicated as a precautionary measure. If abnormal liver
function tests persist or worsen, if clinical signs or symptoms consistent with liver disease develop, or if other manifestation
occur (eg, eosinophilia, rash), Cataflam/Cataflam D should be discontinued. Hepatitis may occur with the use of diclofenac
without prodromal symptoms.
Caution is called for when using Cataflam/Cataflam D in patients with hepatic porphyria, since it may trigger an attack.
Renal Effects: As fluid retention and oedema have been reported in association with NSAID therapy, including diclofenac,
particular caution is called for in patients with impaired cardiac or renal function, history of hypertension, the elderly, patie
receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function, and in
Catapres should be used with caution in patients with mild to moderate bradyarrhythmia eg, low sinus rhythm, with disord
of cerebral or peripheral perfusion, depression, polyneuropathy and constipation. In hypertension caused by
phaeochromocytoma, no therapeutic effect of Catapres can be expected.
As with other antihypertensive drugs, treatment with Catapres should be monitored particularly carefully in patients with
heart failure or severe coronary heart disease.
Patients should be instructed not to discontinue therapy without consulting the physician. Following sudden discontinuatio
of Catapres after prolonged treatment with high doses, restlessness, palpitations, rapid rise in blood pressure, nervousness
tremor, headache or nausea have been reported. When discontinuing therapy with Catapres, the physician should reduce t
dose gradually over 2-4 days.
If long-term treatment with a -receptor blocker has to be interrupted, the -receptor blocker should first be phased out
gradually and then clonidine.
Effects on the Ability to Drive or Operate Machinery: The ability to drive or operate machinery may be impaired by Catapre
Use in pregnancy & lactation: During pregnancy, Catapres, as any drug, should only be administered if clearly needed.
Careful monitoring of mother and child is recommended.
Clonidine passes the placental barrier and may lower the heart rate of fetus. Postpartum and transient rise in blood pressu
in the newborn cannot be excluded.
During pregnancy, the oral forms of Catapres should be preferred. IV injection of clonidine should be avoided.
There is no adequate experience regarding the long-term effects of prenatal exposure.
The use of Catapres during lactation is not recommended due to a lack of supporting information.
Side Effects Most side effects are mild and tend to diminish with continued therapy.
Frequent side effects are dryness of the mouth and sedation.
Occasionally constipation, nausea and vomiting, headache, malaise, impotence, decreased libido, gynaecomastia, orthosta
complaints, paresthesia of the extremities, Raynaud's phenomenon, pain in the parotid gland, drying out of the nasal muco
and reduced lacrimal flow (contact lens wearers should be cautioned) as well as skin reactions with symptoms eg, rash,
urticaria, pruritus and alopecia have been observed. Sleep disturbances, nightmares, depression, perceptual disorders,
hallucinations, confusion and disturbances of accommodation may occur.
In very rare cases, pseudo-obstruction of the large bowel has been observed in predisposed patients.
Clonidine may cause or potentiate bradyarrhythmic conditions eg, sinus bradycardia or AV block.
Rarely, transient elevations of blood sugar levels have been reported.
Do not w/draw prior to treatment completion. Pregnancy.
Liver dysfunction. May cause vit K deficiency in patients w/ poor diet, malabsorption (cystic fibrosis), patients w/ prolonged
alimentation regimen. Periodic monitoring for organ system dysfunction during extended therapy eg, renal, hepatic &
hematopoietic system. Pregnancy & lactation.
Avoid contact w/ eyes.

Glaucoma. May develop tolerance & cross-tolerance to other nitrates & nitrites.
Sensitivity to penicillin; history of allergy eg, bronchial asthma, rash, urticaria; impaired renal function; patient w/ poor ora
nutrition or under therapy w/ parenteral nutrition; history of GI disease eg, colitis. Childn w/ otitis media should be treated
syr only. Discontinue if superinfection occurs. Pregnancy, lactation, childn <6 mth, elderly or debilitated patients.
Cross-allergic reaction may occur in patients hypersensitive to penicillin or other -lactam antibiotics. Monitor kidney functi
in patients receiving aminoglycosides. Monitor haematologic effects in long-term use (>10 days). Prolonged use may cause
resistance. Pregnancy, lactation.
History of hypersensitivity to penicillin & other cephalosporins, personal or familial history of allergy eg, bronchial asthma,
rash, urticaria, severe kidney function impairment, low oral nutrition; concomitant therapy w/ parenteral nutrition. Pregna
lactation. Elderly, debilitated patients. Childn <6 mth (including newborn & premature infants).
Penicillin-allergic patients; impaired renal function; colitis.
Hypersensitivity to penicillins. Impaired renal function. Patients receiving potent diuretics & nephrotoxic antibiotics.
Penicillin allergy, severe renal impairment. Pregnancy & lactation.
History of hypersensitivity to penicillins or cephems. Bronchial asthma, rash or urticaria; serious renal function disorder; po
oral nutrition. Elderly or debilitated states. Pregnancy.
Impaired renal function (CrCl =50 mL/min); developed pseudomembranous colitis or diarrhea during therapy; long-term
usage. Pregnancy & lactation. Elderly.
Adverse Reactions
The following events have been reported during therapy for HIV disease with 3TC alone and in combination with other anti
retroviral agents. With many still unclear whether they are related to the medicinal products or are as a result of the under
disease process.
The following convention has been utilized for the classification of undesirable effects: Very common (>1/10); common (>1
<1/10); uncommon (>1/1000, <1/100); rare (>1/10,000, <1/1000); very rare (<1/10,000).
Blood and Lymphatic Systems Disorders: Uncommon: Neutropenia, anemia, thrombocytopenia. Very Rare: Pure red cell ap
Metabolism and Nutrition Disorders: Common: Hyperlactatemia. Rare: Lactic acidosis (see Precautions).
Redistribution/Accumulation of Body Fat (see Precautions): The incidence of this event is dependent on multiple factors
including the particular antiretroviral drug combination.
Nervous System Disorders: Common: Headache. Very Rare: Paresthesia. Peripheral neuropathy has been reported although
causal relationship to treatment is uncertain.
Gastrointestinal Disorders: Common: Nausea, vomiting, upper abdominal pain, diarrhea. Rare: Pancreatitis, although a cau
relationship to treatment is uncertain. Rises in serum amylase.
Hepatobiliary Disorders: Uncommon: Transient rises in liver enzymes (AST, ALT).
Skin and Subcutaneous Tissue Disorders: Common: Rash, alopecia.
Musculoskeletal and Connective Tissue Disorders: Common: Arthralgia, muscle disorders. Rare: Rhabdomyolysis.
General Disorders and Administration Site Conditions: Common: Fatigue, malaise, fever.
Click to view ADR Monitoring Form
3TC-HBV appears to be well-tolerated. In clinical studies of patients treated for chronic hepatitis B infection, the incidence o
adverse events were similar between placebo and the different doses of lamivudine studied. The most commonly reported
adverse events were symptoms associated with upper respiratory tract infection, headache, nausea, malaise, abdominal pa
and diarrhea.
The incidence of laboratory abnormalities were similar in the lamivudine- and placebo-treated groups. The most commonl
reported laboratory abnormalities were associated with hepatic dysfunction and were more likely to be due to the underly
disease.
Allergic reactions, tingling in the arm, ear & face, blurred vision, headache, nausea, stomachache, jittery feeling.
Mild reaction eg urticaria (treated w/ antihistamies & corticosteroids). Discontinue in case of more severe reactions (eg,
anaphylactic shock), treat w/ high dose corticosteroids & then w/ adrenaline, slowly administered.
Headache, edema, fatigue, somnolence, nausea, abdominal pain, flushing, palpitations, dizziness.
The most frequently reported adverse effects of clarithromycin in clinical studies in adults were gastrointestinal-related
complaints ie, tongue discolouration, oral moniliasis, hepatic abnormalities, nausea, dyspepsia, abdominal pain, vomiting a
diarrhea, stomatitis and glossitis have been reported. Other side effects included headache, taste perversion and transient
elevations of liver enzymes. The safety profile of the paediatric formulation is similar to that of the 250-mg tablet in adult
patients.
Metabolic/Nutritional: Increased serum creatinine and increased glutaryl transferase (GGT).
Immunocompromised Patients: In adult patients, the most frequently reported adverse events by patients treated with tot
doses of clarithromycin 1000 mg and 2000 mg were nausea, vomiting, altered taste, abdominal pain, diarrhea, rash, flatule
headache, constipation, hearing disturbance, and SGOT and SGPT elevations. Additional low-frequency events included
dyspepsia, insomnia and dry mouth. The incidences were comparable for patients treated with 1000 and 2000 mg, but wer
generally about 3-4 times as frequent for those patients who received total daily doses of clarithromycin 4000 mg.
Post-Marketing Experience: Hepatic dysfunction, including increased liver enzymes and hepatocellular and/or cholestatic
hepatitis, with or without jaundice, has been infrequently reported with clarithromycin. This hepatic dysfunction may be se
and is usually reversible. In very rare instances, hepatic failure and fatal outcome has been reported and generally has been
associated with serious underlying diseases and/or concomitant medications.
Allergic reactions ranging from urticaria and mild skin eruptions to anaphylaxis and Stevens-Johnson syndrome have occurr
with orally administered clarithromycin.
There have been reports of transient central nervous system side effects including anxiety, dizziness, insomnia, hallucinatio
bad dreams, confusion and psychosis. However, a cause-and-effect relationship has not been established.
There have been reports of hearing loss with clarithromycin, which is usually reversible upon withdrawal of therapy. Repor
alteration of the sense of smell, usually in conjunction with altered taste have also been reported.
Glossitis, stomatitis, oral monilia and tongue discoloration have been reported with clarithromycin therapy. There have bee
reports of tooth discolouration in patients treated with clarithromycin. Tooth discolouration is usually reversible with
professional dental cleaning.
There have been rare reports of hypoglycemia, some of which have occurred in patients on concomitant oral hypoglycemic
agents or insulin.
Isolated cases of thrombocytopenia have been reported. Rarely, erythromycin has been associated with ventricular arrhyth
including ventricular tachycardia and Torsade de pointes, individuals with prolonged QT intervals.
Adverse events occurred in =10% of patients treated with Abilify Discmelt are headache, nausea, vomiting, constipation, an
insomnia, lightheadedness, somnolence, akathisia, dyspepsia, agitation.
Adverse events occurred in =10% of patients treated with Abilify Oral Solution are headache, nausea, vomiting, constipatio
anxiety, insomnia, lightheadedness, somnolence, akathisia, dyspepsia, agitation.
Aripiprazole has been evaluated for safety in 7951 patients who participated in multiple-dose, premarketing trials in
schizophrenia, bipolar mania and dementia of the Alzheimer's type, and who had approximately 5235 patient-years of expo
A total of 2280 aripiprazole-treated patients were treated for at least 180 days and 1558 aripiprazole-treated patients had a
least 1 year of exposure.
The conditions and duration of treatment with aripiprazole included (in overlapping categories) double-blind, comparative
noncomparative open-label studies, inpatient and outpatient studies, fixed- and flexible-dose studies, and short- and longe
term exposure.
Adverse events during exposure were obtained by collecting volunteered adverse events, as well as results of physical
examinations, vital signs, weights, laboratory analyses and ECG. Adverse experiences were recorded by clinical investigators
terminology of their own choosing. In the tables and tabulations that follow, modified COSTART dictionary terminology has
used initially to classify reported adverse events into a smaller number of standardized event categories, in order to provide
meaningful estimate of the proportion of individuals experiencing adverse events.
The stated frequencies of adverse events represent the proportion of individuals who experienced at least once, a treatme
emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or
worsened while receiving therapy following baseline evaluation. There was no attempt to use investigator causality assessm
ie, all reported events are included.
The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of sid
effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevail
the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigation
involving different treatment, uses and investigators. The cited figures, however, do provide the prescribing physician with s
basis for estimating the relative contribution of drug and nondrug factors to the adverse event incidence in the population
studied.
Adverse Findings Observed in Short-Term, Placebo-Controlled Trials of Patients with Schizophrenia: The following findings a
based on a pool of 5 placebo-controlled trials (four 4-week and one 6-week) in which aripiprazole was administered in dose
ranging from 2-30 mg/day.
Adverse Events Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials: Overall, there was n
difference in the incidence of discontinuation due to adverse events between aripiprazole-treated (7%) and placebo-treate
patients. The types of adverse events that led to the discontinuation were similar between the aripiprazole- and placebo-tr
patients.
Adverse Findings Observed in Short-Term, Placebo-Controlled Trials of Patients with Bipolar Mania: The following findings a
based on a pool of 3-week, placebo-controlled, bipolar mania trials in which aripiprazole was administered at doses of 15 o
mg/day.
Adverse Events Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials: Overall, in patients w
bipolar mania, there was no difference in the incidence of discontinuation due to adverse events between aripiprazole-trea
(11%) and placebo-treated (9%) patients. The types of adverse events that led to discontinuation were similar between the
aripiprazole and placebo-treated patients.
Commonly Observed Adverse Events in Short-Term, Placebo-Controlled Trials of Patients with Bipolar Mania: Commonly
observed adversereactions,
Hypersensitivity events associated withrenal
GI disorders, the use of aripiprazole
& liver in patients
function disorders, with bipolar
changes in bloodmania (incidence
constituent, localofreactions,
=5% and neur
effects, superinfection.
Rash, urticaria, erythema, pruritus or fever; granulocytopenia or eosinophilia; increased SGOT, SGPT or alkaline phosphatas
vomiting, diarrhea, abdominal pain, stomach discomfort, heartburn or anorexia.
Adverse reactions, which have been associated with ACCOLATE treatment, are given in the table (see table).
Hepatic Effects: Elevated serum transaminase levels have been observed in clinical trials with ACCOLATE. The changes usua
resolved during continued treatment or following cessation of therapy. Rarely the transaminase profile has been consistent
a drug-induced hepatitis, which resolved following cessation of ACCOLATE therapy.
Hyperbilirubinemia without elevated liver function tests has also been associated with the use of ACCOLATE.
During post-marketing experience there have been rare reports of symptomatic hepatitis, with and without hyperbilirubine
associated with the use of ACCOLATE. These cases have usually resolved following cessation of therapy with ACCOLATE. Th
predominate majority of cases have been reported in females. Very rarely, fulminant hepatitis and hepatic failure have bee
reported, sometimes with a fatal outcome (see Precautions).
Infection: In placebo-controlled clinical trials, an increased incidence of infection has been observed in elderly patients give
ACCOLATE. Infections were usually mild, predominantly affecting the respiratory tract.
Skin rash, urticaria, irritation.

Asthenia, fatigue, edema, abdominal pain, chest pain, headache, pharyngitis, angina pectoris, 2nd degree AV block, CVA,
hypotension, MI, liver function abnormalities.
Hypersensitivity reactions eg, bronchospasm, angioedema, rashes & pruritus. Nausea & vomiting, fever, syncope, sweating
arthralgia, blurred vision, liver function disturbances.
Nausea, dizziness, somnolence.
Urticaria, angioedema, bronchospasm, nausea, vomiting, HTN, tachycardia, dizziness, fever.

Skin rash, reversible neurological reactions, GI disturbances, increased bilirubin & liver enzymes, increased BUN & creatinin
lowering of haematological index, headache & fatigue.
Burning & stinging. Erythema, mild dry skin, skin flaking.
Diarrhea, nausea, vomiting, abdominal discomfort, headache; skin rashes, urticaria; vaginitis, flatulence, candidiasis; transi
hepatitis, cholestatic jaundice.
Fever, myalgia, flu-like symptoms, arthralgia, headache, fatigue, pain.

Rarely, GI upsets.
Zn supplementation may cause GI upset, nausea, vomiting & diarrhea if taken on an empty stomach (particularly w/ Zn sul
Dizziness, nausea, pharyngitis, chest pain, fatigue, lower back pain, depression, dehydration, myalgia; abdominal cramps,
borborygmi, diarrhoea; rash, pruritus, urticaria, angioedema, bronchospasm.
Mild GI disturbances; skin hypersensitivity reactions; renal dysfunction; reversible elevations of serum creatinine, parathyro
hormone, lactic acid dehydrogenase, transaminase & alkaline phosphatase.
Insomnia; headache; nausea, diarrhea, abdominal pain, dyspepsia, constipation, flatulence; myalgia; asthenia; hypo- &
hyperglycemia, anorexia; peripheral neuropathy, paresthesia; pancreatitis, vomiting; hepatitis, cholestatic jaundice; rash,
pruritus, alopecia; myopathy, myositis, muscle cramps; impotence; angioneurotic edema.
Dizziness, headache, facial redness, flushing, somnolence, muscle fatigue, peripheral oedema (ankles), palpitations, abdom
pain, nausea, drowsiness.
Visual disturbances; changes in hematology, hypoglycemia, increased hepatic enzymes.
Early & late diarrhea, nausea, vomiting, abdominal cramping/pain, anorexia, stomatitis, mucositis. Leukopenia, anemia,
neutropenia, thrombocytopenia. Asthenia, fever, pain. Decreased wt, dehydration, hypovolemia. Alopecia. Infection.
Thromboembolic events includes angina pectoris, arterial thrombosis, cerebral infarct, CVA, deep thrombophlebitis, lower
extremity embolus, heart arrest, MI, myocardial ischemia, peripheral vascular disorder, pulmonary embolus, sudden death
thrombophlebitis, thrombosis, vascular disorder. Bilirubinemia. Dyspnea.
GI complaints, skin reactions, neutropenia, phlebitis.
Drowsiness, muscle weakness, ataxia, amnesia, depression, lightheadedness, confusion, hallucinations, blurred vision.
Central nervous system depression or excitation may occur, drowsiness being reported most frequently. Sleep disturbance
rarely, hallucinations have been reported.
Skin rashes, with or without irritation, tachycardia and dryness of the mouth, nose and throat, have occasionally been repo
Urinary retention has been reported occasionally in men receiving pseudoephedrine; prostatic enlargement could have bee
important predisposing factor.
Drowsiness, gastrointestinal disturbances, psychomotor disturbance, tachycardia, arrhythmia, dry mouth, palpitation, urina
difficulties.
Drowsiness, gastrointestinal disturbances, headache, insomnia, excitation, tremor, tachycardia, arrhythmia, dry mouth,
palpitation, urinary difficulties.
The following adverse events which may be causally related to the administration of Actilyse have been reported. The most
frequent adverse reaction associated with Actilyse is bleeding resulting in a fall in haematocrit and/or haemoglobin values.
type of bleeding associated with thrombolytic therapy can be divided into 2 broad categories: Superficial or surface bleedin
normally from punctures or damaged blood vessels; and internal bleedings into the gastrointestinal or urogenital tract,
retroperitoneum or CNS or bleeding of parenchymatous organs.
Death and permanent disability are reported in patients who have experienced stroke (including intracranial bleeding) and
serious bleeding episodes.
The frequencies given as follows are based on corresponding occurrences in a clinical trial involving 8299 patients treated w
Actilyse for myocardial infarction.
The classification of cholesterol crystal embolisation which was not observed in the clinical trial population was based on
spontaneous reporting.
The number of patients treated in clinical trials with pulmonary embolism and stroke (within the 0-3 hrs time window) is ve
small in comparison to the number in the trial for myocardial infarction described previously. Therefore, small numerical
differences observed in comparison with the number in myocardial infarction were presumably attributable to the small sa
size. Except for intracranial haemorrhage as an adverse reaction in stroke as well as for reperfusion arrhythmias in myocard
infarction, there is no medical reason to assume that the qualitative and quantitative adverse reaction profile of Actilyse in
pulmonary embolism and acute ischaemic stroke is different from the profile in myocardial infarction.
Myocardial Infarction: Cardiac Disorders: Very Common: Reperfusion arrhythmias which can be life threatening and may re
the use of conventional antiarrhythmic therapies.
Myocardial Infarctions and Pulmonary Embolism: Nervous System Disorders: Uncommon: Intracranial haemorrhage.
Acute Ischaemic Stroke: Nervous System Disorders: Common: Intracranial haemorrhage. Symptomatic intracerebral
haemorrhages represent the major adverse event (up to 10% of patients). However, this had not shown an increased overa
morbidity or mortality.
Myocardial Infarction, Pulmonary Embolism and Acute Ischaemic Stroke: Gastrointestinal Disorders: Common: Gastrointesti
tract bleeding, nausea, vomiting. Nausea and vomiting can also occur as symptoms of myocardial infarction. Uncommon:
Retroperitonium and gingival bleeding.
General Disorders and Administration Site Conditions: Very Common: Superficial bleeding, normally from punctures or dam
blood vessels.
Injury and Poisoning and Procedural Complications: Uncommon: Anaphylactoid reactions which are usually mild, but can b
threatening in isolated cases. They may appear as rash, urticaria, bronchospasm, angioedema, hypotension, shock or any o
symptom associated with allergic reactions. If they occur, conventional antiallergic therapy should be initiated. In such case
relatively larger proportion of patients were receiving concomitant ACE inhibitors. No definite anaphylactic (IgE-mediated)
reactions to Actilyse are known. Transient antibody formation to Actilyse has been observed in rare cases and with low titre
a clinical relevance of this finding could not be established. Rare: Cholesterol crystal embolisation which may lead to
corresponding consequences in the organs concerned.
Investigations: Very Common: Drop in blood pressure. Common: Increased temperature.
Reproductive System and Breast Disorders: Common: Urogenital tract bleeding.
Respiratory, Thoracic and Mediastinal Disorders: Common: Epistaxis.
GI disturbances, infection, musculoskeletal pain, HTN, depression, dizziness, rash, cataract, UTI.
Thrombocytopenia, leucopenia, neutropenia, myelosuppression, increased blood or serum creatinine levels, nausea, vomiti
diarrhea, constipation, abdominal pain, wt loss, decrease of hearing acuity, tinnitus, paresthesias, deep tendon reflexes,
cutaneous erythematous eruption, itching, fever; liver function test, alkaline phosphatase, transaminases & total bilirubin
abnormalities; taste alteration, alopecia, chills, fever & hemolytic uremic syndrome.
Adverse reactions reported in excess (0.5%) of placebo and as more than as isolated case in patients receiving piogliatazon
double-blind studies are listed as follows as MedRA preferred term by system organs class and absolute frequency.
Frequency are defined as: Common >1/100; uncommon >1/1000, <1/100; rare >1/10,000, <1/1000; very rare >1/10,000; n
known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Monotherapy: Eye Disorder: Common: Visual disturbance.
Infectious and Infestations: Common: Upper respiratory tract infection. Uncommon: Sinusitis.
Investigations: Common: Increased weight, increased CK.
Nervous System Disorders: Common: Hypoaesthesia. Uncommon: Insomnia.
Plioglitazone in Combination with Metformin: Blood and Lymphatic System Disorder: Common: Anemia.
Eye Disorder: Common: Visual disturbances.
Gastrointestinal Disorders: Common: Flatulence.
Investigations: Common: Increased weight.
Musculoskeletal System and Connective Tissue Disorders: Common: Arthralgia.
Nervous System Disorders:Common: Headache.
Renal and Urinary Disorders: Common: Hematuria.
Reproductive System and Breast Disorders: Common: Erectile dysfunction.
Plioglitazone in Combination with Sulfonylurea Metformin: Blood and Lymphatic System Disorder: Common: Anemia.
Eye Disorder: Common: Visual disturbances.
Gastrointestinal Disorders: Common: Flatulence.
Musculoskeletal System and Connective Tissue Disorders: Common: Arthralgia.
Nervous System Disorders: Common: Headache.
Renal and Urinary Disorders: Common: Hematuria.
Reproductive System and Breast Disorders: Common: Erectile dysfunction.
In Combination with Sulfonylurea: Weight gain, glycosuria, hypoglycaemia, increase of lactose dehydrogenase, increase of
appetite, dizziness, headache, vertigo, visual disorder, sweating, proteinuria, fatigue.
In double-blind studies, oedema occurred in 5.9% of patients treated with Actos + sulfonylurea (sulfonylurea alone 1.9%) a
6 of patients treated with Actos + metformin (metformin alone 2.5%). The reports of oedema were generally mild to mode
and usually did not require discontinuation of treatment.
During treatment with Actos there was a small increase in total cholesterol which was mostly accounted for by an increase
HDL-cholesterol.
In clinical trials with Actos, the incidence of elevations of ALT >3 times the upper limit of normal was equal to placebo (0.2%
But less than that seen in metformin or sulfonylurea comparator groups. The incidence of all adverse events relating to live
biliary systems was also low (Actos 1.1%, placebo 0.9%). Isolated cases of elevated liver enzymes and hepatocellular dysfun
have occurred in post-marketing experience, although causal relationship has not been established.
Heart failure was not reported as an adverse event during double-blind clinical studies of Actos in combination with sulfony
or metformin, but was reported with an incidence of 1.1% during studies of Actos in combination with insulin. After 60 wee
Over 8500 patients with type 2 diabetes have been treated with pioglitazone in randomized, double-blind, controlled clinic
trials. This includes 2605 high-risk patients with type 2 diabetes treated with pioglitazone from the PROactive clinical trial.
6000 patients have been treated for =6 months and over 4500 patients for 1 year or longer. Over 3000 patients have receiv
pioglitazone for at least 2 years.
The most common adverse events reported in at least 5% of patients in the controlled 16-week clinical trial between place
plus metformin and pioglitazone 30 mg plus metformin were upper respiratory tract infection (15.6% and 15.5%), diarrhea
and 4.8%), combined edema/peripheral edema (2.5% and 6%) and headache (1.9% and 6%), respectively.
The incidence and type of adverse events reported in at least 5% of patients in any combined treatment group from the 24
study comparing pioglitazone 30 mg plus metformin, and pioglitazone 45 mg plus metformin are shown in Table 2; the rate
adverse events resulting in study discontinuation between the 2 treatment groups was 7.8% and 7.7%, respectively.
Most clinical adverse events were similar between groups treated with pioglitazone in combination with metformin and tho
treated with pioglitazone monotherapy. Other adverse events reported in at least 5% of patients in controlled clinical trials
between placebo and pioglitazone monotherapy included myalgia (2.7% and 5.4%), tooth disorder (2.3% and 5.3%), diabet
mellitus aggravated (8.1% and 5.1%) and pharyngitis (0.8% and 5.1%), respectively.
In US, double-blind studies, anemia was reported in =2% of patients treated with pioglitazone plus metformin (see General
Piogliitazone Hydrochloride under Precautions).
In monotherapy studies, edema was reported for 4.8% (with doses from 7.5-45 mg) of patients treated with pioglitazone ve
1.2% of placebo-treated patients. Most of these events were considered mild or moderate in intensity (see General: Pioglit
Hydrochloride under Precautions).
Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROactive): In PROactive, 5238 patients with type 2 diabete
a prior history of macrovascular disease were treated with Actos (n=2605), force-titrated up to 45 mg daily, or placebo (n=2
in addition to standard of care. Almost all subjects (95%) were receiving cardiovascular medications (-blockers, ACE inhibit
ARBs, calcium-channel blockers, nitrates, diuretics, aspirin, statins, fibrates). Patients had a mean age of 61.8 years, mean
duration of diabetes 9.5 years and mean HbA1c 8.1%. Average duration of follow-up was 34.5 months. The primary objecti
this trial was to examine the effect of Actos on mortality and macrovascular morbidity in patients with type 2 diabetes mel
who were at high risk for macrovascular events. The primary efficacy variable was the time to the first occurrence of any ev
the cardiovascular composite endpoint (see Table 3). Although there was no statistically significant difference between Act
placebo for the 3-year incidence of a first event within this composite, there was no increase in mortality or in total
macrovascular events with Actos.
Post-marketing reports of new onset or worsening diabetic macular edema with decreased visual acuity have also been rec
(see General: Pioglitazone Hydrochloride under Precautions).
Laboratory Abnormalities: Hematologic: Pioglitazone may cause decreases in hemoglobin and hematocrit. The fall in hemo
and hematocrit with pioglitazone appears to be dose related. Across all clinical studies, mean hemoglobin values declined b
to 4% in patients treated with pioglitazone. These changes generally occurred within the first 4-12 weeks of therapy and
remained relatively stable thereafter.
These changes may be related to increased plasma volume associated with pioglitazone therapy and have rarely been asso
Adverse drug reactions observed in patients using Actrapid HM/Penfill are mainly dose-dependent and due to the
pharmacologic effect of insulin. As for other insulin products, hypoglycemia, in general, is the most frequent adverse reacti
may occur if the insulin dose is too high in relation to the insulin requirement. The symptoms of hypoglycemia usually occu
suddenly. They may include cold sweats, cool pale skin, nervousness or tremor, anxiety, unusual tiredness or weakness,
confusion, difficulty in concentration, dizziness, hunger, blurred vision, headache, nausea and palpitation.
In clinical trials and during market use, the frequency varies with patient population and dose regimens, therefore no speci
frequency can be presented. Severe hypoglycemia may lead to unconsciousness and/or convulsions and may result in temp
or permanent impairment of brain function or even death. During clinical trials, the overall rates of hypoglycemia did not d
between patients treated with human insulin compared to insulin aspart.
Frequencies of adverse drug reactions from clinical trials, which by an overall judgment are considered related to Actrapid
HM/Penfill are as follows. The frequencies are defined as: Uncommon (>1/1000, <1/100). Isolated spontaneous cases prese
as very rare are defined as <1/10,000.
Immune System Disorder: Uncommon: Urticaria, rash. Very Rare: Anaphylactic reactions. Symptoms of generalized
hypersensitivity may include generalized skin rash, itching, sweating, gastrointestinal upset, angioneurotic edema, difficulty
breathing, palpitation, reduction in blood pressure and fainting/loss of consciousness. Generalized hypersensitivity reaction
potentially life threatening.
Nervous System Disorder: Very Rare: Peripheral neuropathy. Fast improvement in blood glucose control may be associated
condition termed "acute painful neuropathy", which is usually reversible.
Eye Disorders: Uncommon: Refraction disorders. Refraction anomalies may occur upon initiation of insulin therapy. These
symptoms are usually of transitory nature. Very Rare: Diabetic retinopathy. Long-term improved glycemic control decreases
risk of progression of diabetic retinopathy. However, intensification of insulin therapy with abrupt improvement in glycemic
control may be associated with temporary worsening of diabetic retinopathy.
Skin and Subcutaneous Tissue Disorders: Uncommon: Lipodystrophy may occur at the injection site as a consequence of fa
to rotate injection sites within an area.
General Disorders and Administration Site Conditions: Uncommon: Injection site reactions (redness, swelling, itching, pain
hematoma at the injection site) may occur during treatment with insulin. Most reactions are transitory and disappear durin
continued treatment. Edema may occur upon initiation of insulin treatment. These symptoms are usually of transitory natu
Adverse reactions were reported in 60 of total 4174 patients (1.44%) treated with Acuatim cream. (The total cases reported
the time of approval and completion of re-examination are as follows.)
Skin: <1%: Pruritus, irritation, redness/flushing, feeling of facial warmth, papules, contact dermatitis, dry skin and hot flush
Transient pain, swelling. Rarely, oedema, rash, flushing, sensation of heat, hypersensitivity reactions, shock.
GI disorders.
Itching, burning, erythema or vesiculation, skin atrophy, telangiectasia, striae or acneform changes of skin & systemic effec
Allergic Rhinitis: In multiple-dose, placebo-controlled trials, 2834 patients received Aerius tablets at doses of 2.5-20 mg dai
whom 1655 patients received the recommended daily dose of 5 mg. In patients receiving 5 mg daily, the rate of adverse ev
was similar between Aerius- and placebo-treated patients. The percent of patients who withdrew prematurely due to adve
events was 2.4% in the Aerius group and 2.6% in the placebo group. There were no serious adverse events in these trials in
patients receiving desloratadine. All adverse events that were reported by =2% of patients who received the recommended
dose of Aerius tablets (5 mg once daily), and that were more common with Aerius tablet than placebo, are listed in Table 5
Table 5.)
The frequency and magnitude of laboratory and electrocardiographic abnormalities were similar in Aerius- and placebo-tre
patients.
There were no differences in adverse events for subgroups of patients as defined by gender, age or race.
Chronic Idiopathic Urticaria: In multiple-dose, placebo-controlled trials of chronic idiopathic urticaria, 211 patients received
Aerius tablets and 205 received placebo. Adverse events that were reported by =2% of patients who received Aerius tablet
that were more common with Aerius than placebo were (rates for Aerius and placebo, respectively): Headache (14%, 13%)
nausea (5%, 2%), fatigue (5%, 1%), dizziness (4%, 3%), pharyngitis (3%, 2%), dyspepsia (3%, 1%) and myalgia (3%, 1%).
The following spontaneous adverse events have been reported during the marketing of desloratadine: Tachycardia, and rar
hypersensitivity reactions (eg, rash, pruritus, urticaria, edema, dyspnea and anaphylaxis), hepatitis and elevated liver enzym
including bilirubin.
In clinical trials in a pediatric population, Aerius syrup was administered to a total of 246 children 6 months to 11 years. The
overall incidence of adverse events in children 2-11 years was similar for Aerius syrup and the placebo groups. In infants an
toddlers 6-23 months, the most frequent adverse events reported in excess of placebo were diarrhea (3.7%), fever (2.3%) a
insomnia (2.3%).
In clinical trials in a range of indications including seasonal allergic rhinitis and chronic idiopathic urticaria, at the recomme
dose of 5 mg daily, undesirable effects with Aerius tablets were reported in 3% of patients in excess of those treated with
placebo. The most frequent adverse events were reported in excess of placebo were fatigue (1.2%), dry mouth (0.8%) and
headache (0.6%). Other undesirable effects reported very rarely during the post-marketing period are as follows: Cardiac
Disorders: Tachycardia, palpitations, psychomotor hyperactivity, seizures.
Gastrointestinal Disorders: Abdominal pain, nausea, vomiting, dyspepsia, diarrhea.
Hepatobiliary Disorders: Hepatitis, elevations of liver enzymes, increased bilirubin.
General Disorders: Hypersensitivity reactions (eg, anaphylaxis, angioedema, pruritus, rash and urticaria).
Common adverse reactions (=1/100, <1/10) reported during clinical trials involving 414 adult for Aerius D-12 are tachycard
mouth dry, dizziness, psychomotoric hyperactivity, pharyngitis, anorexia, constipation, headache, fatigue, insomnia, somno
sleep disorder and nervousness.
Burn sensation, stinging, sneezing, headache, insomnia, palpitation, dry nose.
Headache, dizziness, paresthesia, GI & hematological disorders, rash, pruritus.

GI, CNS effects. Hypersensitivity reactions.
Nausea, seborrhea, hearing loss, tinnitus.

Reduced appetite, nausea, diarrhea, other GI disturbances, skin disorders.
Impaired liver function, nausea, vomiting, gastric pain, heartburn, diarrhea, constipation, gastric bleeding; skin rash, dizzine
bronchospasm, thrombocytopenia, lymphopenia, impaired kidney & liver function; blurred vision.
Fever, urticaria, flushing, nausea, headache, dyspnea, rigors, hypotension, chills, malaise, vomiting, HTN, tachycardia,
bradycardia.
Occasionally, mild local discomfort at beginning of treatment which disappears on discontinuation.
Hot flushes, urticaria, fever, thirst.
Hypersensitivity reactions, nausea, vomiting, increased salivation, chills, febrile reactions.

Insomnia, headache, palpitations, excitation, tremor, arrhythmias, tachycardia, difficulty in micturition.
Insomnia, dry mouth.
Diarrhea, muscle cramps, fatigue, nausea, vomiting, insomnia, dizziness.

GI disturbance, dry mouth, fluid & electrolyte retention, metabolic reaction.
Muscle weakness, loss of muscle mass, steroid myopathy, osteoporosis, vertebral compression fracture, pathological fractu
long bone, osteonecrosis. GI effects. Impaired wound healing, thin fragile skin, facial erythema, sweating. CNS disturbances
electrolyte imbalance, endocrine disorders. Posterior subcapsular cataract, increased intraocular pressure, glaucoma,
exophthalmus. Rarely, anaphylaxis.
Diarrhea, dry mouth, abdominal pain, nausea, vomiting, dyspepsia. Dizziness, fatigue, insomnia, psychomotor hyperactivity
seizures. Tachycardia, palpitations. Fever, hepatitis, elevation of liver enzymes, increased bilirubin, anaphylaxis, angioedem
pruritus, rash & urticaria.
Hypersensitivity reactions, rise in IOP, posterior subcapsular cataracts formation.

Summary of the Safety Profile: The most commonly reported adverse reactions related to pemetrexed, whether used as
monotherapy or in combination, are bone marrow suppression manifested as anaemia, neutropenia, leukopenia,
thrombocytopenia and gastrointestinal toxicities, manifested as anorexia, nausea, vomiting, diarrhoea, constipation, phary
mucositis and stomatitis. Other adverse reactions include renal toxicities, increased aminotransferase, alopecia, fatigue,
dehydration, rash, infection/sepsis and neuropathy. Rarely seen events include Stevens-Johnson syndrome and toxic epider
necrolysis.
Table 7 provides the frequency and severity of adverse reactions that have been reported in >5% of 168 patients with
mesothelioma who were randomised to receive cisplatin and pemetrexed and 163 patients with mesothelioma randomise
receive the single agent cisplatin. In both treatment arms, these chemo-naive patients were fully supplemented with folic a
and vitamin B12.
Frequency Estimate: Very common (=1/10); common (=1/100 and <1/10); uncommon (=1/1000 and <1/100); rare (=1/10,0
and <1/1000); very rare (<1/10,000) and not known (cannot be estimated from available data-spontaneous reports).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 7.)
Clinically relevant circular tumor cell (CTC) toxicities that were reported in =1% and =5% (common) of the patients that wer
randomly assigned to receive cisplatin and pemetrexed include: Renal failure, infection, pyrexia, febrile neutropenia, increa
AST, ALT and gamma-glutamyl transpeptidase (GGT), urticaria and chest pain.
Clinically relevant CTC toxicities that were reported in <1% (uncommon) of the patients that were randomly assigned to rec
cisplatin and pemetrexed include arrhythmia and motor neuropathy.
Table 8 provides the frequency and severity of adverse reactions that have been reported in >5% of 265 patients randomly
assigned to receive single agent pemetrexed with folic acid and vitamin B12 supplementation and 276 patients randomly
assigned to receive single agent docetaxel. All patients were diagnosed with locally advanced or metastatic NSCLC and rece
prior chemotherapy. (See Table 8.)
Clinically relevant CTC toxicities that were reported in =1% and =5% (common) of the patients that were randomly assigned
pemetrexed include: Infection without neutropenia, febrile neutropenia, allergic reaction/hypersensitivity, increased creati
motor neuropathy, sensory neuropathy, erythema multiforme and abdominal pain.
Clinically relevant CTC toxicities that were reported in <1 % (uncommon) of the patients that were randomly assigned to
pemetrexed include supraventricular arrhythmias.
Clinically relevant Grade 3 and Grade 4 laboratory toxicities were similar between integrated Phase 2 results from 3 single a
pemetrexed studies (n=164) and the phase 3 single agent pemetrexed study described in the previous text, with the excepti
neutropenia (12.8% vs 5.3%, respectively) and ALT elevation (15.2% vs 1.9%, respectively). These differences were likely du
differences in the patient population, since the phase 2 studies included both chemo-naive and heavily pre-treated breast c
patients with preexisting liver metastases and/or abnormal baseline liver function tests.
The table as follows provides the frequency and severity of adverse reactions considered possibly related to study drug tha
been reported in >5% of 839 patients with NSCLC who were randomized to receive cisplatin and pemetrexed and 830 patie
with NSCLC who were randomized to receive cisplatin and gemcitabine. All patients received study therapy as initial treatm
for locally advanced or metastatic NSCLC and patients in both treatment groups were fully supplemented with folic acid an
Drowsiness, dizziness; dry mouth; epileptiform seizures (high doses).
Abdominal pain & distention, diarrhoea or constipation, flatulence, musculoskeletal pain & headache.
Diarrhea, muscle cramps, fatigue, nausea, vomiting, insomnia, dizziness, psychiatric disturbances.
Somnolence, dizziness, ataxia, fatigue, nystagmus, headache, tremor, nausea, vomiting, diplopia, amblyopia, rhinitis.
Drowsiness, musculoskeletal weakness, amnesia, depression, lightheadedness, confusion, hallucinations, blurred vision,
headache, insomnia, paradoxical reactions, trembling, hypotension, GI disorder, rash, changes in libido, menstrual irregular
urine retention, blood dyscrasias & jaundice.
GI disorders eg, gastralgia, nausea or vomiting, diarrhoea. Rarely, anaphylactic shock have been reported w/ IM administra
Constipation, dyspepsia, abdominal pain, headache, dizziness, vertigo, insomnia, hemorrhage, perforation, rash, liver & ren
impairment, thrombocytopenia.
Diarrhea, constipation, nausea & vomiting.

Drowsiness, lightheadedness, blurred vision, coordination defects, GI discomfort, autonomic effects, dependence, w/drawa
symptoms.
Nausea & vomiting.
Diarrhea, muscle cramps, weakness, nausea, vomiting, insomnia, dizziness. Mild increased blood creatinine-kinase level.
Hypoglycaemia, temporary visual impairment, GI disturbances, liver impairment. Rarely, thrombopenia, leucopenia & haem
anaemia; itching, urticaria, rashes.
Based on experience with Amaryl and on what is known of other sulfonylureas, the following adverse effects must be
considered.
Hypoglycaemia: As a result of the blood sugar-lowering action of Amaryl, hypoglycaemia may occur and may also be prolon
Possible symptoms of hypoglycaemia include headache, ravenous hunger, nausea, vomiting, lassitude, sleepiness, disorder
sleep, restlessness, aggressiveness, impaired concentration, alertness and reactions, depression, confusion, difficulty in spe
and even speech loss, visual disorders, tremor, pareses, sensory disturbances, dizziness, helplessness, loss of self-control,
delirium, cerebral convulsions, somnolence and loss of consciousness up to and including coma, shallow respiration and slo
heart rate (bradycardia). In addition, signs of adrenergic counter-regulation may be present eg, sweating, clammy skin, anxi
rapid heart rate (tachycardia), hypertension, palpitations, angina pectoris and cardiac arrhythmias. The clinical picture of a
severe hypoglycaemic attack may resemble that of a stroke. The symptoms of hypoglycaemia nearly always subside when
hypoglycaemia is corrected.
Eyes: Especially at the start of treatment, temporary visual impairment may occur due to the change in blood sugar levels.
Digestive Tract: Occasionally, gastrointestinal symptoms may occur eg, nausea, vomiting, sensations of pressure or fullness
epigastrium, abdominal pain and diarrhoea.
In rare cases, liver enzyme levels may increase. In isolated cases, impairment of liver function (eg, with cholestasis and jaun
and hepatitis may develop, leading to liver failure.
Blood: Severe changes in blood picture may occur. Rarely, thrombopenia and in isolated cases, leucopenia, haemolytic anae
or eg, erythrocytopenia, granulocytopenia, agranulocytosis and pancytopenia (eg, due to myelosuppression) may develop.
Others: Occasionally, allergic or pseudoallergic reactions may occur eg, itching, urticaria or rashes (eg, erythema, morbillifo
maculopapular eruptions), if skin reactions persist, Amaryl should be discontinued. Such reactions may be mild, but also m
become more serious and may be accompanied by dyspnoea and a fall in blood pressure, sometimes progressing to shock.
urticaria occurs, a physician must be notified immediately.
In isolated cases, a decrease in serum sodium, inflammation of blood vessels (allergic vasculitis) and hypersensitivity of the
to light may occur.
Consult the physician if any of the adverse effects listed previously or any other undesired effects or unexpected changes o
Since some adverse effects (eg, severe hypoglycaemia, certain changes in blood picture, severe allergic or pseudoallergic
reactions or liver failure) may, under certain circumstances, become life-threatening, it is essential that, if sudden or severe
reactions do occur, inform a physician at once and, on no account, continue taking the drug without a physician's express
guidance.
Further to the previously mentioned adverse effects of Amaryl, the following events have been reported with sulfonylureas
Porphyria cutanea tarda, hepatic porphyria reaction, disulfiram-like reaction, syndrome of inappropriate antidiuretic hormo
(SIADH) secretion. It has been suggested that these sulfonylureas may augment the peripheral action of ADH and/or increa
release of ADH.
Glimepiride: Based on experience with Amaryl M and on what is known of other sulfonylureas, the following adverse reacti
must be considered.
Hypoglycemia: As a result of the blood glucose-lowering action of Amaryl M, hypoglycemia may occur and may also be
prolonged.
Possible symptoms of hypoglycemia include headache, ravenous hunger, nausea, vomiting, lassitude, sleepiness, disordere
sleep, restlessness, aggressiveness, impaired concentration, alertness and reactions, depression, confusion, speech disorde
aphasia, visual disorders, tremor, pareses, sensory disturbances, dizziness, helplessness, loss of self-control, delirium, cereb
convulsions, somnolence and loss of consciousness up to and including coma, shallow respiration and bradycardia. In additi
signs of adrenergic counter-regulation may be present eg, sweating, clammy skin, anxiety, tachycardia, hypertension,
palpitations, angina pectoris and cardiac arrhythmias.
The clinical picture of a severe hypoglycemic attack may resemble that of a stroke. The symptoms nearly always subside wh
hypoglycemia is corrected.
Eyes: Temporary visual impairment may occur due to the change in blood sugar levels especially at the start of treatment.
Digestive Tract: Occasionally, GI symptoms eg, nausea, vomiting, sensations of pressure or fullness in the epigastrium, abdo
pain and diarrhea may occur.
Hepatobiliary: In cases, liver enzyme elevation and liver impairment (eg, cholestasis and jaundice) may occur, as well as hep
which may progress to liver failure.
Blood: Changes in the blood picture may occur. Rarely, thrombopenia and in isolated cases, leucopenia, or hemolytic anem
erythrocytopenia, granulocytopenia, agranulocytosis or pancytopenia may develop. Because it is reported that aplastic ane
and pancytopenia may occur in sulfonylureas, careful monitoring should be performed. If these occur, Amaryl M should be
discontinued and adequate treatment taken.
Hypersensitivity: Occasionally, allergic or pseudoallergic reactions (eg, itching, urticaria or rashes) may occur. These reactio
almost mild but may develop into serious reactions with dyspnea and a fall in blood pressure, sometimes progressing to sh
In the event of urticaria, a physician must be notified immediately.
Others: In isolated cases, allergic vasculitis, skin hypersensitivity to light or a decrease in serum sodium concentration may
Metformin: Lactic Acidosis: See Warnings and Overdosage.
Hypoglycemia.
Gastrointestinal: GI symptoms (diarrhea, nausea, vomiting, abdominal bloating, flatulence and anorexia) are the most com
reactions to Amaryl M and are approximately 30% more frequent in patients on monotherapy than in placebo-treated pati
particularly during therapy initiation. These symptoms are generally transient and resolve spontaneously during continued
treatment. Occasionally, temporary dose reduction may be useful. In clinical trials, Amaryl M was discontinued due to GI
reactions in approximately 4% of patients.
Because GI symptoms during therapy initiation appear to be dose-related, they may be decreased by gradual dose escalatio
and by having patients take Amaryl M with meals.
Because significant diarrhea and/or vomiting may cause dehydration and prerenal azotemia, under such circumstances, Am
M should be temporarily discontinued.
For patients who have been stabilized on Amaryl M, nonspecific GI symptoms should not be attributed to therapy unless
intercurrent illness
Hypersensitivity or lacticGI
reactions, acidosis has been
disturbances, excluded.
blood disorders.
Amlodipine is well tolerated. In placebo-controlled clinical trials involving patients with hypertension or angina, the most
commonly observed side effects were headache, edema, fatigue, somnolence, nausea, abdominal pain, flushing, palpitatio
and dizziness. In these clinical trials, no pattern of clinically significant laboratory test abnormalities related to amlodipine h
been observed.
Less commonly observed adverse effects in marketing experience include altered bowel habits, arthralgia, asthenia, dyspep
dyspnea, gingival hyperplasia, gynecomastia, impotence, increased urinary frequency, mood changes, muscle cramps, mya
pruritus, rash, visual disturbance and rarely, erythema multiforme.
Jaundice and hepatic enzyme elevations have been reported very infrequently (mostly consistent with cholestasis). Some c
severe enough to require hospitalization have been reported in association with the use of amlodipine. In many instances,
association is uncertain.
As with other calcium-channel blockers, the following adverse events have been rarely reported and cannot be distinguishe
from the natural history of the underlying disease: MI, arrhythmia (including ventricular tachycardia and atrial fibrillation) a
chest pain.
Hypercalcemia.
Reactions: Hypersensitivity: =5% or frequency unknown: [Rash, etc].

Gastrointestinal: 0.1%-<5%: Nausea and vomiting.
Cardiovascular: =5% or frequency unknown: [Chest discomfort, palpitation, etc].
Hepatic: 0.1%-<5%: Increases in AST (SGOT), ALT (SGPT), ALP or total bilirubin.
Large Dose and Rapid Administration: (Cerebral, pulmonary and peripheral edema; hyperpotassemia, acidosis, water
intoxication), [acidosis].
Other: =5% or frequency unknown: Vascular pain, phlebitis, [chills, fever, feeling of warmth, headache].
[ ]: Common adverse reactions in amino acid injections.
( ): Common adverse reactions in maintenance solutions.
Caution For Usage Instructions for Use, Handling and Disposal: Admixture: Open the outer wrap just before use, break the
seal between the 2 chambers, and mix the 2 solutions thoroughly. The solution in 1 chamber should not be administered a
without mixing with the solution in the other chamber.
At the Time of Preparation: Physical changes of the solution such as precipitation may occur when Aminofluid is combined
the following drugs: Drugs which are stable in alkaline or acidic conditions and drugs which are not soluble in water.
The solution should not be mixed with drugs containing calcium salt or phosphate, since this will cause the solution to
precipitate.
Since the solution contains calcium salt, hemopexis may occur when mixed with citrated blood.
After opening the outer wrap and mixing the 2 solutions, the mixed solution should be used promptly.
Before Administration: When administering Aminofluid, it is recommended to maintain urine output of >500 mL/day or >2
mL/hr.
To prevent infection, carry out all procedures under aseptic conditions.
Use the solution after warming to near body temperature during cold environmental conditions.
Use the solution immediately after opening the container. After use, discard all unused solution.
During Administration: When vascular pain occurs, use an alternate site or discontinue the administration.
Extravasation of the solution may result in skin necrosis and ulceration. Discontinue the administration promptly after confi
clinical signs of extravasation (eg, redness, infiltration or swelling) at injection site.
Precautions for Handling: Since an oxygen absorbent is enclosed between the bag and the outer wrap to maintain stability
product, do not remove the outer wrap until immediately before use.
A crystalline precipitate may form in the upper chamber solution (amino acid solution) due to changes in environmental
temperature. Shake the solution at temperatures of 15-25C to dissolve precipitates before use.
Do not use the solution if the outer wrap covering the product has been damaged, the solution is discolored, or a precipita
that cannot be dissolved by shaking has formed.
If the 2 solutions packaged in the chambers have already been mixed for any reason or if the center seal between the 2
chambers looks white in color (the sealed area appears white in color when it is peeled off), do not use the product.
Puncture rubber stopper vertically with a needle in the marked circle. If the stopper is not pierced vertically, the needle ma
through the neck of the container and cause leakage of the contents.
Since the bag product may not be infused in tandem using a connection tube, use a Y-type infusion set when 2 bag produc
Hypersensitivity: Skin rashes or other hypersensitivity reactions have been rarely reported and administration should be
discontinued if such signs develop.
Digestive: Nausea and vomiting may infrequently occur.
Cardiovascular: Chest discomfort and palpitations may infrequently occur.
Carbohydrate Metabolism: Hypoglycemia rarely occurs.
Large Dose and Rapid Administration: Acidosis may occur after a rapid and large dose of Aminoleban Infusion.
Others: Chills, fever, headache and vascular pains may infrequently occur.
Caution For Usage Crystals may precipitate in a cool place. Warm the container at 15-25C to dissolve the precipitates and
the solution after cooling at near body temperature.
Since sodium and chloride are formulated in respective volumes of approximately 14 and 94 mEq/L, concomitant use with
electrolyte solutions and the administration of Aminoleban Infusion in large doses require careful supervision of the electro
balance.
Slow IV infusion is recommended.
Local reactions consisting of erythema, phlebitis & thrombosis at the infusion site can occur w/ peripheral infusion. Genera
flushing, vomiting & fever furing infusion of amino acid soln.
Neurotoxicity, ototoxicity, nephrotoxicity; skin rash, drug fever, headache, paresthesia, tremor, nausea & vomiting, eosinop
arthralgia, anemia, hypotension; acute muscular paralysis, apnea.
Hypersensitivity: Rare eruption or other hypersensitivity reactions were reported. If such reactions occur, the solution shou
discontinued.
Cardiovascular: Occasional chest discomfort and palpitation were reported.
Gastrointestinal: Occasional nausea and vomiting were reported.
Hepatic: An occasional increase in SGOT, SGPT and total bilirubin levels was reported.
Renal: An occasional increase in blood urea nitrogen was reported.
Large and Acute Administration: Acidosis was reported after large and acute administration of Amiparen.
Others: Occasional chills, fever, hot flush, headache and vascular pain were reported.
Caution For Usage Crystals may precipitate at cool temperature. Warm the container at 50-60C to dissolve the precipitate
use the solution after cooling to near body temperature.
The Amiparen container is not equipped with an air tube, so it should be punctured with an air needle immediately before
prevent leakage of solution.
Hypersensitivity reactions, nausea, vomiting, chest discomfort, palpitations, increased BUN or creatinine & liver enzymes,
acidosis, chills, fever, flushing, headache, vascular pain, lower extremities edema, hyperkalemia & dry mouth. Increased GO
GPT, ?-GTP, ALP, LDH, LAP, total bilirubin or ammonia.
Headache, edema, fatigue, somnolence, nausea, abdominal pain, flushing, palpitation, dizziness. Rarely joint pain, dyspeps
gingival hyperplasia, gynecomastia, impotence, frequent urination, mood changes, muscle cramps & pain, pruritus, skin ras
visual disturbances.
Occasionally nausea & vomiting; acidosis & CHF (large doses & rapid administration).
Hypersensitivity, haematological & anaphylactoid reactions, GI disturbances.
Fluid & electrolyte disturbance, steroid myopathy, muscle weakness, peptic ulcer, osteoporosis, purpura, striae,
hyperpigmentation.
Fluid & electrolyte disturbance, steroid myopathy, muscle weakness, peptic ulcer, osteoporosis, purpura, striae,
hyperpigmentation.
Minor GI disturbance.
Agranulocytosis, hypersensitivity reactions, skin reactions, drowsiness, dizziness, constipation, depression, hypotension, na
tremor, urinary retention, vertigo.
Nausea, dizziness, somnolence. Asthenia, fatigue, hot flushes; headache, tremor; abdominal pain, constipation, diarrhea,
dyspepsia, flatulence, dry mouth, vomiting; anorexia, anxiety, confusion, euphoria, insomnia, nervousness; pruritus, rash,
increased sweating.
Hypersensitivity, GI disturbances including very rarely pseudomembranous colitis. Haematological changes. Occasionally,
thrombophlebitis (IV inj).
Nausea, vomiting, abdominal pain, diarrhea; skin allerg; possible transient rise of ASAT/ALAT transaminase &/or alkalline
phosphatase.
Rash, urticaria, angioedema, pseudomembranous colitis.

Diarrhoea, pseudomembranous colitis, dyspepsia, nausea, vomiting, candidiasis, rash, urticaria, hypersensitivity reactions.
Transient hepatitis, cholestatic jaundice, Stevens-Johnson syndrome, exfoliative dermatitis.
Skin sensitization.
Allergy or hypersensitivity reactions.
Arterial BP, pulse rate & breathing changes; nausea, vomiting, headache, hiccups, laryngospasm, dyspnea, hallucination, at
skin rash, paradoxical reactions, amnesic episodes, resp depression, apnea.
Excessive reduction in BP; dry (non-productive) tickling cough. Uncommonly/rarely, headache, tachycardia, drowsiness,
peripheral edema, psychiatric symptoms, renal impairment, hyperkalemia, angioneurotic edema.
Shock, hypersensitivity, hematologic & GI disorders, vit K deficiency.
Rarely, GI upset eg nausea & vomiting.

Hypoglycaemia, temporary visual impairment, GI disturbances, liver impairment. Rarely, thrombocytopenia, leucopenia &
haemolytic anaemia; itching, urticaria, rashes.
Rash, palpitation, tachycardia, hot flushes, headache, dizziness, nausea, vomiting, diarrhea.
Anxiety, nervousness, insomnia, drowsiness, fatigue, asthenia, tremor, sweating, anorexia, nausea, diarrhea, dizziness or
lightheadedness.
Drowsiness, dizziness, dry mouth; epileptiform seizures (large doses); skin rashes.
Headache, dizziness; vertigo; nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia; increased
transaminases; rash.
Drowsiness.
Hypoglycemia, the most frequent undesirable effect of insulin therapy, may occur if the insulin dose is too high in relation t
insulin requirement.
The following related adverse reactions from clinical investigations were listed by system organ class and in order of decrea
incidence (Very common: >1/10; common: >1/100, <1/10; uncommon: >1/1,000, <1/100; rare: >1/10,000, <1/10,000; very
<1/10,000).
Metabolism and Nutrition Disorders: Very Common: Hypoglycemia. Symptoms of hypoglycemia usually occur suddenly. Th
may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confu
difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Hypoglycemia can become severe and may lead to unconsciousness and/or convulsions and may result in temporary or
permanent impairment of brain function or even death.
Skin and Subcutaneous Tissue Disorders: Common: Injection site and local hypersensitivity reactions.
Local hypersensitivity reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin
These reactions are usually transitory and normally disappear during continued treatment.
Rare: Lipodystrophy. It may occur at the injection site as a consequence of failure to rotate injection sites within an area.
General Disorders: Uncommon: Systemic hypersensitivity reactions may include uticaria, chest tightness, dyspnea, allergic
dermatitis and pruritus. Severe cases of generalized allergy, including anaphylactic reaction, may be life-threatening.
Blood & lyphatic system disorders, metabolism & nutrition disorders, nervous system, eye, ear & labyrinth, cardiac, vascula
resp, throracic & mediastinal, GI, skin & SC tissue, musculoskeletal & connective tissue, renal & urinary disorders, & reprod
system & breast disorders; fatigue, peripheral edema, edema, gait abnormalities, asthenia, thirsty, chest tightness, pain,
exacerbated anasarca, pyrexia, rigors; increased alanine aminotransferase, blood creatinine, phosphokinase, aspartate
aminotransferase; decreased platelet count; increased blood glucose.
In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between th
irbesartan (56.2%) and the placebo groups (56.5%). Discontinuation due to any clinical or laboratory adverse events was le
frequent for irbesartan-treated patients (3.3%) than for placebo-treated patients (4.5%). The incidence of adverse events w
not related to dose (in the recommended dose range), gender, age, race, or duration of treatment.
In diabetic hypertensive patients with microalbuminuria and normal renal function, orthostatic dizziness and orthostatic
hypotension were reported in 0.5% of the patients (i.e. uncommon) but in excess of placebo.
The following table presents the adverse drug reactions that were reported in placebo-controlled trials in which 1,965
hypertensive patients received irbesartan. Terms marked with a star (*) refer to the adverse reactions that were additionall
reported in >2% of diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria and in excess of pla
The frequency of adverse reactions listed below is defined using the following convention: Very common (= 1/10), common
1/100, <1/10), uncommon (= 1/1,000, < 1/100), rare (= 1/10,000, < 1/1,000), very rare (<1/10,000). Within each frequency
grouping, undesirable effects are presented in order of decreasing seriousness.
Adverse reactions additionally reported from post-marketing experience are also listed. These adverse reactions are derive
from spontaneous reports and therefore, the frequency of these adverse reactions is "not known" (cannot be estimated fro
the available data).
Immune system disorders: Not known: Hypersensitivity reactions such as angiodema, rash, urticaria.
Metabolism and Nutrition Disorders: Not known: Hyperkalaemia.
Nervous System Disorders: Common: Dizziness, orthostatic dizziness*. Not known: vertigo, headache.
Ear and Labyrinth Disorder: Not known: tinnitus.
Cardiac Disorders: Uncommon: Tachycardia.
Vascular Disorders: Common: Orthostatic hypotension*. Uncommon: Flushing.
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Cough.
Gastrointestinal Disorders: Common: Nausea/vomitting. Uncommon: Diarrhoea, dyspepsia/heartburn. Not known: Dysgeu
Hepato-biliary disorders: Not known: Hepatitis, abnormal liver function.
Skin and Subcutaneous Tissue Disorders: Not known: Leukocytoclastic vasculitis.
Musculoskeletal, Connective Tissue and Bone Disorders: Common: Musculoskeletal pain*. Not known: Myalgia, arthralgia (
some cases associated with increased plasma creatine kinase levels), muscle cramps.
Renal and Urinary Disorders: Not known: Impaired renal function including isolated cases of renal failure in patients at risk
Precautions.)
Reproductive System and Breast Disorders: Uncommon: Sexual dysfunction.
General Disorders and Administration Site Conditions: Common: Fatigue. Uncommon: Chest pain.
Investigation: Very common: Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with
placebo.
In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (=5.5 mEq/L) occurred i
29.4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group. In diabetic hypertensiv
patients with chronic renal insufficiency and overt proteinuria, hyperkalemia (=5.5 mEq/L) occurred in 46.3% of the patient
the irbesartan group and 26.3% of the patients in the placebo group.
Common: Significant increases in plasma creatine kinase were commonly observed (1.7%) in irbesartan treated subjects. N
Epigastric pain, nausea, vomiting, diarrhea, abdominal cramps, dyspepsia, flatulence, anorexia, headache, dizziness or verti
drowsiness, sensation disturbances (paresthesia, rashes, skin eruptions); asthma, anaphylactic/anaphylactoid systemic reac
(hypotension).
Occasionally mild agitation in the elderly subject and allergic skin reaction.
GI disturbances, allergic reactions, anaphylaxis, blood disorders.
Fecal impaction (large doses).

In clinical trials, Arcoxia was evaluated for safety in approximately 4800 individuals, including approximately 3400 patients
OA, RA or chronic low back pain (approximately 600 patients with OA or RA were treated for 1 year or longer).
The following drug-related adverse experiences were reported in clinical studies in patients with OA, RA or chronic low bac
treated for up to 12 weeks. These occurred in =1% of patients treated with Arcoxia and at an incidence greater than placeb
Asthenia/fatigue, dizziness, lower extremity edema, hypertension, dyspepsia, heartburn, nausea, headache, increased ALT
AST.
The adverse experience profile was similar in patients with OA or RA treated with Arcoxia for 1 year or longer.
Seven thousand one hundred eleven (7111) patients were enrolled in an additional study in OA that compared the GI toler
of etoricoxib 90 mg once daily (1.5 times above the dose recommended for OA) and diclofenac sodium 50 mg 3 times daily
a mean period of 9 months. The adverse experience profile on Arcoxia was generally similar to that reported in the Phase I
placebo-controlled clinical studies; however, hypertension adverse experiences occurred at a higher rate on Arcoxia than o
diclofenac.
In the initial clinical development program, approximately 3100 patients were treated with etoricoxib 60 mg daily for 12 we
or longer. There was no discernible difference in the rate of serious thrombotic cardiovascular events between patients rec
etoricoxib 60 mg or non-naproxen NSAIDs. However, the rate of these events was higher in patients receiving etoricoxib
compared with those receiving naproxen 500 mg twice daily.
In a clinical study for ankylosing spondylitis, patients were treated with Arcoxia 90 mg once daily for up to 1 year (n=126). T
adverse experience profile in this study was generally similar to that reported in chronic studies in OA, RA and chronic low
pain.
In a clinical study for acute gouty arthritis, patients were treated with Arcoxia 120 mg once daily for 8 days.
In clinical studies for acute analgesia, patients were treated with Arcoxia 120 mg once daily for 1-7 days. The adverse exper
profile in these studies was generally similar to that reported in the combined OA, RA and chronic low back pain studies.
Post-Marketing Experience: The following adverse reactions have been reported in post-marketing experience: Immune Sys
Disorders: Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions.
Psychiatric Disorders: Anxiety, insomnia, confusion, hallucinations.
Nervous System Disorders: Dysgeusia, somnolence.
Cardiac Disorders: Congestive heart failure.
Vascular Disorders: Hypertensive crisis.
Respiratory, Thoracic and Mediastinal Disorders: Bronchospasm.
Gastrointestinal Disorders: Abdominal pain, oral and peptic ulcers including perforation and bleeding (mainly in elderly pati
vomiting, diarrhea.
Hepatobiliary Disorders: Hepatitis.
Skin and Subcutaneous Tissue Disorders: Angioedema, pruritus, rash, Stevens-Johnson syndrome, urticaria.
Renal and Urinary Disorders: Renal insufficiency, including renal failure, usually reversible upon discontinuation of therapy
Precautions).
Minor GI and neurovegetative disorders.

Ischaemia, bradycardia, anxiety, temporary headache, necrosis, extravasation at inj site.
Nausea, vomiting, diarrhea, constipation, abdominal pain or transient burning of the upper stomach, skin rashes,
bronchospasms or thrombocytopenia.
Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis,
allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria.
Abdominal pain, nausea, diarrhea; slight gum bleeding or epistaxis; skin rash, urticaria, itching. Very rarely, serious
hypersensitivity reaction w/ edema, dyspnea & hypotension.
Diarrhoea, muscle cramps, fatigue, nausea, vomiting, insomnia, dizziness, psychiatric disturbances.
Diarrhea, muscle cramps, fatigue, nausea, vomiting, insomnia, headache, anorexia, hallucination, agitation, aggressive beh
depression, abnormalities, somnolence, syncope, dizziness, abdominal disturbance, rash, pruritus, urinary incontinence, pa
decreased wt, ecchymosis, infection.
Dyspepsia, nausea, vomiting, abdominal pain, diarrhea; anemia, leucopenia, thrombocytopenia; pruritus, skin rash; headac
vertigo, tinnitus, drowsiness; edema, increased BP.
Unless specified, the following frequency categories were calculated from the number of adverse events reported in a large
phase III study conducted in 9366 post-menopausal women with operable breast cancer treated for 5 years and unless spe
no account was taken of the frequency within the comparative treatment group or whether the investigator considered it t
related to study medication.
Very Common (=10%): Vascular: Hot flushes, mainly mild or moderate in nature.
General: Asthenia, mainly mild or moderate in nature.
Musculoskeletal and Connective Tissue Disorders: Arthralgia/joint stiffness, arthritis.
Nervous System: Headache, mainly mild or moderate in nature.
Gastrointestinal: Nausea, mainly or mild to moderate in nature.
Skin and Subcutaneous Tissue: Rash, mainly or mild to moderate in nature.
Common (=1% and <10%): Skin and Subcutaneous Tissue: Hair thinning (alopecia), mainly mild or moderate in nature, aller
reactions.
Gastrointestinal: Diarrhoea, mainly mild or moderate in nature, vomiting, mainly mild or moderate in nature.
Nervous System: Somnolence, mainly mild or moderate in nature, carpal tunnel syndrome*, sensory disturbances (includin
paraesthesia, taste loss and taste perversion).
Hepatobiliary Disorders: Increased alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase.
Reproductive System and Breast: Vaginal dryness, mainly mild or moderate in nature; vaginal bleeding, mainly mild or mod
in nature**.
Metabolism and Nutrition: Anorexia, mainly mild in nature; hypercholesterolemia, mainly mild or moderate in nature.
Musculoskeletal and Connective Tissue Disorders: Bone pain, myalgia.
Uncommon (=0.1% and <1%): Metabolism and Nutrition: Hypercalcaemia (with or without an increase in parathyroid horm
Hepatobiliary Disorders: Increased ?-GT and bilirubin. Hepatitis.
Skin and Subcutaneous Tissue: Urticaria.
Musculoskeletal and Connective Tissue Disorders: Trigger finger.
Rare (=0.01% and <0.1%): Skin and Subcutaneous Tissue: Erythema multiform, anaphylactoid reaction. Cutaneous vasculiti
(including some reports of Henoch-Schonlein purpura).
Very Rare (<0.01%): Skin and Subcutaneous Tissue: Stevens-Johnson syndrome, angioedema.
*Events of carpal tunnel syndrome have been reported in patients receiving Arimidex treatment in clinical trials in greater
numbers than those receiving treatment with tamoxifen. However, the majority of these events occurred in patients with
identifiable risk factors for the development of the condition.
**Vaginal bleeding has been reported commonly, mainly in patients with advanced breast cancer, during the 1st few weeks
changing from existing hormonal therapy to treatment with Arimidex. If bleeding persists, further evaluation should be
considered.
As Arimidex lowers circulating estrogen levels, it may cause a reduction in bone mineral density placing some patients at a
risk of fracture (see Precautions).
In a large phase III study conducted in 9366 postmenopausal women with operable breast cancer treated for 5 years, ischa
cardiovascular events were reported more frequently in patients treated with Arimidex compared to those treated with
tamoxifen, although the
Headache, asthenia, difference
fever. Nausea, was not statistically
vomiting, significant.
constipation. Anxiety,The observed
insomnia, difference wassomnolence,
lightheadedness, mainly due toakathisia,
more report
trem
Rhinitis, coughing, rash, blurred vision.
The safety of fondaparinux 2.5 mg has been evaluated in: 3595 patients undergoing major orthopaedic surgery of the lowe
limbs treated up to 9 days, 327 patients undergoing hip fracture surgery treated for 3 weeks following an initial prophylaxis
week, 1407 patients undergoing abdominal surgery treated up to 9 days, 425 medical patients who are at risk for
thromboembolic complications treated up to 14 days, 10,057 patients undergoing treatment of UA or NSTEMI acute corona
syndrome (ACS), 6036 patients undergoing treatment of STEMI ACS.
Adverse reactions are listed as follows by system organ class and frequency and indication. Frequencies are defined as: Ver
common (=1/10); Common (=1/100, <1/10); Uncommon (=1/1000, <1/100); Rare (=1/10,000, <1/1000); Very rare (=1/10,0
These adverse reactions should be interpreted within the surgical or medical context of the indications.
Clinical Trial Data: Undesirable Effects in Patients Undergoing Major Orthopaedic Surgery of Lower Limbs and/or Abdomina
Surgery: Infections and Infestations: Rare: Postoperative wound infections.
Blood and Lymphatic System Disorders: Common: Anaemia, bleeding (various sites including rare cases of
intracranial/intracerebral and retroperitoneal bleedings), purpura. Uncommon: Thrombocytopenia, thrombocythaemia,
abnormal platelets, coagulation disorder.
Immune System Disorders: Rare: Allergic reaction.
Metabolism and Nutrition Disorders: Rare: Hypokalaemia.
Nervous System Disorders: Uncommon: Headache. Rare: Anxiety, confusion, dizziness, somnolence, vertigo.
Vascular Disorders: Rare: Hypotension.
Respiratory, Thoracic and Mediastinal Disorders: Rare: Dyspnoea, coughing.
Gastrointestinal Disorders: Uncommon: Nausea, vomiting. Rare: Abdominal pain, dyspepsia, gastritis, constipation, diarrho
Hepatobiliary Disorders: Uncommon: Abnormal liver function tests, increased hepatic enzymes. Rare: Bilirubinaemia.
Skin and Subcutaneous Tissue Disorders: Uncommon: Rash, pruritus, wound secretion.
General Disorders and Administration Site Conditions: Common: Oedema. Uncommon: Fever, wound secretion, peripheral
oedema. Rare: Injection site reaction, chest and leg pain, fatigue, genital oedema, flushing, syncope.
Undesirable Effects in Medical Patients: Blood and Lymphatic System Disorders: Common: Bleeding (haematoma, haematu
haemoptysis, gingival bleeding). Uncommon: Anaemia.
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Dyspnoea.
Skin and Subcutaneous Tissue Disorders: Uncommon: Rash, pruritus.
General Disorders and Administration Site Conditions: Uncommon: Chest pain.
In other studies or in post-marketing experience, rare cases of intracranial/intracerebral and retroperitoneal bleedings have
reported.
The adverse event profile reported in the ACS program is consistent with the adverse drug reactions identified for VTE
prophylaxis.
Bleeding was a commonly reported event in patients with UA/NSTEMI and STEMI. The incidence of adjudicated major blee
was 2.1% (fondaparinux) versus 4.1% (enoxaparin) up to and including day 9 in the Phase III UA/NSTEMI study and the incid
of adjudicated severe haemorrhage by modified TIMI criteria was 1.1% (fondaparinux) versus 1.4% [control (UFH/placebo)
and including day 9 in the Phase III STEMI study.
In the Phase III UA/NSTEMI study, the most commonly reported non-bleeding adverse events (reported in at least 1% of su
on fondaparinux)glaucoma,
GI disturbances; were headache, chest
mydriasis; pain and
urinary atrial fibrillation.
retention, mental disturbances, excitement.
Mild headache, hallucination, restlessness, insomnia, allergic reactions, photophobia, nausea, vomiting, constipation, diarr
abdominal pain, flatulence, anorexia, dyspepsia, drowsiness, tremor, depression.
Hot flushes, arthralgia, nausea, fatigue, increased sweating, dizziness, headache, insomnia, pain, abdominal pain, anorexia,
vomiting, depression, alopecia, peripheral oedema, constipation, dyspepsia, joint & musculoskeletal pain, increased hepati
enzyme, blood bilirubin, blood alkaline phosphatase, carpal tunnel syndrome, diarrhea, rash, fracture, osteoporosis, asthen
Asthmatic attacks, syncope, ocular pemphigoid, AV block, cardiac arrest, CHF.
Headache, dizziness, paresthesia, GI & hematological disorders, rash, pruritus.
GI reactions including nausea, vomiting, diarrhea, constipation, gastric pain & bleeding. Peptic ulceration. Rarely, insomnia,
irritability, agitation, minor hearing disorders, edema, skin rashes, palpitations. Bronchospasm, thrombocytopenia, lympho
visual disturbances.
Nausea, epigastric pain, heartburn, dizziness, sleeplessness, headache, rash, itching, tinnitus, edema.
Fever, infection on the injection site, venous thrombosis or phlebitis on the injection site, hypervolemia.
Nausea, vomiting, diarrhoea, dizziness, stomach bleeding.

Nausea, vomiting, diarrhea, headache, insomnia, palpitations, tachycardia, ventricular arrhythmia.
Headache, shock, chest pain, pseudomembranous colitis, jaundice, hypoprothrombinemia, Stevens-Johnson syndrome.
Peptic ulceration, GI disturbances, increased bleeding time, hypothrombinemia, hypersensitivity reaction, dizziness, tinnitu
Fine tremor of skeletal muscle, palpitation, tachycardia, headache.
Drowsiness, musculoskeletal weakness, amnesia, depression, lightheadedness, confusion, hallucinations, blurred vision,
headache, insomnia, paradoxical reactions, trembling, hypotension, GI disorder, rash, changes in libido, menstrual irregular
urine retention, blood dyscrasias & jaundice.
Palpitations, tachycardia; tremor & headache; nausea & vomiting; skin rash.
Insomnia; headache; nausea, diarrhea, abdominal pain, dyspepsia, constipation, flatulence; myalgia; asthenia.
Insomnia; headache; nausea, diarrhea, abdominal pain, dyspepsia, constipation, flatulence; myalgia; asthenia; hypo- &
hyperglycemia, anorexia; peripheral neuropathy, paresthesia; pancreatitis, vomiting; hepatitis, cholestatic jaundice; rash,
pruritus, alopecia; myopathy, myositis, muscle cramps; impotence; angioneurotic edema; angina.
Atorvastatin is generally well-tolerated. Adverse reactions have usually been mild and transient. <2% of patients were
discontinued from clinical trials due to side effects attributed to atorvastatin.
The most frequent (=1%) adverse effects associated with atorvastatin therapy, in patients participating in controlled clinical
studies were: Psychiatric Disorders: Insomnia.
Nervous System Disorders: Headache.
Gastrointestinal Disorders: Nausea, diarrhea, abdominal pain, dyspepsia, constipation, flatulence.
Musculoskeletal and Connective Tissue Disorders: Myalgia.
General Disorders and Administration Site Conditions: Asthenia.
The Following Additional Adverse Effects Have Been Reported in Atorvastatin Clinical Trials: Metabolism and Nutrition Diso
Hypoglycemia, hyperglycemia, anorexia.
Nervous System Disorders: Peripheral neuropathy, paresthesia.
Gastrointestinal Disorders: Pancreatitis, vomiting.
Hepatobiliary Disorders: Hepatitis, cholestatic jaundice.
Skin and Subcutaneous Tissue Disorders: Alopecia, pruritus, rash.
Musculoskeletal and Connective Tissue Disorders: Myopathy, myositis, muscle cramps.
Reproductive System and Breast Disorders: Impotence.
Not all effects listed above have been causally associated with atorvastatin therapy.
Children (ages 10-17 years): Patients treated with atorvastatin has an adverse experience profile generally similar to that of
patients treated with placebo, the most common adverse experiences observed in both groups, regardless of causality
assessment, were infections.
In post-marketing experience, the following additional undersirable effects have been reported: Blood and Lymphatic Syste
Disorders: Thromboctytopenia.
Immune System Disorders: Allergic reactions (including anaphylaxis).
Metabolism and Nutrition Disorders: Weight gain.
Nervous System Disorders: Hypoesthesia, amnesia, dizziness.
Ear and Labyrinth Disorders: Tinnitus.
Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, bul
rashes, urticarial.
Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis, arthralgia, back pain.
General Disorders and Administration Site Conditions: Chest pain, peripheral edema, malaise.
GI effects, kidney or liver functions abnormality, hematological changes, CV effects, resp & CNS disorders.
GI motility disorders, dry mouth, headache, tachycardia, palpitations, supraventricular tachycardia, atrial fibrillation, ocular
accommodation disturbances, nausea, urinary retention, cough, local irritation, inhalation-induced bronchospasm, allergic
reactions.
Data from large clinical trial was used to determine the frequency of very common to rare undesirable effects. The frequen
assigned to all other undesirable effects (ie, those occurring at <1/10,000) were mainly determined using post-marketing d
and refer to a reporting rate rather than a true frequency.
The following convention has been used for the classification of frequency: Very Common: >1/10; common: >1/100 and <1
uncommon: >1/1000 and <1/100; rare: >1/10,000 and <1/1000; very rare: <1/10,000.
Infections and Infestations: Common: Mucocutaneous candidiasis.
Blood and Lymphatic System Disorders: Rare: Reversible leucopenia (including neutropenia) and thrombocytopenia. Very R
Reversible agranulocytosis and hemolytic anemia. Prolongation of bleeding time and prothrombin time (see Precautions).
Immune System Disorders: Very Rare: Angioneurotic edema, anaphylaxis, serum sickness-like syndrome, hypersensitivity
vasculitis, interstitial nephritis.
Nervous System Disorders: Uncommon: Dizziness, headache. Very Rare: Reversible hyperactivity and convulsions. Convulsio
may occur in patients with impaired renal function or in those receiving high doses.
Gastrointestinal Disorders: Adults: Very Common: Diarrhea. Common: Nausea, vomiting. Children: Common: Diarrhea, nau
vomiting.
All Populations: Nausea is more often associated with higher oral dosages. If gastrointestinal reactions are evident, they ma
reduced by taking amoxicillin-clavulanate at the start of a meal. Uncommon: Indigestion. Very Rare: Antibiotic-associated c
(including pseudomembranous colitis and hemorrhagic colitis). Superficial tooth discoloration has been reported very rarel
children. Good oral hygiene may help to prevent tooth discoloration as it can usually be removed by brushing*.
Note: *This statement is core safety for the syrup, suspension and chewable tablet formulations.
Hepatobiliary Disorders: Uncommon: A moderate rise in AST and/or ALT has been noted in patients treated with -lactam c
antibiotics, but the significance of these findings is unknown. Very Rare: Hepatitis and cholestatic jaundice. These events ha
been noted with other penicillins and cephalosporins.
Hepatic events have been reported predominantly in males and elderly patients and may be associated with prolonged
treatment.
Children: These events have been rarely reported in children. All Populations: Signs and symptoms usually occur during or
shortly after treatment but in some cases may be not become apparent until several weeks after treatment has ceased. Th
are usually reversible. Hepatic events may be severe and in extremely rare circumstances, deaths have been reported. Thes
have almost always occurred in patients with serious underlying disease or taking concomitant medications known to have
potential for hepatic effects.
Skin and Subcutaneous Tissue Disorders: Uncommon: Skin rash, pruritus, urticaria. Rare: Erythema multiforme. Very Rare:
Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative-dermatitis, acute generalized exanthematous
pustulosis (AGEP). If any hypersensitivity dermatitis occurs, treatment should be discontinued.
Renal and Urinary Disorders: Very Rare: Interstitial nephritis, crystalluria (see Overdosage).
Data from large clinical trials were used to determine the frequency of adverse reactions. The following convention has bee
used for the classification of frequency: Very common (>1/10); common (>1/100 and <1/10); uncommon (>1/1000 and <1/
rare (>1/10,000 and <1/1000); very rare (<1/10,000).
Clinical Trial Data: Respiratory, Thoracic and Mediastinal Disorders: Very Common: Epistaxis.
In adults and adolescents, the incidence of epistaxis was higher in longer-term use (>6 weeks) than in short-term use (up to
weeks). In paediatric clinical studies of up to 12-weeks duration, the incidence of epistaxis was similar between Avamys nas
spray and placebo.
Common: Nasal ulceration.
Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods.
Headache, somnolence, dry mouth, fatigue.
Clinical Trial Data: Avodart Monotherapy: Approximately 19% of the 2167 patients who received dutasteride in the 2-year P
III placebo-controlled trials developed adverse reactions during the 1st year of treatment. The majority of events were mild
moderate and occurred in the reproductive system. No change to the adverse event profile was apparent over a further 2 y
in open-label extension studies.
Table 1 shows adverse reactions from controlled clinical trials and post-marketing experience. The listed adverse events fro
clinical trials are investigator-judged drug-related events (with incidence =1%) reported with a higher incidence in patients
treated with dutasteride compared with placebo during the 1st year of treatment. Adverse events from post-marketing
experience were identified from spontaneous post-marketing reports, therefore, the true incidence is unknown.
Avodart and Tamsulosin Combination Therapy for BPH: The following investigator-judged drug-related adverse events (with
cumulative incidence of =1%) have been reported in the CombAT (combination of Avodart and tamsulosin) study, a compar
of Avodart 0.5 mg and tamsulosin 0.4 mg once daily for 4 years in combination or as monotherapy. (See Table 2.)
Post-Marketing Data: Adverse drug reactions are listed by system organ class and frequency. Frequencies are defined as: Ve
common (=1/10), common (=1/100 and <1/10), uncommon (=1/1000 and <1/100), rare (=1/10,000 and <1/1000) and very
(<1/10,000) including isolated reports. Frequency categories determined from post-marketing data refer to reporting rate r
than true frequency.
Immune System Disorders: Very Rare: Allergic reactions, including rash, pruritus, urticaria, localised oedema and angioedem
Skin and Subcutaneous Tissue Disorders: Rare: Alopecia (primary body hair loss), hypertrichosis.
Fine tremor of skeletal muscle, palpitation & headache.
Acne, oily skin, deepening of voice, hot flushes, mild hirsutism, decrease in breast size, wt gain, clitoral hypertrophy (rarely)
hepatic dysfunction, alteration in value of lab test, allergic, dermatologic, GI, genitourinary, musculoskeletal, CNS, hematolo
Nausea, vomiting, diarrhea or abdominal pain; vertigo, dizzines, headache; skin rash, photosensitivity, angioedema; palpita
chest pain; monilia, vaginitis, nephritis; fatigue.
Diarrhoea, vomiting, abdominal discomfort, flatulence, nausea, gastric distension, gastric pain, dyspepsia, cholestatic jaund
Skin rash, GUT disturbances, headache, vertigo, somnolence, fatigue.
Retrobulbar neuritis w/ a reduction of visual acuity, central scotoma & green-red color blindness. Allergic rashes. GI
disturbances. CNS effects. Hyperuricemia. Peripheral neuritis. Liver damage. Blood disorders.
Retrobulbar neuritis w/ reduced visual acuity, central scotoma, green-red colour blindness. Allergic rashes. GI disturbances
Rarely, jaundice & peripheral neuritis. CNS effects. Hyperuricaemia.
GI disturbances, rash, itching, drowsiness/sedation, fatigue, malaise & headache.
Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, meteorism, dizziness, headache, insomnia, hallucinations, tremor
fatigue, skin reactions, transient elevations of liver enzymes.
Hypersensitivity reactions, GI disorders, renal & liver functions disorders, changes in blood constituent, local reactions,
neurological effects, superinfection.
Rash, burning, pruritus.

Cream: The following convention has been used for the classification of frequency: Common (>1/100 and <1/10).
Skin and Subcutaneous Tissue Disorders: Cutaneous hypersensitivity reactions.
Ointment: Adverse reactions are listed as follows by system organ class and frequency. Frequencies are defined as: Very co
(=1/10), common (=1/100, <1/10), uncommon (=1/1000, <1/100), rare (=1/10,000, <1/1000), very rare (<1/10,000), includi
isolated reports. Common and uncommon adverse reactions were determined from pooled safety data from a clinical trial
population of 1573 treated patients encompassing 12 clinical studies. Very rare adverse reactions were primarily determine
from post-marketing experience data and therefore, refer to reporting rate rather than true frequency.
Immune System Disorders: Very Rare: Systemic allergic reactions have been reported with Bactroban ointment.
Skin and Subcutaneous Tissue Disorders: Common: Burning localized to the area of application. Uncommon: Itching, erythe
stinging and dryness localized to the area of application; cutaneous sensitization reactions to mupirocin or the ointment ba
Loss of appetite, dry mouth, nausea, diarrhoea or constipation, headache, dizziness, somnolence, ataxia, confusion, agitati
visual accommodation disorders. Rarely, allergic skin reactions, fever, haematological effects.
High dose may cause nervousness, fatigue, drowsiness, nausea, headache, resp & CNS depressions.
Local burning or discomfort, itching, lid edema, tearing.
GI disturbances; dizziness, headache, insomnia, hallucinations, tremor, tiredness, visual disturbances; skin reactions; tempo
increase in liver enzyme values.
Clinical Trial Experience: Because clinical trial are conducted under widely varying conditions, adverse reaction rates observ
the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the
observed in practice.
Compensated Liver Disease: Assessment of adverse reactions is based on 4 studies (AI463014, AI463022, AI463026, and
AI463027) in which 1720 subjects with chronic hepatitis B infection and compensated liver disease received double-blind
treatment with Baraclude 0.5 mg/day (n=679), Baraclude 1 mg/day (n=183) or lamivudine (n=858) for up to 2 years. Media
duration of therapy was 69 weeks for Baraclude-treated subjects and 63 weeks for lamivudine-treated subjects in studies
AI463022 and AI463027 and 73 weeks for Baraclude-treated subjects and 51 weeks for lamivudine-treated subjects in stud
AI463026 and AI463014. The safety profiles of Baraclude and lamivudine were comparable in these studies. The safety pro
Baraclude 1 mg (n=51) in HIV/HBV co-infected subjects enrolled in study AI463038 was similar to that of placebo (n=17) thr
24 weeks of blinded treatment and similar to that seen in non-HIV infected patients.
The most common adverse events of any severity with at least a possible relation to study drug for Baraclude-treated subje
were headache, fatigue, dizziness and nausea. The most common adverse events among lamivudine-treated subjects were
headache, fatigue and dizziness. One percent of Baraclude-treated subjects in these 4 studies compared with 4% of lamivu
treated subjects discontinued for adverse events or abnormal laboratory test results (see Warnings and Precautions).
Clinical Adverse Events: Selected clinical adverse events of moderate to severe intensity and considered at least possibly re
to treatment occurring during therapy in 4 clinical studies in which Baraclude was compared with lamivudine are presented
Table 11. (See Table 11.)
Laboratory Abnormalities: Frequencies of selected treatment-emergent laboratory abnormalities reported during therapy i
clinical trials of Baraclude compared with lamivudine are listed in Table 12. (See Table 12.)
Among Baraclude-treated subjects in these studies, on-treatment ALT elevations >10 x ULN and >2 x baseline generally reso
with continued treatment. A majority of these exacerbations were associated with a =2 log10/mL reduction in viral load th
preceded or coincided with the ALT elevation. Periodic monitoring of hepatic function is recommended during treatment.
Exacerbations of Hepatitis After Discontinuation of Treatment: An exacerbation of hepatitis or ALT flare was defined as ALT
ULN and >2 x the subject's reference level (minimum baseline or last measurement at end of dosing). For all subjects who
discontinued the treatment, regardless of reason, Table 12 presents the proportion of subjects in each study who experien
post-treatment ALT flares. In these studies, a subset of subjects was allowed to discontinue treatment at or after 52 weeks
achieved a protocol-defined response to therapy. If Baraclude is discontinued without regard to treatment response, the ra
post-treatment flares could be higher (see Warnings and Precautions). (See Table 13.)
Decompensated Liver Disease: Study AI463048 was a randomized, open-label study of Baraclude 1 mg once daily versus ad
dipivoxil 10 mg once daily given for up to 48 weeks in adult subjects with chronic HBV infection and evidence of hepatic
decompensation, defined as a Child-Turcotte-Pugh (CTP) score of 7 or higher (see Microbiology: Clinical Studies under Actio
Among the 102 subjects receiving Baraclude, the most common treatment emergent adverse events of any severity, regard
of causality, occurring through week 48 were peripheral edema (16%), ascites (15%), pyrexia (14%), hepatic encephalophat
(10%), and upper respiratory infection (10%). Clinical adverse reactions not listed in Table 11 that were observed through w
Tiredness, dizziness, drowsiness & headache.
Diarrhea, nausea, vomiting, maculopapular rash, urticaria, drug fever, reversible neutropenia, decreased Hb or hematocrit,
transient eosinophilia, thrombocytopenia, hypoprothrombinemia, haemolytic anemia, headache, fever, inj pain, chills, tran
elevation of SGOT, SGPT, alkaline phosphatase, & bilirubin level.
Hypersensitivity reactions; constipation, feeling of abdominal enlargement, diarrhea, nausea, vomiting, heartburn, abdomi
pain, belching, taste abnormality; increase in transaminase levels; hematologic reactions.
Hypersensitivity (rash); insomnia, headache, dizziness, convulsion; nausea, anorexia; diplopia; warm sensation; abnormal li
function.
GI disturbances, black stool.
Renal losses due to rapid infusion; nausea & flushing in susceptible patients; febrile response, inj site infection, venous
thrombosis or phlebitis extending from inj site, extravasation & hypervolemia.
Allergy.
Rarely, allergic-anaphylactic reactions.
Many of the listed undesirable effects can be assigned to the anticholinergic and -adrenergic properties of Berodual. As w
inhalation therapy, Berodual may show symptoms of local irritation. Adverse drug reactions were identified from data obta
in clinical trials and pharmacovigilance during post approval use of the drug.
The most frequent side effects reported in clinical trials were cough, dry mouth, headache, tremor, pharyngitis, nausea,
dizziness, dysphonia, tachycardia, palpitations, vomiting, hypersensitivity, anaphylactic reactions, hypokalemia, nervousnes
agitation, mental disorder, glaucoma, increased intraocular pressure, accommodation disorder, mydriasis, blurred vision, ey
pain, corneal oedema, conjunctival hyperaemia, halo vision, increased heart rate, arrhythmia, atrial fibrillation, supraventri
tachycardia, myocardial ischaemia, cough, pharyngitis, bronchospasm, throat irritation, pharyngeal oedema, laryngospasm
paradoxical dry throat, stomatitis, glossitis, gastrointestinal motility disorder, diarrhoea, constipation, mouth oedema, urtic
rash, pruritus, angioedema, hyperhidrosis, muscular weakness, muscle spasms, myalgia, urinary retention, systolic increase
blood pressure, diastolic decreased blood pressure.
As with other -agonists, Berotec may cause the following adverse reactions including serious hypokalaemia. As with all
inhalation therapy, Berotec may show symptoms of local irritation.
Immune System Disorders: Hypersensitivity.
Metabolism and Nutrition Disorders: Hypokalaemia.
Psychiatric Disorders: Agitation, nervousness.
Nervous System Disorders: Tremor, headache, dizziness.
Cardiac Disorders: Myocardial ischaemia, arrhythmia, tachycardia, palpitations.
Respiratory, Thoracic and Mediastinal Disorders (Only Applicable to Inhalative Formulations): Paradoxical bronchospasm, co
throat irritation.
Gastrointestinal Disorders: Nausea, vomiting.
Skin and Subcutaneous Tissue Disorders: Hyperhidrosis; skin reaction eg, rash, pruritus, urticaria.
Musculoskeletal, Connective Tissue and Bone Disorders: Muscle spasm, myalgia, muscular weakness.
Investigations: Increased systolic blood pressure, decreased diastolic blood pressure.
Sedation.
Nausea, vomiting, diarrhea, abdominal pain, indigestion, flatulence, anorexia, dysphagia, dyspepsia; dizziness, headache, fa
insomnia, agitation, tremor; drug eruption of the skin, macula erythema, Stevens-Johnson syndrome, anaphylaxis/anaphyla
reactions, dyspnea; hypersensitivity reactions; eosinophilia, leucocytopenia, leukocytosis, granulositopenic anemia; laborat
urine deposite effects; transient increase of transaminase & alkaline phosphatase conc in the blood, cholestatic jaundice,
transient increase of blood urea, creatinine, bilirubin, hyperglycemia; tendonitis; interstitial nephritis, kidney failure, polyur
urinary retention, urethral bleeding, vaginitis & acidosis; hepatitis, tachycardia, palpitation, atrial flutter, ventricular ectopy,
syncope, angina pectoris, HTN, MI, cardiopulmonary arrest, cerebral thrombosis, flushing, migraine, syncope; joint & musc
pain, malaise, tendovaginitis, mild photosensitivity, tinnitus, hearing disturbances, epistaxis, laryngeal or pulmonary oedem
hemoptysis, bronchospasm, pulmonary embolism.
Irritation, hypersensitivity, rise in IOP, blurred vision, subcapsular cataract, corneal thinning & perforation.
Constipation, diarrhea, dry mouth, abdominal distention, headache, nausea, vomiting, urticaria, rash. Rarely, hepatic enzym
hematologic changes.
Rise in IOP, hypersensitivity reactions, blurred vision, posterior subcapsular cataracts formation.
Headache, dizziness, drowsiness, agitation, GI discomfort, skin reaction, angioedema.
The following undesirable effects have been experienced with the indicated frequencies as follows in betahistine-treated
patients in placebo-controlled clinical trials: Very common (=1/10); common (=1/100 to <1/10); uncommon (=1/1,000 to 1/
rare (=1/10,000 to <1/1,000); very rare (<1/10,000).
Headache.
Gastrointestinal Disorders: Common: Nausea and dyspepsia.
In addition to those events reported during clinical trials, the following undesirable effects have been reported spontaneou
during postmarketing use and in scientific literature. A frequency cannot be estimated from the available data and is theref
classified as "not known".
Immune System Disorders: Hypersensitivity reactions, e.g. anaphylaxis have been reported.
Gastrointestinal Disorders: Mild gastric complaints (e.g. vomiting, gastrointestinal pain, abdominal distention and bloating)
been observed. These can normally be dealt with by taking the dose during meals or by lowering the dose.
Skin and Subcutaneous Tissue Disorders: Cutaneous and subcutaneous hypersensitivity reactions have been reported, in
particular angioneurotic oedema, urticaria, rash and pruritus.
Nausea, diarrhea (rare).

Nausea, vomiting, skin rash.
Local atrophic skin changes.
GI disturbances, hypersensitivity reactions, superinfection, transient leucopenia, eosinophilia, neutropenia, thrombocytosis

Transient SGOT or SGPT & BUN elevations.
GI symptoms (transient). Allergic skin reactions. Potency disorders. Rarely hair loss, rhabdomyolysis.
Nausea, anorexia, epigastric pain, metallic taste, vomiting, GI disturbances, urticaria, skin redness, pruritus, angioedema,
anaphylaxis.
Abdominal discomfort.
Diarrhoea, nausea, abnormal taste, dyspepsia, abdominal pain, headache.
Skin reactions, fever, hematological changes, increased hepatic enzyme function, diarrhea, nausea, vomiting,
pseudomembranous colitis, pain at the inj site, phlebitis.
Zn toxicity (>150 mg/day). Prolonged use & high-dose of Zn may reduce lipoprotein conc & copper absorption.
Anaphylactic shock; serum sickness; fever w/ trembling; pain at inj site after high dose of antisera inj.
Itching, exanthema, cold sensation, fever, hot flushes, nausea, dizziness, anaphylactic shock.
Nausea, vomiting, diarrhea, pseudomembranous colitis, icterus, oliguria, proteinuria, allergic reactions (urticaria, maculopa
rash, SJS) & hypotension.
Hematological, skin reactions, other allergic reactions.
Diarrhea (doses >350 mg daily). Nausea & abdominal cramps.

Nausea, vomiting, gastric or abdominal pain, diarrhea, constipation.
The following adverse reactions have been observed during treatment with perindopril and ranked under the following
frequencies: Very common (1/10); common (1/100, <1/10); uncommon (1/1000, <1/100); rare (1/10,000, <1/1000); very ra
(<1/10,000); not known (cannot be estimated from the available data).
Blood and Lymphatic System Disorders: Decreases in haemoglobin and haematocrit, thrombocytopenia, leucopenia/neutro
and cases of agranulocytosis or pancytopenia, have been reported very rarely. In patients with a congenital deficiency of G
very rare cases of haemolytic anaemia have been reported (see Precautions).
Metabolism and Nutrition Disorders: Not Known: Hypoglycaemia (see Precautions and Interactions).
Psychiatric Disorders: Uncommon: Mood or sleep disturbances.
Nervous System Disorders: Common: Headache, dizziness, vertigo, paraesthesia. Very Rare: Confusion.
Eye Disorders: Common: Visual disturbance.
Ear and Labyrinth Disorders: Common: Tinnitus.
Cardiac Disorders: Very Rare: Arrhythmia, angina pectoris and myocardial infarction, possibly secondary to excessive hypot
in high-risk patients (see Precautions).
Vascular Disorders: Common: Hypotension and effects related to hypotension. Very Rare: Stroke, possibly secondary to exc
hypotension in high-risk patients (see Precautions). Not Known: Vasculitis.
Respiratory, Thoracic and Mediastinal Disorders: Common: Cough, dyspnoea. Uncommon: Bronchospasm. Very Rare:
Eosinophilic pneumonia, rhinitis.
Gastrointestinal Disorders: Common: Nausea, vomiting, abdominal pain, dysgeusia, dyspepsia, diarrhoea, constipation.
Uncommon: Dry mouth. Very Rare: Pancreatitis.
Hepatobiliary Disorders: Very Rare: Hepatitis either cytolytic or cholestatic (see Precautions).
Skin and Subcutaneous Tissue Disorders: Common: Rash, pruritus. Uncommon: Angioedema of face, extremities, lips, muc
membranes, tongue, glottis and/or larynx, urticaria (see Precautions). Very Rare: Erythema multiforme.
Musculoskeletal and Connective Tissue Disorders: Common: Muscle cramps.
Renal and Urinary Disorders: Uncommon: Renal insufficiency. Very Rare: Acute renal failure.
Reproductive System and Breast Disorders: Uncommon: Impotence.
General Disorders and Administration Site Conditions: Common: Asthenia. Uncommon: Sweating.
Investigations: Increases in blood urea and plasma creatinine, hyperkalaemia reversible on discontinuation may occur, espe
in the presence of renal insufficiency, severe heart failure and renovascular hypertension. Elevation of liver enzymes and se
bilirubin have been reported rarely.
Clinical Trials: During the randomised period of the EUROPA study, only serious adverse events were collected. Few patient
experienced serious adverse events: 16 (0.3%) of the 6122 perindopril patients and 12 (0.2%) of the 6107 placebo patients
the perindopril-treated patients, hypotension was observed in 6 patients, angioedema in 3 patients and sudden cardiac arr
1 patient. More patients withdrew for cough, hypotension or other intolerance on perindopril than on placebo, 6.0% (n=36
versus 2.1% (n=129) respectively.
The administration of perindopril inhibits the renin-angiotensin-aldosterone axis and tends to reduce the potassium loss ca
by indapamide. Four percent (4%) of the patients on treatment with Bioprexum Plus experience hypokalemia (potassium le
<3.4 mmol/L).
The following undesirable effects could be observed during treatment and ranked under the following frequency: Very com
(>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10,000, <1/1000), very rare (<1/10,000) and no
known (cannot be estimated from the available data).
Blood and Lymphatic System Disorders: Very Rare: Thrombocytopenia, leucopenia/neutropenia, agranulocytosis, aplastic
anaemia, hemolytic anaemia.
Anaemia has been reported with ACE inhibitors in specific circumstances (patients who have had kidney transplants, patien
undergoing hemodialysis). (See Precautions.)
Psychiatric Disorders: Uncommon: Mood or sleep disturbances.
Nervous System Disorders: Common: Paraesthesia, headache, asthenia, feelings of dizziness, vertigo. Very Rare: Confusion.
Eye Disorders: Common: Visual disturbance.
Ear and Labyrinth Disorders: Common: Tinnitus.
Vascular Disorders: Common: Hypotension, whether orthostatic or not (see Precautions).
Cardiac Disorders: Very Rare: Arrhythmia including bradycardia, ventricular tachycardia, atrial fibrillation, angina pectoris an
myocardial infarction possibly secondary to excessive hypotension in high-risk patients (see Precautions).
Respiratory, Thoracic and Mediastinal Disorders: Common: A dry cough has been reported with the use of ACE inhibitors. It
characterised by its persistence and disappearance when treatment is withdrawn. An iatrogenic etiology should be conside
the presence of this symptom. Dyspnea. Uncommon: Bronchospasm. Very Rare: Eosinophilic pneumonia, rhinitis.
Gastrointestinal Disorders: Common: Constipation, dry mouth, nausea, epigastric pain, anorexia, vomiting, abdominal pain
disturbance, dyspepsia, diarrhea. Very Rare: Pancreatitis.
Hepatobiliary Disorders: Very Rare: Hepatitis either cytolytic or cholestatic (see Precautions). Not Known: In case of hepatic
insufficiency, there is a possibility of onset of hepatic encephalopathy (see Contraindications and Precautions).
Skin and Subcutaneous Tissue Disorders: Common: Rash, pruritus, maculopapular eruptions. Uncommon: Angioedema of f
extremities, lips, mucous membranes, tongue, glottis and/or larynx, urticaria (see Precautions). Hypersensitivity reactions,
mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions; purpura. Possible aggravation o
preexisting acute disseminated lupus erythematosus. Very Rare: Erythema multiforme, toxic epidermal necrolysis, Stevens-
Johnson syndrome. Cases of photosensitivity reactions have been reported (see Precautions).
Musculoskeletal, Connective Tissue and Bone Disorders: Common: Cramps.
Renal and Urinary Disorders: Uncommon: Renal insufficiency. Very Rare: Acute renal failure.
Reproductive System and Breast Disorders: Uncommon: Impotence.
General Disorders and Administration Site Conditions: Common: Asthenia. Uncommon: Sweating.
Investigations: Potassium depletion with particularly serious reduction in levels of potassium in some at risk populations (se
Precautions). Reduced sodium levels with hypovolemia causing dehydration and orthostatic hypotension. Increase in uric a
levels and in blood glucose levels during treatment. Slight increase in urea and in plasma creatinine levels, reversible when
treatment is stopped. This increase is more frequent in cases of renal artery stenosis, arterial hypertension treated with
diuretics, renal insufficiency. Increased levels of potassium, usually transitory. Rare: Raised plasma calcium levels.
Skin tingling, burning or irritation.

Anaphylactic shock; serum sickness; fever w/ trembling; pain at inj site after high dose of antisera inj.
Anaphylactic shock; serum sickness; fever w/ trembling, pain at inj site after high dose of antisera inj.
Blood dyscrasias; anaphylaxis, urticaria; GI disturbances, Gray syndrome.

Feeling of coldness or numbness in the extremities; nausea, vomiting, diarrhea, constipation; tiredness, exhaustion, dizzine
headache; muscular weakness & cramps; AV stimulus disturbances, worsening of heart failure, orthostatic hypotension; sle
disturbances, depression; bronchospasm in patient w/ bronchial asthma or history of obstructive airways disease; nightma
hallucination; hypersensitivity reactions; increased ALAT, ASAT, triglycerides; hepatitis, potency disorders; hearing impairme
allergic rhinitis, reduced tear flow; conjunctivitis; dyspnea, cardiomyopathy, tachycardia, viral infection, pneumonia, fatigue
Hypersensitivity reaction including contact dermatitis.
Local allergic reactions.
Increased IOP, perforation in conditions causing thinning of the cornea, local allergic reactions.
HTN, nausea, vomiting, headache, hypotension, hallucination, diarrhea, chest pain/transient chest pain; tinnitus, diaphores
palpitation, dyspnea, thrombophlebitis, hematuria, leg cramp, nasal congestion, taste disturbance, allergic reaction, severe
arrhythmia, cerebrovascular attack & disturbance, skin eruption, CV reactions.
Pneumonitis, occasionally progresssing to pulmonary fibrosis; pyrexia, thickening of vein wall; nausea & vomiting. Very rare
anaphylaxis.
Reversible ovarian enlargement, abdominal discomfort or pain, nausea, vomiting, transient visual disturbances, headache,
abnormal uterine bleeding, dizziness, fatigue, insomnia, vertigo.
Paralytic ileus, hypoxemia, anginal pain, thrombocytopenia.

Treatment of Hypertension: In controlled clinical studies, adverse events were mild and transient and comparable to placeb
The overall incidence of adverse events showed no association with dose or age.
Withdrawals from treatment due to adverse events were similar with candesartan cilexetil (3.1%) and placebo (3.2%).
In a pooled analysis of clinical trial data, the following common (>1/100) adverse reactions with candesartan cilexetil were
reported based on an incidence of adverse events with at least 1% higher than the incidence seen with placebo: Nervous S
Disorders: Dizziness/vertigo, headache.
Infections and Infestations: Respiratory infection.
Laboratory Findings: In general, there were no clinically important influences of Blopress on routine laboratory variables. A
other inhibitors of the renin-angiotensin-aldosterone system, small decreases in haemoglobin have been seen. Increases in
creatinine, urea or potassium and decrease in sodium have been observed.
Increases in S-GPT were reported as adverse events slightly more often with Blopress than the placebo (1.3% vs 0.5%). No
routine monitoring of laboratory variables is usually necessary for patients receiving Blopress. However, in patients with ren
impairment, periodic monitoring of serum potassium and creatinine levels is recommended.
Treatment of Heart Failure: The adverse experience profile of Blopress in heart failure patients was consistent with the
pharmacology of the drug and the health status of the patients. Adverse reactions commonly (>1/100, <1/10) seen were:
Vascular Disorders: Hypotension.
Metabolism and Nutrition Disorders: Hyperkalaemia.
Renal and Urinary Disorders: Renal impairment.
Laboratory Findings: Increases in creatinine, urea and potassium. Periodic monitoring of serum creatinine and potassium is
recommended.
Post Marketing: The following adverse reactions have been reported very rarely (<1/10,000) in post marketing experiences
Blood and Lymphatic System Disorders: Leukopenia, neutropenia and agranulocytosis.
Metabolism and Nutrition Disorders: Hyperkalaemia, hyponatraemia.
Nervous System Disorders: Dizziness, headache.
Gastrointestinal Disorders: Nausea.
Hepato-Biliary Disorders: Increased liver enzymes, abnormal hepatic function or hepatitis.
Skin and Subcutaneous Tissue Disorders: Angioedema, rash, urticaria, pruritus.
Musculoskeletal, Connective Tissue and Bone Disorders: Back pain, arthralgia, myalgia.
Renal and Urinary Disorders: Renal impairment, including renal failure in susceptible patients.
Candesartan Cilexetil-Hydrochlorothiazide: Blopress Plus has been evaluated for safety in >2800 patients treated for
hypertension. More than 750 of these patients were studied for at least 6 months and >500 patients were treated for at lea
year. Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinu
of therapy. The overall incidence of adverse events reported with Blopress Plus was comparable to placebo. The overall
frequency of adverse experiences was not related to dose, age, gender or race.
In placebo-controlled trials that included 1089 patients treated with various combinations of candesartan cilexetil (doses o
mg) and hydrochlorothiazide (doses of 6.25-25 mg) and 592 patients treated with placebo, adverse events, whether or not
attributed to treatment, occurring in >2% of patients treated with Blopress Plus and that were more frequent for Blopress P
than placebo were: Respiratory System Disorder: Upper respiratory tract infections (3.6% vs 3%).
Body as a Whole: Back pain (3.3% vs 2.4%), influenza-like symptoms (2.5% vs 1.9%).
Central/Peripheral Nervous System: Dizziness (2.9% vs 1.2%).
The frequency of headache was >2% [2.9% in patients treated with Blopress Plus but was less frequent than the rate in pati
treated with placebo (5.2%)].
Other adverse events have been reported whether or not attributed to treatment, with an incidence of =0.5% from >2800
patients worldwide treated with Blopress Plus included: Body as a Whole: Inflicted injury, fatigue, pain, peripheral oedema
asthenia.
Central and Peripheral Nervous System: Vertigo, paresthesia, hypesthesia.
Respiratory System Disorders: Bronchitis, sinusitis, pharyngitis, coughing, rhinitis, dyspnea.
Musculoskeletal System Disorders: Arthralgia, myalgia, arthrosis, arthritis, leg cramps, sciatica.
Gastrointestinal System Disorders: Nausea, abdominal pain, diarrhea, dyspepsia, gastritis, gastroenteritis, vomiting.
Metabolic and Nutritional Disorders: Hyperuricaemia, hyperglycemia, hypokalemia, increased BUN, increased creatinine
phosphokinase.
Urinary System Disorder: Urinary tract infection, hematuria, cystitis.
Liver/Biliary System Disorders: Abnormal hepatic function, increased transaminase levels.
Heart Rate and Rhythm Disorders: Tachycardia, palpitation, extrasystoles, bradycardia.
Psychiatric Disorders: Depression, insomnia, anxiety.
Cardiovascular Disorders: Abnormal ECG.
Skin and Appendages Disorders: Eczema, increased sweating, pruritus, dermatitis, rash.
Platelet/Blood Clotting Disorders: Epistaxis.
Resistance Mechanism Disorders: Infection, viral infection.
Vision Disorder: Conjunctivitis.
Hearing and Vestibular Disorders: Tinnitus.
Reported events seen less frequently than 0.5% included angina pectoris, myocardial infarction and angioedema.
Candesartan Cilexetil: Other adverse experiences that have been reported without regard to causality are as follows: Body
Whole: Fever.
Metabolic and Nutritional Disorders: Hypertriglyceridemia.
Psychiatric Disorders: Somnolence.
Urinary System
Occassional Disorders:
dizziness, Albuminuria.
headaches, fatigue, bradycardia, postural HTN, GI upset, flare-like syndrome, reduced lacrimations.
Hypocalcemia, bone pain, myalgia, pyrexia, influenza, rigors, osteonecrosis of the jaw.
Itching & rash.

Headache, pain in face, flu syndrome, inj site pain & edema, back pain, accidental injury, infections, bronchitis, sinusitis,
pharyngitis, dyspnea, sinus infection, laryngitis, rhinitis, erythema, skin tightness, skin irritation, nausea, dyspepsia, tooth
disorder, abnormal liver function, blepharoptosis, dizziness, paresthesia, anxiety, twitch, muscle weakness, UTI, ecchymosis
HTN.
Epigastric distress, nausea, skin redness, headache, dizziness.
Hypotension, rash, insomnia, drowsiness.
Localised ocular toxicity & hypersensitivity including itching, swelling & conjunctival erythema.
Localized ocular toxicity & hypersensitivity including lid itching, swelling & conjunctival erythema. Secondary infection.
Headache, abdominal pain, nausea, vag hemorrhage, OHSS, abdominal distention, inj site reaction.
Hypersensitivity reactions. May cause collagen loss & SC atrophy.
Drowsiness, ataxia, confusion, dryness of the mouth, blurring of vision, urinary hesitancy & constipation.
Rarely, somnolence & GI disturbances. Aggravation or manifestation of extrapyramidal symptoms (prolonged use in elderly
Rash, itching or swelling (especially of the face, tongue or throat), severe dizziness, trouble in breathing.
Myelosuppression, hypersensitivity, cutaneous & infusion site reactions, fluid retention, neuropathy, GI symptoms (includin
stomatitis, nausea & vomiting), hypotension, elevation of liver enzymes.
The intensity of the adverse reactions depends on dosage and route of administration. An initial dose titration will often re
the adverse reactions. Most of the adverse reactions are characteristic of sympathomimetic amines. The majority of these
effects have reversed spontaneously within the first 1-2 weeks of treatment. (see table.)

Clinical Trials Experience: The following adverse reactions are also discussed elsewhere in the labeling: Dyspnea (see
Precautions).
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials o
drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in pra
BRILINTA has been evaluated for safety in more than 10,000 patients, including more than 3,000 patients treated for >1 yea
Bleeding: PLATO used the following bleeding severity categorization: Major Bleed: Fatal/Life-Threatening: Any one of the
following: Fatal; intracranial; intrapericardial bleed with cardiac tamponade; hypovolemic shock or severe hypotension due
bleeding and requiring pressors or surgery; clinically overt or apparent bleeding associated with a decrease in hemoglobin
of more than 5 g/dL; transfusion of 4 or more units [whole blood or packed red blood cells (PRBCs)] for bleeding.
Major Bleed: Other: Any one of the following: Significantly disabling (eg, intraocular with permanent vision loss); clinically o
or apparent bleeding associated with a decrease in Hb of 3 g/dL; transfusion of 2-3 units (whole blood or PRBCs) for bleedi
Minor Bleed: Requires medical intervention to stop or treat bleeding (eg, epistaxis requiring visit to medical facility for pack
Minimal Bleed: All others (eg, bruising, bleeding gums, oozing from injection sites, etc) not requiring intervention or treatm
Figure 9 shows major bleeding events over time. Many events are early, at a time of coronary angiography, PCI, CABG and o
procedures, but the risk persists during later use of antiplatelet therapy.
Annualized rates of bleeding are summarized in Table 2. About half of the bleeding events were in the first 30 days. (See Ta
As shown in Table 2, BRILINTA was associated with a somewhat greater risk of non-CABG bleeding than was clopidogrel. No
baseline demographic factor altered the relative risk of bleeding with BRILINTA compared to clopidogrel.
In PLATO, 1,584 patients underwent CABG surgery. The percentages of those patients who bled are shown in Table 3. Rates
very high but similar for BRILINTA and clopidogrel. (See Table 3.)
Although the platelet inhibition effect of Brilinta has a faster offset than clopidogrel in in vitro tests and Brilinta is a reversib
binding P2Y12 inhibitor, PLATO did not show an advantage of BRILINTA compared to clopidogrel for CABG-related bleeding.
When antiplatelet therapy was stopped 5 days before CABG, major bleeding occurred in 75% of BRILINTA treated patients a
79% on clopidogrel.
No data exists with Brilinta regarding a hemostatic benefit of platelet transfusions.
Drug Discontinuation: In PLATO, the rate of study drug discontinuation attributed to adverse reactions was 7.4% for BRILINT
5.4% for clopidogrel. Bleeding caused permanent discontinuation of study drug in 2.3% of BRILINTA patients and 1.0% of
clopidogrel patients. Dyspnea led to study drug discontinuation in 0.9% of BRILINTA and 0.1% of clopidogrel patients.
Common Adverse Events: A variety of non-hemorrhagic adverse events occurred in PLATO at rates of =3%. These are shown
Table 4. In the absence of a placebo control, whether these are drug related cannot be determined in most cases, except w
they are more common on BRILINTA or clearly related to the drug's pharmacologic effect (dyspnea). (See Table 4.)
Post-Marketing Experience: The following adverse reactions have been identified during post-approval use of BRILINTA. Bec
these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate
frequency or establish
Nausea, vomiting a causalstomatitis,
& diarrhea, relationship to drug
glottis; exposure.
headache & dizziness; skin reactions; eosinophilia, thrombocytosis, leukop
granulocytopenia & hemolytic anemia; transient elevations of SGOT or SGPT, BUN. Rarely, inflammatory reactions at inj site
Drowsiness, indigestion, psychomotor disorder, tachycardia, arrhythmia, palpitation, urinary retention, liver damage (high d
prolonged use).
Nausea, diarrhea, indigestion, bloating, headache, vertigo, increased sweating, skin, rash, increased serum transaminase.
Mild GI disturbances.
Nausea, abdominal pain, vomiting; rash, urticaria, & coughing; dyspnea, asthma; fever, fatigue, allergic reactions.
The pattern of adverse events reported for ibuprofen is similar to that for other NSAIDs. Immune system disorder, i.e.
hypersensitivity reaction has been reported following treatment with ibuprofen. The most commonly observed adverse eve
are gastrointestinal in nature. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena,
hematemesis, ulcerative stomatitis, gastrointestinal hemorrhage and exacerbation of colitis and Crohn's disease (see
Contraindications) have been reported following ibuprofen administration.
Allergic exanthema, red striae, petechiae, ecchymosis, steroid acne, delayed wound healing, contact dermatitis, muscle
weakness, osteoporosis, aseptic necrosis of the bone, glaucoma, cataract, depression, irritability, euphoria, GI discomfort,
duodenal ulcer, pancreatitis, Cushing's syndrome, HTN, increased risk of thrombosis & vasculitis, delayed immune response
Nausea, vomiting, diarrhea, headache, insomnia, palpitation, tachycardia, ventricular arrhythmia, tachypnea, skin rash,
hyperglycemia.
Headache, edema, fatigue, insomnia, nausea, abdominal pain, vomiting, palpitation, dizziness, pruritus, rash, dyspnea, asth
muscle cramps, dyspepsia, gingival hyperplasia, erythema multiforme.
Adrenal suppression, change of glucose metabolism, protein catabolism, gastric ulcer activation.
Local irritation, erythema, eczema, allergic or non-allergic contact dermatitis (symptoms: Itching, redness, edema, papul, ve
bullae or flaky skin). Systemic reactions eg, skin rash, hypersensitivity reactions (eg, asthma, angioderma) & photosensitivit
GI disturbances, allergic reactions, anaphylaxis, haematologic disorders, nausea, vomiting.
Drowsiness, CV, hematology, neurological, GIT, GUT, resp tract reactions. Skin redness, dry mouth.
Nausea, vomiting, diarrhea, constipation, abdominal pain or transient burning on the upper stomach, skin rashes,
bronchospasm, thrombocytopenia, lymphopenia, blurred or diminished vision.
Maternal hypotension, backache, headache, neuropathy, peripheral nerve injury & arachnoiditis, cutaneous lesions, urticar
oedema or anaphylactoid reactions. CNS, CV effects.
Hypotension, bradycardia, post-spinal headache.

Combination therapy with amlodipine and atorvastatin has been evaluated for safety in 1092 patients in double-blind, plac
controlled studies treated for concomitant hypertension and dyslipidemia. In clinical trials, no adverse events peculiar to
combination therapy with amlodipine and atorvastatin have been observed. Adverse events have been limited to those tha
were reported previously with amlodipine and/or atorvastatin (see respective adverse event experiences as follows).
In general, combination therapy with amlodipine and atorvastatin was well tolerated. For the most part, adverse events ha
been mild or moderate in severity. In controlled clinical trials, discontinuation of therapy due to adverse events or laborato
abnormalities was required in only 5.1% of patients treated with both amlodipine and atorvastatin compared to 4% of pati
given placebo.
The following information is based on clinical trials and post-marketing experience with amlodipine and atorvastatin.
Amlodipine Experience: The following events occurred in 1% but >0.1% of patients treated with amlodipine in controlled-c
trials or under conditions of open trials or marketing experience where a causal relationship is uncertain; the events are lis
alert the physician to a possible relationship: Cardiovascular: Arrhythmia (including ventricular tachycardia and atrial fibrilla
bradycardia, chest pain, hypotension, peripheral ischemia, syncope, tachycardia, postural dizziness, postural hypotension,
vasculitis.
Central and Peripheral Nervous System: Hypoesthesia, peripheral neuropathy, paresthesia, tremor, vertigo.
Gastrointestinal: Anorexia, constipation, dyspepsia, **dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival
hyperplasia.
General: Allergic reaction, asthenia, **back pain, hot flushes, malaise, pain, rigors, weight gain, decreased weight.
Musculoskeletal System: Arthralgia, arthrosis, muscle cramps, **myalgia.
Psychiatric: Sexual dysfunction, (male** and female), insomnia, nervousness, depression, abnormal dreams, anxiety,
depersonalization.
Respiratory System: Dyspnea, **epistaxis.
Skin and Appendages: Angioedema, erythema multiforme, pruritus, **rash, **erythematous rash, maculopapular rash.
**These events occurred in <1% in placebo-controlled-trials but the incidence of these side effects was between 1% and 2%
all multiple dose studies.
Special Senses: Abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus.
Urinary System: Frequent micturition, micturition disorder, nocturia.
Autonomic Nervous System: Dry mouth, increased sweating.
Metabolic and Nutritional: Hyperglycemia and thirst.
Hemapoietic: Leucopenia, purpura, thrombocytopenia.
The following events occurred in =0.1% of patients treated with amlodipine in controlled-clinical trials or under conditions
open trials or marketing experience: Cardiac failure, pulse irregularity, extrasystoles, skin discoloration, urticaria, skin dryne
alopecia, dermatitis, muscle weakness, twitching, ataxia, hypertonia, migraine, cold and clammy skin, apathy, agitation, am
gastritis, increased appetite, loose stools, coughing, rhinitis, dysuria, polyuria, parosmia, taste perversion, abnormal visual
accomodation and xerophthalmia.
Other reactions occurred sporadically and cannot be distiguished from medications or concurrent disease states eg, myoca
infarction and angina.
Amlodipine therapy has not been associated with clinically significant changes in routine laboratory tests. No clinically relev
Irritation.
Mild & transient vasodilation, HTN, feeling of warmth, nausea, dizziness, SC oedema & palpitation.
Hypercalcemia & hypercalciuria.

Constipation; hypercalcaemia & hypercalciuria. Mild GI disturbance.
Hypercalciuria.
Rarely flatulence, diarrhea or constipation.
Rarely, flatulence, diarrhea or constipation.

Headache, edema, fatigue, nausea, flushing, dizziness.
Rarely, flatulence, diarrhea or constipation.
Clinical Studies: Adverse event data has been extensively collected and analyzed for the clinical studies program in metasta
colorectal cancer that recurred or progressed following 5-FU-based therapy (2nd-line) and are presented as follows (patien
population described as follows). The adverse events for other indications are expected to be similar to those for 2nd-line
colorectal cancer.
Clinical Studies of the 100- to 125-mg/m2 Single-Agent Weekly Dosage Schedule: The weekly dosage schedule of irinoteca
evaluated in three clinical studies of 304 patients with metastatic carcinoma of the colon or rectum that had recurred or
progressed following 5-FU-based therapy. Five (1.6%) deaths were potentially drug-related. These 5 patients experienced a
constellation of medical events (myelosuppression, neutropenic sepsis without fever, small bowel obstruction, fluid
accumulation, stomatitis, nausea, vomiting, diarrhea and dehydration) that are known effects of irinotecan. Neutropenic fe
defined as NCI grade 4 neutropenia and =grade 2 fever, occurred in 9 other patients; these patients recovered with supporti
care.
Eighty-one (26.6%) patients were hospitalized for events judged to be related to administration of irinotecan. The primary
reasons for drug-related hospitalization were diarrhea with or without nausea and/or vomiting; neutropenia/leukopenia w
without diarrhea and/or fever; and nausea and/or vomiting.
Adjustments in the dose of irinotecan were made during the cycle of treatment and for subsequent cycles based on individ
patient tolerance. The most common reasons for dose reduction were late diarrhea, neutropenia and leukopenia. Thirteen
(4.3%) patients discontinued treatment with irinotecan because of adverse events.
Clinical Studies of the 300- to 350-mg/m2 Once-Every-3-Week Single-Agent Dosage Schedule: A total of 316 patients with
metastatic colorectal cancer whose disease had progressed following prior 5-FU therapy received irinotecan in 2 studies
involving once-every-3-week administration. Three (1%) deaths were potentially related to irinotecan treatment and were
attributed to neutropenic infection, grade 4 diarrhea and asthenia, respectively. Hospitalizations due to serious adverse eve
whether or not related to irinotecan administration, occurred at least once in 60% of patients who received irinotecan and
patients treated with irinotecan discontinued treatment due to adverse events.
Listing of Adverse Events: The drug-related adverse events (NCI grades 1-4) as judged by the investigator that were reporte
>10% of the 304 patients enrolled in the 3 studies of the weekly dosage schedule are listed by body system in descending o
of frequency as follows: Gastrointestinal Disorders: Late diarrhea, nausea, vomiting, early diarrhea, abdominal cramping/pa
anorexia, stomatitis.
Blood and Lymphatic System Disorders: Leukopenia, anemia, neutropenia.
General Disorders and Administration Site Conditions: Asthenia, fever.
Metabolism and Nutrition Disorders: Decreased weight, dehydration.
Skin and Subcutaneous Tissue Disorders: Alopecia.
Vascular Disorders: Thromboembolic events*.
*Includes angina pectoris, arterial thrombosis, cerebral infarct, cerebrovascular accident, deep thrombophlebitis, embolus
extremity, heart arrest, myocardial infarct, myocardial ischemia, peripheral vascular disorder, pulmonary embolus, sudden
thrombophlebitis, thrombosis, vascular disorder.
NCI grades 3 or 4 adverse events reported in the clinical studies of the weekly and once-every-3-week-dosage schedules (N
are listed as follows: NCI Grade 3 or 4 Drug-Related Adverse Events Observed in >10% of Patients in Clinical Studies:
Gastrointestinal Disorders: Late diarrhea, nausea, abdominal cramping/pain.
Back pain, dizziness, upper resp tract infections, pharyngitis & rhinitis.
GI disturbances.
Hypotension, hyperkalemia, kidney disorders; increase of creatinine, urea, or K; leucopenia, neutropenia, agranulocytosis;
hyponatremia; headache, dizziness; nausea; increase of liver enzyme, impaired liver function or hepatitis; angioedema, skin
urticaria, pruritus; back pain, arthralgia, myalgia.
Erythema, stinging, blistering, peeling, edema, pruritus, urticarial, burning, & irritation of the skin.
Rarely, mild local skin reactions.
Blood dyscrasias, GI & hypersensitivity reactions; headache, mental depression, optic neuritis & Gray syndrome.
Diarrhea, headache, nausea, skin allergy, abdominal pain, constipation, flatulence & vomiting.
Face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest
accidental injury, angina pectoris, AV block, migraine, syncope, tachycardia, palpitation, hypotension, postural hypotension
myocardial ischemia, cerebral thrombosis, cardiac arrest, heart failure, abnormal ECG, cardiomyopathy, vomiting, glossitis,
dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, dry mouth, abnormal liver function tests, rectal hemorrhage,
gingivitis, anemia, leukopenia, thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia,
hypoglycemic reaction, hypernatremia, arthritis, arthrosis, myalgia, tendon rupture, tenosynovitis, bone pain, myasthenia,
synovitis, ataxia, hypertonia, neuralgia, neuropathy, paresthesia, tremor, vertigo, depression, insomnia, somnolence, abnor
dreams, decreased reflexes, hypesthesia, asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, increased sputum,
increased cough, urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis, mydrias
conjunctivitis, photophobia, tinnitus, eye pain, deafness, ear pain, eye hemorrhage, cataract, dry eyes, cystitis, nocturia, ur
frequency, breast enlargement, urinary incontinence, abnormal ejaculation, genital edema, & anorgasmia.
Inflammation, thrombophlebitis, inj site pain; pruritic rash, urticaria; abdominal pain, nausea, vomiting, diarrhea,
pseudomembranous colitis; reversible thrombocythemia, eosinophilia, thrombocytopenia, leucopenia, neutropenia; increa
serum conc eg, bilirubin, transaminases, alkaline phosphatase & lactic dehydrogenase alone or combination; headache,
paresthesia, convulsion; oral & vag candidosis.
Rash, pruritus, urticaria, nausea, vomiting, oral moniliasis, diarrhea, colitis, headache, fever, vaginitis, erythema; abdomina
constipation, vasodilation, dyspnea, dizziness, paresthesia, genital pruritus, taste perversion, chills & unspecified moniliasis
phlebitis & inflammation at inj site; transient BUN &/or serum creatinine elevations, thrombocytopenia, leucopenia,
neutropenia; Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, toxic nephropathy, aplastic ane
hemolytic anemia, hemorrhage.
Drowsiness, dizziness, headache, agitation, dry mouth & GI discomfort; hypersensitivity reactions, including skin reactions
angioedema.
Hypersensitivity reactions; GI disturbances; increased liver enzymes, ?-glutamyl transferase, LDL &/or bilirubin;
thrombocytopenia, eosinophilia; irritation, inflammation & pain at inj site; reversible encephalopathy (at high dose especia
patients w/ renal insufficiency); secondary infections; taste &/or smell disturbances after inj, headache & fever.
Diarrhea, nausea, vomiting, indigestion, pseudomembranous colitis, candidiasis, hepatitis, cholestatic jaundice, urticarial &
erythematous rashes, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis,
angioedema, anaphylaxis, interstitial nephritis, transient leucopenia, thrombocytopenia & hemolytic anemia.
Diarrhea, nausea, vomiting, indigestion, pseudomembranous colitis & candidiasis; hepatitis & cholestatic jaundice; phlebiti
inj site; urticaria & erythematous rashes; erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis &
exfoliative dermatitis; angioedema & anaphylaxis; transient leucopenia, thrombocytopenia & hemolytic anemia.
GI disturbances, leucopenia, thrombocytopenia, anemia, peripheral neuropathy, dysgeusia, ototoxicity, allergic reactions,
alopecia, flu-like symptoms.
Reversible alopecia, hyperpigmentation of nailbeeds & dermal creases especially in childn; nausea, vomiting, stomatitis w/
begins as a burning sensation w/ erythema of the oral mucosa leading to ulceration, anorexia, diarrhoea; phlebosclerosis;
vesication, tissue necrosis, severe cellulitis, erythematous streaking; fever, chills, urticaria, anaphylaxis.
Cardiovascular and Nervous System: An excessive reduction in blood pressure may occur particularly after initial or increase
doses of Cardace, or of an additional diuretic (see Precautions), and may sometimes progress to shock.
Uncommonly, mild symptoms and reactions eg, headache, disorders of balance, rapid heart rate (tachycardia), weakness,
drowsiness, lightheadedness or impaired reactions may occur.
Rarely, mild symptoms and reactions eg, peripheral oedema, flushing, dizziness, noises in the ears (tinnitus), fatigue,
nervousness, depressed mood, tremor, restlessness, visual and sleep disturbances, confusion, feeling of anxiety, transient
erectile impotence, palpitations, sweating, disturbed hearing, extreme sleepiness (somnolence) or feeling faint on standing
standing up (disturbed orthostatic regulation), as well as severe reactions eg, angina pectoris, cardiac arrhythmias and tem
loss of consciousness (syncope) may also occur.
In isolated cases, insufficient supply of blood to the heart muscle or to the brain (myocardial or cerebral ischaemia), myoca
infarction, transient reduced blood flow in the brain (transient ischaemic attack), ischaemic stroke, worsening of circulatory
disturbances due to vascular stenoses, precipitation or intensification of attacks of circulatory disturbances characterized b
whiteness of fingers or toes (Raynaud's phenomenon), or abnormal sensations (paraesthesiae) may occur.
Kidney and Electrolyte Balance: Uncommonly, an increase in serum urea and creatinine (particularly and likely in combinati
with diuretics). In isolated case, progression of renal function impairment to acute renal failure may develop.
Rarely, an increased in serum potassium may occur. In isolated cases, a decrease in serum sodium may develop, as preexisti
pronounced urinary excretion of proteins (proteinuria) may deteriorate (although ACE inhibitors usually reduce proteinuria
urinary output may increase in conjunction with an improvement in cardiac performance.
Respiratory Tract, Anaphylactic/Anaphylactoid and Skin Reactions: Commonly, a dry (nonproductive) tickling cough occurs.
cough is often worse at night and during periods of recumbency (ie, while reclining), and occurs more frequently in women
non-smokers. It may necessitate complete discontinuation of treatment with ACE inhibitors. Rarely, nasal congestion,
inflammation of the nasal sinuses (sinusitis), bronchitis, spasmodic narrowing of the bronchia (bronchospasm) and difficult
breathing (dyspnoea) may develop.
Uncommonly, the desired ACE inhibition may lead to mild angioneurotic oedema. Swelling of the facial region (eg, lips, eye
or of the tongue, throat, or larynx (noticeable, eg, as difficulty in swallowing or breathing) may be signs and symptoms of s
condition. If such signs and symptoms occurs, please inform the physician immediately and stop taking the next scheduled
of Cardace. Other ACE inhibitors must not be used as an alternative. Serious forms of angioneurotic oedema and other
anaphylactic or anaphylactoid reactions, not attributable to the desired effect, to ramipril or to any of the excipients of Card
are rare. Angioneurotic oedema in conjunction with ACE inhibitors appears to occur more frequently in Black patients ie, A
Caribbean than in non-Black patients. Cutaneous or mucosal reactions eg, rash, itching or urticaria may uncommonly occur
In isolated cases, maculopapular rash, pemphigus, worsening of psoriasis, psoriasiform, pemphigoid or lichenoid exanthem
enanthema, erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis, pronounced hair loss (alopecia)
loosening of the nails (onycholysis), or hypersensitivity of the skin to light (photosensitivity) may occur.
The likelihood and severity of anaphylactic and anaphylactoid reactions to insect venoma is increased under ACE inhibition
assumed that this effect may also occur in connection with other allergens.
Digestive Tract: Uncommonly, nausea, increases in hepatic enzymes and/or serum bilirubin, and jaundice due to impaired
excretion of bile pigment (cholestatic jaundice) may occur. Rarely, dryness of the mouth, inflammation of the tongue (gloss
inflammatory reactions of the oral cavity and gastrointestinal tract, abdominal discomfort, gastric (including gastritis-like) p
Headache, edema, fatigue, somnolence, nausea, abdominal pain, flushing, palpitations, dizziness.
Increased heart rate, BP, hypotension, phlebitis, headache, unspecified chest pain, palpitation, dyspnea.
Headache, edema, fatigue, nausea, flushing & dizziness.
Throbbing headache, flushing, dizziness, postural hypotension, tachycardia (but paradoxical bradycardia has occurred).
Hypertension: In controlled hypertension clinical trials, the most common reactions associated with Cardura were of postu
type (rarely associated with syncope) or nonspecific and included dizziness, headache, fatigue, malaise, postural dizziness,
vertigo, edema, asthenia, somnolence, nausea and rhinitis.
The following additional adverse events have been reported in marketing experience among patients treated for hypertens
but these, in general, are not distinguishable from symptoms that might have occurred in the absence of exposure to doxaz
Tachycardia, bradycardia, palpitation, chest pain, angina pectoris, myocardial infarction, cerebrovascular accidents and card
arrhythmias.
Benign Prostatic Hyperplasia: Experience in controlled clinical trials in BPH indicates a similar adverse event profile to that s
in hypertension.
Mild GI symptoms eg, transient nausea & vomiting, abdominal cramps, diarrhea.
Inflammation, thrombophlebitis & inj site pain. Skin rash, pruritus, urticaria. Abdominal pain, nausea, vomiting, diarrhea,
pseudomembranous colitis. Reversible thrombocytopenia, eosinophilia, neutropenia, leucopenia, +ve result in direct or ind
Coombs' test, headache, paresthesia, oral & vag candidiasis.
Gynecomastia, cramping, diarrhea, drowsiness, lethargy, rashes, headache, maculopapular or erythematous cutaneous
eruptions, urticaria, mental confusion, drug fever, ataxia, impotence, disturbances in erection, menstrual irregularities. Rare
agranulocytosis, post-menopausal bleeding.
Nausea & vomiting.
Paralytic ileus, hypoxemia, angina, dyspnea, thrombocytopenia, hepatic dysfunction, jaundice, tachycardia, palpitations, fac
flushing, general malaise; BUN or creatinine elevation; nausea, vomiting. Headache, fever, decrease urine vol, rigors, backp
serum K elevation.
Adverse reactions are defined as follows: Very common (=1/10); common (=1/100 to <1/10); uncommon (=1/1,000 to =1/1
rare (=1/10,000 to =1/1,000); very rare (=1/10,000); not known (cannot be estimated from the available data).
Blood and the Lymphatic System Disorders: Very Common: Anaemia (50 mg). Common: Anaemia (150 mg).
Immune System Disorders: Uncommon: Hypersensitivity, angioedema, urticaria.
Metabolism and Nutrition Disorders: Common: Decreased appetite.
Psychiatric Disorders: Common: Decreased libido, depression.
Nervous System Disorders: Very Common: Dizziness (50 mg). Common: Dizziness (150 mg), somnolence.
Cardiac Disorders: Common: Myocardial infarction (fatal outcomes have been reported)5 and cardiac failure5 (50 mg).
Vascular Disorders: Very Common: Hot flush (50 mg). Common: Hot flush (150 mg).
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Interstitial lung disease (fatal outcomes have been reported).
Gastrointestinal Disorders: Very Common: Abdominal pain, constipation, nausea (50 mg). Common: Dyspepsia, flatulence (
mg); abdominal pain, constipation, dyspepsia, flatulence, nausea (150 mg).
Hepatobiliary Disorders: Common: Hepatotoxicity, jaundice, hypertransaminasaemia1. Rare: Hepatic failure2 (fatal outcom
have been reported).
Skin and Subcutaneous Tissue Disorders: Very Common: Rash (150 mg). Common: Alopecia, hirsutism/hair re-growth, dry s
pruritus; rash (50 mg).
Renal and Urinary Disorders: Very Common: Haematuria (50 mg). Common: Haematuria (150 mg).
Reproductive System and Breast Disorders: Very Common: Gynaecomastia and breast tenderness3,4. Common: Erectile
dysfunction.
General Disorders and Administration Site Conditions: Very Common: Asthenia; oedema (50 mg). Common: Chest pain; oed
(150 mg).
1Hepatic changes are rarely severe and were frequently transient, resolving or improving with continued therapy or follow
cessation of therapy.
2Hepatic failure has occurred rarely, in patients treated with Casodex, but a casual relationship has not been established w
certainty. Periodic liver function testing should be considered (see Warnings and Precautions).
3May be reduced by concomitant castration.
4The majority of patients receiving Casodex 150 mg as monotherapy experience gynaecomastia and/or breast pain. In stud
these symptoms were considered to be severe in up to 5% of the patients. Gynaecomastia may not resolve spontaneously
following cessation of therapy, particularly after prolonged treatment (=1/10,000), not known (cannot be estimated from th
available data).
5Observed in a pharmaco-epidemiology study of LHRH agonist and antiandrogens used in the treatment of prostate cancer
risk appeared to be increased when Casodex 50 mg was used in combination with LHRH agonist but no increase in risk was
evident when Casodex 150 mg was used as a monotherapy to treat prostate cancer.
Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: Common
(=1/100, <1/10); uncommon (=1/1000, </100); rare (=1/10,000, <1/1000); very rare (<1/10,000), including isolated reports
The adverse reactions listed as follows include those reported with Cataflam/Cataflam D and/or other pharmaceutical form
diclofenac, with either short-term or long-term use.
Blood and Lymphatic System Disorders: Very Rare: Thrombocytopenia, leukopenia, anaemia (including haemolytic and apla
anaemia), agranulocytosis.
Immune System Disorders: Rare: Hypersensitivity, systemic anaphylactic and anaphylactoid reactions (including hypotensio
shock). Very Rare: Angioneurotic oedema (including facial oedema).
Psychiatric Disorders: Very Rare: Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.
Nervous System Disorders: Common: Headache, dizziness. Rare: Somnolence. Very Rare: Paraesthesia, memory impairmen
convulsion, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident.
Eye Disorders: Very Rare: Visual disturbance, blurred vision, diplopia.
Ear and Labyrinth Disorders: Common: Vertigo. Very Rare: Tinnitus, impaired hearing.
Cardiac Disorders: Very Rare: Palpitations, chest pain, congestive cardiac failure, myocardial infarction.
Vascular Disorders: Very Rare: Hypertension, vasculitis.
Respiratory, Thoracic and Mediastinal Disorders: Rare: Asthma (including dyspnoea). Very Rare: Pneumonitis.
Gastrointestinal Disorders: Common: Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia, epigast
pain. Rare: Gastritis, GI haemorrhage, haematemesis, melaena, haemorrhagic diarrhoea, GI ulcer (with or without bleeding
perforation). Very Rare: Colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease),
constipation, stomatitis, glossitis, oesophageal disorder, diaphragm-like intestinal strictures, pancreatitis.
Hepatobiliary Disorders: Common: Increased transaminases. Rare: Hepatitis, jaundice, liver disorder. Very Rare: Fulminant
hepatitis, hepatic necrosis, hepatic failure.
Skin and Subcutaneous Tissue Disorders: Common: Rash. Rare: Urticaria. Very Rare: Bullous eruptions, eczema, erythema,
erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, loss
hair, photosensitivity reaction, purpura, allergic purpura, pruritus.
Renal and Urinary Disorders: Very Rare: Acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephr
renal papillary necrosis.
General Disorders and Administration Site Conditions: Rare: Oedema.
Initially dry mouth, sedation & fatigue; orthostatic complaints.
Rarely diarrhea, GI disturbances, nausea, vomiting, urticaria, Stevens-Johnson syndrome.
Diarrhea, nausea, vomiting, maculopapular rash, urticarial, eosinophilia, drug fever, slight decrease of neutrophil, reversible
neutropenia (due to extended therapy), positive result in Coomb's test, eosinophilia, temporary thrombocytopenia,
hypoprothrombinemia, hemolytic anemia, headache, fever, inj pain, chills.
Headache, postural hypotension, nausea.
Diarrhea, abdominal pain, nausea, vomiting, dyspepsia, flatulence, pseudomembranous colitis, anorexia, heartburn,
constipation; hypersensitivity reactions; transient increase of SGPT, SGOT & alkaline phosphatase; hematologic reactions;
dizziness, headache; shock, genital pruritus, vaginitis, candidiasis, toxic epidermal necrolysis, superinfection, renal & hepati
dysfunction, toxic nephropathy, hemorrhagic bleeding & colitis; +ve direct Coombs' test, neutropenia, agranulocytosis, incr
in bilirubin & LDH.
Thrombocytopenia, eosinophilia, leucopenia, granulocytosis, haemolytic anemia; increased SGOT, SGPT, ?-GT, alkaline
phosphatase, LDH, bilirubin; nausea, vomiting, abdominal spasm, diarrhea, urticaria, rash, pruritus, Stevens-Johnson syndr
toxic epidermal necrolysis; headache.
Shock, hypersensitivity reactions, haematological changes, increased SGOT/SGPT/alkaline phosphatase, kidney dysfunction
effects, interstitial pneumonia, stomatitis or candidiasis, vit K or vit B deficiency, headache, +ve direct Coombs' test.
GI discomfort, hypersensitivity reactions. Rarely, pseudomembranous colitis.
Diarrhea, hypersensitivity reactions, eosinophilia, genital & oral candidiasis. Rarely, pseudomembranous colitis, anaphylaxis
neutropenia, thrombocytopenia, leukopenia.
Hypersensitivity, GI & resp disorders, shock, renal impairment, granulocytopenia or eosinophilia, stomatitis, candidiasis, vit
deficiencies.
Shock, hypersensitivity reactions, GI disturbances, vit deficiencies, headache, granulocytopenia, eosinophilia.
Allergy or serious hypersensitivity reactions, pseudomembranous colitis, superinfection.

Urticaria, hypersensitivity reactions.
Interactions
The likelihood of interactions is low due to limited metabolism and plasma protein-binding and
almost complete renal elimination of unchanged lamivudine.
Lamivudine is predominantly eliminated by active organic cationic secretion. The possibility of
interactions with other medicinal products administered concurrently should be considered,
particularly when their main route of elimination is active renal secretion via the organic cationic
transport system eg, trimethoprim. Other active substances (eg, ranitidine, cimetidine) are
eliminated only in part by this mechanism and were shown not to interact with lamivudine.
Active substances shown to be predominately excreted either via the active organic anionic
pathway or by glomerular filtration are unlikely to yield clinically significant interactions with
lamivudine.
Zidovudine: A modest increase in Cmax (28%) was observed for zidovudine when administered with
lamivudine; however, overall exposure (AUC) was not significantly altered. Zidovudine had no effect
on the pharmacokinetics of lamivudine (see Pharmacokinetics under Actions).
Trimethoprim/Sulfamethoxazole: Administration of trimethoprim/sulfamethoxazole 160 mg/800 mg
(co-trimoxazole) causes a 40% increase in lamivudine exposure because of the trimethoprim
component. However, unless the patient has renal impairment, no dosage adjustment of 3TC is
necessary (see Dosage & Administration). Lamivudine has no effect on the pharmacokinetics of
trimethoprim or sulfamethoxazole. The effect of co-administration of 3TC with higher doses of co-
trimoxazole for the treatment of Pneumocystis carinii pneumonia and toxoplasmosis has not been
studied.
Zalcitabine: Lamivudine may inhibit the intracellular phosphorylation of zalcitabine when the 2
medicinal products are used concurrently. 3TC is therefore not recommended to be used in
combination with zalcitabine.
Interaction studies have shown that the potential for metabolic drug interactions is low.
Lamivudine is predominantly eliminated by active organic cationic secretion. The potential for
interactions with concurrently administered drugs sharing this pathway as a major elimination route
(eg, trimethoprim) should be considered, particularly if the patient has renal impairment. Other
drugs (eg, ranitidine, cimetidine) are eliminated only in part by this mechanism and were shown not
to interact with lamivudine.
Drugs shown to be predominantly excreted either via the active organic anionic pathway, or by
glomerular filtration (eg, ganciclovir, foscarnet) are unlikely to yield clinically significant interactions
with lamivudine.
Administration of trimethoprim, a constituent of co-trimoxazole, causes an increase in lamivudine
exposure of about 40%. Lamivudine has a high therapeutic ratio and this increase is not considered
clinically relevant unless the patient has renal impairment. Lamivudine has no effect on the
pharmacokinetics of co-trimoxazole.
There is no known adverse interaction with a-interferon. There are no observed clinically significant
adverse interactions in patients taking 3TC-HBV concurrently with commonly used
immunosuppressant drugs (eg, cyclosporin A). However, formal interaction studies have not been
performed.
Results of clinical studies indicate that there was a modest but statistically significant (p=0.05)
increase of circulating theophylline or carbamazepine levels when either of these drugs are
administered concomitantly with clarithromycin.
Clarithromycin use in patients who are receiving theophylline may be associated with an increase of
serum theophylline concentrations. Monitoring of serum theophylline concentrations should be
considered for patients receiving high doses of theophylline or with baseline concentrations in the
upper therapeutic range. In 2 studies in which theophylline was administered with clarithromycin (a
theophylline sustained-release formulation was dosed at either 6.5 or 12 mg/kg together with
clarithromycin 250 or 500 mg every 12 hrs), the steady-state levels of Cmax, Cmin and area under
the serum concentration-time curve (AUC) increased about 20%.
Single-dose administration of clarithromycin has been shown to result in increased concentrations
of carbamazepine. Blood level monitoring of carbamazepine may be considered strain.
As with other macrolide antibiotics, the use of clarithromycin in patients concurrently taking drugs
metabolized by the cytochrome P-450 system (eg, digoxin, cyclosporine, disopyramide, ergot
alkaloids, lovastatin, midazolam, phenytoin, triazolam and warfarin) may be associated with
elevations in serum levels of these other drugs.
Elevated cisapride levels have been reported in patients receiving clarithromycin and cisapride
concomitantly. This may result in QT prolongation and cardiac arrhythmias including ventricular
tachycardia, ventricular fibrillation and Torsade de pointes. Similar effects have been observed in
patients taking clarithromycin and pimozide concomitantly. (See Contraindications.)
Macrolides have been reported to alter the metabolism of terfenadine resulting in increased levels
of terfenadine which has occasionally been associated with cardiac arrhythmias eg, QT
prolongation, ventricular tachycardia, ventricular fibrillation and Torsade de pointes (see
Contraindications). In 1 study in 14 healthy volunteers, the concomitant administration of
clarithromycin and terfenadine resulted in a 2- to 3-fold increase in the serum level of the acid
metabolites of terfenadine and in prolongation of the QT interval, which did not lead to any
clinically detectable effect. Similar effects have been observed with concomitant administration of
astemizole and other macrolides.
Simultaneous oral administration of clarithromycin tablets and zidovudine to HIV-infected adult
patients may result in decreased steady-state zidovudine concentrations. Because clarithromycin
appears to interfere with the absorption of simultaneously administered oral zidovudine, this
interaction can be largely avoided by staggering the doses of clarithromycin and zidovudine. This
interaction does not appear to occur in pediatric HIV-infected patients taking clarithromycin
suspension with zidovudine or dideoxyinosine.
The following drug interactions have not been reported in clinical trials with clarithromycin;
however, they have been observed with erythromycin products: There have been reports of
increased anticoagulant effects when erythromycin and oral anticoagulants were used
concomitantly.
Both CYP3A4 and CYP2D6 are responsible for Abilify Discmelt metabolism. Agents that induce
CYP3A4 (eg, carbamazepine) could cause an increase in Abilify Discmelt clearance and lower blood
levels. Inhibitors of CYP3A4 (eg, ketoconazole) or CYP2D6 (eg, quinidine, fluoxetine or paroxetine)
can inhibit Abilify Discmelt elimination and cause increased blood levels.
Both CYP3A4 and CYP2D6 are responsible for Abilify Oral Solution metabolism. Agents that induce
CYP3A4 (eg, carbamazepine) could cause an increase in Abilify Oral Solution clearance and lower
blood levels. Inhibitors of CYP3A4 (eg, ketoconazole) or CYP2D6 (eg, quinidine, fluoxetine or
paroxetine) can inhibit Abilify Oral Solution elimination and cause increased blood levels.
Given the primary CNS effects of aripiprazole, caution should be used when Abilify is taken in
combination with other centrally acting drugs and alcohol. Due to its a1-adrenergic receptor
antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive agents.
Potential for Other Drugs to Affect Abilify: Aripiprazole is not a substrate of CYP1A1, CYP1A2,
CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or CYP2E1 enzymes. Aripiprazole also does not
undergo direct glucuronidation. This suggests that an interaction of aripiprazole with inhibitors or
inducers of these enzymes, or other factors eg, smoking is unlikely.
Both CYP3A4 and CYP2D6 are responsible for aripiprazole metabolism. Agents that induce CYP3A4
(eg, carbamazepine) could cause an increase in aripiprazole clearance and lower blood levels.
Inhibitors of CYP3A4 (eg, ketoconazole) or CYP2D6 (eg, quinidine, fluoxetine or paroxetine) can
inhibit aripiprazole elimination and cause increased blood levels.
Ketoconazole: Co-administration of ketoconazole (200 mg/day for 14 days) with a 15-mg single dose
of aripiprazole increased the AUC of aripiprazole and its active metabolite by 63% and 77%,
respectively. The effect of a higher ketoconazole dose (400 mg/day) has not been studied. When
concomitant administration of ketoconazole with aripiprazole occurs, aripiprazole dose should be
reduced to of its normal dose. Other strong inhibitors of CYP3A4 (itraconazole) would be
expected to have similar effects and need similar dose reductions; weaker inhibitors (erythromycin,
grapefruit juice) have not been studied. When the CYP3A4 inhibitor is withdrawn from the
combination therapy, aripiprazole dose should then be increased.
Quinidine: Co-administration of a 10-mg single dose of aripiprazole with quinidine (166 mg/day for
13 days), a potent inhibitor of CYP2D6, increased the AUC of aripiprazole by 112% but decreased
the AUC of its active metabolite, dehydro-aripiprazole, by 35%. Aripiprazole dose should be reduced
to of its normal dose when concomitant administration of quinidine with aripiprazole occurs.
Other significant inhibitors of CYP2D6 eg, fluoxetine or paroxetine, would be expected to have
similar effects and, therefore, should be accompanied by similar dose reductions. When the CYP2D6
inhibitor is withdrawn from the combination therapy, aripiprazole dose should then be increased.
Carbamazapine: Co-administration of carbamazapine (200 mg 2 times a day), a potent CYP3A4
inducer, with aripiprazole (30 mg 4 times a day) resulted in an approximate 70% decrease in Cmax
and AUC values of both aripiprazole and its active metabolite, dehydro-aripiprazole. When
carbamazapine is added to aripiprazole therapy, aripiprazole dose should be doubled. Additional
dose increases should be based on clinical evaluation. When carbamazapine is withdrawn from the
combination therapy, aripiprazole should then be reduced.
No clinically significant effect of famotidine, valproate, or lithium was seen on the pharmacokinetics
of aripiprazole (see Pharmacokinetics under Actions).
Potential for Abilify to Affect Other Drugs: Aripiprazole is unlikely to cause clinically important
pharmacokinetic interactions with drugs metabolized by cytochrome P-450 enzymes. In in vivo
studies, 10- to 30-mg/day doses of aripiprazole had no significant effect on metabolism by CYP2D6
(dextromethorphan),
Aminoglycocides, loopCYP2C9 (warfarin), CYP2C19 (omeprazole, warfarin) and CYP3A4
diuretics.
ACCOLATE may be administered with other therapies routinely used in the management of asthma
and allergy. Inhaled steroids, inhaled and oral bronchodilator therapy, antibiotics and antihistamines
are examples of agents which have been co-administered with ACCOLATE without adverse
interaction.
ACCOLATE may be administered with oral contraceptives without adverse interaction.
Co-administration with warfarin results in an increase in maximum prothrombin time by
approximately 35%. It is therefore recommended that if ACCOLATE is co-administered with warfarin,
prothrombin time should be closely monitored. The interaction is probably due to an inhibition by
zafirlukast of the cytochrome P450 2C9 isoenzyme system.
In clinical trials, co-administration with theophylline resulted in decreased plasma levels of
zafirlukast, by approximately 30%, but with no effect on plasma theophylline levels. However,
during post-marketing surveillance, there have been rare cases of patients experiencing increased
theophylline levels when co-administered ACCOLATE.
Co-administration with terfenadine resulted in a 54% decrease in AUC for zafirlukast, but with no
effect on plasma terfenadine levels.
Co-administration with acetylsalicylic acid ("aspirin", 650 mg four times a day) may result in
increased plasma levels of zafirlukast, by approximately 45%.
Co-administration with erythromycin will result in decreased plasma levels of zafirlukast, by
approximately 40%.
Co-administration with fluconazole, a moderate CYP2C9 inhibitor, resulted in increased plasma
levels of zafirlukast, by approximately 60%. The clinical significance of this interaction is unknown.
Co-administration with itraconazole, a strong CYP3A4 inhibitor, caused no change in plasma levels
of zafirlukast.
The clearance of zafirlukast in smokers may be increased by approximately 20%.
At concentrations of 10 microgram/ml and above, zafirlukast causes increases in the assay value for
bilirubin in animal plasma. However, zafirlukast has not been shown to interfere with the 2,5-
dichlorophenyl diazonium salt method of bilirubin analysis of human plasma.
K-sparing diuretics. May have additive effects w/ other antihypertensives.
Nonselective MAOIs, alcohol, carbamazepine, opioid agonist-antagonist.

Increased half-life w/ probenecid.
Increased t w/ probenecid.
Anticoagulants & other broad-spectrum antibiotics.
Nephrotoxic drugs eg aminoglycosides, or diuretics that may cause dehydration.

Copper, other minerals especially Ca, Fe & high-fiber food.
Increased plasma conc w/ concomitant administration of azole antifungals, HIV protease inhibitors,
nefazodone. Increased risk of arrhythmia & prolongation of QT interval w/ antiarrhythmics, tricyclic
& tetracyclic antidepressants, antipsychotics, astemizole, sparfloxacin. Enhances the effects of
anticoagulants. Increased absorption w/ cimetidine & ranitidine. Effects antagonised by
anticholinergics.
Other bisphosphonates, NSAIDs, aminoglycosides, steroids, diuretics, analgesics or

chemotherapeutic agents, divalent metal ions, food, antacids & mineral supplements.
Antacids, colestipol, digoxin, erythromycin/clarithromycin, protease inhibitors, digoxin, OC-
containing norethindrone & ethinyl estradiol; drugs that decrease the levels of endogenous steroid
hormones eg, ketoconazole, spironolactone & cimetidine.
May prolong the neuromuscular blocking effects of suxamethonium & the neuromuscular blockade
of non-depolarising drugs may be antagonized. May exacerbate the adverse effects eg,
myelosuppression & diarrhea by other antineoplastic agents. May enhance lymphocytopenia &
hyperglycemia w/ dexamethasone. Laxatives & diuretics worsen the incidence or severity of
diarrhea. Reduced exposure to the active metabolite SN-38 w/ CYP3A-inducing anticonvulsant
drugs (eg, carbamazepine, phenobarb, phenytoin) & in patients taking concomitant St. John's wort.
Increased exposure to SN-38 w/ ketoconazole & atazanavir sulfate.
Increased serum clearance & decreased elimination w/ probenecid. Additive effect w/
aminoglycosides.
CNS depressants, alcohol, barbiturates; cimetidine.

Concomitant use of Actifed with other sympathomimetic agents eg, decongestants, tricyclic
antidepressants, appetite suppressants and amphetamine-like psychostimulants or with MAOIs
which interfere with the catabolism of sympathomimetic amines, may occasionally cause a rise in
blood pressure (see Contraindications and Precautions).
Because of its pseudoephedrine content, Actifed may partially reverse the hypotensive action of
drugs which interfere with sympathetic activity, including bretylium, bethanidine, guanethidine,
debrisoquine, methyldopa and a- and -adrenergic-blocking agents (see Precautions).
The antibacterial agent furazolidone is known to cause a dose-related inhibition of monoamine
oxidase. Although there are no reports of hypertensive crises caused by the concurrent
administration of Actifed and furazolidone, they should not be taken together.
Storage Store below 25C. Protect from light. Actifed should not be refrigerated. The tablets should
be kept dry.
Other sympathomimetics eg, decongestants, TCAs, appetite suppressants, amphetamine-like

psychostimulants, MAOIs. Bretylium, bethanidine, guanethidine, debrisoquine, methyldopa, alpha-
& beta-, furazolidone, alcohol, other sedatives.
Other sympathomimetics eg, decongestants, TCAs, appetite suppressants, amphetamine-like

psychostimulants, MAOIs. Bretylium, bethanidine, guanethidine, debrisoquine, methyldopa, beta- &
alpha- adrenergic blockers. Furazolidone. Alcohol, other sedatives.
No formal interaction studies with Actilyse and medicinal products commonly administered in
patients with acute myocardial infarction have been performed.
Medicinal products that affect coagulation or those that alter platelet function may increase the risk
of bleeding prior to, during or after Actilyse therapy.
Concomitant treatment with ACE inhibitors may enhance the risk of suffering an anaphylactoid
reaction, as in the cases describing such reactions a relatively larger proportion of patients were
receiving ACE inhibitors concomitantly.
Incompatibilities: The reconstituted solution may be diluted further with sterile physiological saline
solution (0.9%) up to a minimal concentration of alteplase 0.2 mg/mL. It may not, however, be
diluted further with water for injections or carbohydrate infusion solutions eg, dextrose.
Actilyse must not be mixed with other drugs, neither in the same infusion vial nor via the same
venous line (not even with heparin).
Concomitant administration w/ Ca, antacids or oral medications containing divalent cations will
decrease absorption.
Aminoglycoside antibiotics, Al.
Interaction studies have shown that Actos has no relevant effect on either the pharmacokinetics or
pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin. Co-administration of
Actos with sulfonylurea does not appear to affect the pharmacokinetics of the sulfonylurea.
Studies in man suggest no induction of the main inducible cytochrome P-450, 1A, 2C8/9, 3A4. In
vitro studies have shown no inhibition of any subtype of cytochrome P-450. Interactions with
substances metabolized by these enzymes eg, oral contraceptives, cyclosporine, calcium-channel
blocker and HMG-CoA reductase inhibitors are not to be expected.
Hypoglycemia may occur when administered with sulfonylurea. An inhibitor of CYP2C8 (eg,
gemfibrozil) may increase the AUC of pioglitazone, and an inducer of CYP2C8 (eg, rifampicin) may
decrease the AUC of pioglitazone.
Co-administration of pioglitazone with gemfibrozil is reported to result in 3-fold increase in AUC of
pioglitazone. Since there is a potential for dose-related adverse events with pioglitazone, a decrease
in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered.
Co-administration of pioglitazone with rifampicin is reported to result in a 54% decrease in AUC of
pioglitazone. The pioglitazone dose may need to be increased based on clinical response when
rifampicin is concomitantly administered.
Pioglitazone Hydrochloride: In vivo drug-drug interaction studies have suggested that pioglitazone
may be a weak inducer of CYP450 isoform 3A4 substrate.
An enzyme inhibitor of CYP2C8 (eg, gemfibrozil) may significantly increase the area under the
concentration-time curve (AUC) of pioglitazone and an enzyme inducer of CYP2CB (eg, rifampin)
may significantly decrease the AUC of piogJitazone. Therefore. if an inhibitor or inducer of CYP2CB is
started or stopped during treatment with pioglitazone, changes in diabetes treatment may be
needed based on clinical response (see Drug-Drug Interactions: Pioglitazone Hydrochloride under
Actions).
Metformin Hydrochloride: Glyburide: In a single-dose interaction study in type 2 diabetes patients,
co-administration of metformin and glyburide did not result in any changes in either metformin
pharmacokinetics or pharmacodynamics. Decreases in glyburide AUC and Cmax were observed, but
were highly variable. The single-dose nature of this study and the lack of correlation between
glyburide blood levels and pharmacodynamic effects, makes the clinical significance of this
interaction uncertain.
Furosemide: A single-dose, metformin-furosemide drug interaction study in healthy subjects
demonstrated that pharmacokinetic parameters of both compounds were affected by co-
administration. Furosemide increased the metformin plasma and blood Cmax by 22%, and blood
AUC by 15%, without any significant change in metformin renal clearance. When administered with
metformin, the Cmax and AUC of furosemide were 31% and 12% smaller, respectively, than when
administered alone and the terminal half-life was decreased by 32%, without any significant change
in furosemide renal clearance. No information is available about the interaction of metformin and
furosemide when co-administered chronically.
Nifedipine: A single-dose, metformin-nifedipine drug interaction study in normal healthy volunteers
demonstrated that co-administration of nifedipine increased plasma metformin Cmax and AUC by
20% and 9%, respectively, and increased the amount excreted in the urine. Maximum plasma
concentration (Tmax) and half-life were unaffected. Nifedipine appears to enhance the absorption
of metformin. Metformin had minimal effects on nifedipine.
Cationic Drugs: Cationic drugs (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine,
ranitidine, triamterene, trimethoprim and vancomycin) that are eliminated by renal tubular
secretion theoretically have the potential for interaction with metformin by competing for common
renal tubular transport systems. Such interaction between metformin and oral cimetidine has been
observed in normal healthy volunteers in both single- and multiple-dose, metformin-cimetidine
drug interaction studies with a 60% increase in peak metformin plasma, and whole blood
concentrations and a 40% increase in plasma and whole blood metformin AUC. There was no
change in elimination half-life in the single-dose study. Metformin had no effect on cimetidine
pharmacokinetics. Although such interactions remain theoretical (except for cimetidine), careful
patient monitoring and dose adjustment of Actosmet and/or the interfering drug is recommended
in patients who are taking cationic medications that are excreted via the proximal renal tubular
A number of medicinal products are known to interact with the glucose metabolism.
The following substances may reduce the patient's insulin requirement: Oral hypoglycemic agents
(OHA), monoamine oxidase inhibitors (MAOIs), nonselective -blocking agents, angiotensin-
converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids and sulfonamides.
The following substances may increase the patient's insulin requirement: Oral contraceptives,
thiazides, glucocorticoids, thyroid hormones, -sympathomimetics and danazol.
Beta-blocking agents may mask the symptoms of hypoglycemia and delay recovery from it.
Octreotide/lanreotide may both decrease and increase insulin requirement.
Alcohol may intensify and prolong the hypoglycemic effect of insulin.
Combination of Thiazolidinediones with Insulin: Cases of congestive heart failure (CHF) have been
reported when thiazolidinediones were used in combination with insulin, especially in patients with
risk factors for development of CHF. This should be kept in mind if treatment with the combination
of thiazolidinediones and insulin medicinal products is considered. If this combination is used,
patients should be observed for signs and symptoms of CHF, weight gain and edema.
Thiazolidinediones should be discontinued if any symptom of deterioration in cardiac function
occurs.
The safety and effectiveness of the use of sodium hyaluronate concomitantly with other intra-
articular injection has not yet been established.
As sodium hyaluronate is precipitated by quaternary amine bactericides or disinfectants eg,
benzalkonium chloride and chlorhexidine, etc, adequate attention should be given.
Caution For Usage During Injection: When sodium hyaluronate is administered into the cavity of the
knee joint, it should be performed according to strict aseptic procedure. In case improvement of
symptoms is not recognized after treatment, administration should be limited to 5 times before
discontinuing. When accumulation of articular fluid occurs, it should be drained out of syringe if the
condition necessitates.
Others: Sodium hyaluronate should not be administered into blood vessels, it should not be applied
for ophthalmological treatment. Because the drug is viscous, the use of 22-23 G syringe is desired.
Since it is kept in a cool place, restore to room temperature before administering. It is intended for 1
application, therefore it should be used as soon as possible after opening. Discard after using.
No clinically relevant interactions with Aerius tablets were observed in clinical trials in which
erythromycin or ketoconazole were co-administered (see Pharmacokinetics: Drug Interactions
under Actions).
There was no effect of food or grapefruit juice on the disposition of desloratadine.
Aerius concomitantly taken with alcohol did not potentiate the performance impairing effects of
alcohol.
In clinical pharmacology studies in healthy volunteers, there were no clinically relevant changes in
the safety profile of desloratadine when co-administered with erythromycin, ketoconazole,
azithromycin, fluoxetine and cimetidine as assessed by electrocardiographic parameters (including
the corrected QT interval), clinical laboratory test, vital signs and adverse events. Concurrent
administration with sympathomimetic medicines may result in critical hypertension reactions.
Dihydroergotamine, ergotamine, methylergotamine: Risk of vasoconstriction and increase in blood
pressure.
MAOIs.
Oral anticoagulants eg warfarin, glycoprotein IIb/IIIa inhibitors, ASA, heparin, thrombolytics, NSAIDs.
Phenytoin, tolbutamide, diuretics, -blockers, ACE inhibitors, Ca antagonists, cholesterol lowering
agents, coronary vasodilators, antidiabetic agents (including insulin), antiepileptic agents, hormone
replacement therapy.
Antacid containing Al or Mg(OH)2. Concomitant intake w/ NSAIDs can lead to convulsion. May
increase theophylline plasma levels. Effect of warfarin is intensified.
Antidiabetic drugs.
Acetosal, other drugs which contain paracetamol & ibuprofen, warfarin anticoagulants, alcohol.
ACE inhibitors.
May precipitate a hypertensive crisis if used w/ MAOI.
-blockers, methyldopa, mecamylamine, reserpine, veratrum alkaloids, digitalis, ketoconazole,

erythromycin, cimetidine.
Theophylline, warfarin, cimetidine, digoxin.

Additive effects w/ phenobarb, CNS depressants.
Alcohol, CNS suppressants.
Decreases the effectiveness of warfarin.

Pemetrexed is mainly eliminated unchanged renally by tubular secretion and to a lesser extent by
glomerular filtration. Concomitant administration of nephrotoxic drugs (eg, aminoglycoside, loop
diuretics, platinum compounds, cyclosporin) could potentially result in delayed clearance of
pemetrexed. This combination should be used with caution. If necessary, creatinine clearance
should be closely monitored.
Concomitant administration of substances that are also tubularly secreted (eg, probenecid,
penicillin) could potentially result in delayed clearance of pemetrexed. Caution should be made
when these drugs are combined with pemetrexed. If necessary, creatinine clearance should be
closely monitored.
In patients with normal renal function (CrCl =80 mL/min), high doses of nonsteroidal anti-
inflammatory drugs (NSAIDs eg, ibuprofen >1,600 mg/day) and aspirin at higher dosage (=1.3 g
daily) may decrease pemetrexed elimination and consequently, increase the occurrence of
pemetrexed adverse events. Therefore, caution should be made when administering higher doses
of NSAIDs or aspirin at higher dosage, concurrently with pemetrexed to patients with normal
function (CrCl =80 mL/min).
In patients with mild to moderate renal insufficiency (CrCl 45-79 mL/min), the concomitant
administration of pemetrexed with NSAIDs (eg, ibuprofen) or aspirin at higher dosage should be
avoided for 2 days before, on the day of and 2 days following pemetrexed administration (see
Precautions).
In the absence of data regarding potential interaction with NSAIDs having longer t1/2 as piroxicam
or rofecoxib, the concomitant administration with pemetrexed should be avoided for at least 5 days
prior to, on the day and at least 2 days following pemetrexed administration (see Precautions).
Pemetrexed undergoes limited hepatic metabolism. Results from in vitro studies with human liver
microsomes indicated that pemetrexed would not be predicted to cause clinically significant
inhibition of the metabolic clearance of drugs metabolised by CYP3A, CYP2D6, CYP2C9 and CYP1A2.
Interactions Common to All Cytotoxics: Due to the increased thrombotic risk in patients with cancer,
the use of anticoagulation treatment is frequent. The high intraindividual variability of the
coagulation status during diseases and the possibility of interaction between oral anticoagulants
and anticancer chemotherapy require increased frequency of international normalised ratio (INR)
monitoring, if it is decided to treat the patient with oral anticoagulants.
Concomitant Use Contraindicated: Yellow Fever Vaccine: Risk of fatal generalised vaccinale disease
(see Contraindications).
Concomitant Use Not Recommended: Live Attenuated Vaccines (Except Yellow Fever, for which
Concomitant Use is Contraindicated): Risk of systemic, possibly fatal, disease. The risk is increased in
subjects who are already immunosuppressed by their underlying disease. Use an inactivated
vaccine where it exists (poliomyelitis) (see Precautions).
Incompatibilities: Pemetrexed is physically incompatible with diluents containing calcium, including
lactated Ringer's Injection and Ringer's Injection. In the absence of compatibility studies, Alimta
May potentiate other CNS depressants. Actions prolonged by MAOI.
Hormone replacement therapy, Ca supplements, antacids, NSAIDs, aspirin.
Anesth, drugs w/ anticholinergic activity, succinylcholine, other neuromuscular blockers or

cholinergic agonists.
Reduced bioavailability w/ antacids.
CNS drugs, barbiturates, alcohol, cimetidine.
Probenecid, aspirin, lithium & methotrexate; concomitant use w/ warfarin, hydantoin or

sulfonylurea may prolong prothrombin time & GI bleeding.
Affects absorption of Fe, tetracyclines, INH, quinidine, warfarin, digoxin.

Effects enhanced by CNS depressants, alcohol, barbiturates. Cimetidine may delay clearance.
Anticholinergics, succinylcholine.
Effects potentiated when used w/ insulin & other antidiabetics, ACE inhibitors, allopurinol, anabolic
steroids & male sex hormones, chloramphenicol, coumarin derivatives, cyclophosphamide,
disopyramide, fenfluramine, fenyramidol, fibrates, fluoxetine, guanethidine, ifosfamide, MAOIs,
miconazole, para-aminosalicylic acid, pentoxifylline (high-dose parenteral), phenylbutazone,
azapropazone, oxyphenbutazone, probenecid, quinolones, salicylates, sulfinpyrazone, sulfonamides,
tetracyclines, tritoqualine, trofosfamide. Effects weakened when used w/ acetazolamide,
barbiturates, corticosteroids, diazoxide, diuretics, epinephrine & other sympathomimetics,
glucagon, laxatives (after protracted use), nicotinic acid (high dose), oestrogens & progestogens,
phenothiazines, phenytoin, rifampicin, thyroid hormones. -blockers decrease glucose tolerance.
Patients who take or discontinue taking certain other medicines while undergoing treatment with
Amaryl may experience changes in blood sugar control.
Based on experience with Amaryl and on what is known of other sulfonylureas, the following
interactions must be considered: Potentiation of the blood sugar-lowering effect and thus, in some
instances, hypoglycaemia may occur when one of the following medicines is taken eg, insulin and
other oral antidiabetics, ACE inhibitors, allopurinol, anabolic steroids and male sex hormones,
chloramphenicol, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine,
fenyramidol, fibrates, fluoxetine, guanethidine, ifosfamide, MAO inhibitors, miconazole, fluconazole,
para-aminosalicylic acid, pentoxifylline (high-dose parenteral), phenylbutazone, azapropazone,
oxyphenbutazone, probenecid, quinolones, salicylates, sulfinpyrazone, clarithromycin,
sulfonamides, tetracyclines, tritoqualine and trofosfamide.
Weakening of the blood sugar-lowering effect and thus, raised blood sugar levels may occur when
one of the following medicines is taken eg, acetazolamide, barbiturates, corticosteroids, diazoxide,
diuretics, epinephrine (adrenaline) and other sympathomimetic agents, glucagon, laxatives (after
protracted dose), nicotinic acid (in high doses), oestrogens and progestogens, phenothiazines,
phenytoin, rifampicin and thyroid hormones.
H2-Receptor antagonists, clonidine and reserpine may lead to either potentiation or weakening of
the blood sugar-lowering effect.
Beta-blockers decrease glucose tolerance. In patients with diabetes mellitus, this may lead to
deterioration of metabolic control. In addition, -blockers may increase the tendency to
hypoglycaemia (due to impaired counter-regulation).
Under the influence of sympatholytic drugs eg, -blockers, clonidine, guanethidine and reserpine,
the signs of adrenergic counter-regulation to hypoglycaemia may be reduced or absent.
Both acute and chronic alcohol intake may potentiate or weaken the blood sugar-lowering action of
Amaryl unpredictably.
The effect of coumarin derivatives may be potentiated or weakened.
Glimepiride: When other drugs are concomitantly administered to or withdrawn from a patient
receiving this drug, both undesired increases and decreases in the hypoglycemic action of
glimepiride can occur. Based on experience with this drug and with other sulfonylureas, the
following interactions must be considered:
Glimepiride is metabolized by cytochrome P-450 2C9 (CYP2C9). Its metabolism is known to be
influenced by concomitant administration of CYP2C9 inducers (eg, rifampicin) or inhibitors (eg,
fluconazole).
Drugs potentiating the blood glucose-lowering effect: Insulin and oral antidiabetic products, ACE
inhibitors, allopurinol, anabolic steroids, male sex hormones, chloramphenicol, coumarin
anticoagulants, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluoxetine,
guanethidine, ifosfamide, MAO inhibitors, miconazole, fluconazole, para-aminosalicylic acid,
pentoxifylline (high-dose parenteral), phenylbutazone, probenecid, quinolone antibiotics,
salicylates, sulfinpyrazone, sulfonamide, tetracyclines, tritoqualine, trofosfamide, azapropazone,
oxyphenbutazone.
Drugs weakening the blood glucose-lowering effect: Acetazolamide, barbiturates, corticosteroids,
diazoxide, diuretics, epinephrine (adrenaline) or sympathomimetics, glucagons, laxatives (long-term
use), nicotinic acid (high dose), estrogens, progestogens, phenothiazines, phenytoin, rifampicin,
thyroid hormones.
Drugs either potentiating or weakening the blood glucose-lowering effect: H2-antagonists,
clonidine, reserpine.
Beta-blockers reduce glucose tolerance. Reduction of glucose tolerance may change metabolic
control. Beta-blockers may increase the risk of hypoglycemia (due to failure of counter-regulation).
Drugs reducing or blocking the signs of adrenergic counter-regulation to hypoglycemia:
Sympatholytic drugs (eg, -blockers), clonidine, guanethidine, reserpine.
Both acute and chronic alcohol intake may potentiate or weaken the blood glucose-lowering action
of this drug in an unpredictable fashion.
This drug may either potentiate or weaken the effects of coumarin derivatives.
Metformin: Lactic acidosis may occur by concomitant administration of the following drugs. When
these drugs are administered concomitantly, patients should be closely monitored: Iodinated
contrast materials, antibiotics having strong nephrotoxicity (gentamicin, etc).
The hypoglycemic action of co-administration with the following drugs may be potentiated or
weakened. When these drugs are administered, the blood glucose level and patient should be
observed closely.
Drugs Potentiating the Effect: Insulin, sulfonamides and sulfonylureas products, anabolic steroids,
guanethidine, salicylates (aspirin, etc), -blockers (propranolol, etc), MAO inhibitors.
Drugs Weakening the Effect: Epinephrine, corticosteroids, thyroid hormones, estrogens, diuretics,
pyrazinamide, isoniazid, nicotinic acid, phenothiazines.
Glyburide: In aprobenecid,
Tetracyclines, single-doseOC,
interaction study in type 2 diabetes subjects, co-administration of
allopurinol.
Amlodipine has been safely administered with thiazide diuretics, a-blockers, ACE inhibitors, long-
acting nitrates, sublingual nitroglycerin, nonsteroidal anti-inflammatory (NSAIDs) drugs, antibiotics
and oral hypoglycemic drugs.
Studies have indicated that the co-administration of amlodipine with digoxin did not change serum
digoxin levels or digoxin renal clearance in normal volunteers, and that co-administration of
cimetidine did not alter the pharmacokinetics of amlodipine.
In vitro data from studies with human-plasma indicates that amlodipine has no effect on protein-
binding of the drug tested (digoxin, phenytoin, warfarin or indomethacin).
In healthy male volunteers, the co-administration of amlodipine does not significantly alter the
effect of warfarin on prothrombin response time.
Nonselective MAOIs may cause HTN. Drugs which will form insoluble comp w/ Ca eg tetracycline.
Antacids, other Ca-containing drugs.
Gentamicin, tobramycin, neomycin, streptomycin, cephaloridine, polymixin B, colistin, ethacrynic
acid, furosemide, potent diuretic agents (ethacrynate, furosemide, mannitol).
Ca prep.
Probenecid prolongs blood level of amoxicillin. Allopurinol increases incidence of skin rashes.
Chlorpromazine, cimetidine, alcohol, other CNS depressants.
Selective/non-selective MAOIs, alcohol, carbamazepine & other enzyme inducers, opioid agonist-
antagonist eg buprenorphine, nalbuphine, pentazocine; SSRIs, triptans, other opioid derivatives,
benzodiazepines, barbiturates, CNS depressants, warfarin-like compounds, CYP3A4 inhibitors eg,
ketoconazole & erythromycin, drugs reducing seizure threshold.
Combination w/ aminoglycosides can increase nephrotoxicity.
Increased serum level of terfenadine. Increased absorption of digoxin. Weak interaction w/

theophylline.
Increased & prolonged amoxicillin blood levels w/ probenecid. Increased skin allergic reaction w/
allopurinol.
Enhanced central sedative effect of neuroleptics, tranquilizers, antidepressants, sleep-inducing
drugs, analgesics, anesth. Potentiation w/ alcohol, erythromycin, ketoconazole, itraconazole,
diltiazem, verapamil, cimetidine, hepatic enzyme inhibitors.
K supplements, salt substitutes or diuretics; lithium.

Potentiation of effects when used w/ insulin & other antidiabetics, ACE inhibitors, allopurinol,
anabolic steroids & male sex hormones, chloramphenicol, coumarin derivatives, cyclophosphamide,
disopyramide, fenfluramine, fenylramidol, fibrates, fluoxetine, guanethidine, ifosfamide, MAOIs,
miconazole, para-amino salicylic acid, pentoxifylline, high dose quinolones, salicylates,
sulfinpyrazones, sulfonamides, tetracyclines, tritoqualine, trofosfamide. Weakening of the blood
glucose lowering effects when used w/ acetazoliamide, barbiturates, corticosteroids, diazoxide,
diuretics, epinephrine & other sympathomimetics, glucagon, laxatives (other protracted use),
nicotinic acid (high dose), oestrogens & progesterons, phenothiazines, phenytoin, rifampicin,
thyroid hormones, -blockers decrease glucose tolerance.
Diazepam, MAOIs, drugs highly bound to plasma protein, CNS active drugs.
Antihistamines may potentiate other CNS depressants. Actions prolonged by MAOI. Prolonged use
of paracetamol may potentiate oral anticoagulant.
Increase plasma conc of lithium & digoxin. Diuretics or antihypertensive agents (eg, -blocker, ACE
inhibitors). Increased frequency of GI undesirable effects w/ other systemic NSAIDs or
corticosteroids. Increase the risk of bleeding w/ anticoagulants & antiplatelet agents. Increase risk
of GI bleeding w/ SSRIs. Increased toxicity of methotrexate. May increase nephrotoxicity of
ciclosporin. Antidiabetics, quinolone antibacterials, warfarin.
A number of substances affect glucose metabolism and may require dose adjustment of insulin
glulisine and particularly, close monitoring.
Substances that may enhance the blood glucose-lowering effect and increase susceptibility to
hypoglycemia include oral antidiabetic agents, angiotensin-converting enzyme (ACE) inhibitors,
disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors (MAOIs), pentoxifylline,
propoxyphene, salicylates and sulfonamide antibiotics.
Substances that may reduce the blood glucose-lowering effect include corticosteroids, danazol,
diazoxide, diuretics, glucagon, isoniazid, phenothiazine derivatives, somatropin, sympathomimetic
agents (eg, epinephrine, adrenaline, salbutamol, terbutaline), thyroid hormones, estrogens,
progestins (eg, oral contraceptives), protease inhibitors and atypical antipsychotic medication (eg,
olanzapine and clozapine).
Beta-blockers, clonidine, lithium salts or alcohol may potentiate or weaken the blood glucose-
lowering activity of insulin. Pentamidine may cause hypoglycemia, which may sometimes be
followed by hyperglycemia. In addittion, under the influence of sympatholytic medicinal products
eg, -blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation
may be reduced or absent.
Ethanol & lorazepam.
Diuretics and Other Antihypertensive Agents: Other antihypertensive agents may increase the
hypotensive effects of irbesartan; however, Aprovel has been safely administered with other
antihypertensive agents eg, -blockers, long-acting calcium-channel blockers and thiazide diuretics.
Prior treatment with high-dose diuretics may result in volume-depletion and a risk of hypotension
when initiating therapy with Aprovel (see Precautions).
Potassium Supplements and Potassium-Sparing Diuretics: Based on experience with the use of
other drugs that affect the renin-angiotensin-aldosterone system, concomitant use of potassium-
sparing diuretics, potassium supplements, salt substitutes containing potassium or other drugs that
may increase serum potassium levels (eg, heparin) may lead to increases in serum potassium and is,
therefore, not recommended (see Precautions).
Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported
during concomitant administration of lithium with ACE inhibitors. Similar effects have been rarely
reported with irbesartan so far. Therefore, this combination is not recommended (see Precautions).
If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): When angiotensin II antagonists are administered
simultaneously with NSAIDs [ie, selective COX-2 inhibitors, acetylsalicylic acid (>3 g/day) and
nonselective NSAIDs], attenuation of the antihypertensive effect may occur.
As with ACE inhibitors, concomitant use of angiotensin II antagonists and NSAIDs may lead to an
increased risk of worsening of renal function, including possible acute renal failure and an increase
in serum potassium, especially in patients with poor preexisting renal function. The combination
should be administered with caution, especially in the elderly. Patients should be adequately
hydrated and consideration should be given to monitoring renal function after initiation of
concomitant therapy, and periodically thereafter.
Additional Information on Drug Interactions: In clinical studies, the pharmacokinetics of irbesartan
is not affected by hydrochlorothiazide. Irbesartan is mainly metabolized by CYP2C9 and to a lesser
extent by glucuronidation. No significant pharmacokinetic or pharmacodynamic interactions were
observed when irbesartan was co-administered with warfarin, a drug metabolized by CYP2C9.
The effects of CYP2C9 inducers eg, rifampicin on the pharmacokinetics of irbesartan have not been
evaluated. The pharmacokinetics of digoxin was not altered by co-administration of irbesartan.
Lithium, digoxin, diuretics, systemic NSAIDs, anticoagulants, methotrexate, cyclosporin.
No drug interactions have been reported.

Probenecid prolongs plasma t of amoxicillin. Allopurinol increases incidence of skin rashes.
Reduces effectiveness of OC.
Lincomycin, promazine, pseudoephedrine.

Warfarin: In subjects stabilized on chronic warfarin therapy, the administration of Arcoxia 120 mg
daily was associated with an approximate 13% increase in International Normalized Ratio (INR)
prothrombin time. Standard monitoring of INR values should be conducted when therapy with
Arcoxia is initiated or changed, particularly in the first few days, in patients receiving warfarin or
similar agents.
Rifampin: Co-administration of Arcoxia with rifampin, a potent inducer of hepatic metabolism,
produced a 65% decrease in etoricoxib plasma area under the curve (AUC). This interaction should
be considered when Arcoxia is co-administered with rifampin.
Methotrexate: Two studies investigated the effects of Arcoxia 60, 90 or 120 mg administered once
daily for 7 days in patients receiving once-weekly methotrexate doses of 7.5-20 mg for rheumatoid
arthritis. Arcoxia at 60 mg and 90 mg had no effect on methotrexate plasma concentrations (as
measured by AUC) or renal clearance. In one study, Arcoxia 120 mg had no effect on methotrexate
plasma concentrations (as measured by AUC) or renal clearance. In the other study, Arcoxia 120 mg
increased methotrexate plasma concentrations by 28% (as measured by AUC) and reduced renal
clearance of methotrexate by 13%. Monitoring for methotrexate-related toxicity should be
considered when Arcoxia at doses >90 mg daily and methotrexate are administered concomitantly.
Diuretics, Angiotension Converting Enzyme (ACE) Inhibitors and Angiotensin II Antagonists (AIIAs):
Reports suggest that NSAIDs including selective COX-2 inhibitors may diminish the antihypertensive
effect of diuretics, ACE inhibitors and AIIAs. This interaction should be given consideration in
patients taking Arcoxia concomitantly with these products.
Lithium: Reports suggest that nonselective NSAIDs and selective COX-2 inhibitors may increase
plasma lithium levels. This interaction should be given consideration in patients taking Arcoxia
concomitantly with lithium.
Aspirin: Arcoxia can be used concomitantly with low-dose aspirin at doses for cardiovascular
prophylaxis. However, concomitant administration of low-dose aspirin with Arcoxia results in an
increased rate of GI ulceration or other complications compared to use of Arcoxia alone. At steady-
state, etoricoxib 120 mg once daily had no effect on the antiplatelet activity of low-dose aspirin (81
mg once daily). (See Precautions).
Oral Contraceptives: Arcoxia 60 mg given concomitantly with an oral contraceptive containing 35
mcg ethinyl estradiol (EE) and 0.5-1 mg norethindrone for 21 days increased the steady state AUC0-
24hr of EE by 37%. Arcoxia 120 mg given with the same oral contraceptive concomitantly or
separated by 12 hrs, increased the steady-state AUC0-24hr of EE by 50-60%. This increase in EE
concentration should be considered when selecting an oral contraceptive for use with etoricoxib. An
increase in EE exposure can increase the incidence of adverse events associated with oral
contraceptives (eg, venous thromboembolic events in women at risk).
Hormone Replacement Therapy: Administration of Arcoxia 120 mg with hormone replacement
therapy consisting of conjugated estrogens (0.625 mg Premarin) for 28 days, increased the mean
steady state AUC0-24hr of unconjugated estrone (41%), equilin (76%) and 17--estradiol (22%). The
Cyclopropane & halothane, MAOIs, tryptiline- or imipramine-type antidepressants.
Anesth, medications w/ anticholinergic activity, succinylcholine, other neuromuscular blockers or

cholinergic agonists.
Anesth, ketoconazole, quinidine, dexamethasone, phenobarb, rifampicin, phenytoin,

carbamazepine, drugs w/ anticholinergic activity, succinylcholine, other neuromuscular blockers or
cholinergic agonists eg, bethanechol.
NSAIDs, oral anticoagulants, ticlopidine, heparin, thrombolytics, methotrexate, lithium;

cyclosporine.
Antipyrine and cimetidine clinical interaction studies indicate that the co-administration of Arimidex
with other drugs is unlikely to result in clinically significant drug interactions mediated by
cytochrome P-450.
A review of the clinical trial safety database did not reveal evidence of clinically significant
interaction in patients treated with Arimidex who also received other commonly prescribed drugs.
Tamoxifen and/or other therapies containing oestrogen should not be co-administered with
Arimidex, as they may diminish its pharmacological action (see Contraindications).
Incompatibilities: Not applicable.
Antihypertensive agents. Ketoconazole, quinidine, fluoxetine, paroxetine, carbamazepine, alcohol.

Fondaparinux does not markedly inhibit CYP-450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6,
CYP2E1 or CYP3A4) in vitro. Thus, Arixtra is not expected to interact with other medicinal products
in vivo by inhibition of CYP-mediated metabolism.
Since fondaparinux does not bind significantly to plasma proteins other than ATIII, no interaction
with other medicinal products by protein-binding displacement is expected.
Bleeding risk is increased with concomitant administration of fondaparinux and agents that may
enhance the risk of haemorrhage (see Precautions).
In clinical studies performed with fondaparinux, the concomitant use of warfarin (oral
anticoagulant), acetylsalicylic acid (platelet inhibitor), piroxicam (nonsteroidal anti-inflammatory)
and digoxin (cardiac glycoside) did not significantly affect the pharmacokinetics or
pharmacodynamics of fondaparinux. In addition, fondaparinux neither influenced the INR activity
of warfarin, nor the bleeding time under acetylsalicylic acid or piroxicam treatment, nor the
pharmacokinetics or pharmacodynamics of digoxin at steady-state.
Follow-Up Therapy with Another Anticoagulant Medicinal Product: If follow-up treatment is to be
initiated with heparin or LMWH, the 1st injection should, as a general rule, be given 1 day after the
last fondaparinux injection.
If follow-up treatment with a vitamin K antagonist is required, treatment with fondaparinux should
be continued until the target INR value has been reached.
Incompatibilities: In the absence of compatibility studies, Arixtra must not be mixed with other
medicinal products.
Imipramine, desipramine, other anticholinergic-like drugs.
Metallic ion, Al- or Mg-containing antacids, NSAIDs, antidiabetics.

May negate the pharmacological action w/ oestrogen-containing medicines. May reduce efficacy w/
rifampicin, anticonvulsants (eg, phenytoin & carbamazepine) & St. John's wort.
Warfarin, aspirin, heparin, thrombolytics or NSAIDs.
Digoxin, diuretics, lithium, phenytoin, ibuprofen-containing drugs, oral anticoagulants (eg, warfarin).
Aspirin.
Concomitant use w/ coumarin anticoagulant may increase risk of bleeding. Acetosal may reduce
ibuprofen conc in blood & reduce anti-inflammatory effect.
Oral anticoagulants.
Effects of ephedrine diminished by guanethidine, methyldopa, reserpine. Pressor effects enhanced
by MAOIs. Xanthine may increase CNS stimulation caused by sympathomimetics & the excretion of
lithium & phenytoin. Xanthine & -blockers may be mutual antagonists.
Aminoglycosides, diuretics.
Alcohol, anticoagulants, probenecid, sulfonylureas.

MAOIs, selective & nonselective -blockers.
CNS drugs, barbiturates, alcohol, cimetidine.
Epinephrine, isoproterenol, theophylline, diprophylline, betamethasone, prednisolone,

hydrocortizone Na succinate, furosemide.
Antacids, colestipol, digoxin, erythromycin/clarithromycin, OC-containing norethindrone & ethinyl

estradiol, protease inhibitors, protease inhibitors; drugs that decrease the levels of endogenous
steroid hormones eg, ketoconazole, spironolactone & cimetidine.
Increased risk of myopathy w/ cyclosporine, fibric acid derivatives, erythromycin, azole antifungals
or niacin. Decreased plasma conc w/ oral antacid susp. Increased plasma conc w/ erythromycin,
clarithromycin, protease inhibitors. Digoxin, OCs.
The risk of myopathy during treatment with drugs in this class in increased with concurrent
administration of cyclosporine, fibric acid derivatives, erythromycin, azole antifungals or niacin (see
Precautions).
Antacids: Co-administration of atorvastatin with an oral antacid suspension containing magnesium
and alumunium hydroxides, decreased atorvastatin plasma concentrations approximately 35%;
however, LDL-C reduction was not altered.
Antypirine: Because atorvastatin does not affect the pharmacokinetics of antipyrine, interactions
with other drugs metabolized via the same cytochrome isozyme are not expected.
Colestipol: Plasma concentrations of atorvastatin were lower (approximately 25%) when colestipol
was administered with atorvastatin. However, lipid effects were greater when atorvastatin and
colestipol were co-administered than when either drug was given alone.
Digoxin: When multiple doses of digoxin and atorvastatin 10 mg were co-administered, steady state
plasma digoxin concentrations were unaffected. However, digoxin concentrations increased
approximately 20% following administration of digoxin with atorvastatin 80 mg daily. Patients taking
digoxin should be monitored appropriately.
Erythromycin/Clarithromycin: Co-administration of atorvastatin and erythromycin (500 mg 4 times
daily) or clarithromycin (500 mg twice daily) known inhibitors of cytochrome P450 3A4, was
associated with higher plasma concentrations of atorvastatin (see Precautions).
Azithromycin: Co-administration of atorvastatin (10 mg once daily) and azithromycin (500 mg once
daily) did not alter the plasma concentrations of atorvastatin.
Terfenadine: Co-administration of atorvastatin and terfenadine did not produce a clinically
significant effect on the pharmacokinetics of terfenadine.
Oral Contraceptives: Co-administration with an oral contraceptive containing norethindrone and
ethinyl estradiol increased area under the curve (AUC) values for norethindrone and ethinyl
estradiol by approximately 30% and 20%. These increases should be considered when selecting an
oral contraceptive for a woman taking atorvastatin.
Warfarin: An atorvastatin interaction studies with warfarin was conducted and no clinically
significant interactions were seen.
Cimetidine: An atorvastatin interaction study with cimetidine was conducted and no clinically
significant interactions were seen.
Amlodipine: Atorvastatin pharmacokinetics were not altered by the co-administration of
atorvastatin 80 mg and amlodipine 10 mg at steady state.
Protease Inhibitors: Co-administration of atorvastatin and protease inhibitors, known inhibitors of
cytochrome P450 3A4, was associated with increased plasma concentrations of atorvastatin.
Other Concomitant Therapy: In clinical studies, atorvastatin was used concomitantly with
antihypertensive agents and estrogen replacement therapy without evidence of clinically significant
adverse interactions. Interaction studies with specific agents have not been conducted.
Endocrine Function: HMG-CoA reductase inhibitors interfere with cholesterol synthesis and
Other NSAIDs, ticlopidine, systemic heparin, thrombolytics, antihemostatic drugs, lithium,
methotrexate, IUD, diuretic, antihypertensives, cholestyramine, cylcosporin.
Beta-adrenergics and xanthine preparations may intensify the bronchodilatory effect of Atrovent.
The risk of acute glaucoma in patients with a history of narrow-angle glaucoma (see Precautions)
may be increased when nebulised ipratropium bromide and -mimetics are administered
simultaneously.
Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular
secretion of amoxicillin. Concomitant use with Augmentin may result in increased and prolonged
blood levels of amoxicillin but not of clavulanic acid.
Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of
allergic skin reactions. There are no data on the concomitant use of amoxicillin-clavulanate and
allopurinol.
In common with other broad-spectrum antibiotics, amoxicillin-clavulanate may reduce the efficacy
of oral contraceptives and patients should be warned accordingly.
Incompatibilities: None known.
Fluticasone furoate is rapidly cleared by extensive first-pass metabolism mediated by the
cytochrome P-450 3A4. Based on data with another glucocorticoid (fluticasone propionate) that is
metabolized by CYP3A4, co-administration with ritonavir is not recommended because of the risk of
increased systemic exposure of fluticasone furoate. Caution is recommended when co-
administering fluticasone furoate with potent CYP3A4 inhibitors as an increase in systemic exposure
cannot be ruled out. In a drug interaction study of fluticasone furoate with the potent CYP3A4
inhibitor ketoconazole, there were more subjects with measurable fluticasone furoate plasma
concentrations in the ketoconazole group (6 of the 20 subjects) compared to placebo (1 of the 20
subjects). This small increase in exposure did not result in a statistically significant difference in 24-
hr serum cortisol levels between the 2 groups. The enzyme induction and inhibition data suggest
that there is no theoretical basis for anticipating metabolic interactions between fluticasone furoate
and the cytochrome P-450-mediated metabolism of other compounds at clinically relevant
intranasal doses. Therefore, no clinical studies have been conducted to investigate interactions of
fluticasone furoate on other drugs (see Pharmacokinetics under Actions and Precautions).
Incompatibilities: None.
Alcohol, theophylline & other CNS depressants.
For information on the decreased serum PSA levels during treatment with dutasteride and guidance
concerning prostate cancer detection see Precautions.
Effects of Other Drugs on the Pharmacokinetics of Dutasteride: Use Together with CYP3A4 and/or P-
Glycoprotein-Inhibitors: Dutasteride is mainly eliminated via metabolism. In vitro studies indicate
that this metabolism is catalysed by CYP3A4 and CYP3A5. No formal interaction studies have been
performed with potent CYP3A4 inhibitors. However, in a population pharmacokinetic study,
dutasteride serum concentration were on average 1.6-1.8 times greater, respectively, in a small
number of patients treated concurrently with verapamil or diltiazem (moderate inhibitors of
CYP3A4 and inhibitors of P-glycoprotein) than in other patients.
Long-term combination of dutasteride with drugs that are potent inhibitors of the enzyme CYP3A4
(eg, ritonavir, indinavir, nefazodone, itraconazole, ketoconazole administered orally) may increase
serum concentrations of dutasteride. Further inhibition of 5a-reductase at increased dutasteride
exposure, is not likely. However, a reduction of the dutasteride dosing frequency can be considered
if side effects are noted. It should be noted that in the case of enzyme inhibition, the long t may
be further prolonged and it can take >6 months of concurrent therapy before a new steady-state is
reached.
Administration of cholestyramine 12 g 1 hr before a 5 mg single-dose of dutasteride did not affect
the pharmacokinetics of dutasteride.
Effects of Dutasteride on the Pharmacokinetics of Other Drugs: Dutasteride has no effect on the
pharmacokinetics of warfarin or digoxin. This indicates that dutasteride does not inhibit/induce
CYP2C9 or the transporter P-glycoprotein. In vitro interaction studies indicate that dutasteride does
not inhibit the enzyme CYP1A2, CYP2D6, CYP2C9, CYP2C19 or CYP3A4.
In a small study (N=24) of 2 weeks duration in healthy men, dutasteride (0.5 mg daily) had no effect
on the pharmacokinetics of tamsulosin or terazosin. There was also no indication of a
pharmacodynamic interaction in this study.
-blockers & xanthines.
Warfarin: Prolongation of prothrombin time occurs in patients stabilized on warfarin.

Carbamazepine: Therapy with Azol may reduce the plasma clearance of carbamazepine, increasing
its elimination half-life and plasma concentration.
Cyclosporin: Therapy with Azol may cause an increase in the serum levels of concomitantly
administered cyclosporin.
Oral Contraceptives: Although no specific interaction has been recorded, it is recommended that
oral contraceptives should not be used concurrently with Azol.
Laboratory Tests: Azol treatment may interfere with laboratory determinations of testosterone,
androstenedione and dehydroepiandrosterone.
Theophylline, warfarin, carbamazepine, ergot alkaloids, cyclosporine, digoxin, antacids.
Al- & Mg-containing antacids, warfarin, ergot derivatives, theophylline. Disturb cyclosporin
metabolism. Increase digoxin conc.
Ethambutol reduces the efficacy of uricosuric agents, esp in the presence of INH & pyridoxine. INH
enhances the effects of phenytoin & inhibits metabolism of primidone.
May reduce efficacy of uricosurics, esp in the presence of INH & pyridoxine. Al-containing antacids.
Al- or Mg-containing antacids may reduce absorption. May increase plasma theophylline levels.
Probenecid, clindamycin, metronidazole.
Aminoglycosides, loop diuretics.

None reported.
Plasma conc increased by erythromycin, isoniazid, verapamil, diltiazem, dextropropoxyphene,

viloxazine, possibly cimetidine. Reversible neurotoxic manifestations may occur if combined w/
lithium (rare). Oral anticoagulants, OC, alcohol.
Antihypertensives or antidepressants.
Absorption reduced by Al- or Mg(OH)2-containing antacids. Elevates plasma conc of theophylline.

Since entecavir is primarily eliminated by the kidneys (see Pharmacology: Pharmacokinetics:
Metabolism and Elimination under Actions), co-administration of Baraclude with drugs that reduce
renal function or compete for active tubular secretion may increase serum concentrations of either
entecavir or the co-administered drug. Co-administration of entecavir with lamivudine, adefovir
dipivoxil, or tenofovir disoproxil fumarate did not result in significant drug interactions. The effects
of co-administration of Baraclude with other drugs that are renally eliminated or are known to
affect renal function have not been evaluated, and patients should be monitored closely for adverse
events when Baraclude is co-administered with such drugs.
MAOIs, OCs; alcohol.
Alcohol, false +ve reaction in the urine may occur w/ Benedict's or Fehling's soln.
Immunosuppressants.
Other -adrenergics, anticholinergics and xanthine derivatives (eg, theophylline) may enhance the
bronchodilatory effect of Berodual. The concurrent administration of other -mimetics, systemically
available anticholinergics and xanthine derivatives (eg, theophylline) may increase the side effects.
A potentially serious reduction in bronchodilatation may occur during concurrent administration of
-blockers.
Beta-agonist-induced hypokalemia may be increased by concomitant treatment with xanthine
derivatives, corticosteroids and diuretics. This should be taken into account particularly in patients
with severe airway obstruction.
Hypokalemia may result in an increased susceptibility to arrhythmias in patients receiving digoxin.
Additionally, hypoxia may aggravate the effects of hypokalemia on cardiac rhythm. It is
recommended that serum potassium levels are monitored in such situations.
Beta-adrenergic agonists should be administered with caution to patients being treated with
monoamine oxidase inhibitors or tricyclic antidepressants, since the action of -adrenergic agonists
may be enhanced.
Inhalation of halogenated hydrocarbon anesthetics eg, halothane, trichloroethylene and enflurane
may increase the susceptibility on the cardiovascular effects of -agonists.
Beta-adrenergics, anticholinergics and xanthine derivatives (eg, theophylline) may enhance the
effect of Berotec. The concurrent administration of other -mimetics, systemically available
anticholinergics and xanthine derivatives (eg, theophylline) may increase the side effects.
A potentially serious reduction in bronchodilation may occur during concurrent administration of -
blockers.
Beta-adrenergic agonists should be administered with caution to patients being treated with
monoamine oxidase inhibitors or tricyclic antidepressants, since the action of -adrenergic agonists
may be enhanced.
Inhalation of halogenated hydrocarbon anaesthetics eg, halothane, trichloroethylene and enflurane
may increase the susceptibility to the cardiovascular effects of -agonists.
Alcohol, CNS depressants.
Reduced absorption w/ Al-/Mg- containing antacids. May increase plasma conc of theophylline.
Increased serum creatinine level w/ cyclosporine; bleeding time w/ oral anticoagulant; may
accelerate absorption w/ metoclopramide. Probenecid.
Penicillins, amphotericin, cephalosporins, erythromycin, heparin, Na bicarbonate.
Theophylline, antacids.
Alcohol.
No in vivo interaction studies have been performed. Based on in vitro data, no in vivo inhibition on
cytochrome P450 enzymes is expected.
Concomitant use w/ other drugs.

Decreased absorption by cholestyramine. Potentiates action of coumarin, sulfonylureas & insulin.
Theophylline, carbamazepine, digoxin, triazolam, anticoagulants.
Potentially nephrotoxic substances, aminoglycosides.

May reduce absorption w/ Fe, Ca, copper; may increased w/ L-histidine, L-cysteine, L-methionine.
May reduce the effects of levodopa.
Neuromuscular blockers, erythromycin.

Alcohol, oral anticoagulants, chloramphenicol, aspirin, phenobarb, liver enzyme inducers,
hepatotoxic agents.
Concommitant use w/ biphosponate (alendronate, etidronate, risedronate), quinolone

(ciprofloxacin, gatifloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin,
ofloxacin,sparfloxacin, trofafloxacin), tetracyclines (doxycycline, monocycline, tetracycline) may
reduce absorption of these drugs (bisphosphonate, quinolone, tetracycline). Increased Mg level in
plasma w/ boron. Ca, manganese, Fe, Na alginate reduces the absorption of Mg. Inositol
hexaphosphate suppresses the absorption of Mg. Indigestible oligosaccharide increases the
absorption of Mg in the colon. Phosphate reduces the absorption of phosphate & Mg. Concomitant
use w/ oxalic acid-rich food (spinach, potatoes, rhubarb, legumes) or phytate acid (legumes)
reduces the absorption of Mg.
Diuretics: Patients on diuretics and especially those who are volume- and/or salt-depleted, may
experience excessive reduction in blood pressure after initiation of therapy with an ACE inhibitor.
The possibility of hypotensive effects can be reduced by discontinuation of the diuretic, by
increasing volume or salt intake prior to initiating therapy with low and progressive doses of
perindopril.
Potassium-Sparing Diuretics, Potassium Supplements or Potassium-Containing Salt Substitutes:
Although serum potassium usually remains within normal limits, hyperkalaemia may occur in some
patients treated with perindopril. Potassium-sparing diuretics (eg, spironolactone, triamterene or
amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant
increases in serum potassium. Therefore, the combination of perindopril with the previously-
mentioned drugs is not recommended (see Precautions). If concomitant use is indicated because of
demonstrated hypokalaemia, they should be used with caution and with frequent monitoring of
serum potassium.
Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported
during concomitant administration of lithium with ACE inhibitors. Concomitant use of thiazide
diuretics may increase the risk of lithium toxicity and enhance the already increased risk of lithium
toxicity with ACE inhibitors. Use of perindopril with lithium is not recommended, but if the
combination proves necessary, careful monitoring of serum lithium levels should be performed (see
Precautions).
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Including Aspirin =3 g/day: When ACE inhibitors are
administered simultaneously with NSAIDs (ie, acetylsalicylic acid at anti-inflammatory dosage
regimens, COX-2 inhibitors and nonselective NSAIDs), attenuation of the antihypertensive effect
may occur. Concomitant use of ACE inhibitors and NSAIDs may lead to an increased risk of
worsening of renal function, including possible acute renal failure and an increase in serum
potassium, especially in patients with poor preexisting renal function. The combination should be
administered with caution, especially in the elderly. Patients should be adequately hydrated and
consideration should be given to monitoring renal function after initiation of concomitant therapy
and periodically thereafter.
Antihypertensive Agents and Vasodilators: Concomitant use of these agents may increase the
hypotensive effects of perindopril. Concomitant use with nitroglycerin and other nitrates, or other
vasodilators, may further reduce blood pressure.
Antidiabetic Agents: Epidemiological studies have suggested that concomitant administration of ACE
inhibitors and antidiabetic medicines (insulins, oral hypoglycaemic agents) may cause an increased
blood-glucose lowering effect with risk of hypoglycaemia. This phenomenon appeared to be more
likely to occur during the 1st weeks of combined treatment and in patients with renal impairment.
Tricyclic Antidepressants/Antipsychotics/Anaesthetics: Concomitant use of certain anaesthetic
medicinal products, tricyclic antidepressants and antipsychotics with ACE inhibitors may result in
further reduction of blood pressure (see Precautions).
Perindopril and Indapamide: Concomitant Use Not Recommended: Lithium: Reversible increases in
serum lithium concentrations and toxicity have been reported during concomitant administration of
lithium with ACE inhibitors. Concomitant use of thiazide diuretics may further increase lithium
levels and enhance the risk of lithium toxicity with ACE inhibitors. Use of perindopril combined with
indapamide with lithium is not recommended, but if the combination proves necessary, careful
monitoring of serum lithium levels should be performed (see Precautions).
Concomitant Use which Requires Special Care: Baclofen: Potentiation of antihypertensive effect.
Monitoring of blood pressure and renal function and antihypertensive dose-adaptation if necessary.
Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Including Acetylsalicylic Acid (ASA) at High Doses:
When ACE inhibitors are administered simultaneously with NSAIDs (ie, ASA at anti-inflammatory
dosage regimens, COX-2 inhibitors and nonselective NSAIDs), attenuation of the antihypertensive
effect may occur. Concomitant use of ACE inhibitors and NSAIDs may lead to an increased risk of
worsening of renal function, including possible acute renal failure and an increase in serum
potassium, especially in patients with poor preexisting renal function. The combination should be
administered with caution, especially in the elderly. Patients should be adequately hydrated and
consideration should be given to monitoring renal function after initiation of concomitant therapy
and periodically thereafter.
Concomitant Use which Requires Some Care: Imipramine-Like Antidepressants (Tricyclics),
Neuroleptics: Increased antihypertensive effect and risk of orthostatic hypotension (additive effect).
Corticosteroids, Tetracosactide: Reduction in antihypertensive effect (salt and water retention due
to corticosteroids).
Other Antihypertensive Agents: Use of other antihypertensive medicinal products with
perindopril/indapamide could result in additional blood pressure lowering effect.
Perindopril: Concomitant Use Not Recommended: Potassium-Sparing Diuretics (Spironolactone,
Triamterene, Alone or In Combination), Potassium (Salts): Angiotensin-converting enzymes
inhibitors attenuate diuretic-induced potassium loss. Potassium-sparing diuretics eg,
spironolactone, triamterene or amiloride, potassium supplements or potassium-containing salt
substitutes may lead to significant increases in serum potassium (potentially lethal). If concomitant
use is indicated because of documented hypokalaemia they should be used with caution and with
frequent monitoring of serum potassium and by electrocardiogram (ECG).
Concomitant Use which Requires Special Care: Antidiabetic Agents (Insulin, Hypoglycemic
Sulphonamides): Reported with captopril and enalapril.
The use of ACE inhibitors may increase the hypoglycemic effect in diabetics receiving treatment
with insulin or with hypoglycaemic sulphonamides. The onset of hypoglycaemic episodes is very
rare (improvement in glucose tolerance with a resulting reduction in insulin requirements).
Concomitant Use which Requires Some Care: Allopurinol, Cytostatic or Immunosuppressive Agents,
Systemic Corticosteroids or Procainamide: Concomitant administration with ACE inhibitors may lead
to an increased risk for leukopenia.
Anticoagulants.
Dicumarol, phenytoin, tolbutamide, phenobarb.
Ca antagonist, clonidine, MAOIs (except MAO-B inhibitors), class I & III antiarrhythmics,
parasympathomimetics, other -blockers (including eye drops); insulin & oral antidiabetics, anesth
agents, digitalis glycosides, prostaglandin synthetase inhibitors, ergotamine derivatives,
sympathomimetics, TCA, barbiturates, phenothiazines, other antihypertensives, rifampicin.
Anesth drugs, nitroglycerine, ergot alkaloid vasoconstrictors.
Other antitumor drugs, vinblastine.
Saquinavir, ritonavir, -blockers, fentanyl, cimetidine, digoxin, phenytoin, rifampicin, dantrolene Na,
tandospirone citrate, nitroglycerin, pancuronium Br, vecuronium Br.
No drug interactions of clinical significance have been identified.
Compounds which have been investigated in clinical pharmacokinetic studies include
hydrochlorothiazide, warfarin, digoxin, oral contraceptives (i.e. ethinylestradiol/levonorgestrel),
glibenclamide, nifedipine and enalapril.
Candesartan is eliminated only to a minor extent by hepatic metabolism (CYP2C9). Available
interaction studies indicate no effect on CYP2C9 and CYP3A4 but the effect on other cytochrome
P450 isoenzymes is presently unknown.
The antihypertensive effect of Blopress may be enhanced by other antihypertensives.
Based on experiences with the use of other drugs that affect the renin-angiotensin-aldosterone
system, concomitant use of potassium-sparing diuretics, potassium supplements, salts substitutes
containing potassium, or other drugs that may increase potassium levels (e.g. heparin) may lead to
increase in serum potassium.
Reversible increase in serum lithium concentrations and toxicity have been reported during
concomitant administration of lithium with ACE inhibitors. A similar effect may occur with
angiotensin II receptor antagonists and careful monitoring of serum lithium levels is recommended
during concomitant use.
As with other antihypertensive agents, the antihypertensive effect of candesartan may be
attenuated by non-steroidal anti-inflammatory drugs such as indomethacin.
The bioavailability of candesartan is not affected by food.
Candesartan Cilexetil: No significant drug interactions have been reported in studies of candesartan
cilexetil given with other drugs eg, glyburide, nifedipine, digoxin, warfarin, hydrochlorothiazide and
oral contraceptives in healthy volunteers. Because candesartan is not significantly metabolized by
the cytochrome P-450 system, and at therapeutic concentrations has no effects on P-450 enzymes,
interactions with drugs that inhibit, or rarely metabolized by those enzymes would not be expected.
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with
thiazide diuretics: Alcohol, barbiturates or narcotics. Potentiation of orthostatic hypotension may
occur.
Antidiabetic Drugs (Oral Agent and Insulin): Dosage adjustment of the antidiabetic drug may be
required.
Other Antihypertensive Drugs: Additive effect or potentiation.
Cholestyramine and Colestipol Resins: Absorption of hydrochlorothiazide is impaired in the
presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind
the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and
43%, respectively.
Corticosteroids: ACTH-intensified electrolyte depletion, particularly hypokalemia.
Pressor Amines (eg, Norepinephrine): Possible decreased response to pressor amines but not
sufficient to preclude their use.
Nondepolarizing Skeletal Muscle Relaxants (eg, Tubocurarine): Possible increased responsiveness to
the muscle relaxant.
Lithium: Generally should not be given with diuretic agents because the renal clearance of lithium is
reduced and a high risk of lithium toxicity is added. Refer to the package insert for lithium
preparation before use of such preparations with Blopress Plus.
Nonsteroidal Anti-Inflammatory Drugs: In some patients, the administration of a nonsteroidal anti-
inflammatory agent can reduce the diuretic, natriuretic and antihypertensive effects of loop,
potassium-sparing and thiazide diuretics.
Therefore, when Blopress Plus and nonsteroidal anti-inflammatory agents are used concomitantly,
the patient should be observed closely to determine if the desired effect of diuretic is obtained.
Rifampicin may reduce AUC or Cmax. Cimetidine & grapefruit juice may increase AUC. Quinidine,
fluoxetine, paroxetine & propafenone may increase blood levels of R(+) enantiomer. Digoxin plasma
conc increased when administered concomitantly. Clonidine may potentiate BP & heart rate-
lowering effects.
Ranitidine, aminoglycosides.
Mg-containing prep, digitalis prep, Ca & vit D derivatives, barbiturates & other anticonvulsants.
Neuromuscular transmission may be potentiated by aminoglycosides, curare-like nondepolarizing
blockers, lincosamides, polymyxins, quinidine, Mg sulfate, anticholinesterases, succinylcholine
chloride.
Enhanced follicular response w/ clomiphene citrate.
Cimetidine; alcohol, other CNS depressants.

Compd that induce, inhibit or are metabolized by CYP450 3A4 eg, cyclosporine, terfenadine,
ketoconazole, erythromycin & troleandomycin. Increased clearance w/ doxorubicin. Carboplatin.
-receptor blocking agents (including eye drops) especially those which are nonselective may partly
or totally inhibit the effect of -receptor stimulants.
Hypokalemia may result from 2-agonist therapy and may be potentiated by concomitant
treatment with xanthine derivatives, steroids and diuretics (see Precautions).
Effects of Other Drugs: Ticagrelor is predominantly metabolized by CYP3A4 and to a lesser extent by
CYP3A5. Ticagrelor is also a p-glycoprotein (P-gp) substrate.
CYP3A Inhibitors: Avoid use of strong inhibitors of CYP3A (eg, ketoconazole, itraconazole,
voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and
telithromycin). (See Pharmacology under Actions, Warnings and Precautions.)
CYP3A Inducers: Avoid use with potent inducers of CYP3A (eg, rifampin, dexamethasone, phenytoin,
carbamazepine and phenobarbital). (See Pharmacology under Actions, Warnings and Precautions.)
Aspirin: Use of BRILINTA with aspirin maintenance doses >100 mg reduced the effectiveness of
Brilinta (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions, Warnings and
Precautions).
Effect of Brilinta on Other Drugs: Ticagrelor is an inhibitor of CYP3A4/5 and the P-gp transporter.
Simvastatin and Lovastatin: BRILINTA will result in higher serum concentrations of simvastatin and
lovastatin because these drugs are metabolized by CYP3A4. Avoid simvastatin and lovastatin doses
greater than 40 mg (see Pharmacology under Actions).
Digoxin: Because of inhibition of the P-gp transporter, monitor digoxin levels with initiation of or any
change in BRILINTA therapy (see Pharmacology under Actions).
Other Concomitant Therapy: BRILINTA can be administered with unfractionated or low-molecular-
weight heparin, GPIIb/IIIa inhibitors, proton-pump inhibitors, -blockers, angiotensin converting
enzyme inhibitors and angiotensin receptor blockers.
May cause hypertensive crisis w/ MAOIs.

Amoxicillin, cefuroxime, erythromycin, doxycycline.
Ibuprofen concomitant use with anti-hypertensives, diuretics, lithium, methotrexate, anti-
coagulants, anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs), aminoglycosides,
acetylsalicylic acid, cardiac glycosides, cyclosporine, corticosteroids, COX-2 inhibitors and other
NSAIDs, herbal extract, mifepristone, quinolone antibiotics, tacrolimus, zidovudine.
Live viral vaccines, cardiac glycosides, K-sparing diuretics, ketoconazole, troleandomycin,
erythromycin, cyclosporine, cimetidine, cholestyramine.
Cimetidine, erythromycin, troleandomycin, OC, xanthine derivatives; rifampicin.
Probenecid, allopurinol.
MAOI may prolong & enhance antihistamine effects which can lead to severe hypotension. W/
alcohol, TCAs, barbiturate or other antidepressants may enhance sedative effect of
dexchlorpheniramine maleate.
Potentiation of cardiac effects may occur w/ mexiletine & lignocaine.
Data from a drug-drug interaction study involving 10 mg of amlodipine and 80 mg of atorvastatin in
healthy subjects indicate that the pharmacokinetics of amlodipine are not altered when the drugs
are co-administered. The effect of amlodipine on the pharmacokinetics of atorvastatin showed no
effect on the Cmax: 91% (90% confidence interval: 80-103%), but the AUC of atorvastatin increased
by 18% (90% confidence interval: 109-127%) in the presence of amlodipine.
No drug interaction studies have been conducted with Caduet and other drugs, although studies
have been conducted in the individual amlodipine and atorvastatin components, as described as
follows:
In Studies with Amlodipine: Amlodipine has been safely administered with thiazide diuretics, a-
blockers, -blockers, ACE inhibitors, long-acting nitrates, sublingual glyceryl trinitrate, nonsteroidal
anti-inflammatory drugs, antibiotics and oral hypoglycemic drugs.
In vitro data from studies with human plasma, indicate that amlodipine has no effect on protein-
binding of the drugs tested (digoxin, phenytoin, warfarin or indomethacin).
In the following studies, there were no significant changes in the pharmacokinetics of either
amlodipine or another drug within the study, when co-administered.
Special Studies: Effect of Other Agents on Amlodipine: Cimetidine: Co-administration of cimetidine
did not alter the pharmacokinetics of amlodipine.
Grapefruit Juice: Co-administration of 240 mL of grapefruit juice with a single oral dose of
amlodipine 10 mg in 20 healthy volunteers had no significant effect on the pharmacokinetics of
amlodipine.
Aluminum/Magnesium (Antacid): Co-administration of an aluminum/magnesium antacid with a
single dose of amlodipine had no significant effect on the pharmacokinetics of amlodipine.
Sildenafil: A single 100-mg dose of sildenafil in subjects with essential hypertension had no effect on
the pharmacokinetic parameters of amlodipine. When amlodipine and sildenafil were used in
combination, each agent independently exerted its own blood pressure lowering effect.
Special Studies: Effect of Amlodipine on Other Agents: Digoxin: Co-administration of amlodipine
with digoxin did not change serum digoxin levels or digoxin renal clearance in normal volunteers.
Ethanol (Alcohol): Single and multiple 10 mg doses of amlodipine had no significant effect on the
pharmacokinetics of ethanol.
Warfarin: Co-administration of amlodipine with warfarin did not change the warfarin prothrombin
response time.
Cyclosporine: Pharmacokinetic studies with cyclosporine have demonstrated that amlodipine does
not significantly alter the pharmacokinetics of cyclosporine.
Drug/Laboratory Test Interactions: None known.
In Studies with Atorvastatin: The risk of myopathy during treatment with HMG-CoA reductase
inhibitors is increased with concurrent administration of cyclosporin, fibric acid derivatives, lipid-
modifying doses of niacin or cytochrome P-450 3A4 inhibitors (eg, erythromycin and azole
antifungals) (see Use in Combination with Other Medicinal Compounds under Dosage &
Antihypertensives, cimetidine & -blockers, digoxin, quinidine (monitor plasma level).
Inhibits absorption of tetracycline.

Enhances cardiac effects of digitalis glycosides. Inhibits absorption of tetracycline.
Anticoagulant effect of warfarin may be reduced.
Oral tetracycline or fluoride prep; milk & dairy product.

Reduces enteral absorption of tetracycline & fluoride prep.

CalSource/CalSource Forte/CalSource Plus Vitamin C may reduce the absorption of oral tetracycline
or fluoride preparations. An interval of at least 3 hrs should be observed in case of concomitant
therapy. Concomitant therapy with vitamin D enhances calcium absorption.
Calcium absorption from the gastrointestinal tract may be diminished by the concomitant intake of
certain foods eg, spinach, rhubarb, bran, cereal, milk and milk products.
When given in high doses concomitantly with vitamin D, calcium may reduce the response to
verapamil and possibly other calcium channel blockers. In digitalized patients, administration of
large doses of oral calcium may increase the risk of cardiac arrhythmias.
High doses of vitamin C may interfere with some methods of urinary glucose determination.
Oestrogen, warfarin, Fe.

Neuromuscular-Blocking Agents: Interaction between irinotecan HCl and neuromuscular-blocking
agents cannot be ruled out. Since Campto has anticholinesterase activity, drugs with
anticholinesterase activity may prolong the neuromuscular-blocking effects of suxamethonium and
the neuromuscular blockade of nondepolarizing drugs may be antagonized.
Antineoplastic Agents: The adverse effects of irinotecan eg, myelosuppression and diarrhea, would
be expected to be exacerbated by other antineoplastic agents having a similar adverse effect
profile.
Dexamethasone: Lymphocytopenia has been reported in patients receiving irinotecan and it is
possible that the administration of dexamethasone as antiemetic prophylaxis may have enhanced
the likelihood of lymphocytopenia. However, serious opportunistic infections have not been
observed and no complications have specifically been attributed to lymphocytopenia.
Hyperglycemia has been observed in patients with a history of diabetes mellitus or evidence of
glucose intolerance prior to administration of irinotecan. It is probable that dexamethasone, given
as antiemetic prophylaxis, contributed to hyperglycemia in some patients.
Laxatives: Laxative use during therapy with irinotecan is expected to worsen the incidence or
severity of diarrhea.
Diuretics: Dehydration secondary to vomiting and/or diarrhea may be induced by irinotecan. The
physician may wish to withhold diuretics during dosing with irinotecan and during periods of active
vomiting or diarrhea.
Anticonvulsants: Concomitant administration of CYP3A-inducing anticonvulsant drugs (eg,
carbamazepine, phenobarbital or phenytoin) leads to reduced exposure to the active metabolite
SN-38. Consideration should be given to starting or substituting non-enzyme-inducing
anticonvulsants at least 1 week prior to initiation of irinotecan therapy in patients requiring
anticonvulsant treatment.
Ketoconazole: Irinotecan clearance is greatly reduced in patients receiving concomitant
ketoconazole, leading to increased exposure to SN-38. Ketoconazole should be discontinued at least
1 week prior to starting irinotecan therapy and should not be administered during irinotecan
therapy.
St. John's wort (Hypericum perforatum): Exposure to the active metabolite SN-38 is reduced in
patients taking concomitant St. John's wort. St. John's wort should be discontinued at least 1 week
prior to the first cycle of irinotecan and should not be administered during irinotecan therapy.
Atazanavir Sulfate: Co-administration of atazanavir sulfate, a CYP3A4 and UGT1A1 inhibitor has the
potential to increase systemic exposure to SN-38, the active metabolite of irinotecan. Physicians
should take this into consideration when co-administering these drugs.
Other BP-lowering agents, lithium, NSAIDs ie, indomethacin.

Serum K level may be increased in concomitant use of candesartan cilexetil w/ K-sparing diuretics, K
supplements, K-containing salt substitutes. W/ ACE inhibitors may increase serum litium level &
toxicity. Antihypertensive effect may be reduced by NSAIDs eg, indomethacin.
Chloramphenicol, dicoumarol, phenytoin, tolbutamide, phenobarbital.
Weak CYP450 inducers, OCs, phenytoin, theophylline, antacids & sucralfate.
Cimetidine, erythromycin, ketoconazole, ritonavir, rifampicin.

Probenecid; other nephrotoxic drugs.
Aminoglycosides & potent diuretics may cause nephrotoxicity. Ampicillin, metronidazole,

vancomycin, gentamicin, tobramycin, netilmicin sulfate, aminophylline.
Sedative & alcohol.
Aminoglycosides or loop diuretics may cause nephrotoxicity; probenecid increases drug plasma
conc of cefpirome; drugs which may cause fecal stasis.
Corticosteroid, thiazide, high diuretic agent, cardiac glycoside, spironolactone or amiloride.

OCs, anticoagulants.
Blood products or proteinaceous fluids eg protein hydrolysates or w/ IV lipid. Aminoglycoside,

should not be mixed in the syringe or IV fluid container because loss of activity of the
aminoglycoside can occur. OCs. May prolong bleeding time & prothrombin time in patients w/
anticoagulant therapy.
Nephrotoxic drugs, other myelosuppressive drugs.
Cyclophosphamide, dactinomycin, mitomycin. Increased cardiotoxicity w/ propanolol. Raised conc

of blood uric acid w/ allopurinol, colchicine. Increased toxicity w/ high dose of methotrexate.
Extracorporeal treatments involving blood contact with negatively charged surfaces carry the risk of
severe anaphylactoid reactions (see Contraindications).
When potassium salts or potassium-retaining diuretics are given concurrently, a rise in serum
potassium concentration may occur. Concomitant treatment with potassium-retaining diuretics (eg,
spironolactone) or with potassium salts must be accompanied by close monitoring of serum
potassium.
When antihypertensive agents (eg, diuretics) or other medicines with blood pressure-lowering
potential (eg, nitrates, tricyclic antidepressants, anaesthetics) are used concomitantly, potentiation
of the antihypertensive effect is to be anticipated (concerning diuretics, see also Dosage &
Administration, Precautions and Adverse Reactions). Serum sodium should be regularly monitored
in patients receiving diuretics.
Vasopressor sympathomimetics (eg, adrenaline, noradrenaline) may reduce the antihypertensive
effect. Therefore, blood pressure should be monitored particularly closely.
Allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other medicines
that may alter the blood picture increase the likelihood of blood picture changes (see Precautions).
Angiotensin-converting enzyme inhibitors may reduce lithium excretion, possibly increasing its
levels in serum and the risk of its toxic effects. Therefore, lithium levels must be monitored.
Angiotensin-converting enzyme inhibitors may potentiate the effect of antidiabetic agents (eg,
insulin or sulfonylurea derivatives). In isolated cases, this may lead to an excessive reduction in
blood sugar levels (hypoglycaemic reactions). Therefore, in the initial phase of combined
administration, blood sugar levels should be monitored particularly closely.
Concurrent administration of certain medicines for the control of pain and inflammation
(nonsteroidal anti-inflammatory drugs) eg, acetylsalicylic acid or indomethacin, may weaken the
antihypertensive effect. Moreover, combined use may increase serum potassium and the risk of a
deterioration of renal function.
Concomitant use of heparin may lead to an increase in serum potassium concentration.
Cardace may potentiate the effect of alcohol.
Increased dietary salt intake may weaken the antihypertensive effect.
Anaphylactic and anaphylactoid reactions to insect venoma and possibly, other allergens are
increased under ACE inhibition (see Adverse Reactions).
Nitroprusside, -blocker.
BP-lowering effect may be potentiated by antihypertensives. Avoid use w/ sildenafil.

Most (98%) of plasma Cardura is protein bound. In vitro data in human plasma indicate that Cardura
has no effect on protein-binding of digoxin, warfarin, phenytoin or indomethacin. Cardura has been
administered without any adverse drug interaction in clinical experience with thiazide diuretics,
furosemide, -blockers, nonsteroidal anti-inflammatory drugs, antibiotics, oral hypoglycemic drugs,
uricosuric agents or anticoagulants.
Warfarin.
Concomitant use w/ aminoglycosides may increase the risk of nephrotoxicity.
Concomitant use w/ K supplements or other K-sparing agents.
Saquinavir, ritonavir, other hypotensives, -blockers, fentanyl, digoxin, phenytoin, nitroglycerine,

muscle relaxants, rifampicin, immunosuppressants, dantrolene Na, tandospiron citrate.
In vitro studies have shown that R-bicalutamide is an inhibitor of CYP3A4, with lesser inhibitory
effects on CYP2C9, 2C19 and 2D6 activity.
Although clinical studies using antipyrine as a marker of cytochrome P-450 (CYP) activity showed no
evidence of a drug interaction potential with Casodex, mean midazolam exposure (AUC) was
increased by up to 80% after co-administration of Casodex for 28 days. For drugs with a narrow
therapeutic index, such an increase could be of relevance. As such, concomitant use of terfenadine,
astemizole and cisapride is contraindicated (see Contraindications) and caution should be exercised
with the co-administration of Casodex with compounds eg, ciclosporin and calcium-channel
blockers. Dosage reduction may be required for these drugs particularly if there is evidence of
enhanced or adverse drug effect. For ciclosporin, it is recommended that plasma concentrations
and clinical condition be closely monitored following initiation or cessation of Casodex therapy.
Caution should be exercised when prescribing Casodex with other drugs which may inhibit drug
oxidation eg, cimetidine and ketoconazole. In theory, this could result in increased plasma
concentrations of Casodex which theoretically could lead to an increase in side effects.
In vitro studies have shown that Casodex can displace the coumarin anticoagulant, warfarin, from
its protein-binding sites. It is therefore, recommended that if Casodex is started in patients who are
already receiving coumarin anticoagulants, prothrombin time should be closely monitored.
50 mg: There is no evidence of any pharmacodynamic or pharmacokinetic interactions between
Casodex and LHRH analogues.
The following interactions include those observed with Cataflam/Cataflam D and/or other
pharmaceutical forms of diclofenac.
Lithium, Digoxin: Cataflam/Cataflam D may raise plasma concentrations of lithium or digoxin.
Monitoring of serum lithium or digoxin level is recommended.
Diuretics and Antihypertensive Agents: Like other NSAIDs, concomitant use of diclofenac with
diuretics or antihypertensive agents (eg, -blockers, ACE inhibitors) may cause a decrease in their
antihypertensive effect. Therefore, the combination should be administered with caution and
patients, especially the elderly, should have their blood pressure periodically monitored. Patients
should be adequately hydrated and consideration should be given to monitoring of renal function
after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE
inhibitors due to the increased risk of nephrotoxicity.
Concomitant treatment with potassium-sparing drugs may be associated with increased serum
potassium levels, which should therefore be monitored frequently (see Precautions).
Other NSAIDs and Corticosteroids: Concomitant administration of diclofenac and other systemic
NSAIDs may increase the frequency of side effects (See Warnings and Precaution).
Anticoagulants and Antiplatelet Agents: Caution is recommended since concomitant administration
could increase the risk of bleeding (see Warnings and Precautions). Although clinical investigations
do not appear to indicate that Cataflam/Cataflam D affects the action of anticoagulants, there are
isolated reports of an increased risk of haemorrhage in patients receiving Cataflam/Cataflam D and
anticoagulants concomitantly. Close monitoring of such patients is therefore recommended.
Selective Serotonin Re-Uptake Inhibitors (SSRIs): Concomitant administration of systemic NSAIDs,
including diclofenac, and SSRIs may increase the risk of GI bleeding (see Warnings and Precautions).
Antidiabetics: Clinical studies have shown that Cataflam/Cataflam D can be given together with oral
antidiabetic agents without influencing their clinical effect. However, isolated cases have been
reported of both hypoglycaemic and hyperglycaemic effects necessitating changes in the dosage of
hypoglycaemic agents during treatment with diclofenac. For this reason, monitoring of the blood
glucose level is recommended as a precautionary measure during concomitant therapy.
Methotrexate: Caution is recommended when NSAIDs, including diclofenac, are administered <24
hrs before or after treatment with methotrexate since blood concentrations of methotrexate may
rise and the toxicity of methotrexate increased.
Ciclosporin: Diclofenac, like other NSAIDs, may increase the nephrotoxicity of ciclosporin due to the
effect on renal prostaglandins. Therefore, Cataflam/Cataflam D should be given at doses lower than
those that would be used in patients not receiving ciclosporin.
Quinolone Antibacterials: There have been isolated reports of convulsions which may have been
due to concomitant use of quinolones and NSAIDs.
Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both
drugs together have a risk of serious GI bleeding higher than users of either drug alone.
The reduction in blood pressure induced by clonidine can be further potentiated by concurrent
administration of other hypotensive agents. This can be of therapeutic use in the case of other
antihypertensive agents eg, diuretics, vasodilators, -receptor blockers, calcium antagonists and ACE
inhibitors, but not a1-blocking agents.
Substances which raise blood pressure or induce a Na+- and water-retaining effect eg, nonsteroidal
anti-inflammatory agents, can reduce the therapeutic effect of clonidine.
Substances with a2-receptor-blocking properties eg, phentolamine or tolazoline may abolish the a2-
receptor-mediated effects of clonidine in a dose-dependent manner.
Concomitant administration of substances with a negative chronotropic or dromotropic effect eg, -
receptor blockers or digitalis glycosides, can cause or potentiate bradycardic rhythm disturbances.
It cannot be ruled out that concomitant administration of a -receptor blocker will cause or
potentiate peripheral vascular disorders.
The antihypertensive effect of clonidine may be reduced or abolished and orthostatic regulation
disturbances may be provoked or aggravated by concomitant administration of tricyclic
antidepressants or neuroleptics with a-receptor-blocking properties.
Based on observations in patients in a state of alcoholic delirium, it has been suggested that high IV
doses of clonidine may increase the arrhythmogenic potential (QT-prolongation, ventricular
fibrillation) of high IV doses of haloperidol. Causal relationship and relevance for antihypertensive
treatment have not been established.
The effects of centrally-depressant drugs or alcohol can be potentiated by clonidine.
Alcohol, may cause false positive in urine glucose test by Benedict's or Fehling's soln.
Enhanced hypotensive action w/ antihypertensives, sildenafil, tadalafil, vardenafil.
Aminoglycosides, cephalosporins, false +ve Coombs' test, probenecid.
Aminoglycosides, potent diuretics & probenecid.
Bacteriostatic antibiotics may reduce cephalosporin effectiveness. Probenecid may increase &
prolong cephalosporin plasma levels & toxicity.
Potent diuretics, nephrotoxics & nephrotic antibiotics; probenecid.
Aminoglycosides & potent diuretics.

May potentiate nephrotoxic effects of aminoglycosides or loop diuretics.
Pregnancy Safety (US)
Category C: Either studies in animals have revealed adverse effects on
the foetus (teratogenic or embryocidal or other) and there are no
controlled studies in women or studies in women and animals are not
available. Drugs should be given only if the potential benefit justifies
the potential risk to the foetus.



Category B: Either animal-reproduction studies have not demonstrated

a foetal risk but there are no controlled studies in pregnant women or
animal-reproduction studies have shown an adverse effect (other than
a decrease in fertility) that was not confirmed in controlled studies in
women in the 1st trimester (and there is no evidence of a risk in later
trimesters).
trimesters).
Category D: There is positive evidence of human foetal risk, but the
benefits from use in pregnant women may be acceptable despite the
risk (e.g., if the drug is needed in a life-threatening situation or for a
serious disease for which safer drugs cannot be used or are
ineffective).

trimesters).


trimesters).
trimesters).

trimesters).

trimesters).

ineffective).

trimesters).
Category X: Studies in animals or human beings have demonstrated
foetal abnormalities or there is evidence of foetal risk based on human
experience or both, and the risk of the use of the drug in pregnant
women clearly outweighs any possible benefit. The drug is
contraindicated in women who are or may become pregnant.



ineffective).
trimesters).

ineffective).

ineffective).

trimesters).

trimesters).



ineffective).
Caution For Usage Special Precautions for Disposal and Other
Handling: Use aseptic technique during the reconstitution and further
dilution of pemetrexed for IV infusion administration. Calculate the
dose and the number of Alimta vials needed. Each vial contains an
excess of pemetrexed to facilitate delivery of label amount.
Alimta 100 mg: Reconstitute 100 mg vials with 4.2 mL of sodium
chloride 9 mg/mL (0.9 %) solution for injection, without preservative,
resulting in a solution containing pemetrexed 25 mg/mL. Gently swirl
each vial until the powder is completely dissolved. The resulting
solution is clear and ranges in colour from colourless to yellow or
green-yellow without adversely affecting product quality. The pH of the
reconstituted solution is between 6.6-7.8. Further dilution is required.
Alimta 500 mg: Reconstitute 500 mg vials with 20 mL of sodium
chloride 9 mg/mL (0.9%) solution for injection, without preservative,
resulting in a solution containing pemetrexed 25 mg/mL. Gently swirl
each vial until the powder is completely dissolved. The resulting
solution is clear and ranges in colour from colourless to yellow or
green-yellow without adversely affecting product quality. The pH of the
reconstituted solution is between 6.6-7.8. Further dilution is required.
The appropriate volume of reconstituted pemetrexed solution should
be further diluted to 100 mL with sodium chloride 9 mg/mL (0.9%)
solution for injection, without preservative and administered as an IV
infusion over 10 min.
Pemetrexed infusion solutions prepared as directed are compatible
with polyvinyl chloride and polyolefin lined administration sets and
infusion bags. Parenteral medicinal products should be inspected
visually for particulate matter and discolouration prior to
administration. If particulate matter is observed, do not administer.
Pemetrexed solutions are for single use only. Any unused product or
waste material should be disposed of in accordance with local
trimesters).

ineffective).
ineffective).


trimesters).
ineffective).
trimesters).
C, D (in 1st trimester)


trimesters).

trimesters).
trimesters).
ineffective).

ineffective).
trimesters).

Caution For Usage Instruction For Use and Handling: Apidra Vials:
Apidra vials are for use with insulin syringes with the corresponding
unit scale and for use with an insulin pump system.
Inspect the vial before use. It must only be used if the solution is clear,
colourless, with no solid particles visible. Since Apidra is a solution, it
does not require resuspension before use. When used with an insulin
infusion pump, Apidra should not be mixed with diluents or any other
insulin. Pateints using CSII should be comprehensively instructed on
the use of the pump system. The infusion set and reservoir should be
changed every 48 hrs using aseptic technique. Patients administering
Apidra by CSII must have alternative insulin available in case of pump
system failure.


ineffective).
trimesters).
C, D (in 3rd trimester or near delivery)


C, D (in 3rd trimester or near term)


trimesters).
Caution For Usage Instructions for Use and Handling: Parenteral
solutions should be inspected visually for particulate matter and
discoloration prior to administration.
Arixtra is administered by SC or IV injection. It must not be
administered by IM injection.
The SC injection is administered in the same way as with a standard
syringe. IV administration should be through an existing IV line either
directly or using a small volume (25 or 50 mL) 0.9% saline minibag.
Arixtra pre-filled syringe has been designed with an automatic needle
protection system to prevent needle stick injuries following injection.
Instruction for self-administration by SC injection is included in the
package leaflet.
Any unused product or waste material should be disposed of in
accordance with local requirements.
Instructions for Use: Wash hands thoroughly with soap and water and
dry them with a towel.
Remove the syringe from the carton and check that the expiry date has
not passed, the solution is clear, colourless and does not contain
particles and the syringe has not been opened or damaged.
Sit or lie down in a comfortable position. Choose a place in the lower
abdominal (tummy) area, at least 5 cm below the belly button.
Alternate the left and right side of the lower abdominal area at each
injection. This will help reduce injection site discomfort. If injecting in
the lower abdominal area is not possible, ask the nurse or doctor for
advice.
Clean the injection area with an alcohol wipe.
Gently pinch the skin that has been cleaned to make a fold. Hold the
fold between the thumb and the forefinger during the entire injection.
Hold the syringe
Category C: Eitherfirmly by in
studies theanimals
finger grip.
haveInsert the adverse
revealed full length of the
effects on


trimesters).

ineffective).


C, D (In 3rd trimester or near term.)

trimesters).
trimesters).
Caution For Usage Children: For administration of suspensions to
children <3 months, a graduated syringe to permit accurate and
reproducible volumes to be dispensed, should be used.
For administration to children up to 2 years, amoxicillin-clavulanate
suspensions may be diluted to half-strength using water.
trimesters).

Caution For Usage Instructions for Use/Handling: Once the device has
been primed (approximately 6 sprays), each spray delivers fluticasone
furoate 27.5 mcg. Re-priming is only necessary if the cap is left off for 5
days or the nasal spray has not been used for =30 days.
Nasal Spray: Avamys nasal spray comes in a glass bottle inside a plastic
casing. A window on the side of the casing allows seeing how much
medicine is left. The medicine sprays out of the nozzle when the
button on the side is firmly pressed. The nozzle is protected by a
removable cap.
Testing the Nasal Spray: In using the nasal spray for the first time, it
must be tested if it is working properly. If the cap has been left off or
the patient have not used the spray for nearly a month, test it again.
1. With the cap on, shake the nasal spray.
2. Remove the cap by gently squeezing the sides of the cap with the
thumb and forefinger and pull it straight off.
3. Point the nozzle away and firmly press the button on the side at least
6 times to release a fine spray into the air.
4. The nasal spray is now ready for use.
If the nasal spray was dropped accidentally, check for damage and test
it again. If the spray is damaged, if it produces anything other than a
fine mist (eg, a jet of liquid), or if discomfort is felt while using the
spray, return it to the pharmacist.
How to Use the Nasal Spray: Blow the nose before using the spray to
clear the nostrils. Shake the spray gently before each use.
1. Tilt the head forward a little bit.
2. Hold the nasal spray upright and carefully place the nozzle in 1 of
the nostrils.
3. Point the end of the nozzle toward the outside of the nose, away
from the center ridge of the nose. This helps get the medicine to the
right part of the nose.
trimesters).
Caution For Usage Instructions for Use/Handling: Dutasteride is
absorbed through the skin; therefore, women and children must avoid
contact with leaking capsules (see Use in pregnancy & lactation under
Contraindications). If contact is made with leaking capsules, the
contact area should be washed immediately with soap and water.

trimesters).

trimesters).

Parenteral


trimesters).
trimesters).
Caution For Usage Any Bactroban content remaining at the end of
treatment should be discarded.

ineffective).



trimesters).
trimesters).

trimesters).
trimesters).



trimesters).
trimesters).

trimesters).
ineffective).

ineffective).


ineffective).
ineffective).
C, D (in 2nd & 3rd trimesters)

trimesters).



ineffective).
Parenteral/PO

Caution For Usage Turbuhaler: Instructions for Use, Handling and
Disposal: Turbuhaler is a multidose inhaler from which very small
amounts of powder are administered. When the patient breathe in
through turbuhaler, the powder is delivered to the lungs. It is therefore
important that the patient inhale forcefully and deeply through the
mouthpiece.
How to Prepare a New Inhaler to Use: Before using turbuhaler for the
1st time, the patient need to prepare the inhaler for use.
1. Unscrew and lift off the cover.
2. Hold the inhaler upright with the red grip downwards. Do not hold
the mouthpiece when turning the grip. Turn the grip as far as it will go
in 1 direction and then back again in the opposite direction as far as it
will go. It does not matter which way to turn first. During this
procedure, a click will be heard.
The inhaler is now ready for use and this procedure should not be
repeated again.
How to Use Bricasma Turbuhaler: To administer 1 dose, simply follow
the instructions as follows.
1. Unscrew and lift off the cover.
2. Hold the inhaler upright with the red grip downwards. Do not hold
the mouthpiece when turning the grip. To load the inhaler with a dose
turn the grip as far as it will go in 1 direction, and then back again in
the opposite direction as far as it will go. It does not matter which way
to turn first. During this procedure, a click will be heard.
3. Hold the inhaler away from the mouth. Breathe out. Do not breathe
out through the mouthpiece.
4. Place the mouthpiece gently between the teeth, close lips and
inhale forcefully and deeply through the mouth. Do not chew or bite
on the mouthpiece.
5. Remove the inhaler from the mouth, before breathing out.
Caution For Usage Incompatibilities: Not applicable.

trimesters).





trimesters).

trimesters).



trimesters).

ineffective).
Caution For Usage Preparation and Handling: As with other
antineoplastic agents, Campto must be prepared and handled with
caution. The use of glasses, mask and gloves is required.
If Campto solution or infusion solution should come into contact with
the mucous membranes, wash immediately with water.
The Campto solution should be used immediately after reconstitution
as it contains no antibacterial preservative. Campto solution should be
used (infusion completed) within 12 hrs at room temperature or within
24 hrs, if stored at 2-8C after the first breakage.
Disposal: All materials used for dilution and administration should be
disposed of according to hospital standard procedure applicable to
cytotoxic agents.

ineffective).

ineffective).

trimesters).
trimesters).

trimesters).

trimesters).
trimesters).

trimesters).

trimesters).
trimesters).

trimesters).
ineffective).

ineffective).
ineffective).

trimesters).


trimesters).
C, D (if used in gestational HTN)


trimesters).
trimesters).

trimesters).

trimesters).

trimesters).
trimesters).

trimesters).

trimesters).
Storage Description
Do not store above 30C. The tablets are contained in a high-density

polyethylene (HDPE) bottle with a child
resistant/tamper evident closure.
Store below 30C.
Abbotic: Store at 25-30C. Abbotic Granules: Each 5 mL dry syrup
Abbotic Granule: Store at cool contains 125 or 250 mg clarithromycin which is
temperature. The reconstituted an oral dosage form of clarithromycin for use
suspension can be used for up to 7 days primarily in children, with potassium sorbate
when stored at cool temperature. 0.4% w/w as preservative.
Abbotic XL: Store at room temperature Abbotic XL: Abbotic XL modified-release tablet
below 25C. Protect from light. is a homogenous matrix, which provides
sustained release during its transit through the
gastrointestinal tract.
Clarithromycin is a semisynthetic macrolide
antibiotic obtained by substitution of the
hydroxyl group in position 6 by a CH3O group
in the erythromycin lactonic ring. Specifically,
clarithromycin is 6-O-methyl erythromycin A.
Clarithromycin is a white to off-white antibiotic
powder which is bitter, practically odorless,
essentially insoluble in water and slightly
soluble in ethanol, methanol and acetonitrile.
Its molecular formula is C38H69NO13 and the
molecular weight is 747.96.
Store at 25C (77F); excursions It also contain the following inactive
permitted to 15-30C (59-86F). ingredients: Cornstarch, hydroxypropyl
cellulose, lactose monohydrate, magnesium
stearate and microcrystalline cellulose.
Colorants include ferric oxide (yellow or red).
Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-
piperazinyl]butoxy]-3,4-dihydrocarbostyril. The
empirical formula is C23H27Cl2N3O2 and its
molecular weight is 448.39.
Do not store above 30C. Excipients/Inactive Ingredients: Croscarmellose
sodium, hypermellose E464, lactose
monohydrate, magnesium stearate E572,
povidone and titanium dioxide E171.
Store below 25C. Protect from light. Each 5-mL syrup contains triprolidine HCl BP
Actifed should not be refrigerated. The 1.25 mg and pseudoephedrine HCl BP 30 mg.
tablets should be kept dry.
Each 5 mL of syrup contains triprolidine HCl

1.25 mg, pseudoephedrine HCl 30 mg,
dextromethorphan HBr 10 mg and ethanol
9.90% v/v
Each 5 mL of syrup contains triprolidine HCl

1.25 mg, pseudoephedrine HCl 30 mg,
guaiphenesin 100 mg and ethanol 6.93% v/v.
Store below 30C. The prepared solution Each pack contains 1 injection vial containing
may be stored in a refrigerator up to 24 recombinant human tissue-type plasminogen
hrs and up to 8 hrs at temperatures not activator 50 mg, 1 vial of solvent containing
exceeding 30C. Protect the lyophilised sterile water for injection 50 mL and 1 IV kit.
substance from light. The reconstituted solution contains alteplase 1
Actilyse should be used immediately mg/mL.
after reconstitution. If not used Each vial also contains L-arginine, phosphoric
immediately, in-use storage times and acid and polysorbate 80 as excipients.
conditions prior to use are the
responsibility of the user and would
normally not be longer than 24 hrs at
2-8C.
Store below 30C. Protect from light and Each tablet contains pioglitazone
humidity. hydrochloride 16.53 or 33.06 mg equivalent to
pioglitazone 15 or 30 mg, respectively.
Store below 25C. Protect from moisture Each tablet contains pioglitazone
and humidity. hydrochloride 15 mg and metformin
hydrochloride 850 mg.
Actosmet tablets contain 2 oral
antihyperglycemic drugs used in the
management of type 2 diabetes: Pioglitazone
hydrochloride and metformin hydrochloride.
The concomitant use of pioglitazone and
metformin has been previously approved
based on clinical trials in patients with type 2
diabetes inadequately controlled on
metformin. Additional efficacy and safety
information about pioglitazone and metformin
monotherapies may be found in the
prescribing information for each individual
drug.
Pioglitazone hydrochloride is an oral
antihyperglycemic agent that acts primarily by
decreasing insulin resistance. Pioglitazone is
used in the management of type 2 diabetes.
Pharmacological studies indicate that
pioglitazone improves sensitivity to insulin in
muscle and adipose tissue, and inhibits hepatic
gluconeogenesis. Pioglitazone improves
glycemic control while reducing circulating
insulin levels.
Pioglitazone [(-5-[[4-[2-(5-ethyl-2-
pyridinyl)ethoxy]phenyl]methyl]-2,4-
thiazolidinedione monohydrochloride belongs
to a different chemical class and has a different
pharmacological action than the sulfonylureas,
biguanides, or the a-glucosidase inhibitors. The
molecule contains 1 aymmetric center, and the
synthetic compound is a racemate. The 2
enantiomers of pioglitazone interconvert in
vivo.
Pioglitazone hydrochloride is an odorless white
crystalline powder that has a molecular
Store Actrapid HM/Penfill which are not Each mL of Actrapid HM/Penfill contains
in use in a refrigerator (2-8C) in the human insulin 100 IU, rDNA (produced by
original package, not in or near the recombinant DNA technology in
cooling compartment. Do not freeze. Saccharomyces cerevisiae).
Keep the vial or cartridge in the outer Actrapid HM/Penfill is a clear, colorless,
carton and the pen cap in order to aqueous solution.
protect from light. Protect from One IU (international unit) corresponds to
excessive heat and sunlight. anhydrous human insulin 0.035 mg.
Actrapid HM/Penfill in use should not Excipients/Inactive Ingredients: Zinc chloride,
be kept in a refrigerator. It may be kept glycerol, metacresol, sodium hydroxide and/or
at room temperature (Penfill: Below hydrochloric acid (for pH adjustment), and
30C; Vial: Below 30C) for up to 6 water for injections.
weeks after first opening.
Shelf-Life: 30 months.
Store at 25C. Protect from light. Each g of cream contains nadifloxacin 10 mg.
Nadifloxacin is ()-9-fluoro-6,7-dihydro-8-(4-
hydroxy-1-piperidyl)-5-methyl-1-oxo-1H,5H-
benzo[ij] quinolizine-2-carboxylic acid. It has a
molecular formula of C19H21FN2O4 and a
molecular weight of 360.39.
Keep in a cool place (2-8C). Protect Sodium hyaluronate is [->3)-2-acetamido-2-
from light. Do not freeze. deoxy--D-glucopyranosil-(1->4)--D-
glucopyranosyluronic acid-(1->]n. It is a white
powder, slightly soluble in water and almost
insoluble in ethanol, acetone or in ether.
Molecular Formula: (C14H20NNaO11)n.
Molecular Weight: Average 600,000-
1,200,000. Optical Rotation: [a]20D= -70 to
-81.
Adant Dispo has a pH of 6.8-7.8 and a specific
osmotic pressure of 1-1.2.
Tablet: Store between 25-30C. Protect Each tablet also contains the following
from excessive moisture. excipients: Dibasic calcium phosphate
Syrup: Store in the original container dihydrate, microcrystalline cellulose, corn
below 30C. starch, talc, carnauba wax and white wax.
Coating: Lactose monohydrate, hydroxypropyl
methylcellulose, titanium dioxide,
polyethylene glycol and FD&C Blue No. 2
aluminum lake.
Desloratadine is 8-chloro-6,11-dihydro-11-(4-
piperdinylidene)-5H-benzo[5,6]cyclohepta[1,2-
b]pyridine. It has an empirical formula of
C19H19ClN2 and a molecular weight of 310.8.
Desloratadine is a white to off-white powder
that is slightly soluble in water, but very
soluble in ethanol and propylene glycol.
Each tablet contains pseudoephedrine sulfate
120 mg and desloratadine 2.5 mg.
Unopened Vial: Store below 25C. Each vial of powder for concentrate for
Excursion permitted up to 30C. solution for infusion contains 100 mg and 500
Shelf-Life: 2 years. mg of pemetrexed as pemetrexed disodium.
Reconstituted and Infusion Solutions: Reconstituted solution contains premetexed
When prepared as directed, 25 mg/mL.
reconstituted and infusion solutions of It also contains the following excipients:
Alimta contain no antimicrobial Mannitol, hydrochloric acid and sodium
preservatives. Chemical and physical in- hydroxide.
use stability of reconstituted and
infusion solutions of pemetrexed were
demonstrated for 24 hrs at refrigerated
temperature. From a microbiological
point of view, Alimta should be used
immediately. If not used immediately,
in-use storage times and conditions
prior to use are the responsibility of the
user and would normally not be longer
than 24 hrs at 2-8C, unless
reconstitution/dilution has taken place
in controlled and validated aseptic
conditions.
Tab: Store below 30C. IV: Store at 25- Alinamin: Each tablet contains thiamine
30C. tetrahydrofurfuryl disulfide HCl 5.46 mg
(equivalent to its base TTFD 5 mg).
Alinamin-F: Each tablet contains thiamine
tetrahydrofurfuryl disulfide HCl 54.58 mg
(equivalent to TTFD base 50 mg) and riboflavin
5 mg. It also contains erythrocin Cl 45430,
lactose, amylum manihot, gelatin, magnesium
stearate, talc, gummi arabicum and ethyl
cellulose as inactive ingredients.
Information of Nutritional Values: Total Serving
Size Per Package: 100.
Each serving size (1 tab:360 mg) contains
thiamine 50 mg (4170% AKG*) and riboflavin 5
mg (385% AKG*).
*AKG is based on 2000 cal diet.
Each mL of ampoule contains thiamine
tetrahydrofurfuryl disulfide HCl 2.73 mg
(equivalent to TTFD base 2.5 mg) and glucose
200 mg.
Store below 25C. Excipients/Inactive Ingredients: Lactose,
sodium starch glycolate, polyvidone 25,000,
microcrystalline cellulose, magnesium
stearate, red ferric oxide (1-mg tablet only),
yellow ferric oxide (2- and 3-mg tablets only),
indigo carmine aluminium lake (2- and 4-mg
tablets only).
Do not store above 30C.
Store below 30C. Each 5- and 10-mg amlodipine base tablet
contains amlodipine besylate 7 and 14 mg,
respectively.
Store below 25C. The upper chamber contains amino acid soln
and the lower chamber contains glucose and
electrolytes. Each soln has the following
composition: Upper Chamber (Amino Acid
Solution) 300 mL: L-Leucine 4.2 g, L-isoleucine
2.4 g, L-valine 2.4 g, L-lysine hydrochloride
3.93 g (L-lysine equivalent to 3.146 g), L-
threonine 1.71 g, L-tryptophan 0.6 g, L-
methionine 1.17 g, L-cysteine 0.3 g, L-
phenylalanine 2.1 g, L-tyrosine 0.15 g, L-
arginine 3.15 g, L-histidine 1.5 g, L-alanine 2.4
g, L-proline 1.5 g, L-serine 0.9 g, glycine 1.77 g,
L-aspartic acid 0.3 g, L-glutamic acid 0.3 g,
dipotassium phosphate 0.915 g (contains K+ at
10.5 mEq (35 mEq/L). Sodium bisulfite 0.2 g/L
is used as a stabilizer and glacial acetic acid is
used as a pH adjuster.
Lower Chamber (Glucose and Electrolyte
Solution) 700 mL: Glucose 74.998 g, sodium
chloride 0.798 g, sodium lactate 2.289 g,
dipotassium phosphate 0.826 g [contains K+ at
9.5 mEq (14 mEq/L)], calcium gluconate 1.12 g,
magnesium sulfate 0.623 g, zinc sulfate 1.4
mg. Sodium bisulfite 0.075 g/L is used as a
stabilizer and citric acid is used as a pH
adjuster.
After Mixing the 2 Solutions (1000 mL): Na+*
35 mEq, K+ 20 mEq, Mg2+ 5 mEq, Ca2+ 5 mEq,
Cl- 35 mEq, SO42- 5 mEq, acetate- 13 mEq,
gluconate- 5 mEq, lactate- 20 mEq, citrate3-* 6
mEq, P 10 mmol, Zn 5 micromol. Glucose 75 g,
glucose concentration 7.5%. Total free amino
acids 30 g, total nitrogen 4.7 g,
essential/nonessential amino acids 1.44,
branched-chain amino acids 30% (w/w). Total
calories 420 kcal, nonprotein calories 300 kcal,
nonprotein calories/nitrogen 64.
* Includes the amount derived from the
Store in a cool and dry place, away from See table.
light.
Store in a cool place, away from direct Each liter of Aminovel 600 contains amino
sunlight. acids (L-form) 50 g, D-sorbitol 100 g, ascorbic
acid 400 mg, inositol 500 mg, nicotinamide 60
mg, pyridoxine HCl 40 mg, riboflavin sodium
phosphate 2.5 mg and the following
electrolytes: Sodium 35 mEq, potassium 25
mEq, magnesium 5 mEq, acetate 35 mEq,
maleate 22 mEq, chloride 38 mEq.
Each 50 g of amino acids contains the
following: L-isoleucine 3.2 g, L-leucine 2.4 g, L-
lysine (calculated as base) 2 g, L-methionine 3
g, L-phenylalanine 4 g, L-threonine 2 g, L-
tryptophan 1 g, L-valine 3.2 g, L-arginine
(calculated as base) 6.2 g, L-histidine
(calculated as base) 1 g, L-alanine 6 g, glycine
14 g, L-proline 2 g.
Aminovel 600 is a sterile aqueous solution
supplying approximately 600 cal/L. Each lot is
examined by exothermic substance test,
sterility test and toxicity test, and is
manufactured under severe standards.
Store in a cool place, away from direct Each liter of Amiparen solution contains L-
sunlight. leucine 14 g, L-isoleucine 8 g, L-valine 8 g,
lysine acetate 14.8 g (L-lysine equivalent to
10.5 g), L-threonine 5.7 g, L-tryptophan 2 g, L-
methionine 3.9 g, L-phenylalanine 7 g, L-
cysteine 1 g, L-tyrosine 0.5 g, L-arginine 10.5 g,
L-histidine 5 g, L-alanine 8 g, L-proline 5 g, L-
serine 3 g, aminoacetic acid 5.9 g, L-aspartic
acid 1 g, L-glutamic acid 1 g. Total free amino
acids 100 g, essential amino acids (E) 59.1 g,
non-essential amino acids (N) 40.9 g, E/N ratio
7.2, branched-chain amino acids 30% w/w,
total nitrogen 15.7 g, sodium approximately 2
mEq, acetate approximately 120 mEq. Sodium
bisulfite is added as a stabilizer.
Average pH Immediately After Manufacture:
About 6.9. pH Specification: 6.5-7.5. Specific
Gravity (20C): 1.032. Osmotic Pressure: About
3 (ratio to saline solution).
Store in a refrigerator (2-8C). Do not Each mL of the solution for injection contains
freeze. Protect from light. Ensure that the active substance, insulin glulisine 3.49 mg
the container is not directly touching corresponding to human insulin 100 IU.
the freezer compartmet or freezer Excipients/Inactive Ingredients: Metacresol,
packs. sodium chloride, trometamol, polysorbate 20,
Once in use, do not store above 25C. concentrated hydrochloric acid, sodium
Shelf-Life: 2 years. hydroxide and water for injections.
Insulin glulisine is an insulin analogue
produced by recombinant DNA technology
using Escherichia coli.
Do not store above 30C. Excipients/Inactive Ingredients: Tablet Core:
Lactose monohydrate, microcrystalline
cellulose, croscarmellose sodium,
hypromellose, silicon dioxide and magnesium
stearate.
Film-Coating: Lactose monohydrate,
hypromellose, titanium dioxide (E171),
macrogol and carnauba wax.
Each tablet contains the following excipients:
Maize starch, sodium carboxymethylcellulose,
white beeswax, titanium dioxide,
pregelatinized maize starch, ethylcellulose,
anhydrous glucose, lactose, sunset yellow FCF,
glyceryl mono-oleate, polysorbate 80,
polyvidone excipient, saccharose, anhydrous
colloidal silica, magnesium stearate and talc.
Store below 30C.
Do not store above 30C. Arimidex contains the following excipients:
Shelf-Life: 2 years. Lactose monohydrate, povidone, sodium
starch glycolate, magnesium stearate,
hypromellose, macrogol 300, titanium dioxide.
Store below 25C. Do not freeze. Each syringe contains fondaparinux sodium 2.5
Shelf-Life: If Arixtra is added to a 0.9% mg in 0.5 mL solution for injection. Each
saline minibag, it should ideally be syringe contains fondaparinux 5 mg in 0.4 mL
infused immediately, but can be stored solution for injection. Each syringe contains
at room temperature for up to 24 hrs. fondaparinux 7.5 mg in 0.6 mL solution for
injection. Each syringle contains fondaparinux
10 mg in 0.8 mL solution for injection.
It also contains sodium chloride, water for
injection, hydrochloric acid or sodium
hydroxide (for pH adjustment as necessary) as
excipients.
Arixtra is a sterile, preservative-free, clear and
colorless injectable solution for SC and IV use,
with a pH between 5 and 8, in a single dose
pre-filled syringe.
Each liter contains electrolytes (mEq/L):
Sodium 130, potassium 4, chloride 109,
calcium 3 and acetate 28. Asering-5 also
contains anhydrous dextrose 50 g (5%).
Asering-5 has a pH of 5-5.2.
Store below 25C. Each film-coated tablet contains the following
inactive ingredients: Magnesium oxide,
microcrystalline cellulose, lactose
monohydrate, croscarmellose sodium,
hydroxypropyl cellulose, anhydrous colloidal
silica and magnesium stearate.
Store below 30C. Ipratropium bromide is (8r)-3a-hydroxy-8-
isopropyl-1aH, 5aH-tropanium bromide ()-
tropate monohydrate.
All amoxicillin-clavulanate preparations Each 375-, 625-mg and 1-g tablet contains co-
should be stored in unopened, well- amoxiclav: Amoxicillin 250, 500 and 875 mg
sealed package in a dry place at less respectively, and clavulanate potassium 125
than 25C. Bottles of tablets should be mg.
kept tightly closed and moisture-proof Each 5-mL suspension contains co-amoxiclav:
containers. Amoxicillin 125 mg and clavulanic acid 31.25
mg.
Each 5-mL Forte suspension contains co-
amoxiclav: Amoxicillin 250 mg and clavulanic
acid 62.5 mg.
Store below 30C. Do not refrigerate or Avamys nasal spray is a white, uniform
freeze. suspension contained in an amber glass bottle,
fitted with a metering (50 microliter) atomizing
spray pump. The inner pack is incorporated
within a predominantly off-white plastic device
with a blue side-actuated lever and a lid which
contains a stopper. Each spray of the
suspension delivers approximately 27.5 mcg of
micronized fluticasone furoate as an ex-device
dose.
Do not store above 30C. Each capsule also contains the following
excipients: Capsule Contents:
Monodiglycerides of caprylic/capric acid and
butylated hydroxytoluene.
Capsule Shell: Gelatin, glycerol, titanium
dioxide (E171, CI 77891), yellow iron oxide
(E172, CI 77492), red printing ink containing
red iron oxide (E172, CI 77491) as the
colourant, polyvinyl acetate phthalate,
polyethylene glycol, propylene glycol, and
medium chain triglycerides and lecithin as
capsule lubricants.
Store at temperature below 25C.
Store at room temperature (below Bactroban cream contains mupirocin calcium
25C). equivalent to mupirocin free acid 2% w/w. It
Cream: Do not freeze. also contains the following excipients: Xanthan
gum, liquid paraffin, cetomacrogol 1000,
stearyl alcohol and cetyl alcohol,
phenoxyethanol, benzyl alcohol and purified
water.
Bactroban ointment is formulated in a
polyethylene glycol base.
Store below 30C. Each film-coated tablet also contains the
Shelf-Life: 2 years. following excipients: Lactose monohydrate,
microcrystalline cellulose, crospovidone,
povidone and magnesium stearate. Film-
Coating: Titanium dioxide, hypromellose,
polyethylene glycol 400, polysorbate 80 (0.5-
mg tablet only) and red iron oxide (1-mg tablet
only).
Entecavir is a guanosine nucleoside analogue
with selective activity against hepatitis B virus
(HBV). Entecavir is 2-amino-1,9-dihydro-9-
[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-
methylenecyclopentyl]-6H-purin-6-one,
monohydrate. Its molecular formula is
C12H15N5O3H2O, which corresponds to a
molecular weight of 295.3. It is slightly soluble
in water (2.4 mg/mL), and the pH of the
saturated solution in water is 7.9 at 250.5C.
Store below 30C. Each metered-dose (puff) contains ipratropium
bromide, (8r)-3a-hydroxy-8-isopropyl-1aH,5aH-
tropanium bromide ()-tropate monohydrate
21 mcg corresponding to 20 mcg anhydrous
ipratropium bromide and fenoterol HBr, 1-(3,5-
dihydroxyphenyl)-2-[[1-(4-hydroxybenzyl)-
ethyl]-amino]-ethanol hydrobromide 50 mcg.
Metered-Dose Aerosol: Store below Fenoterol HBr is 1-(3,5-dihydroxy-phenyl)-2-
30C. {[1-(4-hydroxy-benzyl)-ethyl]-amino}-ethanol
Inhalation Solution: Store below 30C. hydrobromide.
Berotec metered aerosol also contains a
propellant: 1,1,1,2-tetrafluoroethane (HFA
134a), and the following excipients: Anhydrous
citric acid, purified water, absolute ethyl
alcohol.
Store below 30C. Store in original pack Each 8 mg tablet has a diameter of 7 mm and
in order to protect from light. weighing 125 mg.
Shelf-Life: 3 years. Each 24 mg tablet has a diameter of 10 mm
Any unused product or waste material and weighing 375 mg. Betaserc 24 mg can be
should be disposed of in accordance divided into equal halves.
with local requirements. Excipients/Inactive Ingredients:
Microcrystalline cellulose, mannitol (E421),
citric acid monohydrate, colloidal anhydrous
silica and talc.
Keep the container tightly closed. Bioprexum 5 mg contains perindopril 3.395 mg
Protect from moisture. corresponding to perindopril arginine 5 mg. It
Shelf-Life: 3 years. also contains lactose monohydrate 72.58 mg.
Bioprexum 10 mg contains perindopril 6.79 mg
corresponding to perindopril arginine 10 mg. It
also contains lactose monohydrate 145.16 mg.
Each tablet also contains the following
excipients: Core: Lactose monohydrate,
magnesium stearate, maltodextrin,
hydrophobic colloidal silica and sodium starch
glycolate (type A). Film-Coating: Glycerol,
hypromellose, copper chlorophyllin (not 2.5
mg), macrogol 6000, magnesium stearate and
titanium dioxide.
Bioprexum 5-mg tablet can be divided into
equal halves.
Keep container tightly closed. Protect Each film-coated tablet contains perindopril
from moisture. 3.395 mg corresponding to perindopril
Shelf-Life: 3 years. arginine 5 mg and indapamide 1.25 mg.
It also contains the following excipients: Core:
Lactose monohydrate 71.33 mg, magnesium
stearate (E470B), maltodextrin, colloidal
anhydrous silica (E551) and sodium starch
glycolate (type A). Film-Coating: Glycerol
(E422), hypromellose (E464), macrogol 6000,
magnesium stearate (E470B) and titanium
dioxide (E171).
Store at room temperature (25-30C).
Protect from light.
Shelf-Life: 3 years.
Store below 25C. Protect from light. Each tablet contains candesartan cilexetil 16
mg and hydrochlorothiazide 12.5 mg.
Ointment: Store at room temperature. Each gram of rectal ointment and each
Suppository: Store in a cool place. suppository contains Lithospermi radix extract
0.09 and 0.18 mg, ethyl aminobenzoate 10 and
20 mg, dibucaine HCl 0.25 and 0.5 mg,
diphenhydramine HCl 0.25 and 0.5 mg and
cetrimide 1.25 and 2.5 mg, respectively.
Ointment: Store at room temperature. Each gram of ointment and each suppository
Suppository: Store in a cool place. contains Lithospermi radix extract 0.1 and 0.18
mg, prednisolone 0.5 and 1 mg, lidocaine 7.5
and 15 mg, ethyl aminobenzoate 10 and 20
mg, cetrimide 1.25 and 2.5 mg, respectively.
Tablet: Store below 30C. Protect from Bricasma solution for nebulization is istonic.
light and moisture. Bricasma solution for nebulization and
Injection: Store at temperatures not injection contains no preservatives.
exceeding 25C. Protect from light. Excipients/Inactive Ingredients: Injection:
Respules: Store below 30C. Do not Sodium chloride, hydrochloric acid, water.
refrigerate. Protect from light. Respules: Sodium chloride, disodium edetate,
Turbuhaler: Do not store above 30C. hydrochloric acid, water.
Should be stored with the cover
tightened.
Do not store above 30C. Each BRILINTA tablet contains ticagrelor 90 mg.
BRILINTA contais ticagrelor, a
cyclopentyltriazolopyrimidine, inhibitor of
platelet activation and aggregation mediated
by the P2Y12 ADP-receptor. Chemically, it is
(1S,2S,3R,5S)-3-[7-{[(1R,2S)-2-(3,4-
difluorophenyl)cyclopropyl]amino}-
5(propylthio)-3H-[1,2,3]-triazolo[4,5-
d]pyrimidin-3-yl]-5-
(2hydroxyethoxy)cyclopentane-1,2-diol. The
empirical formula of ticagrelor is
C23H28F2N6O4S and its molecular weight is
522.57.
Ticagrelor is a crystalline powder with an
aqueous solubility of approximately 10
mcg/mL at room temperature.
Excipients/Inactive Ingredients: Core: Mannitol
(E421), dibasic calcium phosphate, magnesium
steareate, sodium starch glycolate,
hydroxypropyl cellulose.
Coating: Talc, titanium dioxide (E171), yellow
ferric oxide, polyethylene glycol 400 and
hypromellose.
Susp: Each 5 mL (1 scoop) contains 100 mg
ibuprofen.
Store below 30C. Caduet also contains the following excipients:
Shelf-Life: 24 months. Calcium carbonate, croscarmellose sodium,
microcrystalline cellulose, pregelatinised
starch, polysorbate 80, hydroxypropyl
cellulose, purified water, colloidal silicon
dioxide (anhydrous), magnesium stearate,
opadry II white 85F28751 or opadry II Blue
85F10919.
The amlodipine besylate component of Caduet
is chemically described as (R.S.) 3-ethyl-5-
methyl-2-(2-aminoethoxymethyl)-4-(2-
chlorophenyl)-1,4-dihydro-6-methyl-3,5-
pyridinedicarboxylate benzenesulphonate. Its
empirical formula is C20H25ClN2O5C6H6O3S.
The atorvastatin calcium component of Caduet
is chemically described as [R-(R*, R*)]-2-(4-
fluorophenyl)-, d-dihydroxy-5-(1-
methylethyl)-3-phenyl-4-
[(phenylamino)carbonyl]-1H-pyrrole-1-
heptanoic acid, calcium salt (2:1) trihydrate.
The empirical formula of atorvastatin calcium
is (C33H34FN2O5)2Ca3H2O.
CalSource: Store at 2-25C. CalSource: Each measuring spoon (5 mL)
CalSource Forte: Protect from light and contains calcium gluconolactobionate 1.437 g
humidity. and calcium lactobionate 0.295 g equivalent to
CalSource Plus Vitamin C: Store below ionizable calcium 110 mg. It also contains
30C. Protect from humidity. sugar 1.51 g.
CalSource Forte: Each effervescent tablet
contains calcium lactate-gluconate 2.94 g and
calcium carbonate 0.3 g equivalent to ionizable
calcium 500 mg. It also contains sugar 0.87 g
and sodium 0.28 g.
CalSource Plus Vitamin C: Each effervescent
tablet contains calcium lactate-gluconate 1 g,
calcium carbonate 0.327 g, ascorbic acid
(vitamin C) 1 g, sodium bicarbonate (sodium
274 mg) 1 g and sugar 2 g. The amounts of
calcium lactate-gluconate and calcium
carbonate are equivalent to ionizable calcium
260 mg.
CalSource Junior Strength: Each tablet contains
calcium carbonate 625 mg equivalent to
calcium 250 mg.
CalSource Junior Growth: Each tablet contains
calcium 250 mg, iron 5 mg, zinc 5 mg.
Store below 30C. Each tablet contains calcium carbonate 1500

mg equivalent to elemental calcium 600 mg
and cholecalciferol 10 mcg (vitamin D3 400
IU).
Store below 30C. Each tablet contains calcium carbonate 1500
mg equivalent to elemental calcium 600 mg,
cholecalciferol 10 mcg (vitamin D3 400 IU),
magnesium 500 mg in oxide form, zinc 7.5 mg
in oxide form, copper 500 mcg in sulphate
form and manganese 1.8 mg in sulphate form.
Do not store above 25C. Protect from Each mL of concentrate contains irinotecan HCl
light. trihydrate 20 mg (equivalent to irinotecan
17.33 mg). It also contains the following
excipients: Sorbitol, lactic acid and water for
injections. The pH of the solution is adjusted to
3.5 with sodium hydroxide.
Store at temperatures below 30C. Excepients/Inactive Ingredients:
Methylhydroxypropylcellulose, pregelatinized
maize starch, microcrystalline cellulose,
sodium stearyl fumarate, yellow ferric oxide
(for Cardace 2.5 mg) and red ferric oxide (for
Cardace 5 mg).
Store in a dry place below 30C. Each tablet also contains sodium starch
glycolate, microcrystalline cellulose, lactose,
magnesium stearate and sodium lauryl sulfate
as inert ingredients.
Doxazosin mesylate, a quinazoline derivative, is
1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-
(1,4-benzodioxan-2-yl-carbonyl) piperazine
methanesulfonate. It has a molecular weight
of 547.6 (free base 451.5).
Doxazosin mesylate is soluble in
dimethylsulfoxide and dimethylformamide;
slightly soluble in methanol and sparingly
soluble in water (<0.1% at 25C), ethanol,
acetone and chloroform.
Do not store above 30C. Casodex contains the following excipients:
Shelf-Life: 2 years. Lactose, sodium starch glycolate, povidone,
magnesium stearate, titanium oxide.
50 mg: Methylhydroxypropylcellulose,
polyethylene glycol 300.
150 mg: Hypromellose, macrogol 300.
Store below 25C. Protect from heat and Cataflam: Each sugar-coated tablet also
moisture. contains the following excipients: Core: Silica
aerogel, calcium phosphate, magnesium
stearate, pregelatinized maize starch,
polyvidone and sodium carboxymethyl starch.
Coat: Microcrystalline cellulose, iron oxide,
titanium dioxide, macrogol 8000, polyvidone,
sucrose and talc.
Diclofenac potassium is potassium-[0-(2,6-
dichlorophenyl)-amino-phenyl]-acetate.
Cataflam D: Each dispersible tablet contains
diclofenac free acid 46.5 mg which is
equivalent to diclofenac sodium 50 mg. It also
contains the following excipients:
Microcrystalline cellulose, sodium
carboxymethyl starch, croscarmellose sodium,
silica aerogel, hydrogenated castor oil and talc.
Diclofenac free acid in Cataflam D is [0-(2,6-
dichlorophenyl)-amino-phenyl]-acetic acid.
Store at room temperature. Clonidine HCl is 2,6-dichloro-N-2-
imidazolidinylidenebenzenamine
hydrochloride.
Each tablet contains calcium hydrogen

phosphate 500 mg and cholecalciferol 133 IU.
Mechanism of Action
Pharmacotherapeutic Group: Nucleoside analogue. ATC Code: J05AF05.

Pharmacology: Pharmacodynamics: Lamivudine is a potent, selective inhibitor of HIV-1 and HIV-2 replication in vitro. It is a
clinical isolates of HIV. Lamivudine is metabolized intracellularly to the 5'-triphosphate, the active moiety, which has an intr
5'-triphosphate is a weak inhibitor of the RNA and DNA dependent activities of HIV reverse transcriptase; its main mode of
reverse transcription. Lamivudine has been shown to act additively or synergistically with other anti-HIV agents, particularl
HIV in cell culture.
Lamivudine does not interfere with cellular deoxynucleotide metabolism and has little effect on mammalian cell and mitoc
In vitro, lamivudine demonstrates low cytotoxicity to peripheral blood lymphocytes, to established lymphocyte and monoc
of bone marrow progenitor cells in vitro. Lamivudine therefore has, in vitro, a high therapeutic index.
HIV-1 resistance to lamivudine involves the development of a M184V amino acid change close to the active site of the viral
arises both in vitro and in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy. M184V mutant
lamivudine and show diminished viral replicative capacity in vitro. In vitro studies indicate that zidovudine-resistant virus is
when they simultaneously acquire resistance to lamivudine. The clinical relevance of such findings remains, however, not w
Cross-resistance conferred by the M184V RT is limited within the nucleoside inhibitor class of antiretroviral agents. Zidovud
antiretroviral activities against lamivudine-resistant HIV-1. Abacavir maintains its antiretroviral activities against lamivudine
mutation. The M184V RT mutant shows a less than 4-fold decrease in susceptibility to didanosine and zalcitabine; the clinic
unknown. In vitro susceptibility testing has not been standardised and results may vary according to methodological factor
In clinical trials, lamivudine in combination with zidovudine has been shown to reduce HIV-1 viral load and to increase CD4
that lamivudine in combination with zidovudine alone or in combination with zidovudine containing treatment regimens re
disease progression and mortality.
Reduced in vitro sensitivity to lamivudine has been reported for HIV isolates from patients who have received 3TC therapy.
Evidence from clinical studies show that lamivudine plus zidovudine delays the emergence of zidovudine-resistant isolates
therapy.
Lamivudine has been widely used as a component of antiretroviral combination therapy with other antiretroviral agents of
transcriptase inhibitors) or different classes (protease inhibitors, non-nucleoside reverse transcriptase inhibitors).
Multiple drug antiretroviral therapy containing lamivudine has been shown to be effective in antiretrovirally-naive patients
viruses containing the M184V mutations.
The relationship between in vitro susceptibility of HIV to lamivudine and the clinical response to therapy remain under inve
Post-Exposure Prophylaxis (PEP): Internationally recognised guidelines (Centre for Disease Control and Prevention - June 19
accidental exposure to HIV infected blood eg, from a needlestick injury, a combination of zidovudine and lamivudine should
In cases of higher risk of infection a protease inhibitor should be included in the regimen. It is recommended that antiretro
weeks. No controlled clinical studies have been carried out in post-exposure prophylaxis and supporting data is limited. Ser
treatment with antiretroviral agents.
Pharmacokinetics: Absorption: Lamivudine is well absorbed from the gastrointestinal tract and the bioavailability of oral lam
and 85%. Following oral administration, the mean time (tmax) to maximal serum concentrations (Cmax) is about an hour. A
(as two 12-hourly doses), Cmax is in the order of 1-1.9 mcg/mL.
Co-administration of lamivudine with food resulted in a delay of tmax and a lower Cmax (decreased by up to 47%). Howeve
lamivudine absorbed was not influenced. No dose adjustment is needed when co-administered with food.
Pharmacology: Pharmacodynamics: Lamivudine is an antiviral agent, which is active against hepatitis B virus (HBV) both in
Lamivudine is metabolized by both infected and uninfected cells to the triphosphate (TP) derivative, which is the active form
half-life of the triphosphate in hepatocytes is 17-19 hrs in vitro. Lamivudine-TP acts as an inhibitor of, and substrate for, the
further viral DNA is blocked by incorporation of lamivudine-TP into the chain and subsequent chain termination.
Lamivudine-TP does not interfere with normal cellular deoxynucleotide metabolism. It is also only a weak inhibitor of mam
Furthermore, lamivudine-TP has little effect on mammalian cell DNA content.
In assays relating to potential drug effects on mitochondrial structure, DNA content and function, lamivudine lacked apprec
potential to decrease mitochondrial DNA content, is not permanently incorporated into mitochondrial DNA and does not a
polymerase ?.
Preclinical Virology: Lamivudine demonstrated potent anti-HBV activity in all cell lines tested with treatment resulting in red
between in vitro susceptibility of HBV to lamivudine and the clinical response to therapy has not been established.
Clinical Virology: Lamivudine has potent activity in vivo, reducing serum HBV DNA to undetectable levels within 2-4 weeks
polymerase activity. Following short-term therapy (28 days) however, HBV DNA levels increased within 14 days of cessation
In a clinical study, lamivudine therapy continued for 1 year was associated with sustained reductions in serum HBV DNA an
significant improvements in liver histology and necro-inflammatory activity. In addition, some patients experienced HBe an
lamivudine therapy. The efficacy of 3TC-HBV following longer term therapy is under investigation.
Lamivudine-resistant HBV has been detected in small percentage of patients by 1 year of therapy. A higher percentage of th
transplant patients than in immunocompetent carriers. This virus displays a reduced sensitivity to lamivudine in vitro. The c
be determined.
When lamivudine therapy is stopped in patients infected with resistant virus, lamivudine-sensitive HBV may rapidly reappe
Pharmacokinetics: Absorption: Lamivudine is well absorbed from the gut and the bioavailability of oral lamivudine in adult
Following oral administration, the mean time (Tmax) to maximal serum concentration (Cmax) is about 1 hr. At therapeutic d
the order of 1.1-1.5 mcg/mL. Co-administration of lamivudine with food generally results in a delay of Tmax by 0.25-2.5 hrs
lamivudine bioavailability (based on AUC) is not altered, therefore, 3TC-HBV can be administered with or without food.
Distribution: From IV studies, the mean volume of distribution is 1.3 L/kg. The mean systemic clearance of lamivudine is ap
predominantly renal clearance (>70%) via the organic cationic transport system. The observed dominant half-life of elimina
Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays limited binding to the major plas
albumin in vitro studies).
Limited data shows lamivudine penetrates the central nervous system and reaches the cerebrospinal fluid (CSF).
Metabolism: Lamivudine is predominantly cleared by renal excretion of unchanged drug. The likelihood of metabolic drug i
the small (5-10%) extent of metabolism to a trans-sulphoxide derivative and the low plasma protein-binding.
Elimination: The majority of lamivudine is excreted unchanged in the urine. Renal clearance accounts for about 70% of the
Special Population: Studies in patients with renal impairment show lamivudine elimination is affected by renal dysfunction.
creatinine clearance of <30 mL/min is necessary.
A study in hepatically impaired patients (non-HIV and non-HBV infected) showed lamivudine is well tolerated in this patien
parameters or the adverse event profile of lamivudine. The pharmacokinetics of lamivudine are unaffected by hepatic impa
Limited data in patients undergoing liver transplant show that impairment of hepatic function does not impact significantly
unless accompanied by renal dysfunction.
Microbiology: Clarithromycin exerts its antibacterial action by binding to the 50s ribosomal subunits of susceptible bacteria
Clarithromycin has demonstrated in vitro activity against both standard strains of bacteria and clinical isolates. It is highly p
anaerobic gram-positive and gram-negative organisms. The minimum inhibitory concentrations (MICs) of clarithromycin are
than the MICs of erythromycin.
In vitro data also indicate that clarithromycin has activity against Legionella pneumophila and Mycoplasma pneumoniae. It
activity of clarithromycin is greater at neutral pH than at acid pH. In vitro and in vivo data show that this antibiotic has activ
mycobacterial species.
The in vitro antibacterial spectrum of clarithromycin against respiratory tract and skin structure pathogens is as follows: Us
agalactiae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus pneumoniae, Streptococcus (Groups C, F and G)
parainfluenzae, Neisseria gonorrhoeae, Listeria monocytogenes, Legionella pneumophila, Pasteurella multocida, Mycoplas
(Campylobacter) pylori, Campylobacter jejuni, Chlamydia pneumoniae (TWAR), Chlamydia trachomatis, Moraxella (Branham
Borrelia burgdorferi, Staphylococcus aureus, Clostridium perfringens, Peptococcus niger, Propionibacterium acnes, Bactero
avium, Mycobacterium leprae, Mycobacterium intracellulare and Mycobacterium kansasii.
Nonsensitive Bacteria: Enterobacteriaceae and Pseudomonas sp.
The principal metabolite of clarithromycin in man and other primates is a microbiologically active metabolite, 14-OH-clarith
to 2-fold less active than the parent compound for most organisms, except for H. influenzae against which it is twice as acti
metabolite exert either an additive or synergistic effect on H. influenzae in vitro and in vivo, depending on bacterial strains.
Clarithromycin was found to be 2-10 times more active than erythromycin in several experimental animal infection models
effective than erythromycin in mouse systemic infection, mouse subcutaneous abscess and mouse respiratory tract infectio
pyogenes and H. influenzae.
In guinea pigs with Legionella infection, this effect was more pronounced; an intraperitoneal dose of clarithromycin 1.6 mg
erythromycin 50 mg/kg/day.
Susceptibility Testing: Diffusion Techniques: Quantitative methods that require measurement of zone diameters give the m
bacteria to antimicrobial agents. One recommended procedure uses discs impregnated with clarithromycin 15 mcg for testi
test); interpretations correlate inhibition zone diameters of this disc test with MIC values for clarithromycin. The MICs are d
method. The recommended test medium for susceptibility testing of Haemophilus influenzae according to the National Com
(NCCLS) is the Haemophilus Test Medium (HTM).
The correlation of disc inhibition zone diameters with MICs is given in Table 1.
With these procedures, a report from the laboratory of "susceptible" indicates that the infecting organism is likely to respo
indicates that the infective organism is not likely to respond to therapy. A report of "intermediate susceptibility" suggests th
be equivocal or that the organism would be susceptible if higher doses were used. (Intermediate susceptibility is also referr
category provides a better zone, which prevents small uncontrolled technical factors from causing major discrepancies in in
However, standardized diffusion methods for routine in vitro susceptibility testing, using the 15-mcg clarithromycin disc, do
activity of the 14-OH metabolite and thus may underestimate the drug's potential activity against Haemophilus influenzae
category which often respond to treatment.
Standardized procedures require the use of laboratory control organisms. The 15-mcg clarithromycin disc should be given t
25923: 23-30 mm.
Pharmacology: Pharmacodynamics: Aripiprazole exhibits high affinity for dopamine D2 and D3, serotonin 5-HT1A and 5-HT
3.4 nM, respectively), moderate affinity for dopamine D4, serotonin 5-HT2C and 5-HT7, a1-adrenergic and histamine H1 re
nM, respectively), and moderate affinity for the serotonin re-uptake site (Ki=98 nM). Aripiprazole has no appreciable affinit
>1000 nM). Aripiprazole functions as a partial agonist at the dopamine D2 and the serotonin 5-HT1A receptors, and as an a
The mechanism of action of aripiprazole, as with other drugs having efficacy in schizophrenia and bipolar disorder is unkno
efficacy of aripiprazole is mediated through a combination of partial agonist activity at D2 and 5-HT1A receptors and antag
receptors other than D2, 5-HT1A and 5-HT2A may explain some of the other clinical effects of aripiprazole eg, the orthosta
may be explained by its antagonist activity at adrenergic a1-receptors.
Pharmacokinetics: Abilify activity is presumably primarily due to the parent drug, aripiprazole, and to a lesser extent, to its
which has been shown to have affinities for D2 receptors similar to the parent drug and represents 40% of the parent drug
half-lives are about 75 and 94 hrs for aripiprazole and dehydro-aripiprazole, respectively. Steady-state concentrations are att
active moieties. Aripiprazole accumulation is predictable from single-dose pharmacokinetics. At steady state, the pharmaco
proportional. Elimination of aripiprazole is mainly through hepatic metabolism involving two P-450 isozymes, CYP2D6 and C
Absorption: Aripiprazole is well absorbed after administration of the tablet, with peak plasma concentrations occurring wit
of the tablet formulation is 87%. Abilify can be administered with or without food. Administration of a 15-mg tablet with a
affect the Cmax or AUC of aripiprazole or its active metabolite, dehydro-aripiprazole, but delayed Tmax by 3 hrs for aripipra
Distribution: The steady-state volume of distribution of aripiprazole following IV administration is high (404 L or 4.9 L/kg), in
distribution. At therapeutic concentrations, aripiprazole and its major metabolite are >99% bound to serum proteins, prima
volunteers administered with aripiprazole 0.5-30 mg/day for 14 days, there was dose-dependent D2-receptor occupancy in
humans.
Metabolism and Elimination: Aripiprazole is metabolized primarily by 3 biotransformation pathways: Dehydrogenation, hyd
vitro studies, CYP3A4 and CYP2D6 enzymes are responsible for dehydrogenation and hydroxylation of aripiprazole, and N-d
Aripiprazole is the predominant drug moiety in the systemic circulation. At steady state, dehydro-aripiprazole, the active m
aripiprazole AUC in plasma.
Approximately 8% of Caucasians lack the capacity to metabolize CYP2D6 substrates and are classified as poor metabolizers
metabolizers (EM). PMs have about an 80% increase in aripiprazole exposure and about a 30% decrease in exposure to the
resulting in about a 60% higher exposure to the total active moieties from a given dose of aripiprazole compared to EMs. C
inhibitors of CYP2D6 eg, quinidine in EMs, results in a 112% increase in aripiprazole plasma exposure, and dosing adjustme
elimination half-lives are about 75 and 146 hrs for aripiprazole in EMs and PMs, respectively. Aripiprazole does not inhibit o
Following a single oral dose of [14C]-labeled aripiprazole, approximately 25% and 55% of the administered radioactivity wa
respectively. Less than 1% of unchanged aripiprazole was excreted in the urine and approximately 18% of the oral dose was
Special Populations: In general, no dosage adjustment for Abilify is required on the basis of a patient's age, gender, race, sm
function (see Dosage & Administration). The pharmacokinetics of aripiprazole in special populations are described as follow
Hepatic Impairment (HI): In a single-dose study (aripiprazole 15 mg) in subjects with varying degrees of liver cirrhosis (Child
aripiprazole, compared to healthy subjects, increased 31% in mild HI, increased 8% in moderate HI, and decreased 20% in s
require dose adjustment.
Renal Impairment: In patients with severe renal impairment (creatinine clearance <30 mL/min), Cmax of aripiprazole (given
aripiprazole increased by 36% and 53%, respectively, but AUC was 15% lower for aripiprazole and 7% higher for dehydro-ar
Pharmacotherapeutic Group: Leukotriene-receptor antagonist. ATC Code: R03D C01.
Pharmacology: Pharmacodynamics: The cysteinyl leukotrienes (LTC4, LTD4 and LTE4) are potent inflammatory eicosanoids r
cells and eosinophils. These important pro-asthmatic mediators bind to cysteinyl leukotriene receptors found in the human
Leukotriene production and receptor occupation have been implicated in the pathophysiology of asthma. Effects include sm
and altered cell activity associated with the inflammatory process, including eosinophil influx to the lung.
Accolate is a competitive, highly selective and potent oral peptide leukotriene antagonist of LTC4, LTD4 and LTE4 componen
anaphylaxis. In vitro studies have shown that ACCOLATE antagonises the contractile activity of all three peptide leukotriene
conducting airway smooth muscle to the same extent. Animal studies have shown ACCOLATE to be effective in preventing p
vascular permeability, which give rise to oedema in the airways and to inhibit peptide leukotriene-induced influx of eosinop
The specificity of ACCOLATE has been shown by its action on leukotriene receptors and not on prostaglandin, thromboxane
In a placebo-controlled study where segmental bronchoprovocation with allergen was followed by bronchoalveolar lavage
in basophils, lymphocytes and histamine, and reduced the stimulated production of superoxide by alveolar macrophages.
ACCOLATE attenuated the increase in bronchial hyper-responsiveness that follows inhaled allergen challenge. Further, meth
long-term dosing with ACCOLATE 20 mg twice daily.
Further, in clinical trials evaluating chronic therapy with ACCOLATE, the lung function measured when plasma levels were a
over baseline.
ACCOLATE shows a dose-dependent inhibition of bronchoconstriction induced by inhaled LTD4. Asthmatic patients are app
bronchoconstricting activity of inhaled LTD4. A single oral dose of ACCOLATE can enable an asthmatic patient to inhale 100
protection at 12 and 24 hours.
ACCOLATE inhibits the bronchoconstriction caused by several kinds of challenge, such as the response to sulphur dioxide, e
the early and late phase inflammatory reaction caused by various antigens such as grass, cat dander, ragweed and mixed an
In asthmatic patients not adequately controlled by beta-agonist therapy (given as required), ACCOLATE improves symptoms
symptoms), improves lung function, reduces the need for concomitant beta-agonist medication and reduces incidence of e
seen in patients with more severe asthma receiving high-dose inhaled steroids.
In clinical studies, there was a significant first-dose effect on baseline bronchomotor tone observed within 2 hours of dosin
not yet been achieved. Initial improvements in asthma symptoms occurred within the first week and often the first few day
Pharmacokinetics: Peak plasma concentrations of zafirlukast are achieved approximately 3 hours after oral administration o
Administration of ACCOLATE with food increased the variability in the bioavailability of zafirlukast and reduced bioavailabili
was approximately 40%.
Following twice-daily administration of ACCOLATE (30 to 80 mg bd), accumulation of zafirlukast in plasma was low (not det
1.45; median 1.27). The terminal half-life of zafirlukast is approximately 10 hours. Steady-state plasma concentrations of za
predictable from single-dose pharmacokinetic data.
Zafirlukast is extensively metabolised. Following a radiolabelled dose, the urinary excretion accounts for approximately 10%
Zafirlukast is not detected in urine. The metabolites identified in human plasma were found to be at least 90-fold less poten
of activity.
Zafirlukast is approximately 99% protein bound to human plasma proteins, predominantly albumin, over the concentration
Pharmacokinetic studies in special populations have been performed in a relatively small number of subjects, and the clinic
is not established.
Pharmacology: Triprolidine provides symptomatic relief in conditions believed to depend wholly or partly upon the triggere
histamine H1-receptor antagonist of the pyrrolidine class with mild central nervous system depressant properties which ma
Pseudoephedrine has direct and indirect sympathomimetic activity and is an upper respiratory decongestant. Pseudoephed
ephedrine in producing both tachycardia and elevation in systolic blood pressure and considerably less potent in causing sti
Pharmacokinetics: After the administration of Actifed to healthy adult volunteers, the peak plasma concentration (Cmax) o
occurring at about 2 hrs (Tmax) for the tablet and 1.5 hrs for the syrup.
The plasma half-life of triprolidine is approximately 3.2 hrs. The Cmax of pseudoephedrine is approximately 180 ng/mL for
approximately 2 hrs for the tablet and 1.5 hrs for the syrup after drug administration. The plasma half-life of pseudoephedr
maintained between 5-7). The plasma half-life of pseudoephedrine is markedly decreased by acidification of urine and incr
After oral administration of a single dose of 2.5 mg triprolidine to adults, the onset of action, as determined by the ability t
flares in the skin, is within 1-2 hrs. Peak effects occur at about 3 hrs and although activity declines thereafter, significant inh
flares still occurs 8 hrs after dosing.
Pseudoephedrine produces its decongestant effect within 30 min, which persists for at least 4 hrs.
Pseudoephedrine is partly metabolised in the liver by N-demethylation to norpseudoephedrine, an active metabolite. Pseu
excreted in the urine; 55-75% of a dose is excreted unchanged. The rate of urinary excretion of pseudoephedrine is acceler
as the urine pH increases, the rate of urinary excretion is slowed.
Animal hepatic microsomal enzyme studies have revealed the presence of several triprolidine metabolites with an oxidised
predominating. In man, it has been reported that only about 1% of an administered dose is eliminated as unchanged tripro
Teratogenicity: In rats and rabbits, systemic administration of triprolidine up to 75 times the human daily dosage did not pr
administration of pseudoephedrine, up to 50 times the human daily dosage in rats and up to 35 times the human daily dos
effects.
Pharmacotherapeutic Group: Fibrinolytic.
Pharmacology: The active ingredient of Actilyse is alteplase, a recombinant human tissue-type plasminogen activator. It is a
directly to plasmin. When administered IV, alteplase remains relatively inactive in the circulatory system. Once bound to fib
of plasminogen to plasmin leading to the dissolution of the fibrin clot.
Acute Myocardial Infarction (AMI) Patients: Two (2) Actilyse dose regimens have been studied in patients experiencing acut
efficacy of these 2 regimens has not been evaluated.
Accelerated Infusion in AMI Patients: Accelerated infusion of Actilyse was studied in an international, multi-center trial (GU
acute myocardial infarction to 4 thrombolytic regimens. Administration of Actilyse 100 mg over 90 min, with concomitant I
after 30 days (6.3%) as compared to the administration of streptokinase, 1.5 million IU over 60 min, with SC or IV heparin (7
mortality for Actilyse compared to streptokinase was statistically significant (p=0.007).
Actilyse treated patients showed higher infarct related vessel patency rates at 60 and 90 min after thrombolysis than the st
in patency rates were noted at =180 min.
A large scale mortality trial (ASSENT 2) in approximately 17,000 patients showed that alteplase and tenecteplase are therap
(6.2% for both treatments, at 30 days). The use of tenecteplase was associated with a significantly lower incidence of non-i
(26.4% vs 28.9%, p=0.0003). The reduction of the risk of bleeding is likely to be related to the increased fibrin specificity of
regimen.
Three-Hour Infusion in AMI Patients: In a double-blind, randomized trial (5013 patients) comparing Actilyse to placebo (ASS
within 5 hrs of the onset of symptoms of acute myocardial infarction experienced improved 30-day survival compared to th
overall mortality rates were 7.2% for the Actilyse treated group and 9.8% for the placebo-treated group (p=0.001). This ben
Actilyse treated patients (10.4%) compared to those treated with placebo (13.1%, p=0.008).
In a double-blind, randomized trial (721 patients) comparing Actilyse to placebo, patients infused with Actilyse within 5 hrs
improved ventricular function 10-22 days after treatment compared to the placebo group, when global ejection fraction wa
(50.7% versus 48.5%, p=0.01). Patients treated with Actilyse had a 19% reduction in infarct size, as measured by cumulative
dehydrogenase) activity compared to placebo-treated patients (p=0.001). Patients treated with Actilyse had significantly fe
ventricular fibrillation (p<0.04) and pericarditis (p=0.01) compared to patients treated with placebo. Mortality at 21 days in
3.7% compared to 6.3% in placebo-treated patients (1-sided, p=0.05). Although these data do not demonstrate unequivoca
this study, they do indicate a trend that is supported by the results of the ASSET study.
In a placebo controlled trial (LATE) in 5711 AMI patients with onset of symptoms between 6 and 24 hrs a 100-mg Actilyse o
placebo. A nonsignificant reduction of 14.1% (95% CI: 0-28.1%, p>0.05) in 30-day-mortality was observed with Actilyse. In a
treated within 12 hrs of symptom onset, a significant 25.6% reduction in mortality in favour of Actilyse (95% CI: 6.3-45%; p=
Pulmonary Embolism Patients: In a comparative randomized trial of alteplase versus urokinase in 63 patients with angiogra
pulmonary embolism both treatment groups experienced a significant reduction in pulmonary embolism-induced pulmona
haemodynamics improved significantly faster with Actilyse than with urokinase.
Acute Ischaemic Stroke Patients: Several studies have been carried out in the field of acute ischaemic stroke. The NINDS stu
limit ie, which also included patients >80 years. All other randomized trials have excluded patients >80 years. Therefore, tre
require particular care on an individual patient basis.
Two (2) placebo-controlled, double-blind trials (NINDS t-PA Stroke Trial, Part 1 and Part 2) enrolled patients with measurabl
screening and begin study treatment within 3 hrs from symptom onset. A cranial computerized tomography (CT) scan was
Pharmacology: Actos decreases insulin resistance, with activation of "nuclear receptor" (peroxisome proliferator-activated
sensitivity of liver, lipid tissue and skeletal muscle cells of animals. In the case of insulin resistance, Actos reduces glucose p
peripheral glucose uptake.
Fasting and postprandial glycaemic control is improved in patients with type 2 diabetes mellitus. The improved glycaemic c
fasting and postprandial plasma insulin concentration.
Recent studies have shown that pioglitazone improves -cell function as well as increasing insulin sensitivity.
Pharmacokinetics: Absorption: Pioglitazone is rapidly absorbed after oral administration. Peak level is reached 2 hrs after ad
increases proportionally with 2-60 mg administration. Steady state is reached after 4-7 days. Repeated dosing does not cau
metabolites. Its absorption is not influenced by food. Absolute bioavailability is >80%.
Distribution: The estimated volume of distribution in humans is about 0.25 L/kg. Pioglitazone and all of active metabolites a
(>99%).
Metabolism: Actos is metabolised in the liver by hydroxylation of aliphatic methylene groups. This is predominantly via cyto
multiple other isoforms are involved to a lesser degree. Three of 6 of its metabolites are active (M-II, M-III and M-IV). When
binding are taken into account, Actos and metabolite M-III contribute equally to efficacy. On this basis, M-IV contribution to
Actos, whilst the relative efficacy of M-II is minimal.
Elimination: Upon oral administration of radioactive Actos in men, the radiolabeled pioglitazone is found in the faeces (55%
amount of intact pioglitazone is found in the urine or faeces. The mean half-time of elimination in man is 5-6 hrs (pioglitazo
Elderly: Steady state in patients =65 years is similar in younger patients.
Patients with Renal Failure: Concentration of pioglitazone and its metabolites are lower in patients with renal failure than t
have similar oral clearance. Concentration of intact pioglitazone remains unchanged.
Patients with Liver Failure: Concentration of plasma pioglitazone is unchanged but the volume of distribution is increased a
Pharmacology: Mechanism of Action: Actosmet combines 2 antihyperglycemic agents with complementary mechanisms of
patients with the type 2 diabetes: Pioglitazone hydrochloride, a member of the thiazolidinedione class, and metformin hyd
class. Thiazolidinediones are insulin-sensitizing agents that act primarily by enhancing peripheral glucose utilization, where
endogenous hepatic glucose production.
Pioglitazone Hydrochloride: Pioglitazone depends on the presence of insulin for its metabolism of action. Piolitazone decre
in the liver resulting in increased insulin-dependent glucose disposal, and decreased hepatic glucose output. Unlike sulfony
secretagogue. Pioglitazone is a potent and highly selective agonist for peroxisome proliferator-activated receptor-? (PPAR?)
important for insulin action eg, adipose tissue, skeletal muscle and liver. Activation of PPAR? nuclear receptors modulates t
responsive genes involved in the control of glucose and lipid metabolism.
In animal models of diabetes, pioglitazone reduces the hyperglycemia, hyperinsulinemia and hypertriglyceridemia characte
diabetes. The metabolic changes produced by pioglitazone result in increased responsiveness of insulin-dependent tissues
models of insulin resistance.
Since pioglitazone enhances the effects of circulating insulin (by decreasing insulin resistance), it does not lower blood gluc
insulin.
Metformin Hydrochloride: Metformin hydrochloride improves glucose tolerance in patients with type 2 diabetes, lowering
Metformin decreased hepatic glucose production, decreased intestinal absorption of glucose and improves insulin sensitivi
and utilization. Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or n
circumstances, see General: Metformin Hydrochloride under Precautions) and does not cause hyperinsulinemia. With metf
unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.
Pharmacodynamics: Clinical Effects: Pioglitazone Hydrochloride: Clinical studies demonstrate that pioglitazone improves ins
Pioglitazone enhances cellular responsiveness to insulin, increases insulin-dependent glucose disposal, improves hepatic se
dysfunctional glucose homeostasis. In patients with type 2 diabetes, the decreased insulin resistance produced by pioglitaz
concentrations, lower plasma insulin levels, and lower HbA1c values. Based on results from an open-label extension study,
appear to persist for at least 1 year. In controlled clinical studies, pioglitazone in combination with metformin had an additi
Patients with lipid abnormalities were included in placebo-controlled monotherapy clinical studies with pioglitazone. Overa
mean decreases in triglycerides, mean increases in HDL-cholesterol, and no consistent mean changes in LDL-cholesterol an
group. A similar pattern of results was seen in 16- and 24-week combination therapy studies of pioglitazone with metformi
Pharmacokinetics: Absorption and Bioavailability: In bioequivalence studies of Actosmet 15 mg/850 mg, the area under the
(Cmax) of both the pioglitazone and the metformin component following a single dose of the combination tablet were bioe
administered with metformin hydrochloride 850-mg tablet under fasted conditions in healthy subjects (see Table 1).
Administration of Actosmet 15 mg/850 mg with food resulted in no change in overall exposure of pioglitazone. With metfo
mean peak serum concentration of metformin was decreased by 28% when administered with food. A delayed time to pea
both components (1.9 hrs for pioglitazone and 0.8 hrs for metformin) under fed conditions. These changes are not likely to
Pioglitazone Hydrochloride: Following oral administration, in the fasting state, pioglitazone is 1st measurable in serum with
observed within 2 hrs. Food slightly delays the time to peak serum concentration to 3-4 hrs, but does not alter the extent o
Metformin Hydrochloride: The absolute bioavailabifity of a metformin 500-mg tablet given under fasting conditions is appr
oral doses of metformin tablets of 500 mg to 1500 mg and 850 mg to 2550 mg, indicate that there is a lack of dose proporti
Pharmacotherapeutic Group: Insulins and analogues, fast-acting, insulin (human). ATC Code: A10AB01.
Pharmacology: Pharmacodynamics: The blood glucose-lowering effect of insulin occurs when the molecules facilitate the u
receptors on muscle and fat cells, thus simultaneously inhibiting the output of glucose from the liver.
Actrapid HM/Penfill is a fast-acting insulin with an onset of action within hr, reaching a maximum effect within 1.5-3.5 hr
approximately 7-8 hrs.
Pharmacokinetics: Insulin in the blood stream has a half-life of a few minutes. Consequently, the time-action profile of an in
its absorption characteristics. This process is influenced by several factors (eg, insulin dosage, injection route and site, thick
pharmacokinetics of insulin are therefore affected by significant intra- and inter-individual variation.
Absorption: The maximum plasma concentration of insulin is reached within 1.5-2.5 hrs after SC administration.
Distribution: No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
Metabolism: Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly prote
cleavage (hydrolysis) sites on the human insulin molecule have been proposed; none of the metabolites formed following t
Elimination: The terminal half-life (t) is determined by the rate of absorption from the SC tissue. The t is therefore a mea
elimination per se of insulin from plasma (insulin in the blood stream has a t of a few minutes). Trials have indicated a t
The pharmacokinetic profile of Actrapid HM/Penfill has been studied in a small number (n=18) of diabetic children (6-12 ye
data are limited but suggest that the pharmacokinetic profile in children and adolescents may be similar to that in adults. H
age groups in Cmax stressing the importance of individual dose titration.
Toxicology: Preclinical Safety Data: Preclinical data reveal no specific hazard for humans based on conventional studies of sa
genotoxicity, carcinogenic potential, toxicity to reproduction.
Microbiology: Antibacterial Spectrum: In vitro antibacterial activity of nadifloxacin showed a potent and broad spectrum ag
and anaerobic bacteria, including Propionibacterium acnes and Staphylococcus epidermidis. Acuatim activity is bactericida
activity against methicillin-resistant Staphylococcus aureus (MRSA) that was similar to the potency against methicillin-sensi
Acuatim was also active against new quinolone-resistant MRSA. Nadifloxacin was not cross-resistant with other new quinol
In vivo Antibacterial Activity: The in vivo therapeutic effect of Acuatim cream was superior to the cream base alone in expe
were subcutaneously infected with P. acnes and S. epidermidis.
Antibacterial Effects: Results of follicular analysis obtained in clinical studies using acne patients indicated that Acuatim cre
acnes and other microorganisms in the follicles, as compared to the control (cream base) treatment. Microbacterial tests w
CNS, P. acnes and other microorganisms in 86.4% of the patients with folliculitis or sycosis vulgaris after the application of A
concentrations (MIC) of nadifloxacin against 394 clinical isolates of P. acnes, 76 of Staphylococcus epidermidis, 45 of CNS an
higher than 0.78, 0.39, 0.05 and 0.39 mcg/mL, respectively, evidencing its potent antibacterial activity. In addition, no resis
Mechanism of Action: Nadifloxacin showed an inhibitory effect on bacterial DNA gyrase activity (involved in DNA synthesis
to supercoiled DNA.
Development of Resistance: The development of resistance after serial passage of nadifloxacin was rare as compared with
agents. The frequency of spontaneous mutants resistant to nadifloxacin was <10-8.
Pharmacokinetics: Following a single topical application of nadifloxacin 1% cream at 10 g to normal human back skin, the h
determined to be 1.7 ng/mL with an elimination half-life of 19.4 hrs. Approximately 0.09% of the administered dose was ex
The plasma concentration reached a steady state on day 5 of the repeated administration study when nadifloxacin 1% crea
normal healthy individuals for a period of 7 days. The plasma concentration reached a peak of 4.1 ng/mL at 8 hrs post-final
hrs. The urinary excretion rate reached 0.16% on day 7.
Clinical Studies: Clinical Efficacy: Nadifloxacin was studied in a total of 519 acne patients using both the open and double-b
the face twice (morning and evening) daily after washing for 4 weeks. Efficacy (effective or markedly effective) was obtaine
double-blind study in acne patients with multiple inflamed lesions demonstrated that 81.3% (39/48) of the treated patient
and improvement of inflammation.
Pharmacology: Sodium hyaluronate has a covering and protective action to the cartilage surface of the joint, a suppressive
cartilage tissue and an ameliorative action to the mobility range in articular contracture. It relieves pain in general arthrosis
joints and normalizes synovial fluid.
Action to the Cartilage of the Joint: Sodium hyaluronate was recognized to have entered into the surface layer of the cartila
knee joint of a normal rabbit. Moreover, in the cartilage of man with arthrosis deformans in the knee (in vitro), distribution
the surface layer into the entire layer of the cartilage with the progress of time. This distribution within the cartilage was in
proteoglycan. Separation of proteoglycan in the cells of articular cartilage of a cow is suppressed by sodium hyaluronate. A
joint cavity of the knee using a rabbit as the model of arthrosis deformans of the knee and the model of fixed articular con
suppressed degeneration of cartilage.
Improvement of Mobility Range of the Joints: In the model of fixed articular contracture using the rabbit, mobility range of
sodium hyaluronate into articular cavity.
Toxicology: Nonclinical Tests: Acute Toxicity: LD50 value obtained when single administration was given intra-abdominally i
mg/kg, respectively.
Subacute Toxicity: When repeated intra-abdominal administrations were given in rats during 28 days at a dose level of 30, 6
recognized was 30 mg/kg. Doses of >60 mg/kg caused a decrease of red blood cells (RBC) and total protein, which was reco
considered to have relation with the change of blood picture by the use of sodium hyaluronate, however a tendency of rec
the drug.
Antigenicity: Sodium hyaluronate was allowed to exhibit its action by IM and intra-articular administration in guinea pigs, a
and PCA reactions was carried out. The result showed that there was no antigenicity observed in any of the tests.
Mutagenicity: In the Ames test using bacteria, occurrence of mutagenicity was not recognized.
Local Irritability: Sodium hyaluronate 0.1 mL was dropped into the rabbit eyes and it showed no influence on the cornea, ir
membrane of the eyes was also negative.
Pharmacotherapeutic Group: Antihistamine-H1 antagonist. ATC Code: R06AX27.
Pharmacology: Mechanism of Action: Desloratadine is a non-sedating, long-acting tricyclic histamine antagonist with selecti
antagonist activity. Receptor-binding data indicate that at a concentration of 2-3 ng/mL (7 nM), desloratadine shows signifi
H1-receptor. Desloratadine inhibited histamine release from human mast cells in vitro.
Results of a radiolabeled tissue distribution study in rats and a radioligand H1-receptor-binding study in guinea pigs showed
the blood-brain barrier.
After oral administration, desloratadine selectively blocks peripheral histamine H1-receptors because the substance is exclu
system. Desloratadine does not readily penetrate the central nervous system. At the recommended dose of 5 mg daily for a
incidence of somnolence as compared to placebo. Aerius tablets given at a single daily dose of 7.5 mg to adults and adoles
performance in clinical trials. In a single-dose study performed in adults, desloratadine 5 mg did not affect standard measu
exacerbation of subjective sleepiness or tasks related to flying.
Desloratadine has demonstrated antiallergic properties from in vitro studies. These include inhibiting the release of proinfla
IL-13 from human mast cells/basophils, as well as inhibition of the expression of the adhesion molecule-P selection on end
observations remains to be confirmed.
Efficacy of Aerius syrup has not been investigated in separate pediatric trials. Safety of Aerius syrup was demonstrated in 3
were candidates for antihistamine therapy received a daily dose of 1.25 mg (1-5 years) and 2.5 mg (6-11 years). Treatment
clinical laboratory tests, vital signs and ECG internal data including QTc. When given at the recommended doses, the plasm
comparable in the pediatric and adult populations. Thus, since the course of seasonal allergic rhinitis/chronic idiopathic urti
similar in adults and pediatric patients, desloratadine efficacy data in adults can be extrapolated to the pediatric population
In a multiple dose clinical trial in adults and adolescents in which up to 20 mg of desloratadine was administered daily for 1
cardiovascular effect was observed in a clinical pharmacology trial in adults and adolescents, in which desloratadine was ad
daily (9 times the clinical dose) for 10 days, no prolongation of QTc interval was seen.
Pharmacodynamics: Wheal and Flare: Human histamine skin wheal studies following single and repeated 5-mg doses of de
exhibits an antihistaminic effect by 1 hr; this activity may persist for as long as 24 hrs. There was no evidence of histamine-i
desloratadine 5-mg group over the 28-day treatment period.
The clinical relevance of histamine wheal skin testing is unknown.
Effects on QTc: Single-dose administration of desloratadine did not alter the corrected QT interval (QTc) in rats (up to 12 mg
Repeated oral administration at doses up to 24 mg/kg for durations up to 3 months in monkeys did not alter the QTc at an e
that was approximately 955 times the mean AUC in humans at the recommended daily oral dose. (See Overdosage for info
Clinical Trials: Seasonal Allergic Rhinitis: The clinical efficacy and safety of Aerius tablets were evaluated in >2300 patients 1
total of 1838 patients received Aerius 2.5-20 mg/day in 4 double-blind, randomized, placebo-controlled clinical trials of 2- t
States. The results of these studies demonstrated the efficacy and safety of Aerius 5 mg in the treatment of adult and adole
rhinitis. In a dose ranging trial, Aerius 2.5-20 mg/day was studied. Doses of 5, 7.5, 10 and 20 mg/day were superior to place
doses >5 mg. In the same study, an increase in the incidence of somnolence was observed at doses of 10 and 20 mg/day (5
placebo (2.3%).
In two 4-week studies of 924 patients (15-75 years) with seasonal allergic rhinitis and concomitant asthma, Aerius tablets 5
with no decrease in pulmonary function. This supports the safety of administering Aerius tablets to adult patients with sea
asthma.
Pharmacotherapeutic Group: Folic acid analogues. ATC Code: L01BA04.
Pharmacology: Pharmacodynamics: Pemetrexed is a multi-targeted anticancer antifolate agent that exerts its action by disr
processes essential for cell replication.
In vitro studies have shown that pemetrexed behaves as a multi-targeted antifolate by inhibiting thymidylate synthase (TS),
glycinamide ribonucleotide formyltransferase (GARFT), which are key folate-dependent enzymes for the de novo biosynthe
Pemetrexed is transported into cells by both the reduced folate carrier and membrane folate binding protein transport syst
and efficiently converted to polyglutamate forms by the enzyme folylpolyglutamate synthetase. The polyglutamate forms a
potent inhibitors of TS and GARFT. Polyglutamation is a time- and concentration-dependent process that occurs in tumour
tissues. Polyglutamated metabolites have an increased intracellular half-life resulting in prolonged drug action in malignant
Clinical Efficacy: Mesothelioma: EMPHACIS, a multicentre, randomised, single-blind phase 3 study of Alimta plus cisplatin v
malignant pleural mesothelioma, has shown that patients treated with Alimta and cisplatin had a clinically meaningful 2.8-
patients receiving cisplatin alone. During the study, low-dose folic acid and vitamin B12 supplementation was introduced to
primary analysis of this study was performed on the population of all patients randomly assigned to a treatment arm who r
treated). A subgroup analysis was performed on patients who received folic acid and vitamin B12 supplementation during t
supplemented). The results of these analyses of efficacy are summarised in Table 1. (See Table 1.)
A statistically significant improvement of the clinically relevant symptoms (pain and dyspnoea) associated with malignant p
arm (212 patients) versus the cisplatin arm alone (218 patients) was demonstrated using the lung cancer symptom scale. St
pulmonary function tests were also observed. The separation between the treatment arms was achieved by improvement
and deterioration of lung function over time in the control arm.
There are limited data in patients with malignant pleural mesothelioma treated with Alimta alone. Alimta at a dose of 500 m
chemo-naive patients with malignant pleural mesothelioma. The overall response rate was 14.1%.
Non-Small Cell Lung Cancer (NSCLC) 2nd-Line Treatment: A multicentre, randomised, open-label phase 3 study of Alimta ve
advanced or metastatic NSCLC after prior chemotherapy has shown median survival times of 8.3 months for patients treate
(ITT) n=283] and 7.9 months for patients treated with docetaxel (ITT n=288). An analysis of the impact of NSCLC histology o
was in favour of Alimta versus docetaxel for other than predominantly squamous histologies (n=399, 9.3 versus 8 months, a
and was in favour of docetaxel for squamous cell carcinoma histology (n=172, 6.2 versus 7.4 months, adjusted hazard ratio
There were no clinically relevant differences observed for the safety profile of Alimta within the histology subgroups.
Limited clinical data from a separate randomized, phase 3, controlled trial, suggest that efficacy data (overall survival, progr
similar between patients previously pre-treated with docetaxel (n=41) and patients who did not receive previous docetaxel
Non-Small Cell Lung Cancer, 1st-Line Treatment: A multicentre, randomised, open-label, phase 3 study of Alimta plus cispla
chemonaive patients with locally advanced or metastatic (stage IIIb or IV) NSCLC showed that Alimta plus cisplatin (ITT pop
and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT n=863) in overall survival (adjusted HR 0.94; 95% CI=0
had an eastern cooperative oncology group (ECOG) performance status 0 or 1.
The primary efficacy analysis was based on the ITT population. Sensitivity analyses of main efficacy endpoints were also ass
population. The efficacy analyses using PQ population are consistent with the analyses for the ITT population and support t
Progression free survival (PFS) and overall response rate were similar between treatment arms: Median PFS was 4.8 month
Alinamin/Alinamin-F enhances the metabolism activity in the whole body.
Vitamins B1 (thiamine) and B2 (riboflavin) are essential substances for nerve function and carbohydrate metabolism.
Vitamins B1 and B2 supplements are needed in the following conditions: Increase in requirement eg, during pregnancy and
more energy; impairment of absorption eg, in diarrhoea and other digestive disturbances. Alinamin/Alinamin-F tablet cont
tetrahydrofurfuryl disulfide HCl). TTFD cannot be damaged by enzyme aneurinase, an enzyme produced by several bacteria
Pharmacokinetics: Absorption of TTFD in the gastrointestinal tract is optimal.
Pharmacology: Glimepiride is a sulfonylurea antidiabetic agent which decreases blood glucose concentrations. The primary
appears to be dependent on stimulating the release of insulin from functioning pancreatic cells. Glimepiride acts in conce
of cells to physiological glucose stimulus, resulting in insulin secretion in the rhythim of meals. In addition, extrapancreati
glucose production and increased peripheral tissue sensitivity to insulin and glucose uptake) may also play a limited role in
In nonfasting diabetic patients, the hypoglycaemic action of a single dose of glimepiride persist for 24 hrs.
Evidence from in vitro and animal studies suggests that there is lower glucagon secretion with glimepiride than glibenclam
reduction of blood glucose levels without increased plasma insulin levels. The clinical significance of these findings is yet to
placebo-controlled clinical trial demonstrated that Amaryl therapy improves postprandial insulin/C-peptide responses and
clinically meaningful increases in fasting insulin/C-peptide levels.
The efficacy of Amaryl is not affected by age, gender or weight. Amaryl therapy is effective in controlling blood glucose with
lipoprotein profile in patients. The physiological response to acute exercise (ie, reduction of insulin secretion) is still presen
Pharmacology: Glimepiride is a blood sugar-lowering agent belonging to the sulfonylurea group. The decrease in blood sug
stimulation of insulin release from pancreatic -cells. This effect is predominantly based on improved responsiveness of the
stimulus. Glimepiride augments the normal action of insulin on peripheral glucose uptake. Moreover, it mimics such action
Good metabolic control over 24 hrs can be achieved with a single dose of Amaryl M.
In patients with insufficient response to the maximum dose, combined use with an additional oral antidiabetic containing m
metabolic control.
Metformin is a blood sugar-lowering agent belonging to the biguanide group. The decrease in blood sugar is achieved princ
Moreover, metformin is not metabolized in the liver; excretion is through urine and feces.
Pharmacology: Pharmacodynamics: Amlodipine is a calcium ion-influx inhibitor (slow channel blocker or calcium-ion antag
influx of calcium ions into cardiac and vascular smooth muscles.
The mechanism of the antihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle. T
amlodipine relieves angina has not been fully determined but amlodipine reduces the total ischemic burden by the followi
arterioles and thus, reduces the total peripheral resistance (afterload) against which the heart works. Since the heart rate r
reduces myocardial energy consumption and oxygen requirements.
The mechanism of action of amlodipine also probably involves dilatation of the main coronary arteries and coronary arterio
This dilatation increases myocardial oxygen delivery in patients with coronary artery spasm (prinzmetal's or variant angina)
In patients with hypertension, once a day dosing provides clinically significant reductions of blood pressure in both the sup
24-hr interval. Due to the slow onset of action, acute hypotension is not a feature of amlodipine administration.
In patients with angina, once a day administration of amlodipine increases total exercise time, time to angina onset and tim
decreases both angina attack frequency and nitroglycerine tablet consumption.
In vitro studies have shown that approximately 97.5% of circulating amlodipine is bound to plasma proteins. Amlodipine ha
metabolic effect or change in plasma lipids and is suitable for use in patients with asthma, diabetes and gout.
Pharmacokinetic studies with cyclosporin have demonstrated that amlodipine does not significantly alter the pharmacokin
Hemodynamic studies and exercise-based controlled clinical trial in NYHA Class II-IV heart failure patients have shown that
deterioration as measured by exercise tolerance, left ventricular ejection fraction (LVEF) and clinical symptomatology.
A placebo-controlled study (PRAISE) designed to evaluate patients with NYHA Class II-IV heart failure receiving digoxin, diur
(ACE) inhibitors has shown that amlodipine did not lead to an increase risk of mortality or combined mortality and morbidi
study, in a group of patients without clinical signs or symptoms suggestive of underlying ischemic disease, a clinically and st
and combined mortality and morbidity was observed with amlodipine.
Pharmacokinetics: Absorption: After oral administration of therapeutic doses, amlodipine is well absorbed with peak blood
Absolute bioavailability has been estimated to be between 64% and 80%. The volume of distribution is approximately 21 L/
by consumption of food.
Biotransformation/Elimination: The terminal plasma elimination half-life is about 35-50 hrs and is consistent with once-dail
reached after 7-8 days of consecutive dosing. Amlodipine is extensively metabolized by the liver to inactive metabolites wit
metabolites excreted in the urine.
Pharmacology: Aminoleban Infusion normalized the pattern of free amino acids in the plasma and brain, improved seroton
sleep-wakefulness pattern in a rat model of chronic hepatic insufficiency which underwent a portacaval shunt operation.
When infused to portacaval-shunted rats loaded with ammonia, Aminoleban Infusion improved EEG pattern, and corrected
evidenced by correction of the free amino acid pattern in the plasma and brain, and by suppression of an increase of the fa
Aminovel 600 is a well-balanced mixture of L-amino acids optimally proportioned for maximum protein synthesis.
Sorbitol, vitamins and electrolytes supplement nutritional needs for the body.
Aminovel 600 supplies the following essential components for parenteral nutrition:
L-Forms of amino acids which can only be utilized in the body for the synthesis of its various protein constituents. It is know
preserve nitrogen balance with D-isomers of amino acids.
Eight Essential Amino Acids: Isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan and valine are in
Semi-Essential Amino Acids: Histidine utilizes optimally amino acid mixtures and is essential for infants and in uraemia; argi
and is essential for detoxification.
L-Alanine and L-proline are necessary for optimal utilization of amino acid mixtures.
Glycine is a source for nonspecific nitrogen.
Sorbitol to supply sufficient non-nitrogen calories to meet metabolic energy requirements.
Vitamins to prevent deficiencies and to promote the biosynthesis of protein.
Minerals to maintain electrolyte balance and to promote protein synthesis.
Water to meet the body's requirements.
Aminovel 600 provides all these substances optimally and in exactly balanced proportions necessary to ensure maximum p
body's own reserves.
Amiparen is a new formula of total amino acid solution intended for use in hyperalimentation and general parenteral nutriti
Amiparen contains relatively larger amounts of branched-chain amino acids (leucine, isoleucine and valine), which suppres
synthesis in muscle tissue, and smaller amounts of aromatic and acidic amino acids. A series of preclinical and clinical studi
effective in sparing protein under various types of insults and malnutritional state.
Amiparen is also formulated to contain no chloride ions and minimum sodium ions to facilitate easy supplementation of ele
Pharmacology: The value of Amiparen as a source of amino acids in nutritional support was assessed in hyperalimentation
Amiparen promptly improved and maintained nitrogen balance, and exhibited a pronounced nitrogen-sparing effect in the
The solution promoted synthesis of plasma total protein and albumin.
The urinary 3-methylhistidine/creatinine ratio, an indicator of protein catabolism in the muscle under insult, was low after
inhibitory effect of the solution on muscle protein breakdown.
Plasma concentrations of free amino acids, including branched-chain amino acids, showed minor fluctuation during infusio
judged to be steady during Amiparen therapy.
Clinical Studies: Clinical studies of Amiparen were conducted in a total of 546 patients undergoing central or peripheral ven
These studies provided evidence of the high clinical value of Amiparen as a source of amino acids in terms of major protein
nitrogen balance, serum total protein and albumin levels, rapid protein turnover, and urinary 3-methylhistidine/creatinine r
Adverse Reactions and Abnormal Laboratory Values: In 546 treated patients, 17 cases of side effects were reported. Compl
and vomiting (0.4%). Abnormal laboratory tests showed an increase in SGOT and/or SGPT (0.7%), an increase in BUN (0.5%
Pharmacokinetics: 14C-amino acids formulated in Amiparen were readily taken up into plasma protein fractions after IV inf
age. The radioactivity was distributed in higher concentrations to protein fractions of the spleen, liver and kidneys, as well
Respiratory excretion accounted for 37.1-44.2% over 72 hrs post-infusion.
As other major routes of elimination, 3.9-5.2% and 1.2-3.1% of the radioactivity were recovered from the urine and feces, r
Amino acid fractions in the urine contained only 1.1-1.5% of the amino acids given. The overall retention of amino acids in
Toxicology: Acute Toxicity: LD50 values (IV, infusion rate: 4 mL/min): 107 mL/kg male rabbits, 120 mL/kg female rabbits.
Long-Term Toxicity Studies (Rabbits, IV, 13 and 26 Weeks): An antigenicity study and a local irritation study did not reveal an
symptoms.
Pharmacotherapeutic Group: Insulin and analogues, fast-acting. ATC Code: A10AB06.
Pharmacology: Pharmacodynamics: Insulin glulisine is a recombinant human insulin analogue that is equipotent to regular
rapid onset of action and a shorter duration of action than regular human insulin. The primary activity of insulins and insuli
glulisine, is regulation of glucose metabolism. Insulins lower blood glucose levels by stimulating peripheral glucose uptake,
inhibiting hepatic glucose production. Insulin inhibits lypolysis in the adipocyte, inhibits proteolysis and enhances protein s
Studies in healthy volunteers and patients with diabetes demonstrated that insulin glulisine is more rapid in onset of action
regular human insulin when given subcutaneously. When insulin glulisine is injected subcutaneously, the glucose-lowering
glucose-lowering activities of insulin glulisine and regular human insulin are equipotent when administered by IV route. On
glucose-lowering activity as one unit of regular human insulin.
A phase I study in patients with type 1 diabetes mellitus assessed the glucose-lowering profiles of insulin glulisine and regu
subcutaneously at a dose of 0.15 u/kg at different times in relation to a 15-min standard meal. Data indicated that insulin g
gives similar postprandial glycemic control compared to regular insulin given 30 min before the meal. When given 2 min pr
postprandial control than regular human insulin given 2 min before the meal. Insulin glulisine administered 15 min after sta
control as regular human insulin given 2 min before the meal.
Obesity: A phase I study carried out with insulin glulisine, lispro and regular human insulin in an obese population has dem
rapid-acting properties.
In this study, the time to 20% of total AUC and the AUC (0-2 hrs) representing the early glucose-lowering activity were 144
min and 354 mg/kg for lispro, 150 min and 197 mg/kg for regular human insulin.
Clinical Studies: Type 1 Diabetes Mellitus: In a 26-week, phase III clinical study comparing insulin glulisine with insulin lispro
min) before a meal in patients with type 1 diabetes mellitus using insulin glargine as basal insulin, insulin glulisine was com
as reflected by changes in glycated hemoglobin (expressed as HbA1c equivalent) from baseline to endpoint. Comparable se
observed. No increase in the basal insulin dose was needed with insulin glulisine, in contrast to insulin lispro.
A 12-week, phase III clinical study performed in patients with type 1 diabetes mellitus receiving insulin glargine as basal the
administration of insulin glulisine provides efficacy that was comparable to immediate premeal insulin glulisine (0-15 min) o
In the per-protocol population, there was a significantly larger observed reduction in GHb in the premeal glulisine group co
Type 2 Diabetes Mellitus: A 26-week, phase III clinical study followed by a 26-week extension safety study was conducted t
a meal) with regular human insulin (30-45 min before a meal) injected subcutaneously in patients with type 2 diabetes me
The average body mass index (BMI) of patients was 34.55 kg/m2.
Insulin glulisine was shown to be comparable to regular human insulin with regard to glycated hemoglobin (expressed as H
the 6-month endpoint (-0.46% for insulin glulisine and -0.3% for regular human insulin, p=0.0029) and from baseline to the
glulisine and -0.13% for regular human insulin, difference is not significant). In this study, the majority of patients (79%) mix
insulin immediately prior to injection and 58% of subjects used oral hypoglycemic agents at randomization and were instru
dose.
Race and Gender: In controlled clinical trials in adults, insulin glulisine did not show differences in safety and efficacy in sub
Pharmacokinetics: In insulin glulisine, the replacement of the human insulin amino acid, asparagine, in position B3 by lysin
acid favors more rapid absorption.
Absorption and Bioavailability: Pharmacokinetic profiles in healthy volunteers and diabetes patients (type 1 or 2) demonstr
about twice as fast with peak concentration approximately twice as high as compared to regular human insulin.
Pharmacotherapeutic Group: Angiotensin II receptor antagonist. ATC Code: C09CA04.
Pharmacology: Irbesartan is a potent, orally active, selective angiotensin II receptor (type AT1) antagonist.
Mechanism of Action: It is expected to block all actions of angiotensin II mediated by the AT1 receptor, regardless of the so
The selective antagonism of the angiotensin II (AT1) receptors results in increases in plasma renin levels and angiotensin II
concentration. Serum potassium levels are not significantly affected by irbesartan alone at the recommended doses. Irbesa
converting enzyme (ACE) (kininase II)], an enzyme which generates angiotensin II and also degrades bradykinin into inactive
metabolic activation for its activity.
Clinical Efficacy: Hypertension: Irbesartan lowers blood pressure with minimal change in heart rate. The decrease in blood
doses with a tendency towards plateau at doses >300 mg. Doses of 150-300 mg once daily lower supine or seated blood pr
an average of 8-13/5-8 mmHg (systolic/diastolic) greater than those associated with placebo.
Peak reduction of blood pressure is achieved within 3-6 hrs after administration and the blood pressure-lowering effect is m
reduction of blood pressure was 60-70% of the corresponding peak diastolic and systolic responses at the recommended d
produced trough and mean 24-hr responses similar to twice-daily dosing on the same total dose.
The blood pressure-lowering effect of Aprovel is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks
effects are maintained during long-term therapy. After withdrawal of therapy, blood pressure gradually returns toward base
observed.
The blood pressure-lowering effects of irbesartan and thiazide-type diuretics are additive. In patients not adequately contr
low dose of hydrochlorothiazide (12.5 mg) to irbesartan once daily results in a further placebo-adjusted blood pressure red
(systolic/diastolic).
The efficacy of Aprovel is not influenced by age or gender. As is the case with other drugs that affect the renin-angiotensin
notably less response to irbesartan monotherapy. When irbesartan is administered concomitantly with a low dose of hydro
antihypertensive response in Black patients approaches that of White patients.
There is no clinically important effect on serum uric acid or urinary uric acid secretion.
Hypertension and Type 2 Diabetes with Renal Disease: The "Irbesartan Diabetic Neuropathy Trial (IDNT)" shows that irbesa
disease in patients with chronic renal insufficiency and overt proteinuria. IDNT was a double-blind, controlled, morbidity an
amlodipine and placebo. In 1715 hypertensive patients with type 2 diabetes, proteinuria =900 mg/day and serum creatinin
effects (mean 2.6 years) of Aprovel on the progression of renal disease and all-cause mortality were examined. Patients we
dose of Aprovel 300 mg, from amlodipine 2.5 mg to 10 mg, or placebo as tolerated.
Patients in all treatment groups typically received between 2 and 4 antihypertensive agents (eg, diuretics, -blockers, a-blo
goal of =135/85 mmHg or a 10 mmHg reduction in systolic pressure if baseline was >160 mmHg. Sixty percent (60%) of pati
target blood pressure whereas this figure was 76% and 78% in the irbesartan and amlodipine groups respectively. Irbesarta
the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all-cause mortality. Appro
group reached the primary renal composite endpoint compared to 39% and 41% in the placebo and amlodipine groups [20
23% relative risk reduction compared to amlodipine (p=0.006)]. When the individual components of the primary endpoint
mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum cre
Subgroups consisting of gender, race, age, duration of diabetes, baseline blood pressure, serum creatinine and albumin exc
effect. In the female and Black subgroups which represented 32% and 26% of the overall study population respectively, a re
confidence intervals do not exclude it. As for the secondary endpoint of fatal and nonfatal cardiovascular events, there was
Pharmacotherepeutic Group: Antiasthenic drug.
Pharmacology: In Animals: Pharmacological studies carried out in animals, either with acute or chronic administration, hav
Sulbutiamine increases physical resistance to fatigue, neuromuscular efficiency and learning and memory; and improves th
cortex.
In Man: The activity of sulbutiamine has been studied in functional asthenia in the course of controlled clinical studies (aga
psychometric scales (Middlesex Hospital Questionnaire, Crocq Scale for the evaluation of nonpsychotic depressive conditio
statistical analysis of the results. These studies showed the activity of sulbutiamine in the symptomatic treatment of functio
Pharmacokinetics: Sulbutiamine is rapidly absorbed and the blood concentration is maximum in 1-2 hrs after oral administr
the whole organism and is eliminated with a biological half-life of 5 hrs.
The urinary excretion is maximal 2-3 hrs after administration.
Arcoxia (etoricoxib) is a member of a class of arthritis/analgesia medications called coxibs. It is a highly selective inhibitor o
Pharmacology: Mechanism of Action: Arcoxia is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammat
animal models. Arcoxia is a potent, orally active, highly selective COX-2 inhibitor within and above the clinical dose range. T
identified: Cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated norm
cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric dama
shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation and fever. Selective inhib
these clinical signs and symptoms with decreased GI toxicity and without effects on platelet function.
Across clinical pharmacology studies, Arcoxia produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at
The influence on gastroprotective COX-1 activity was also assessed in a clinical study where prostaglandin synthesis was me
subjects administered either Arcoxia 120 mg daily, naproxen 500 mg twice daily or placebo. Arcoxia did not inhibit gastric p
placebo. In contrast, naproxen inhibited gastric prostaglandin synthesis by approximately 80% compared with placebo. The
selectivity of Arcoxia.
Platelet Function: Multiple doses of Arcoxia up to 150 mg administered daily up to 9 days had no effect on bleeding time re
was not altered in a single-dose study with Arcoxia 250 or 500 mg. There was no inhibition of ex vivo arachidonic acid- or c
steady-state with doses of Arcoxia up to 150 mg. These findings are consistent with the COX-2 selectivity of etoricoxib.
Pharmacokinetics: Absorption: Orally administered etoricoxib is well absorbed. The mean oral bioavailability is approximate
dosing to steady-state, the peak plasma concentration (geometric mean Cmax = 3.6 mcg/mL) was observed at approximate
adults. The geometric mean AUC0-24hr was 37.8 mcghr/mL. The pharmacokinetics of etoricoxib are linear across the clini
In studies specifically designed to measure the onset of action of etoricoxib, the onset of action occurred as early as 29 min
A standard meal had no clinically meaningful effect on the extent or rate of absorption of a dose of etoricoxib 120 mg. In cl
without regards to food.
The pharmacokinetics of etoricoxib in 12 healthy subjects were similar (comparable AUC, Cmax within approximately 20%)
magnesium/aluminum hydroxide antacid or a calcium carbonate antacid (approximately 50 mEq acid-neutralizing capacity)
Distribution: Etoricoxib is approximately 92% bound to human plasma protein over the range of concentrations of 0.05-5 m
steady-state (Vdss) is approximately 120 L in humans.
Etoricoxib crosses the placenta in rats and rabbits and the blood-brain barrier in rats.
Metabolism: Etoricoxib is extensively metabolized with <1% of a dose recovered in urine as the parent drug. The major rou
hydroxymethyl derivative is catalyzed by cytochrome P-450 (CYP) enzymes.
Five metabolites have been identified in man. The principal metabolite is the 6'-carboxylic acid derivative of etoricoxib form
hydroxymethyl derivative. These principal metabolites either demonstrate no measurable activity or are only weakly active
metabolites inhibit COX-1.
Elimination: Following administration of a single 25-mg radiolabeled IV dose of etoricoxib to healthy subjects, 70% of radio
feces, mostly as metabolites. Less than 2% was recovered as unchanged drug.
Elimination of etoricoxib occurs almost exclusively through metabolism followed by renal excretion. Steady-state concentra
days of once-daily administration of 120 mg, with an accumulation ratio of approximately 2, corresponding to an accumula
clearance is estimated to be approximately 50 mL/min.
Characteristics in Patients (Special Populations): Gender: The pharmacokinetics of etoricoxib are similar between men and
Elderly:
ATC Code:Pharmacokinetics
C05CA in the elderly (=65 years) are similar to those in the young. No dosage adjustment is necessary fo
Pharmacotherapeutic Group: Enzyme inhibitors. ATC Code: L02BG03.
Pharmacology: Pharmacodynamics: Arimidex is a potent and highly selective nonsteroidal aromatase inhibitor. In postmen
primarily from the conversion of androstenedione to estrone through the aromatase enzyme complex in peripheral tissues
estradiol. Reducing circulating estradiol levels have been shown to produce a beneficial effect in women with breast cancer
In postmenopausal women, Arimidex at a daily dose of 1 mg produced estradiol suppression of >80% using a highly sensiti
Arimidex does not possess any progestogenic, androgenic or estrogenic activity.
Daily doses of Arimidex up to 10 mg do not have any effect on cortisol or aldosterone secretion, measured before or after s
(ACTH) challenge testing. Corticoid supplements are therefore, not needed.
Primary Adjuvant Treatment of Early Breast Cancer: In a large phase III study conducted in 9366 postmenopausal women w
years, Arimidex was shown to be statistically superior to tamoxifen in disease-free survival. A greater magnitude of benefit
favor of Arimidex versus tamoxifen for the prospectively defined hormone-receptor positive population.
Arimidex was statistically superior to tamoxifen in time to recurrence. The difference was of greater magnitude than in dise
treat (ITT) population and hormone-receptor positive population.
Arimidex was statistically superior to tamoxifen in terms of time to distant recurrence. There was also a numerical trend in
survival.
The incidence of contralateral breast cancer was statistically reduced for Arimidex compared to tamoxifen.
The overall survival benefit of tamoxifen was maintained with Arimidex. The additional analysis of time to death following r
favour of Arimidex compared to tamoxifen.
Overall, Arimidex was well tolerated. The following adverse events were reported regardless of causality. Patients receiving
vaginal bleeding, vaginal discharge, endometrial cancer, venous thromboembolic events and ischemic cerebrovascular even
tamoxifen. Patients receiving Arimidex had an increase in joint disorders (including arthritis, arthrosis and arthralgia) and fr
tamoxifen. A fracture rate of 22 per 1000 patient-years was observed on Arimidex and 15 per 1000 patient-years with the t
68 months. The fracture rate for Arimidex falls within the broad range of the fracture rates reported in an age-matched pos
The combination of Arimidex and tamoxifen did not demonstrate any efficacy benefits in comparison with tamoxifen in all
positive population. This treatment arm was discontinued from the study.
Adjuvant Treatment of Early Breast Cancer for Patients Being Treated with Adjuvant Tamoxifen: In a phase III trial (ABCSG 8
women with hormone-receptor positive early breast cancer being treated with adjuvant tamoxifen, patients had a superior
Arimidex compared with those continuing on tamoxifen.
Time to any recurrence, time to local or distant recurrence and time to distant recurrence confirmed a statistical advantage
disease-free survival. The incidence of contralateral breast cancer was very low in the 2 treatment arms, with a numerical a
similar for the 2 treatment groups.
Two further similar trials (GABG/ARNO 95 and ITA) with Arimidex, as well as a combined analysis of ABCSG 8 and GABG/AR
The Arimidex safety profile in these 3 studies was consistent with the known safety profile established in postmenopausal w
early breast cancer.
Pharmacokinetics: Absorption of anastrozole is rapid and maximum plasma concentrations typically occur within 2 hrs of d
is eliminated slowly with a plasma elimination half-life (t) of 40-50 hrs. Food slightly decreases the rate but not the extent
of absorption is not expected to result in a clinically significant effect on steady-state plasma concentrations during once-da
Approximately 90-95% of plasma anastrozole steady-state concentrations are attained after 7 daily doses. There is no evide
Pharmacotherapeutic Group: Antithrombotic agents. ATC Code: B01AX05.
Pharmacology: Mechanism of Action: Fondaparinux is a synthetic and selective inhibitor of activated Factor X (Xa). The anti
result of antithrombin III (ATIII) mediated selective inhibition of Factor Xa. By binding selectively to ATIII, fondaparinux pote
neutralization of Factor Xa by ATIII. Neutralization of Factor Xa interrupts the blood coagulation cascade and inhibits both t
development. Fondaparinux does not inactivate thrombin (activated Factor II) and has no known effects on platelet functio
Pharmacodynamics: At the 2.5-mg dose, Arixtra does not have a clinically relevant effect on routine coagulation tests eg, ac
activated clotting time (ACT) or prothrombin time (PT)/international normalised ratio (INR) tests in plasma, nor bleeding or
Fondaparinux does not cross-react with sera from patients with heparin-induced thrombocytopenia (HIT) type II.
Anti-Xa Activity: The pharmacodynamics/pharmacokinetics of fondaparinux are derived from fondaparinux plasma concen
Only fondaparinux can be used to calibrate the anti-Xa assay. The international standards of heparin or low molecular weig
this use. As a result, the concentration of fondaparinux is expressed as milligrams (mg) of the fondaparinux calibrator/L.
Clinical Studies: Prevention of Venous Thromboembolic Events (VTE) in Patients Undergoing Major Orthopaedic Surgery of
The clinical program included patients undergoing major orthopaedic surgery of the lower limbs eg, hip fracture, major kne
Arixtra 2.5 mg once daily started 6-8 hrs postoperatively was compared with enoxaparin 40 mg once daily started 12 hrs be
12-24 hrs after surgery. Both treatments were administered for 72 days.
In a pooled analysis of these studies, Arixtra was associated with a significant decrease in VTE compared to enoxaparin (6.8
the type of surgery performed. The majority of endpoint events consisted mainly of distal deep vein thrombosis (DVT), but
significantly reduced. The incidence of symptomatic VTE, including pulmonary embolism (PE) was not significantly different
In studies versus enoxaparin 40 mg once daily started 12 hrs before surgery, major bleeding was observed in 3.3% of Arixtr
dose, compared to 2.6% with enoxaparin. In patients treated with Arixtra according to the recommended regimen (6 hrs aft
2.8%. In studies versus enoxaparin 30 mg twice daily started 12-24 hrs after surgery, major bleeding was observed in 1.9% o
recommended dose, compared to 1.1% with enoxaparin.
Extended Prophylaxis: Prevention of VTE in Patients Undergoing Hip Fracture Surgery Treated for up to 24 Days Following a
treatment with Arixtra 2.5 mg for 71 day, hip fracture surgery patients were randomised to receive Arixtra 2.5 mg once da
Extended prophylaxis with Arixtra provided a significant reduction in the overall rate of VTE compared with placebo (1.4% v
significant reduction in the rate of symptomatic VTE (0.3% vs 2.7%, respectively). Major bleeding, all at surgical site and non
patients compared to 0.6% with placebo.
Prevention of VTE in Patients Undergoing Abdominal Surgery at Risk of Thromboembolic Events: Patients were randomised
or dalteparin 5000 IU once daily, with one 2500 IU preoperative injection and a first 2500 IU postoperative injection, for 7
Arixtra was non-inferior to dalteparin (VTE rates 4.6% vs 6.1%, respectively). The incidence of symptomatic VTE was similar
vs 0.3% on dalteparin).
In patients undergoing cancer surgery, representing the major subgroup of the clinical study (69% of the population), the V
7.7% in the dalteparin group.
Major bleeding was observed in 3.4% of the patients in the Arixtra group and in 2.4% of the dalteparin group. In patients tr
recommended regimen (6 hrs after surgery), the rate of major bleeding was 2.8%.
Prevention of VTE in Medical Patients: Acutely ill medical patients, aged =60 years and expected to require bed rest for at le
either Arixtra 2.5 mg once daily or placebo for 6-14 days. Arixtra significantly reduced the overall rate of VTE compared to p
majority of events were asymptomatic distal DVT. Arixtra also significantly reduced the rate of adjudicated fatal PE (0% vs 1
Sodium chloride salt regulates tissue and osmotic pressure.
Potassium and calcium chloride are salts which maintain electrolyte balance in the blood and tissue. Sodium acetate acts a
metabolized to bicarbonate.
Pharmacology: Pharmacodynamics: Atorvastatin calcium is a synthetic lipid-lowering agent, which is an inhibitor of 3-hydro
CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in choles
Mechanism of Action: Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme tha
coenzyme A to mevalonate, a precursor of sterols, including cholesterol. In patients with homozygous and heterozygous fam
forms of hypercholesterolemia, and mixed dyslipidemia, atorvastatin reduces total cholesterol (total-C), low-density lipopro
B (apo B). Atorvastatin also reduces very-low-density lipoprotein cholesterol (VLDL-C) and triglycerides (TG) and produces v
cholesterol (HDL-C). Triglycerides and cholesterol in the liver are incorporated into VLDL and released into the plasma for d
from VLDL and is catabolized primarily through the high affinity LDL receptor. Like LDL, cholesterolenriched triglycerideric
remnants can also promote artherosclerosis. Elevated plasma triglycerides are frequently found in a trial with low HDL-C le
association with non-lipid metabolic risk factors for coronary heart disease. As such total plasma TG has inconsistently been
for CHD. Furthermore, the independent effect of raising HDL or lowering TG on the risk of coronary and cardiovascular mor
determined.
Atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in
hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.
Atrovent is a quaternary ammonium compound with anticholinergic (parasympatholytic) properties. In preclinical studies, i
reflexes by antagonising the action of acetylcholine, the transmitter agent released from the vagus nerve. Anticholinergics
concentration of cyclic guanosine monophosphate (cyclic GMP) caused by interaction of acetylcholine with the muscarinic
The bronchodilation following inhalation of Atrovent is induced by a local drug concentration sufficient for anticholinergic e
not by systemic drug concentrations.
In controlled 90-day studies in patients with chronic obstructive pulmonary disease (chronic bronchitis and emphysema), s
function (FEV1 and FEF25-75% increases of =15%) occurred within 15 min, reached a peak in 1-2 hrs, and persisted in the m
Preclinical and clinical evidence suggest no deleterious effect of ipratropium bromide on airway mucous secretion, mucocil
The bronchodilator effect of ipratropium bromide in the treatment of acute bronchospasm associated with asthma has bee
>6 years. In most of these studies ipratropium bromide was administered in combination with an inhaled -agonist.
Data are limited to show that ipratropium bromide has a therapeutic effect in the treatment of bronchospasm associated w
bronchopulmonary dysplasia in infants and very small children.
Pharmacology: Amoxicillin-clavulanate (-lactam antibacterial penicillin co-formulated with a -lactamase inhibitor) is an a
spectrum of activity against the commonly occurring bacterial pathogens in general practice and hospital. The -lactamase
spectrum of amoxicillin to embrace a wider range of organisms, including many resistant to other -lactam antibiotics.
Pharmacodynamics: Mechanism of Action: Amoxicillin is a semisynthetic antibiotic with a broad spectrum of antibacterial a
gram-negative microorganisms. Amoxicillin is, however, susceptible to degradation by -lactamases and therefore the spec
not include organisms which produce these enzymes.
Clavulanic acid is a -lactam, structurally related to penicillins, which possesses the ability to inactivate a wide range of -la
microorganisms resistant to penicillins and cephalosporins. In particular, it has good activity against the clinically important
responsible for transferred drug resistance. It is generally less effective against chromosomally-mediated type 1 -lactamas
The presence of clavulanic acid in amoxicillin-clavulanate formulations protects amoxicillin from degradation by -lactamas
antibacterial spectrum of amoxicillin to include many bacteria normally resistant to amoxicillin and other penicillins and ce
possesses the distinctive properties of a broad-spectrum antibiotic and a -lactamase inhibitor.
Microbiology: Amoxicillin-clavulanate is bactericidal to a wide range of organisms including:
Gram-Positive: Aerobes: Bacillus anthracis*, Corynebacterium spp, Enterococcus faecalis*, Enterococcus faecium*, Listeria
coagulase-negative staphylococci* (Staphylococcus epidermidis*), Streptococcus agalactiae, Streptococcus pneumoniae, St
Streptococcus viridans*.
Gram-Positive: Anaerobes: Clostridium spp, Peptococcus spp, Peptostreptococcus spp.
Gram-Negative: Aerobes: Bordetella pertussis, Brucella spp, Escherichia coli*, Gardnerella vaginalis, Haemophilus influenza
Legionella spp, Moraxella catarrhalis* (Branhamella catarrhalis), Neisseria gonorrhoeae*, Neisseria meningitidis*, Pasteure
vulgaris*, Salmonella spp*, Shigella spp*, Vibrio cholerae, Yersinia enterolitica*.
Gram-Negative Anaerobes: Bacteroides spp* (including Bacteroides fragilis), Fusobacterium spp*.
Note: *Some members of these species produce -lactamase, rendering them insensitive to amoxicillin alone.
Pharmacokinetics: Absorption: The 2 components of amoxicillin-clavulanate, amoxicillin and clavulanic acid are fully dissoc
pH. Both components are rapidly and well absorbed by the oral route of administration. Absorption of amoxicillin-clavulana
the meal. Amoxicillin serum concentrations achieved with amoxicillin-clavulanate are similar to those produced by the oral
amoxicillin alone.
Distribution: Following IV administration, therapeutic concentrations of both amoxicillin and clavulanic acid may be detecte
Therapeutic concentrations of both drugs have been found in gallbladder, abdominal tissues, skin, fat and muscle tissues; fl
include synovial and peritoneal fluids, bile and pus.
Neither amoxicillin nor clavulanic acid is highly protein bound, studies show that about 25% for clavulanic acid and 18% for
bound to protein. From animal studies, there is no evidence to suggest that either component accumulates in any organ.
Amoxicillin, like most penicillins, can be detected in breast milk. Trace quantities of clavulanate can also be detected in brea
sensitization associated with this excretion, there are no known detrimental effects for the breastfed infant.
Reproduction studies in animals have shown that both amoxicillin and clavulanic acid penetrate the placental barrier. Howe
harm to the fetus was detected.
Metabolism: Amoxicillin is partly excreted in the urine as the inactive penicilloic acid in quantities equivalent to 10-25% of t
metabolized in man to 2,5-dihydro-4-(2-hydroxyethyl)-5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butan-2-o
carbon dioxide in expired air.
Pharmacology: Mechanism of Action: Fluticasone furoate is a synthetic trifluorinated corticosteroid that possesses a very h
and has a potent anti-inflammatory action.
Pharmacokinetics: Absorption: Fluticasone furoate undergoes extensive first-pass metabolism and incomplete absorption i
systemic exposure. The intranasal dosing of 110 mcg once daily does not typically result in measurable plasma concentratio
bioavailability for fluticasone furoate administered as 880 mcg 3 times daily (2640 mcg total daily dose) is 0.5%.
Distribution: The plasma protein-binding of fluticasone furoate is >99%. Fluticasone furoate is widely distributed with volum
average, 608 L.
Metabolism: Fluticasone furoate is rapidly cleared (total plasma clearance of 58.7 L/hr) from systemic circulation principally
carboxylic metabolite (GW694301X) by the cytochrome P-450 enzyme CYP3A4. The principal route of metabolism was hyd
function to form 17-carboxylic acid metabolite. In vivo studies have revealed no evidence of cleavage of the furoate moie
Elimination: Elimination was primarily via the fecal route following oral and IV administration indicative of excretion of fluti
bile. Following IV administration, the elimination phase half-life averaged 15.1 hrs. Urinary excretion accounted for approxi
administered dose, respectively.
Special Patient Populations: Elderly: Only a small number of elderly subjects (n=23/872; 2.6%) provided pharmacokinetic d
incidence of subjects with quantifiable fluticasone furoate concentrations in the elderly, when compared to younger subjec
Children: Fluticasone furoate is typically not quantifiable (<10 pg/mL) following intranasal dosing of 110 mcg once daily. Qu
pediatric patients following intranasal dosing of 110 mcg once daily and only <7% of pediatric patients following 55 mcg on
incidence of quantifiable levels of fluticasone furoate in younger children (<6 years).
Renal Impairment: Fluticasone furoate is not detectable in urine from healthy volunteers after intranasal dosing. Less than
urine and therefore renal impairment would not be expected to affect the pharmacokinetics of fluticasone furoate.
Hepatic Impairment: A study of a single 400-mcg dose of orally inhaled fluticasone furoate in patients with moderate hepa
(42%) and AUC(0-8) (172%) and a modest (on average 23%) decrease in cortisol levels in patients compared to healthy subj
exposure for intranasal fluticasone furoate 110 mcg in patients with moderate hepatic impairment would not be expected
Therefore, moderate hepatic impairment is not predicted to result in a clinically relevant effect for the normal adult dose. T
hepatic impairment. The exposure of fluticasone furoate is likely to be further increased in such patients.
Others: Fluticasone furoate is typically not quantifiable (<10 pg/mL) following intranasal dosing of 110 mcg once daily. Qua
of patients =12 years and in <16% of pediatric patients following intranasal dosing of 110 mcg once daily. There was no evid
or race to be related to those subjects with quantifiable levels, when compared to those without.
Clinical Studies: Adult and Adolescent Seasonal Allergic Rhinitis: Avamys nasal spray 110 mcg once daily resulted in a signifi
patient felt over the preceding 12 hrs) and instantaneous (how patient felt at the time of assessment) pre-dose total nasal
comprising rhinorrhea, nasal congestion, sneezing and nasal itching) and daily reflective and instantaneous total ocular sym
itching/burning, tearing/watering and redness of the eyes) versus placebo (see table). The improvement in nasal and ocula
hrs after once-daily administration. (See table.)
The distribution of the patients' perception of overall response to therapy (using a 7-point scale ranging from significantly i
Avamys nasal spray 110 mcg over placebo, with a statistically significant treatment difference. Onset of action was experien
administration in 2 studies. Significant improvement in symptoms was observed in the first 24 hrs in all 4 studies and contin
patients' quality of life (as assessed by the Rhinoconjunctivitis Quality of Life Questionnaire - RQLQ), was significantly impro
Pharmacology: Pharmacodynamics: Dutasteride is a dual inhibitor of 5a-reductase. It inhibits both type 1 and type 2, 5a-re
for the conversion of testosterone to 5a-dihydrotestosterone (DHT). DHT is the androgen primarily responsible for hyperpla
Effects on DHT/Testosterone: The maximum effect of daily doses of Avodart on the reduction of DHT is dose-dependent an
week and 2 weeks of daily dosing of Avodart 0.5 mg, median serum DHT concentrations were reduced by 85% and 90%, re
In benign prostatic hyperplasia (BPH) patients treated with 0.5 mg of dutasteride daily, the median decrease in DHT was 94
median increase in serum testosterone was 19% at both 1 and 2 years. This is an expected consequence of 5a-reductase in
adverse events.
Clinical Studies: Avodart Monotherapy: Dutasteride 0.5 mg/day or placebo was evaluated in 4325 male subjects with enlar
2-year multicenter, placebo-controlled, double-blind studies.
In men with BPH, Avodart treats and prevents disease progression by reducing the risk of both acute urinary retention (AU
and by providing statistically significant improvement of lower urinary tract symptoms (LUTS), maximum urinary flow rate (
placebo. These improvements in LUTS, Qmax and prostate volume were seen in the course of 24 months, and LUTS and Qm
years in open-label extension studies. In addition, reductions in prostate volume were sustained for a further 2 years in ope
Avodart and Tamsulosin Combination Therapy: Avodart 0.5 mg/day, tamsulosin 0.4 mg/day or the combination of Avodart
evaluated in 4844 male subjects with enlarged prostates =30 cc) in a multicenter, double blind, parallel group study over 2
years of treatment was the level of improvement from baseline in the international prostate symptom score (IPSS).
After 2 years of treatment, combination therapy showed a statistically significant adjusted mean improvement in symptom
adjusted mean improvements in symptom scores observed with the individual therapies were -4.9 units for Avodart and -4
improvement in flow rate from baseline was 2.4 mL/sec for the combination, 1.9 mL/sec for Avodart and 0.9 mL/sec for tam
in BPH Impact Index (BII) from baseline was -2.1 units for the combination, -1.7 for Avodart and -1.5 for tamsulosin.
The reduction in total prostate volume and transition zone volume after 2 years of treatment was statistically significant for
tamsulosin monotherapy alone.
The primary efficacy endpoint at 4 years of treatment was time to first event of AUR or BPH-related surgery. After 4 years o
statistically significantly reduced the risk of AUR or BPH-related surgery (65.8% reduction in risk p<0.001 [95% CI 54.7% to 7
monotherapy. The incidence of AUR or BPH-related surgery by Year 4 was 4.2% for combination therapy and 11.9% for tam
monotherapy, combination therapy reduced the risk of AUR or BPH-related surgery by 19.6%; the difference between treat
[95% CI -10.9% to 41.7%]). The incidence of AUR or BPH-related surgery by Year 4 was 4.2% for combination therapy and 5
Clinical progression was defined as a composite of worsening symptoms, (IPSS), and BPH-related events of AUR, incontinen
Combination therapy was associated with a statistically significantly lower rate of clinical progression compared with tamsu
CI: 33.6% to 53.0%]) after 4 years. The rates of clinical progression for combination therapy, tamsulosin, and Avodart were:
The statistically significant adjusted mean improvement in symptom scores (IPSS) from baseline was maintained from year
improvements in symptom scores observed were -6.3 units for combination therapy, -5.3 units for Avodart monotherapy a
After 4 years of treatment, the adjusted mean improvement in flow rate (Qmax) from baseline was 2.4 mL/sec for combina
monotherapy and 0.7 mL/sec for tamsulosin monotherapy. Compared with tamsulosin, the adjusted mean improvement fr
significantly greater with combination therapy at each 6-month assessment from Month 6 to Month 48 (p<0.001). Compar
improvement from baseline in Qmax was not statistically significantly different than with combination therapy (p=0.05 at M
Combination therapy was significantly superior (p<0.001) to tamsulosin monotherapy and to Avodart monotherapy for the
parameters BII and BPH-related Health Status (BHS) at 4 years. The adjusted mean improvement in BII from baseline was -2
Pharmacology: Mode of Action: Endometriosis and Menorrhagia: In woman of reproductive age, Azol suppresses the pituit
probably a combination of depressed hypothalamic-pituitary response to lowered estrogen production, the alteration of se
Azol with sex hormone receptors.
The only other demonstrable hormonal effect is weak androgenic activity and associated anabolic activity. No significant es
attributable to Azol has been found.
Azol depressed the output of both follicle-stimulating hormone (FSH) and luteinizing hormone (LH).
In the treatment of endometriosis, Azol alters the normal and ectopic endometrial tissue so that it becomes inactive and at
lesions occurs in the majority of cases.
Change in vaginal cytology and cervical mucus reflect the suppressive effect of Azol on the pituitary-ovarian axis.
The mechanism of action of Azol in the suppression of menstrual blood loss is not clear. However, Azol inhibits ovulation an
Whether endometrial proliferation is inhibited by reduced oestradiol levels or by a direct effect of Azol on endometrial oes
Generally, the pituitary suppressive action of Azol is reversible. When Azol treatment is discontinued, ovulation usually resu
by the major surge of luteinizing hormone (LH) and minor follicle stimulating hormone (FSH) surge that accompany ovulatio
Fibrocystic Breast Disease: Azol suppresses the ovulatory luteinizing surge, interferes with gonadal steroidogenesis (directly
gonadotrophin response to luteinizing hormone.
Clinical Experience: Endometriosis and Menorrhagia: Clinically, the action of Azol has been demonstrated by human pharm
sufficiently high daily dose, Azol therapy results in inhibition of ovulation, suppression of menses, regressive changes of the
endometrium.
Vaginal spotting or bleeding may occur in some patients during therapy with Azol; in cases where it has been examined, thi
endometrium.
Azol therapy has been successful in the treatment of endometriosis, relief of the common presenting symptoms of dysmen
resolution of ectopic endometrial implants and induration of the cul-de-sac has been obtained. Significant reversal of inferti
followed a course of Azol therapy.
Clinical studies have demonstrated the efficacy of Azol in the short-term management of menorrhagia. The reduction in blo
stopping treatment. Other benefits have been relief of dysmenorrhoea, failure to influence menstrual cycle length, reducti
steady improvement in haemoglobin values despite the absence of iron therapy.
Fibrocystic Breast Disease: Both placebo-controlled and open studies with Azol in treating severe fibrocystic breast disease
disease have shown Azol to produce partial to complete disappearance of nodularity and complete relief of pain and tende
effective in reducing breast cyst formation. Changes in the menstrual pattern may occur.
Pharmacology: Pharmacodynamics: Mupirocin is a novel antibiotic produced through fermentation by Pseudomonas fluore
RNA synthetase, thereby arresting bacterial protein synthesis. Due to this particular mode of action and its unique chemica
cross-resistance with other clinically available antibiotics. Mupirocin shows little risk of selection of bacterial resistance if u
bacteriostatic properties at minimum inhibitory concentrations and bactericidal properties at the higher concentrations rea
Pharmacokinetics: Systemic absorption of mupirocin through intact human skin is low although it may occur through broke
have shown that when given systemically, it is metabolised to the microbiologically inactive metabolite monic acid and rapi
eliminated from the body by metabolism to its inactive metabolite monic acid, which is rapidly excreted by the kidney.
Toxicology: Preclinical Safety Data: No further information of relevance.
Microbiology: Mupirocin is a topical antibacterial agent showing in vivo activity against Staphylococcus aureus (including m
and -hemolytic Streptococcus species.
The in vitro spectrum of activity includes the following bacteria: Aerobic Gram-Positive: Staphylococcus aureus (including
resistant strains); Staphylococcus epidermidis (including -lactamase-producing and methicillin-resistant strains); other coa
methicillin-resistant strains); Streptococcus species.
Aerobic Gram-Negative: Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis, Moraxella catarrhalis and
Microbiology: Mechanism of Action: Entecavir, a guanosine nucleoside analogue with activity against HBV polymerase, is e
triphosphate form, which has an intracellular half-life of 15 hrs. By competing with the natural substrate deoxyguanosine tr
functionally inhibits all three activities of the HBV polymerase [reverse transcriptase (RT)]: 1) Base priming. 2) Reverse trans
pregenomic messenger RNA. 3) Synthesis of the positive strand of HBV DNA. Entecavir triphosphate is a weak inhibitor of c
mitochondrial DNA polymerase ? with Ki values ranging from 18 to >160 mcM.
Antiviral Activity: Entecavir inhibited HBV DNA synthesis [50% reduction, maximum effective concentration (EC50)] at a con
cells transfected with wild-type HBV. The median EC50 value for entecavir against lamivudine-resistant HBV (rtL180M, rtM2
mcM).
The co-administration of human immunodeficiency virus (HIV) nucleoside reverse transcriptase inhibitors (NRTIs) with Bara
efficacy of Baraclude against HBV or of any of these agents against HIV. In HBV combination assays in cell culture, abacavir,
tenofovir or zidovudine were not antagonistic to the anti-HBV activity of entecavir over a wide range of concentrations. In H
antagonistic to the cell culture anti-HIV activity of these 6 NRTIs at >4 times the peak plasma drug concentration (Cmax) of
Antiviral Activity Against Human Immunodeficiency Virus (HIV): A comprehensive analysis of the inhibitory activity of entec
clinical human immunodeficiency virus type 1 (HIV-1) isolates using a variety of cells and assay conditions yielded EC50 valu
EC50 values were observed when decreased levels of virus were used in the assay. In cell culture, entecavir selected for an
transcriptase at micromolar concentrations, confirming inhibitory pressure at high entecavir concentrations. HIV variants co
loss of susceptibility to entecavir.
Resistance: In Cell Culture: In cell-based assays, 8- to 30-fold reductions in entecavir phenotypic susceptibility were observe
reductions (>70-fold) in entecavir phenotypic susceptibility required the presence of amino acid substitutions rtM204I/V an
substitutions at residues rtT184, rtS202 or rtM250, or a combination of these substitutions with or without an rtI169 substi
Clinical Studies: All patients in clinical trials initially treated with entecavir 0.5 mg (nucleoside-naive, studies AI463022, AI46
(lamivudine-refractory, studies AI463026, AI463014, AI463015 and rollover study AI463901) and with an on-therapy PCR H
were monitored for resistance.
Nucleoside-Naive Subjects: Genotypic evidence of entecavir resistance-associated (ETVr) substitutions at rtT184, rtS202 an
patients treated with entecavir for up to 144 weeks in nucleoside-naive studies (Table 1). These substitutions were observe
resistance-associated (LVDr) substitutions (rtM204V and rtL180M) (see Table 1).
Lamivudine-Refractory Subjects: ETVr substitutions were observed at baseline in isolates from 10/187 (5%) lamivudine-refr
monitored for resistance, indicating that prior lamivudine treatment can select these resistance substitutions and that they
entecavir treatment. Through week 144, 3 of the 10 patients experienced virologic rebound (=1 log10 increase above nadir
lamivudine-refractory studies through week 144 is summarized in Table 2. (See Table 2.)
Cross-Resistance: Cross-resistance has been observed among HBV nucleoside analogues. In cell-based assays, entecavir had
synthesis for HBV containing lamivudine and telbivudine resistance substitutions rtM204I/V rtL180M than for wild-type H
rtL80I/V or rtV173L, which are associated with lamivudine and telbivudine resistance, also confer decreased phenotypic su
genomes encoding adefovir resistance-associated substitutions at either rtN236T or rtA181V had 0.3- and 1.1-fold shifts in
respectively. The efficacy of entecavir against HBV harboring adefovir resistance-associated substitutions has not been esta
lamivudine-refractory subjects failing entecavir therapy were susceptible in cell culture to adefovir but remained to lamivud
Trials with treatment duration of up to 3 months involving adult asthmatics and chronic obstructive pulmonary disease (CO
which the hydrofluroalkane (HFA) formulation and the chlorofluorocarbon (CFC) formulation have been compared, have sh
therapeutically equivalent.
Berodual contains 2 active bronchodilating ingredients: Ipratropium bromide, exhibiting an anticholinergic effect and fenot
Ipratropium bromide: Quaternary ammonium compound with anticholinergic (parasympatholytic) properties. In preclinical
by antagonizing the action of acetylcholine, the transmitter agent released from the vagus nerve. Anticholinergics prevent
Ca++ caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle, Ca++ release is med
consisting of IP3 (inositol triphosphate) and DAG (diacylglycerol).
The bronchodilatation following inhalation of ipatropium bromide is primarily a local, site-specific effect, not a systemic on
Preclinical and clinical evidence suggest no deleterious effect of ipratropium bromide on airway mucous secretion, mucocil
Fenoterol hydrobromide: Direct-acting sympathomimetic agent, selectively stimulating 2-receptors in the therapeutic dos
comes into effect at a higher dose range (eg, as administered in tocolysis). Occupation of 2-receptors activates adenyl cycl
increase in cyclic AMP activates protein kinase A which then phosphorylates target proteins in smooth muscle cells. This in
light chain kinase, inhibition of phosphoinositide hydrolysis, and the opening of large-conductance calcium-activated potas
Fenoterol hydrobromide relaxes bronchial and vascular smooth muscle and protects against bronchoconstricting stimuli eg
allergen (early response). After acute administration, the release of bronchoconstricting and pro-inflammatory mediators f
increase in mucociliary clearance has been demonstrated after administration of doses of fenoterol (0.6 mg).
Higher plasma concentrations, which are more frequently achieved with oral, or even more so, with IV administration, inhib
metabolic effects are observed: Lipolysis, glycogenolysis, hyperglycemia and hypokalemia, the latter caused by increased K+
Beta-adrenergic effects on the heart eg, increased heart rate and contractility are caused by the vascular effects of fenotero
supratherapeutic doses, by 1-receptor stimulation. As with other -adrenergic agents, QT prolongations have been report
and observed at doses higher than recommended. However, systemic exposure after administration with nebulisers (UDVs,
than with recommended metered dose inhalers (MDI) doses. The clinical significance has not been established. Tremor is a
agonists. Unlike the effects on the bronchial smooth muscle, the systemic effects of -agonists are subject to the developm
Concurrent use of these 2 active ingredients dilates the bronchi by affecting different pharmacological sites of action. The 2
other in their spasmolytic action on the bronchial muscles and allow a broad therapeutic use in the field of bronchopulmon
of the respiratory tract. The complementary action is such that only a very low proportion of the -adrenergic component i
facilitating individual dosage suited to each patient with a minimum of adverse reactions.
In patients with asthma and with chronic obstructive pulmonary disease (COPD), better efficacy compared to its componen
demonstrated. Two studies (1 with asthma patients, 1 with COPD patients) have shown that Berodual is as efficacious as do
without ipratropium but was better tolerated in cumulative dose response studies.
In acute bronchoconstriction, Berodual is effective shortly after administration and is, therefore, also suitable for treating a
Pharmacology: Berotec is an effective bronchodilator for use in acute asthma and in other conditions with reversible airway
bronchitis with or without pulmonary emphysema. After oral administration, Berotec acts within a few mins with a duratio
Following inhalation of fenoterol hydrobromide in obstructive lung diseases, bronchodilatation occurs within a few minutes
Trials with a treatment duration of up to 3 months involving adult asthmatics and chronic obstructive pulmonary disease (C
which the HFA formulation and the CFC formulation have been compared have shown the 2 formulations to be therapeutic
Fenoterol HBr is a direct-acting sympathomimetic agent, selectively stimulating 2-receptors in the therapeutic dose range
effect at a higher dose range (eg, as administered in tocolysis). Occupation of 2-receptors activates adenyl cyclase via a sti
AMP activates protein kinase A which then phosphorylates target proteins in smooth muscle cells. This in turn leads to the
kinase, inhibition of phosphoinositide hydrolysis and the opening of large-conductance calcium-activated potassium chann
K channel" can be directly activated via the Gs-protein.
Fenoterol relaxes bronchial and vascular smooth muscle and protects against bronchoconstricting stimuli eg, histamine, me
response).
After acute administration, the release of bronchoconstricting and pro-inflammatory mediators from mast cells is inhibited
clearance has been demonstrated after administration of doses of fenoterol (0.6 mg).
Higher plasma concentrations, which are more frequently achieved with oral, or even more so with IV administration, inhib
metabolic effects are observed: Lipolysis, glycogenolysis, hyperglycaemia and hypokalaemia, the latter caused by increased
Beta-adrenergic effects on the heart eg, increase in heart rate and contractility, are caused by the vascular effects of fenote
supratherapeutic doses, by 1-receptor stimulation. As with other -adrenergic agents, QTc prolongation has been reporte
discrete and observed at doses higher than recommended. However, systemic exposure after adminstration with nebuliser
higher than with recommended MDI doses (see Dosage & Administration). The clinical significance has not been establishe
effect of -agonists. Unlike the effects on the bronchial smooth muscle, the systemic effects on skeletal muscle of -agonist
tolerance.
In clinical studies, fenoterol was shown to be highly efficacious in manifest bronchospasm. It prevents bronchoconstriction
exercise cold air and the early response following allergen exposure.
Pharmacotherapeutic Group: Anti-vertigo preparations. ATC Code: N07CA01.
Pharmacology: Pharmacodynamics: The mechanism of action of betahistine is partly known.
In biochemical studies, betahistine was found to have weak H1 receptor agonistic and potent H3 antagonistic properties in
Pharmacological testing in animals has shown that the blood circulation in the striae vascularis of the inner ear improves, p
precapillary sphincters of the microcirculation of the inner ear.
Betahistine was also found to have a dose dependent inhibiting effect on spike generation of neurons in lateral and medial
Betahistine accelerates the vestibular recovery after unilateral neurectomy, by promoting and facilitating central vestibular
characterized by an up-regulation of histamine turnover and release, is mediated through the H3 receptor antagonism.
Taken together, these properties contribute to the beneficial therapeutic effects of betahistine in Meniere's disease and ve
Betahistine increases histamine turnover and release by blocking presynaptic H3-receptors and inducing H3-receptor down
system provides explanation for the efficacy of betahistine in the treatment of vertigo and vestibular diseases.
Pharmacokinetics: Orally administered betahistine is readily and almost completely absorbed from all parts of the gastroint
rapidly and almost completely metabolized into 2-PAA (which has no pharmacological activity). Plasma levels of betahistine
of 100 pg/ml). All pharmacokinetic analyses are therefore based on 2-PAA measurements in plasma and urine.
The plasma concentration of 2-PAA reaches its maximum 1 hour after intake. The half-life of approximately 3.5 hours. 2-PA
range between 8 and 48 mg, about 85% of the original dose is recovered in the urine. Renal or fecal excretion of betahistin
rates are constant over the oral dose range of 8-48 mg indicating that the pharmacokinetics of betahistine are linear, and su
pathway is not saturated. Under fed conditions, Cmax is lower compared to fasted conditions. However, total absorption of
conditions, indicating that food intake only slows down the absorption of betahistine.
Toxicology: Preclinical Safety Data: Oral dosing up to and above 250 mg/kg in dogs and in rats, respectively, of betahistine d
months did not result in adverse effects. Side effects in the nervous system were seen in dogs and baboons after intraveno
was observed at 300 mg/kg and 120 mg/kg following oral and IV dosing, respectively, in dogs and sporadically in baboons.
Betahistine has not shown any mutagenic effect.
Pharmacotherapeutic Group: ACE inhibitor, plain. ATC Code: C09AA04.
Pharmacology: Pharmacodynamics: Perindopril is an inhibitor of the enzyme that converts angiotensin I into angiotensin II
converting enzyme, or kinase, is an exopeptidase that allows conversion of angiotensin I into the vasoconstrictor angiotens
the vasodilator bradykinin into an inactive heptapeptide. Inhibition of ACE results in a reduction of angiotensin II in the pla
activity (by inhibition of the negative feedback of renin release) and reduced secretion of aldosterone. Since ACE inactivate
an increased activity of circulating and local kallikrein-kinin systems (and thus also activation of the prostaglandin system).
contributes to the blood pressure-lowering action of ACE inhibitors and is partially responsible for certain of their side effec
Perindopril acts through its active metabolite, perindoprilat. The other metabolites show no inhibition of ACE activity in vit
Hypertension: Perindopril is active in all grades of hypertension: Mild, moderate, severe; a reduction in systolic and diastoli
standing positions is observed.
Perindopril reduces peripheral vascular resistance, leading to blood pressure reduction. As a consequence, peripheral bloo
rate. Renal blood flow increases as a rule, while the glomerular filtration rate (GFR) is usually unchanged. The antihyperten
after a single dose and is sustained for at least 24 hrs: Trough effects are about 87-100% of peak effects.
The decrease in blood pressure occurs rapidly. In responding patients, normalisation is achieved within a month and persis
Discontinuation of treatment does not lead to a rebound effect.
Perindopril reduces left ventricular hypertrophy.
In man, perindopril has been confirmed to demonstrate vasodilatory properties. It improves large artery elasticity and decr
arteries.
An adjunctive therapy with a thiazide-diuretic produces an additive-type of synergy. The combination of an ACE inhibitor an
hypokalaemia induced by the diuretic treatment.
Heart Failure: Perindopril reduces cardiac work by a decrease in pre- and afterload. Studies in patients with heart failure ha
ventricular filling pressures, reduced total peripheral vascular resistance, increased cardiac output and improved cardiac in
In comparative studies, the 1st administration of perindopril arginine 2.5 mg to patients with mild to moderate heart failure
reduction of blood pressure as compared to placebo.
Patients with Stable Coronary Artery Disease: The EUROPA trial was a multicentre, international, randomised, double-blind
years.
Twelve thousand two hundred and eighteen (12,218) patients >18 years were randomised to perindopril tert-butylamine 8
mg) (n=6110) or placebo (n=6108).
The trial population had evidence of coronary artery disease with no evidence of clinical signs of heart failure. Overall, 90%
infarction and/or a previous coronary revascularisation. Most of the patients received the study medication on top of conve
inhibitors, lipid-lowering agents and -blockers.
The main efficacy criterion was the composite of cardiovascular mortality, nonfatal myocardial infarction and/or cardiac arr
treatment with perindopril tert-butylamine 8 mg (equivalent to perindopril arginine 10 mg) once daily resulted in a significa
endpoint of 1.9% [relative risk reduction (RRR) of 20%, 95% CI (9.4; 28.6); p<0.001].
In patients with a history of myocardial infarction and/or revascularisation, an absolute reduction of 2.2% corresponding to
p<0.001] in the primary endpoint was observed by comparison to placebo.
Pharmacokinetics: After oral administration, the absorption of perindopril is rapid and the peak concentration is achieved w
perindopril is equal to 1 hr.
Pharmacotherapeutic Group: Perindopril and diuretics. ATC Code: C09BA04.
Pharmacology: Mechanism of Action: Bioprexum Plus produces an additive synergy of the antihypertensive effects of the t
Pharmacodynamics: Bioprexum Plus is a combination of perindopril arginine salt, an ACE inhibitor and indapamide, a chlor
properties are derived from those of each of the components taken separately, in addition to those due to the additive syn
combined.
Perindopril: Perindopril is an angiotensin-converting enzyme (ACE) inhibitor which converts angiotensin I to angiotensin II,
the enzyme stimulates the secretion of aldosterone by the adrenal cortex and the degradation of bradykinin, a vasodilatory
This results in a reduction in aldosterone secretion; an increase in plasma renin activity, since aldosterone no longer exercis
total peripheral resistance with a preferential action on the vascular bed in muscle and the kidney, with no accompanying s
tachycardia, with chronic treatment.
The antihypertensive action of perindopril also occurs in patients with low or normal renin concentrations.
Perindopril acts through its active metabolite, perindoprilat. The other metabolites are inactive.
Perindopril reduces the work of the heart by a vasodilatory effect on veins, probably caused by changes in the metabolism
reduction in preload; by reduction of the total peripheral resistance, therefore having a reduction in afterload.
Studies carried out on patients with cardiac insufficiency have shown a reduction in left and right ventricular filling pressure
an increase in cardiac output and regional blood flow in muscle and an improvement in the cardiac index. Exercise test resu
Indapamide: Indapamide is a sulphonamide derivative with an indole ring, pharmacologically related to the thiazide group
reabsorption of sodium in the cortical dilution segment. It increases the urinary excretion of sodium and chlorides and to a
and magnesium, thereby increasing urine output and having an antihypertensive action.
Characteristics of Antihypertensive Action: Bioprexum Plus: In hypertensive patients regardless of age, Bioprexum Plus exer
effect on diastolic and systolic arterial pressure whilst supine or standing. This antihypertensive effect lasts for 24 hrs. The r
month without tachyphylaxis; stopping treatment has no rebound effect. During clinical trials, the concomitant administrati
produced antihypertensive effects of a synergistic nature in relation to each of the products administered alone.
PICXEL, a multicenter, randomised, double-blind active controlled study has assessed on echocardiography the effect of pe
ventricular hypertrophy (LVH) versus enalapril monotherapy.
In PICXEL, hypertensive patients with LVH, defined as left ventricular mass index (LVMI) >120 g/m2 in male and >100 g/m2
perindopril tert-butylamine 2 mg (equivalent to perindopril arginine 2.5 mg)/indapamide 0.625 mg or to enalapril 10 mg on
was adapted according to blood pressure control, up to perindopril tert-butylamine 8 mg (equivalent to perindopril arginin
enalapril 40 mg once a day. Only 34% of the subjects remained treated with perindopril tert-butylamine 2 mg (equivalent t
0.625 mg (versus 20% with enalapril 10 mg).
At the end of treatment, LVMI had decreased significantly more in the perindopril/indapamide group (-10.1 g/m2) than in t
randomised patients population. The between group difference in LVMI change was -8.3 [95% CI (-11.5, -5), p<0.0001].
A better effect on LVMI was reached with higher perindopril/indapamide doses than those licensed for Bioprexum Plus.
Regarding blood pressure, the estimated mean between group differences in the randomised population were -5.8 mm Hg
blood pressure and -2.3 mm Hg [95% CI (-3.6, -0.9), p=0.0004] for diastolic blood pressure respectively, in favor of the perin
Perindopril: Perindopril is active in all grades of hypertension, from mild to moderate or severe. A reduction in systolic and
lying and standing position.
The antihypertensive activity after a single dose is maximal between 4 and 6 hrs and is maintained over 24 hrs.
Pharmacology: Angiotensin II is the primary vasoactive hormone of the renin-angiotensin-aldosterone system and plays a s
hypertension, heart failure and other cardiovascular disorders. It is also has an important role in the pathogenesis of end o
The major physiological effects of angiotensin II, such as vasoconstriction, aldosterone stimulation, regulation of salt and w
growth, are mediated via the type I (AT1) receptor.
Blopress is a prodrug suitable for oral use. It is rapidly converted to the active drug, candesartan, by ester hydrolysis during
Blopress is an angiotensin II receptor antagonist, selective for AT1 receptor, with tight binding to and slow dissociation from
Candesartan does not inhibit ACE, which convert angiotensin I to angiotensin II and degrades bradykinin. There is no effect
or substance P. In controlled clinical trials comparing Blopress with ACE-inhibitor, the incidence of cough was lower in patie
not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Hypertension: In hypertension, Blopress causes a dose-dependent, long lasting reduction in arterial blood pressure. The an
systemic peripheral resistance, while heart rate, stroke volume and cardiac output are not affected. There is no indication o
or rebound effect after cessation of treatment.
Blopress is effective in all grades of hypertension.
After administration of a single dose. Onset of antihypertensive effect generally occurs within 2 hours. With continuous tre
pressure with any dose generally attained within 4 weeks and is sustained during long-term treatment. It provides effective
the 24-hr with little difference between maximum and trough effects during the dosing interval.
When Blopress is used together with hydrochlorothiazide, the reduction in blood pressure is additive. Blopress is similarly e
gender.
Blopress increases renal blood flow and either has no effect on, or increases glomerular filtration rate while renal vascular r
reduced. Blopress has no adverse effect on blood glucose or lipid profile.
Heart Failure: Treatment with candesartan cilexetil reduces mortality, reduces hospitalization due to heart failure and impr
ventricular systolic dysfunction as shown in the Candesartan in Heart Failure - Assessment of Reduction in Mortality and M
This multinational, placebo controlled, double-blind study programme in chronic heart failure (CHF) patients with NYHA fun
separate studies: CHARM-Alternative (n=2,028) in patients with LVEF =40% not treated with an ACE inhibitor because of int
CHARM-Added (n=2,548) in patients with LVEF =40% and treated with an ACE inhibitor, and CHARM-Preserved (n=3,023) in
optimal CHF therapy at baseline were randomised to placebo or candesartan cilexetil (titrated from 4 mg or 8 mg once dail
tolerated dose, mean dose 24 mg) and followed for a median of 37.7 months. After 6 months of treatment, 63% of the pati
were at the target dose of 32 mg.
In CHARM-Alternative, the composite endpoint of cardiovascular mortality or first CHF hospitalisation was significantly redu
placebo [hazard ratio (HR) 0.77, 95% CI 0.67-0.89, p <0.001]. This corresponds to a relative risk reduction of 23%. Fourteen
duration of the study to prevent one patient from dying of a cardiovascular event or being hospitalised for treatment of he
cause mortality or first CHF hospitalisation was also significantly reduced with candesartan (HR 0.80, 95% CI 0.70-0.92, p=0
(CHF hospitalisation) components of these composite endpoints contributed to the favourable effects of candesartan. Trea
improved NYHA functional class (p=0.008).
In CHARM-Added, the composite endpoint of cardiovascular mortality or first CHF hospitalisation was significantly reduced
placebo (HR 0.85, 95% CI 0.75-0.96, p=0.011). This corresponds to a relative risk reduction of 15%. Twenty-three patients n
study to prevent one patient from dying of a cardiovascular event or being hospitalised for treatment of heart failure. The c
first CHF hospitalisation was also significantly reduced with candesartan (HR 0.87, 95% CI 0.78-0.98, p=0.021). Both the mo
Pharmacology: Blopress Plus contains candesartan cilexetil, an angiotensin II antagonist and hydrochlorothiazide, a diuretic
Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Ang
the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone
reabsorption of sodium. Candesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selec
to the AT1 receptor in many tissues such as vascular smooth muscle and the adrenal gland. Its action is therefore, independ
synthesis.
There is also an AT2 receptor found in many tissues, but AT2 is not known to be associated with cardiovascular homeostasi
(>10,000-fold) for the AT1 receptor than for the AT2 receptor.
Blockade of the renin-angiotensin system with ACE inhibitor, which inhibits the biosynthesis of angiotensin II from angioten
hypertension. ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalysed by ACE. Because candesar
not affect the response of bradykinin. Whether this difference has clinical relevancies not yet known. Candesartan does no
or ion channels known to be important in cardiovascular regulation.
Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but th
and angiotensin II circulating levels do not overcome the effect of candesartan on blood pressure.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanism's electrolyte reabsorption, directly
in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with co
increases in aldosterone secretion, increases in urinary potassium loss and decreases in serum potassium. The renin-aldost
therefore co-administration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with the
The mechanism of the antihypertensive effects of thiazides is unknown.
Antihemorrhoidal.
It alleviates inflammation, itching, edema, pain and allergic symptoms, and promotes healing.
Borraginol-N has prompt antiphlogistic, analgesic, antiseptic, antipruritic and hemostatic actions on hemorrhoids, hemorrh
accelerates the formation of granulation and epithelium of ulcerated wounds.
Antihemorrhoidal.
Borraginol-S is a therapeutic agent for hemorrhoids. It alleviates inflammation, itching, edema, pain and allergic symptoms
Borraginol-S has prompt antiphlogistic, analgesic, antiseptic, antipruritic and hemostatic actions on hemorrhoids, hemorrh
the formation of granulation and epithelium of ulcerated wounds.
Pharmacotherapeutic Group: Selective 2-agonist, terbutaline. ATC Code: R03C C03.
Pharmacology: Pharmacodynamics: Terbutaline is a sympathomimetic bronchodilator with a degree of selective 2-stimula
Terbutaline is an adrenergic agonist which predominantly stimulates 2-receptors, thus, producing relaxation of bronchial s
endogenous spasmogens, inhibition of edema caused by endogenous mediators and increased mucociliary clearance.
Injection: After SC injection of terbutaline the duration of onset regarding the bronchodilating effect is <5 minutes. Maximu
Respules: Inhaled terbutaline acts within a few min and has a duration for up to 6 hours. Bricasma respules is to be used in
breathing in acute or subacute disorders where conventional inhalers prove unsatisfactory, and in maintenance therapy in
Bricasma respules is ready for use without dilution. Bricasma respules is isotonic and contains no preservatives.
Turbuhaler: Inhaled terbutaline acts within a few min and has a duration for up to 6 hours.
About 10% of the dose is deposited in the lungs. Terbutaline is metabolized mainly by conjugation with the sulphuric acid a
active metabolites are formed. BRICASMA TURBUHALER contains pure terbutaline sulphate and is free from propellants lub
other additives.
BRICASMA TURBUHALER is breath actuated and hence, there is no need to coordinate the release of the dose and the inha
inhaling, the substance follows the inspired air into the airways.
Pharmacokinetics: Terbutaline is metabolized mainly by conjugation with the sulphuric acid and excreted as the sulphate co
Injection: The plasma half-life is about 16 hours. After IV and SC administration of terbutaline 90% is excreted renally durin
of unmetabolized terbutaline.
Turbuhaler: About 20-30% of the metered dose is deposited in the lungs at a normal inhalation flow rate.
Toxicology: Preclinical Safety Data: Ampoule: The major toxic effect of terbutaline, observed in toxicological studies, is focal
cardiotoxicity is a well-known class effect and the effect of terbutaline is similar to or less pronounced than that of other -
used extensively over many years for the relief of bronchospasm without identifying any areas of concern.
Pharmacology: Mechanism of Action: Ticagrelor and its major metabolite reversibly interact with the platelet P2Y12 ADP-re
platelet activation. Ticagrelor and its active metabolite are approximately equipotent.
Pharmacodynamics: The inhibition of platelet aggregation (IPA) by ticagrelor and clopidogrel was compared in a 6 week stu
platelet inhibition effects in response to adenosine diphosphate (ADP) 20 micromolar as the platelet aggregation agonist.
The onset of IPA was evaluated on day 1 of the study following loading doses of ticagrelor 180 mg or clopidogrel 600 mg. A
ticagrelor group at all time points. The maximum IPA effect of ticagrelor was reached at around 2 hrs and was maintained f
The offset of IPA was examined after 6 weeks on ticagrelor 90 mg twice daily or clopidogrel 75 mg daily, again in response t
As shown in Figure 2, mean maximum IPA following the last dose of ticagrelor was 88% and 62% for clopidogrel. The insert
the ticagrelor group (58%) was similar to IPA in clopidogrel group (52%), indicating that patients who miss a dose of ticagre
trough IPA of patients treated with clopidogrel. After 5 days, IPA in the ticagrelor group was similar to IPA in the placebo gro
or thrombotic risk track with IPA, for either ticagrelor or clopidogrel. (See Figures 1 and 2.)
Transitioning from clopidogrel to BRILINTA resulted in an absolute IPA increase of 26.4% and from BRILINTA to clopidogrel r
24.5%. Patients can be transitioned from clopidogrel to BRILINTA without interruption of antiplatelet effect (see Dosage & A
Clinical Studies: The clinical evidence for the effectiveness of BRILINTA is derived from PLATO, a randomized double-blind st
clopidogrel (N=9,291), both given in combination with aspirin and other standard therapy, in patients with acute coronary s
at least 6 months and for up to 12 months. Study endpoints were obtained until the study was complete, even if drug was d
Patients who presented within 24 hours of onset of the most recent episode of chest pain or symptoms were randomized t
who had already been treated with clopidogrel could be enrolled and randomized to either study treatment. Patients could
manage the ACS medically or invasively, but patient randomization was not stratified by this intent. Subjects in the clopidog
dose of clopidogrel 300 mg, if previous clopidogrel therapy had not been given prior to randomization. Patients undergoing
300 mg at investigator discretion. All subjects randomized to BRILINTA received a loading dose of 180 mg followed by a ma
Concomitant aspirin was recommended at a loading dose of 160-500 mg. A daily maintenance dose of aspirin 75-100 mg w
doses of aspirin were allowed according to local judgment.
Because of ticagrelor's metabolism by CYP3A enzymes, the protocol recommended limiting the maximum dosage of simvas
arms. Because of an increased bleeding risk, the study excluded patients with previous intracranial hemorrhage, a gastroint
other factors that predispose to bleeding.
PLATO patients were predominantly male (72%) and Caucasian (92%). About 43% of patients were >65 years and 15% were
The study's primary endpoint was the composite of 1st occurrence of cardiovascular death, nonfatal MI (excluding silent M
were assessed as secondary endpoints.
Median exposure to study drug was 277 days. About half of the patients received pre-study clopidogrel and about 99% of t
during PLATO. About 35% of patients were receiving a statin at baseline and 93% received a statin sometime during PLATO.
Table 1 shows the study results for the primary composite endpoint and the contribution of each component to the primar
analyses are shown for the overall occurrence of CV death, MI, and stroke and overall mortality. (See Table 1.)
The difference between treatments on the composite resulted from effects on CV death and MI; each was statistically signi
endpoint and there was no beneficial effect on strokes. For all-cause mortality the benefit was also statistically significant (p
Pharmacology: Amlodipine/Atorvastatin Pharmacodynamics: Caduet combines 2 mechanisms of action: The dihydropyridin
antagonist or slow-channel blocker) action of amlodipine and the HMG-CoA reductase inhibition of atorvastatin. The amlod
amlodipine/atorvastatin inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle
amlodipine/atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts
mevalonate, a precursor of sterols including cholesterol.
Clinical Studies of Combined Amlodipine and Atorvastatin in Patients with Hypertension and Dyslipidemia: In a double-blin
with co-morbid hypertension and dyslipidemia, once daily treatment with 8 dose combinations of amlodipine and atorvast
5/80, or 10/80 mg) was compared versus amlodipine alone (5 or 10 mg), atorvastatin alone (10, 20, 40 or 80 mg), and place
hypertension and dyslipidemia, 15% of the patients had diabetes mellitus, 22% were smokers and 14% had a positive famil
weeks, all 8 combination-treatment groups demonstrated statistically significant dose-related reductions in systolic blood p
(DBP) and LDL-C compared to placebo, with no overall modification of effect of either component on SBP, DBP and LDL-C (s
In an open-label trial, 1220 patients with co-morbid hypertension and dyslipidemia received elective dose-titration with am
period. Patients were required to have uncontrolled blood pressure to enter the trial (whether or not they were using antih
patients were allowed to continue on previous antihypertensives, other than calcium-channel blockers, during the 14-week
either controlled or uncontrolled LDL-C. As a result, no patient entered the trial with both blood pressure and LDL-C contro
patients. Treatment with amlodipine/atorvastatin reduced mean blood pressure by -17.1 mmHg systolic and -9.6 mmHg dia
resulting in control of both blood pressure and LDL-C for 58% of these patients (controlled blood pressure and LDL-C were d
<160 mg/dL for patients with co-morbid hypertension and dyslipidemia only; <140/90 mmHg and <130 mg/dL for patients
dyslipidemia plus 1 additional cardiovascular risk factor, excluding known coronary heart disease (CHD) or diabetes mellitus
patients with co-morbid hypertension and dyslipidemia plus known CHD, diabetes mellitus, or other atherosclerotic diseas
amlodipine/atorvastatin as initial therapy for co-morbid hypertension and dyslipidemia, whereas the amlodipine compone
add-on therapy for hypertension in 56% of patients, including patients for whom the atorvastatin component of amlodipine
dyslipidemia (20%), a substitution for atorvastatin taken previously (18%), or a switch from another statin (18%). When eva
and lipid-lowering medications at enrollment, results showed that both blood pressure and LDL-C were brought under cont
amlodipine/atorvastatin as initial therapy for co-morbid hypertension and dyslipidemia and for 55-64% of patients for who
amlodipine/atorvastatin constituted add-on therapy for hypertension (55% for such patients who had previously used lipid
atorvastatin, 58% for such patients who had previously used atorvastatin, and 64% for such patients who had not previousl
Amlodipine Pharmacodynamics: Amlodipine is a calcium-ion influx inhibitor (slow channel blocker or calcium-ion antagonis
calcium ions into cardiac and vascular smooth muscle.
The mechanism of the antihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle. T
amlodipine relieves angina has not been fully determined but amlodipine reduces total ischemic burden by the following 2
Amlodipine dilates peripheral arterioles and thus, reduces the total peripheral resistance (afterload) against which the hear
stable, this unloading of the heart reduces myocardial energy consumption and oxygen requirements.
The mechanism of action of amlodipine also probably involves dilatation of the main coronary arteries and coronary arterio
This dilatation increases myocardial oxygen delivery in patients with coronary artery spasm (Prinzmetal's or variant angina)
vasoconstriction.
In patients with hypertension, once-daily dosing provides clinically significant reductions of blood pressure in both the supi
Calcium is an essential mineral necessary for the maintenance of electrolyte equilibrium in the body and for the proper fun
mechanisms. Calcium deficiency is associated with neuromuscular disorders and bone demineralization.
CalSource/CalSource Forte: Contains readily soluble and ionizable calcium salts. About 30% of ionized calcium is absorbed
the prevention and therapy of acute and chronic calcium deficiency states, and for treatment of various forms of disturbed
adults.
CalSource Plus Vitamin C: Ascorbic acid (vitamin C) plays an important role in biological oxidation and reduction processes,
essential for collagen formation and tissue repair.
Calcium and ascorbic acid deficiency can be the result of inadequate nutrition or may occur in various conditions associate
CalSource Plus Vitamin C provides vitamin C and ionizable calcium in sufficient amounts for covering the daily needs at tim
Pharmacotherapeutic Group: Cytostatic topoisomerase I inhibitor.
Pharmacology: Pharmacodynamics: The intensity of the major toxicities encountered with Campto (eg, leukoneutropenia
(AUC) to parent drug and metabolite SN-38.
Significant correlations were observed between hematological toxicity (decrease in white cells and neutrophils at nadir) or
HCl and metabolite SN-38 AUC values in monotherapy.
Experimental Data: Irinotecan is a semisynthetic derivative of camptothecin. It is an antineoplastic agent which acts as a sp
metabolized by carboxylesterase in most tissues to SN-38, which was found to be more active than irinotecan in purified to
irinotecan against several murine and human tumor cell lines. The inhibition of DNA topoisomerase I by irinotecan or SN-3
blocks the DNA replication fork and are responsible for the cytotoxicity. This cytotoxic activity was found to be time-depend
Therapeutic Class: Irinotecan HCl is an antineoplastic agent of the topoisomerase I inhibitor class, clinically investigated as C
derivative of camptothecin, an alkaloid extract from plants eg, Camptotheca acuminata or is chemically synthesized.
Mechanism of Action: Irinotecan and its active metabolite SN-38 bind to the topoisomerase I-DNA complex and prevent re
Current research suggests that the cytotoxicity of irinotecan is due to double-strand DNA damage produced during DNA sy
with the ternary complex formed by topoisomerase I, DNA and either irinotecan or SN-38.
Irinotecan serves as a water-soluble precursor of the lipophilic metabolite SN-38. SN-38 is formed from irinotecan by carbo
carbamate bond between the camptothecin moiety and the dipiperidino side chain. SN-38 is approximately 1000 times as
topoisomerase I purified from human and rodent tumor cell lines. In vitro cytotoxicity assays show that the potency of SN-3
2000-fold. However, the plasma area under the concentration versus time curve (AUC) values for SN-38 are 2-8% of irinote
proteins compared to approximately 50% bound to plasma proteins for irinotecan. The precise contribution of SN-38 to the
Both irinotecan and SN-38 exist in an active lactone form and an inactive hydroxy acid anion form. A pH-dependent equilib
an acid pH promotes the formation of the lactone, while a more basic pH favors the hydroxy acid anion form.
Pharmacokinetics: Absorption and Distribution: After IV infusion in humans, irinotecan plasma concentrations decline in a m
terminal elimination half-life of about 6 hrs. The mean terminal elimination half-life of the active metabolite SN-38 is about
forms of irinotecan and SN-38 are similar to those of total irinotecan and SN-38, as the lactone and hydroxy acid forms are
Over the dose range of 50-350 mg/m2, the AUC of irinotecan increases linearly with dose; the AUC of SN-38 increases less
concentrations of the active metabolite SN-38 are generally seen within 1 hr following the end of a 90-min infusion of irino
Irinotecan exhibits moderate plasma protein-binding (30-68% bound). SN-38 is highly bound to human plasma proteins (ap
protein to which irinotecan and SN-38 predominantly binds is albumin.
Metabolism and Excretion: The metabolic conversion of irinotecan to the active metabolite SN-38 is mediated by carboxyle
liver. SN-38 subsequently undergoes conjugation predominantly by the enzyme UDP-glucuronosyl transferase 1A1 (UGT1A1
UGT1A1 acitivity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity eg, the UGT1A
38 glucuronide had 1/50-1/100 the activity of SN-38 in cytotoxicity assays using 2 cell lines in vitro. The disposition of irinot
humans. The urinary excretion of irinotecan is 11-20%; SN-38, <1%; and SN-38 glucuronide, 3%. The cumulative biliary and
metabolites (SN-38 and SN-38 glucuronide) over a period of 48 hrs following administration of irinotecan in 2 patients rang
50% (300 mg/m2).
Special Populations: Geriatric: The pharmacokinetics of irinotecan administered using the weekly schedule was evaluated i
prospectively designed to investigate the effect of age on irinotecan toxicity. Results from this trial indicate that there are n
irinotecan, SN-38 and SN-38 glucuronide in patients <65 years compared with patients =65 years. In a study of 162 patients
Pharmacology: Ramiprilat, the active metabolite of ramipril, is a potent and long-acting angiotensin-converting enzyme (AC
Administration of Cardace results in vasodilatation especially in hypertensive patients, and in the reduction of blood pressu
single dose occurs within 1-2 hrs after intake, reaching its peak within 3-6 hrs and usually lasts for 24 hrs.
Cardace is also effective in the treatment of congestive heart failure. Further, in patients demonstrating clinical signs of con
myocardial infarction. Cardace has been shown to decrease the mortality risk including the risks of sudden death, progress
failure-related hospitalization.
Cardace, when administered on a preventive basis, significantly reduces the incidence of myocardial infarction, stroke or ca
increased cardiovascular risk attributable to vascular diseases (eg, manifest coronary heart disease or a history of stroke or
mellitus with at least 1 additional risk factor [microalbuminuria, hypertension, elevated total cholesterol levels, low high-de
smoking]. Moreover, it reduces total mortality as well as the need for revascularizations, and delays the start and the progr
diabetic and nondiabetic patients, it significantly reduces the occurrence of microalbuminuria and diminishes the risk of de
occur both in hypertensive and in normotensive patients.
Pharmacodynamics: Ramipril is a product which, after absorption from the gastrointestinal tract, is hydrolysed in the liver t
which is a potent and long-acting ACE inhibitor.
Administration of ramipril causes an increase in plasma renin activity and a decrease in plasma concentrations of angiotens
haemodynamic effects resulting from ACE inhibition are consequences of the reduction in angiotensin II causing dilatation
vascular resistance. There is evidence suggesting that tissue ACE particularly in the vasculature, rather than circulating ACE
haemodynamic effects.
Angiotensin-converting enzyme is identical with kininase II, one of the enzymes responsible for the degradation of bradykin
ramipril appears to have some effects on the kallikrein-kinin prostaglandin systems. It is assumed that effects on these syste
metabolic activity of ramipril.
Administration of Cardace to hypertensive patients results in reduction of both supine and standing blood pressure. The an
hrs after the drug intake; peak effect occurs 3-6 hrs after drug intake and has been shown to be maintained for at least 24 h
Pharmacokinetics: Following oral administration, ramipril is rapidly absorbed from the gastrointestinal tract, and peak plasm
within 1 hr. Peak plasma concentrations of the active metabolite, ramiprilat, are reached within 2-4 hrs.
Plasma concentrations of ramiprilat decline in a polyphasic manner. The effective t of ramiprilat after multiple-once daily
ramipril 5-10 mg and markedly longer for lower doses of ramipril 1.25-2.5 mg. This difference is related to the long termina
curve observed at very low plasma concentrations. This terminal phase is independent of this dose indicating a saturable ca
Steady-state plasma concentrations of ramiprilat after once-daily dosing with the usual dose of ramipril are reached by abo
Ramipril is almost completely metabolized and the metabolites are excreted mainly via the kidneys. In addition to the bioac
metabolites have been identified including diketopiperazine ester, diketopiperazine acid and conjugates.
Pharmacology: Cardura exerts its vasodilator effect via selective blockade of a1-adrenoceptors located in the vasculature.
Administration of Cardura to hypertensive patients causes a clinically significant reduction in blood pressure as a result of a
With once-daily dosing, clinically significant reductions in blood pressure are present throughout the day and at 24 hrs pos
pressure occurs with maximum reduction usually occurring 2-6 hrs after dosing. In patients with hypertension, blood press
similar in both the supine and standing positions. Unlike nonselective a-adrenoreceptor-blocking agents, tolerance has not
Cardura. Elevations of plasma renin activity and tachycardia were seen infrequently in sustained therapy.
Cardura, in addition to its antihypertensive effect, produce favorable effects on blood lipids, with a significant increase in th
reductions in total triglycerides and total cholesterol. It therefore confers an advantage over diuretics and -adrenoceptor-b
parameters. Based on the established association of hypertension and blood lipids with coronary heart disease, the favorab
blood pressure and lipids indicate a reduction in risk of developing coronary heart disease.
Treatment with Cardura has been shown to result in regression of left ventricular hypertrophy, inhibition of platelet aggreg
activator capacity. Additionally, Cardura improves insulin sensitivity in patients who have impairment.
Cardura has been shown to be free of adverse metabolic effects and is suitable for use in patients with asthma, diabetes, le
Administration of Cardura to patients with symptomatic benign prostatic hyperplasia (BPH) results in a significant improvem
effect in BPH is thought to result from selective blockade of the a-adrenoceptors located in the prostatic muscular stroma,
Pharmacokinetics: Absorption: After oral administration of therapeutic doses, Cardura is well absorbed with peak blood lev
Pharmacokinetic studies in patients with renal impairment have shown no significant alterations compared to patients with
limited data in patients with liver impairment nor studies of the effects of drugs known to influence hepatic metabolism (eg
Biotransformation/Elimination: The plasma elimination is biphasic with the terminal elimination half-life being 22 hrs and h
dosing. Cardura is extensively metabolized with <5% excreted as unchanged drug.
Pharmacotherapeutic Group: Antiandrogen. ATC Code: L02BB03.
Pharmacology: Pharmacodynamics: Bicalutamide is a nonsteroidal antiandrogen, devoid of other endocrine activity. It bind
gene expression and thus, inhibits the androgen stimulus. Regression of prostatic tumours results from this inhibition. Clini
in antiandrogen withdrawal syndrome in a subset of patients.
Casodex 50 mg is a racemate with its antiandrogenic activity being almost exclusively in the (R)-enantiomer.
Casodex 150 mg was studied as a treatment for patients with localised (T1-T2, N0 or NX, M0) or locally advanced (T3-T4, an
prostate cancer in a combined analysis of 3 placebo controlled, double-blind studies in 8,113 patients, where Casodex was
adjuvant to radical prostatectomy or radiotherapy (primarily external beam radiation). At 9.7 years median follow-up, 36.6%
treated patients, respectively, had experienced objective disease progression.
A reduction in risk of objective disease progression was seen across most patient groups but was most evident in those at h
Therefore, clinicians may decide that the optimum medical strategy for a patient at low risk of disease progression particula
prostatectomy, may be to defer hormonal therapy until signs that the disease is progressing.
No overall survival difference was seen at 9.7 years median follow-up with 31.4% mortality (HR=1.01; 95% CI 0.94-1.09). Ho
exploratory subgroup analyses.
Data on progression-free survival and overall survival over time based on Kaplan-Meier estimates for patients with locally a
1 and 2. (See Tables 1 and 2.)
For patients with localized disease receiving Casodex alone, there was no significant difference in progression free survival.
overall survival in patients with localized disease who received Casodex as adjuvant therapy, following radiotherapy (HR=0.
(HR=1.03; 95% Cl 0.85-1.25). In patients with localized disease, who would otherwise have been managed by watchful waiti
decreased survival compared with placebo patients (HR=1.15; 95% Cl 1-1.32). In view of this, the benefit-risk profile for the
in patients with localized disease.
In a separate programme, the efficacy of Casodex 150 mg for the treatment of patients with locally advanced nonmetastati
castration was indicated, was demonstrated in a combined analysis of 2 studies with 480 previously untreated patients with
56% mortality and a median follow-up of 6.3 years, there was no significant difference between Casodex and castration in s
equivalence of the 2 treatments could not be concluded statistically.
In a combined analysis of 2 studies with 805 previously untreated patients with metastatic (M1) disease at 43% mortality, C
less effective than castration in survival time (HR=1.3; CI 1.04-1.65), with a numerical difference in estimated time to death
time of 2 years.
Bicalutamide is a racemate with its antiandrogen activity being almost exclusively in the (R)-enantiomer.
Pharmacokinetics: Bicalutamide is well absorbed following oral administration. There is no evidence of any clinically releva
The (S)-enantiomer is rapidly cleared relative to the (R)-enantiomer, the latter having a plasma elimination half-life (t) of a
On daily administration of Casodex, the (R)-enantiomer accumulates about 10-fold in plasma as a consequence of its long t
daily dosing.
Steady-state plasma concentrations of the (R)-enantiomer of approximately 22 mcg/mL are observed during daily administ
during daily administration of Casodex 50 mg. At steady state, the predominantly active (R)-enantiomer accounts for 99% o
The pharmacokinetics of the (R)-enantiomer are unaffected by age, renal impairment or mild to moderate hepatic impairm
Pharmacotherapeutic Group: Anti-inflammatory and antirheumatic products, nonsteroids, acetic acid derivatives and relate
Pharmacology: Mechanism of Action: Cataflam contains the potassium salt of diclofenac, a nonsteroidal compound with pr
antipyretic properties. Inhibition of prostaglandin biosynthesis, which has been demonstrated in experiments, is considered
action. Prostaglandins play a major role in causing inflammation, pain and fever.
Cataflam tablets have a rapid onset of action which makes them particularly suitable for the treatment of acute painful and
Diclofenac potassium in vitro does not suppress proteoglycan biosynthesis in the cartilage at concentrations equivalent to t
Pharmacodynamics: Cataflam has been found to exert a pronounced analgesic effect in moderate and severe pain. In the p
or following surgical interventions, it rapidly relieves both spontaneous pain and pain on movement and diminishes inflamm
Clinical studies have also revealed that in primary dysmenorrhoea, diclofenac is capable of relieving pain and reducing the
In migraine attacks, Cataflam has been shown to be effective in relieving headache and in improving the accompanying sym
Pharmacokinetics: Absorption: Diclofenac is rapidly and completely absorbed from Cataflam tablets. The absorption sets in
same amount is absorbed as from an equivalent dose of diclofenac sodium enteric-coated tablets.
Mean peak plasma concentrations of 3.8 micromol/L are attained 20-60 min after ingestion of one 50-mg tablet. Ingestion
amount of diclofenac absorbed, although onset and rate of absorption may be slightly delayed.
The amount absorbed is linear in proportion to the size of the dose.
Since about of diclofenac is metabolized during its 1st passage to the liver (first-pass effect), the AUC is about half as larg
is following a parenteral dose of equal size.
Pharmacokinetic behaviour does not change after repeated administration. No accumulation occurs, provided the recomm
Distribution: 99.7% of diclofenac binds to serum proteins, mainly to albumin (99.4%). The apparent volume of distribution
Diclofenac enters the synovial fluid, where maximum concentrations are measured 2-4 hrs after the peak plasma values ha
elimination from the synovial fluid is 3-6 hrs. Two hrs after reaching peak plasma levels, concentrations of diclofenac are alr
plasma, and they remain higher for up to 12 hrs.
Biotransformation: Biotransformation of diclofenac takes place partly by glucuronidation of the intact molecule, but mainly
methoxylation, resulting in several phenolic metabolites (3'-hydroxy-, 4'-hydroxy-, 5-hydroxy-, 4',5-dihydroxy- and 3'-hydrox
converted to glucuronide conjugates.
Two of these phenolic metabolites are biologically active, but to a much lesser extent than diclofenac.
Elimination: Total systemic clearance of diclofenac from plasma is 26356 mL/min (mean value SD). The terminal t in pla
including the 2 active ones, also have short plasma half-lives of 1-3 hrs. One metabolite, 3'-hydroxy-4'-methoxy-diclofenac,
metabolite is virtually inactive.
About 60% of the administered dose is excreted in the urine as the glucuronide conjugate of the intact molecule and as me
to glucuronide conjugates. Less than 1% is excreted as unchanged substance. The rest of the dose is eliminated as metabol
Characteristics in Patients: No relevant age-dependent differences in the drug's absorption, metabolism or excretion have b
In patients suffering from renal impairment, no accumulation of the unchanged diclofenac can be inferred from the single-
dosage schedule. At a creatinine clearance of <10 mL/min, the calculated steady-state plasma levels of the hydroxy metabo
normal subjects. However, the metabolites are ultimately cleared through the bile.
In patients with chronic hepatitis or nondecompensated cirrhosis, the kinetics and metabolism of diclofenac are the same a
Toxicology: Preclinical Safety Data: Preclinical data from acute and repeated-dose toxicity studies, as well as from genotoxic
studies with diclofenac, revealed no specific hazard for humans at the intended therapeutic doses. There was no evidence
Pharmacology: Clonidine acts primarily on the central nervous system, resulting in reduced sympathetic outflow and a decr
resistance, heart rate and blood pressure. Renal blood flow and glomerular filtration rate remain essentially unchanged. No
therefore, orthostatic symptoms are mild and infrequent.
During long-term therapy, cardiac output tends to return to control values, while peripheral resistance remains decreased.
observed in most patients given clonidine, but the drug does not alter normal hemodynamic response to exercise.
MIMS Class ATC Classification
Topical Antifungals & Antiparasites D11AC08 - sulfur compounds ; Belongs to the
class of medicated shampoos.
Antivirals J05AF05 - lamivudine ; Belongs to the class of
nucleoside and nucleotide reverse transcriptase
inhibitors. Used in the systemic treatment of viral
infections.
Antivirals J05AF05 - lamivudine ; Belongs to the class of
infections.
Cytotoxic Chemotherapy L01BC02 - fluorouracil ; Belongs to the class of

antimetabolites, pyrimidine analogues. Used in
the treatment of cancer.
Haemostatics B02BD02 - coagulation factor VIII ; Belongs to the

class of blood coagulation factors. Used in the
treatment of hemorrhage.
Topical Antifungals & Antiparasites P03AC04 - permethrin ; Belongs to the class of

pyrethrines, including synthetic compounds used
as ectoparasiticides.
Haemostatics B02BD02 - coagulation factor VIII ; Belongs to the

class of blood coagulation factors. Used in the
Anti-Anginal Drugs / Calcium Antagonists C08CA01 - amlodipine ; Belongs to the class of
dihydropyridine derivative selective calcium-
channel blockers with mainly vascular effects.
Used in the treatment of cardiovascular diseases.
Analgesics (Non-Opioid) & Antipyretics N02BE51 - paracetamol, combinations excl.

psycholeptics ; Belongs to the class of anilide
preparations. Used to relieve pain and fever.
Macrolides J01FA09 - clarithromycin ; Belongs to the class of

macrolides. Used in the systemic treatment of
infections.
Vitamins & Minerals (Paediatric) A11BA - Multivitamins, plain ; Used as dietary

supplements.
Antipsychotics N05AX12 - aripiprazole ; Belongs to the class of
other antipsychotics.


Cephalosporins J01DE02 - cefpirome ; Belongs to the class of

fourth generation cephalosporins. Used in the
systemic treatment of infections.
Cephalosporins J01DD08 - cefixime ; Belongs to the class of third-

generation cephalosporins. Used in the systemic
treatment of infections.
Antiasthmatic & COPD Preparations R03DC01 - zafirlukast ; Belongs to the class of
leukotriene receptor antagonists. Used in the
systemic treatment of obstructive airway
diseases.
ACE Inhibitors/Direct Renin Inhibitors C09AA06 - quinapril ; Belongs to the class of ACE
inhibitors. Used in the treatment of
cardiovascular disease.
Topical Antibiotics D06AX01 - fusidic acid ; Belongs to the class of

other topical antibiotics used in the treatment of
dermatological diseases.
ACE Inhibitors/Direct Renin Inhibitors C09AA01 - captopril ; Belongs to the class of ACE
ACE Inhibitors/Direct Renin Inhibitors C09AA09 - fosinopril ; Belongs to the class of ACE
Intravenous & Other Sterile Solutions B05BB01 - electrolytes ; Belongs to the class of
solutions affecting the electrolyte balance used in
I.V. solutions.
Angiotensin II Antagonists C09CA01 - losartan ; Belongs to the class of

angiotensin II antagonists. Used in the treatment
of cardiovascular disease.
Cough & Cold Preparations R05CB01 - acetylcysteine ; Belongs to the class of

mucolytics. Used in the treatment of wet cough.
Analgesics (Opioid) N02AX52 - tramadol, combinations ; Belongs to

the class of other opioids. Used to relieve pain.
Macrolides J01FA02 - spiramycin ; Belongs to the class of

infections.
Antidotes & Detoxifying Agents V03AB23 - acetylcysteine ; Belongs to the class of

antidotes. Used to neutralize paracetamol
overdose.
Antacids, Antireflux Agents & Antiulcerants A02BA02 - ranitidine ; Belongs to the class of H2-
receptor antagonists. Used in the treatment of
peptic ulcer and gastro-oesophageal reflux
disease (GERD).
Antacids, Antireflux Agents & Antiulcerants A02AX - Antacids, other combinations ; Used in
the treatment of acid-related disorders.
Antivirals J05AB01 - aciclovir ; Belongs to the class of
nucleosides and nucleotides excluding reverse
transcriptase inhibitors. Used in the systemic
treatment of viral infections.
Topical Antivirals D06BB03 - aciclovir ; Belongs to the class of

topical antivirals used in the treatment of
Antacids, Antireflux Agents & Antiulcerants A02AF02 - ordinary salt combinations and
antiflatulents ; Belongs to the class of antacids
with antiflatulents.
Penicillins J01CR02 - amoxicillin and enzyme inhibitor ;

Belongs to the class of penicillin combinations,
including beta-lactamase inhibitors. Used in the
Agents Affecting Bone Metabolism M05BA08 - zoledronic acid ; Belongs to the class
of bisphosphonates. Used in the treatment of
bone diseases.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) M01AB05 - diclofenac ; Belongs to the class of

acetic acid derivatives and related substances of
non-steroidal antiinflammatory and antirheumatic
products.
Supplements & Adjuvant Therapy D11AX - Other dermatologicals ; Used in the
treatment of dermatological diseases.
Supplements & Adjuvant Therapy D11AX - Other dermatologicals ; Used in the

Acne Treatment Preparations D10AB02 - sulfur ; Belongs to the class of sulfur-

containing topical preparations used in the
treatment of acne.
Acne Treatment Preparations / Emollients, Cleansers & D11AC30 - others ; Belongs to the class of
Skin Protectives medicated shampoos.
Acne Treatment Preparations D10AX - Other anti-acne preparations for topical

use ; Used in the treatment of acne.
GIT Regulators, Antiflatulents & Anti-Inflammatories A03FA02 - cisapride ; Belongs to the class of
propulsives. Used in the treatment of functional
gastrointestinal disorders.
disease (GERD).
Antidiabetic Agents A10BF01 - acarbose ; Belongs to the class of alpha

glucosidase inhibitors. Used in the treatment of
diabetes.
Agents Affecting Bone Metabolism M05BA02 - clodronic acid ; Belongs to the class of
bisphosphonates. Used in the treatment of bone
diseases.
Cephalosporins J01DE01 - cefepime ; Belongs to the class of
Antacids, Antireflux Agents & Antiulcerants A02AB01 - aluminium hydroxide ; Belongs to the
class of aluminium-containing antacids.
Dyslipidaemic Agents C10AA05 - atorvastatin ; Belongs to the class of

HMG CoA reductase inhibitors. Used in the
treatment of hyperlipidemia.
Calcium Antagonists C08CA01 - amlodipine ; Belongs to the class of

Antidiabetic Agents A10BB12 - glimepiride ; Belongs to the class of

sulfonylureas. Used in the treatment of diabetes.
Cytotoxic Chemotherapy L01XX19 - irinotecan ; Belongs to the class of

other antineoplastic agents. Used in the
treatment of cancer.
Cephalosporins J01DD04 - ceftriaxone ; Belongs to the class of
third-generation cephalosporins. Used in the
Anxiolytics N05BA12 - alprazolam ; Belongs to the class of

benzodiazepine derivatives anxiolytics. Used in
the management of anxiety, agitation or tension.
Vaccines, Antisera & Immunologicals J07AG01 - hemophilus influenzae B, purified

antigen conjugated ; Belongs to the class of
hemophilus influenzae B bacterial vaccines.
Surgical Dressings & Wound Care D09AA - Medicated dressings with antiinfectives ;
Used as medicated dressings.
Surgical Dressings & Wound Care D09AA - Medicated dressings with antiinfectives ;
Used as medicated dressings.
Cough & Cold Preparations R01BA52 - pseudoephedrine, combinations ;
Belongs to the class of systemic sympathomimetic
preparations used as nasal decongestants.
Cough & Cold Preparations R05DA20 - combinations ; Belongs to the class of

opium alkaloids and derivatives. Used as cough
suppressant.
Cough & Cold Preparations R05CA10 - combinations ; Belongs to the class of

expectorants. Used in the treatment of wet
cough.
Cough & Cold Preparations N02BE51 - paracetamol, combinations excl.
Anticoagulants, Antiplatelets & Fibrinolytics B01AD02 - alteplase ; Belongs to the class of

(Thrombolytics) enzymes. Used in the treatment of thrombosis.
Supplements & Adjuvant Therapy A13A - TONICS ; Used as tonics.
Other Drugs Acting on Musculo-Skeletal System M01AX05 - glucosamine ; Belongs to the class of
other non-steroidal antiinflammatory and
antirheumatic products.
Agents Affecting Bone Metabolism M05BA07 - risedronic acid ; Belongs to the class
bone diseases.
Agents Affecting Bone Metabolism M05BA07 - risedronic acid ; Belongs to the class
bone diseases.
Cytotoxic Chemotherapy L01XA02 - carboplatin ; Belongs to the class of

platinum-containing antineoplastic agents. Used
in the treatment of cancer.
Antidiabetic Agents A10BG03 - pioglitazone ; Belongs to the class of

thiazolidinediones. Used in the treatment of
diabetes.
Antidiabetic Agents A10BD05 - metformin and pioglitazone ; Belongs
to the class of combinations of oral blood glucose
lowering drugs. Used in the treatment of
diabetes.
Insulin Preparations A10AB01 - insulin (human) ; Belongs to the class
of fast-acting insulins and analogues. Used in the
treatment of diabetes.
Topical Antibiotics J01MA - Fluoroquinolones ; Used in the systemic
Topical Antivirals D06BB03 - aciclovir ; Belongs to the class of

topical antivirals used in the treatment of


Vitamins & Minerals (Paediatric) A11JB - Vitamins with minerals ; Used as dietary
supplements.
Vitamins & Minerals (Paediatric) A11JA - Combinations of vitamins ; Used as
dietary supplements.
Calcium Antagonists C08CA05 - nifedipine ; Belongs to the class of


Other Drugs Acting on Musculo-Skeletal System M09AX01 - hyaluronic acid ; Belongs to the class
of other drugs for disorders of the musculo-
skeletal system.

supplements.
Antidiabetic Agents A10BA02 - metformin ; Belongs to the class of
biguanides. Used in the treatment of diabetes.
Vitamins &/or Minerals A11AB - Multivitamins, other combinations ; Used

as dietary supplements.
Vitamins & Minerals (Pre & Post Natal) / Antianemics B03AE10 - various combinations ; Belongs to the
class of iron in other combinations. Used in the
treatment of anemia.
Haemostatics B02BX02 - carbazochrome ; Belongs to the class

of other systemic hemostatics. Used in the
Vasoconstrictors C01CA24 - epinephrine ; Belongs to the class of

adrenergic and dopaminergic cardiac stimulants
excluding glycosides. Used in the treatment of
heart failure.
Cytotoxic Chemotherapy L01DB01 - doxorubicin ; Belongs to the class of

cytotoxic antibiotics, anthracyclines and related
substances. Used in the treatment of cancer.
Haemostatics B02BX02 - carbazochrome ; Belongs to the class

of other systemic hemostatics. Used in the
Topical Corticosteroids D07AC14 - methylprednisolone aceponate ;

Belongs to the class of potent (group III)
corticosteroids. Used in the treatment of
Antihistamines & Antiallergics R06AX27 - desloratadine ; Belongs to the class of
other antihistamines for systemic use.
Antihistamines & Antiallergics R01BA52 - pseudoephedrine, combinations ;
GIT Regulators, Antiflatulents & Anti-Inflammatories A03AX13 - silicones ; Belongs to the class of other
drugs used for functional bowel disorders.
Anaesthetics - Local & General N01AB06 - isoflurane ; Belongs to the class of

halogenated hydrocarbons. Used as general
anesthetics.
Antimalarials P01BC01 - quinine ; Belongs to the class of

methanolquinoline antimalarials.
Targeted Cancer Therapy L01XE10 - everolimus ; Belongs to the class of

protein kinase inhibitors, other antineoplastic
agents. Used in the treatment of cancer.
Supplements & Adjuvant Therapy A11AA03 - multivitamins and other minerals, incl.
combinations ; Belongs to the class of
multivitamins with minerals. Used as dietary
supplements.
Nasal Decongestants & Other Nasal Preparations R01AA05 - oxymetazoline ; Belongs to the class of
topical sympathomimetic agents used as nasal
decongestants.
Topical Antibiotics D06AX01 - fusidic acid ; Belongs to the class of

Anticoagulants, Antiplatelets & Fibrinolytics B01AC23 - cilostazol ; Belongs to the class of

(Thrombolytics) platelet aggregation inhibitors excluding heparin.
Used in the treatment of thrombosis.
Anticoagulants, Antiplatelets & Fibrinolytics B01AC30 - combinations ; Belongs to the class of

Anticoagulants, Antiplatelets & Fibrinolytics B01AC04 - clopidogrel ; Belongs to the class of


Vaccines, Antisera & Immunologicals J07BB02 - influenza, inactivated, split virus or

surface antigen ; Belongs to the class of influenza
viral vaccines.
Anticoagulants, Antiplatelets & Fibrinolytics L01XX35 - anagrelide ; Belongs to the class of
(Thrombolytics) other antineoplastic agents. Used in the
Anticoagulants, Antiplatelets & Fibrinolytics B01AC05 - ticlopidine ; Belongs to the class of

Quinolones J01MA01 - ofloxacin ; Belongs to the class of

fluoroquinolones. Used in the systemic treatment
of infections.
Ear Anti-Infectives & Antiseptics S02AA16 - ofloxacin ; Belongs to the class of

antiinfectives used in the treatment of ear
infections.
Antidiarrheals A07BC54 - attapulgite, combinations ; Belongs to

the class of other intestinal adsorbents.
Cardiac Drugs C01CA30 - combinations ; Belongs to the class of

heart failure.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) M01AA01 - phenylbutazone ; Belongs to the class

of non-steroidal antiinflammatory and
antirheumatic products, butylpyrazolidines.
Vitamins &/or Minerals / Vitamins & Minerals A11BA - Multivitamins, plain ; Used as dietary
(Paediatric) supplements.
Vitamin B-Complex / with C A11EB - Vitamin B-complex with vitamin C ; Used

Vitamins &/or Minerals A11JB - Vitamins with minerals ; Used as dietary
supplements.
Infant Nutritional Products V06DB -

Fat/carbohydrates/proteins/minerals/vitamins,
combinations ; Used as general nutrients.
Supplements & Adjuvant Therapy A16AX01 - thioctic acid ; Belongs to the class of
various alimentary tract and metabolism
products.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) M01AE51 - ibuprofen, combinations ; Belongs to

the class of propionic acid derivatives of non-
steroidal antiinflammatory and antirheumatic
products.
Intravenous & Other Sterile Solutions B05AA01 - albumin ; Belongs to the class of blood
substitutes and plasma protein fractions. Used as
blood substitutes.
Anthelmintics P02CA03 - albendazole ; Belongs to the class of
benzimidazole derivative agents. Used as
antinematodal.
Other Antibiotics J01FF01 - clindamycin ; Belongs to the class of

lincosamides. Used in the systemic treatment of
infections.
Skin Antiseptics & Disinfectants D08AE02 - policresulen ; Belongs to the class of

phenol and derivatives antiseptics. Used in the
Eye Anti-Infectives & Antiseptics S01AB04 - sulfacetamide ; Belongs to the class of

antiinfectives, sulfonamides. Used in the
treatment of eye infections.
blood substitutes.
blood substitutes.
blood substitutes.
blood substitutes.
blood substitutes.
Eye Anti-Infectives & Antiseptics S01AE03 - ciprofloxacin ; Belongs to the class of

quinolone antiinfectives. Used in the treatment of
eye infections.
Diuretics C03DA01 - spironolactone ; Belongs to the class

of aldosterone antagonists. Used as potassium-
sparing diuretics.
Diuretics C03BA11 - indapamide ; Belongs to the class of

low-ceiling sulfonamide diuretics.
Diuretics C03EA14 - butizide and potassium-sparing

agents ; Belongs to the class of low-ceiling
diuretics in combination with potassium-sparing
agents. Used as diuretics.
Antidiabetic Agents A10BB07 - glipizide ; Belongs to the class of

disease (GERD).
Antihistamines & Antiallergics / Cough & Cold R01BA52 - pseudoephedrine, combinations ;

Preparations Belongs to the class of systemic sympathomimetic
Neurodegenerative Disease Drugs N06DA02 - donepezil ; Belongs to the class of

anticholinesterases. Used in the management of
dementia.
Supplements & Adjuvant Therapy A11JC - Vitamins, other combinations ; Used as

Antihistamines & Antiallergics R01AD53 - dexamethasone, combinations ;
Belongs to the class of topical corticosteroids
used for prophylaxis and treatment of allergic
rhinitis.
Ophthalmic Decongestants, Anesthetics, Anti- S01GX - Other antiallergics ; Used as

Inflammatories ophthalmologic antiallergics.
Agents Affecting Bone Metabolism M05BA04 - alendronic acid ; Belongs to the class
bone diseases.
Antihistamines & Antiallergics R01AD53 - dexamethasone, combinations ;

Belongs to the class of topical corticosteroids
used for prophylaxis and treatment of allergic
rhinitis.

Antihistamines & Antiallergics R06AB04 - chlorphenamine ; Belongs to the class

of substituted alkylamines used as systemic
antihistamines.
Antihistamines & Antiallergics R06AX13 - loratadine ; Belongs to the class of

Antihistamines & Antiallergics R06AX27 - desloratadine ; Belongs to the class of

Eye Corticosteroids S01BA06 - betamethasone ; Belongs to the class

of corticosteroids. Used in the treatment of
inflammation of the eye.
Supplements & Adjuvant Therapy C01EB09 - ubidecarenone ; Belongs to the class of

other cardiac preparations.
Cytotoxic Chemotherapy L01BC01 - cytarabine ; Belongs to the class of
antimetabolites, pyrimidine analogues. Used in
the treatment of cancer.

products.

Other Dermatologicals / Other Drugs Acting on M02AC - Preparations with salicylic acid
Musculo-Skeletal System derivatives ; Used in the topical treatment of joint
and muscular pains.
Surgical Dressings & Wound Care B02BC08 - calcium alginate ; Belongs to the class
of local hemostatics. Used in the treatment of
hemorrhage.
Hyperuricemia & Gout Preparations M04AA01 - allopurinol ; Belongs to the class of

preparations inhibiting uric acid production. Used
in the treatment of gout.
Supplements & Adjuvant Therapy A11HA05 - biotin ; Belongs to the class of other
plain vitamin preparations. Used as dietary
supplements.
Cytotoxic Chemotherapy L01BA04 - pemetrexed ; Belongs to the class of
antimetabolites, folic acid analogues. Used in the
Vitamin B-Complex / with C A11JA - Combinations of vitamins ; Used as
Anticoagulants, Antiplatelets & Fibrinolytics C04AX - Other peripheral vasodilators ; Used as

(Thrombolytics) peripheral vasodilators.
Cytotoxic Chemotherapy L01AA03 - melphalan ; Belongs to the class of

alkylating agents, nitrogen mustard analogues.
Used in the treatment of cancer.
Skin Antiseptics & Disinfectants D08AX08 - ethanol ; Belongs to the class of other
antiseptics and disinfectants. Used in the

cough.
Surgical Dressings & Wound Care D09A - MEDICATED DRESSINGS ; Used as

medicated dressings.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) M01AG01 - mefenamic acid ; Belongs to the class
antirheumatic products, fenamates.






Preparations for Oral Ulceration & Inflammation A01AB11 - various ; Belongs to the class of local
antiinfective and antiseptic preparations. Used in
the treatment of diseases of the mouth.
Preparations for Oral Ulceration & Inflammation A01AB11 - various ; Belongs to the class of local
antiinfective and antiseptic preparations. Used in
the treatment of diseases of the mouth.

Other Eye Preparations S01GX05 - lodoxamide ; Belongs to the class of

other ophthalmologic antiallergics.
Drugs for Bladder & Prostate Disorders D11AX10 - finasteride ; Belongs to the class of
other dermatologicals.
Vitamins & Minerals (Pre & Post Natal) / Antianemics B03AE04 - iron, multivitamins and minerals ;
Belongs to the class of iron in other combinations.
Used in the treatment of anemia.
Aminoglycosides J01GB06 - amikacin ; Belongs to the class of other

aminoglycosides. Used in the systemic treatment
of infections.
Agents Affecting Bone Metabolism M05BA04 - alendronic acid ; Belongs to the class
bone diseases.
Other Dermatologicals D11AX01 - minoxidil ; Belongs to the class of


dementia.
Antihistamines & Antiallergics R06AX12 - terfenadine ; Belongs to the class of

Anticonvulsants N03AX12 - gabapentin ; Belongs to the class of

other antiepileptics.
Topical Corticosteroids D07AC01 - betamethasone ; Belongs to the class

of potent (group III) corticosteroids. Used in the
Skin Antiseptics & Disinfectants D08AG02 - povidone-iodine ; Belongs to the class

of iodine product antiseptics. Used in the
Preparations for Oral Ulceration & Inflammation R02AA15 - povidone-iodine ; Belongs to the class
of antiseptics used in throat preparations.
Cough & Cold Preparations R06AA52 - diphenhydramine, combinations ;

Belongs to the class of aminoalkyl ethers used as
systemic antihistamines.
Analgesics (Non-Opioid) & Antipyretics N02BE01 - paracetamol ; Belongs to the class of

anilide preparations. Used to relieve pain and
fever.
Antihistamines & Antiallergics R06AX02 - cyproheptadine ; Belongs to the class

of other antihistamines for systemic use.
Antidiarrheals A07DA03 - loperamide ; Belongs to the class of

antipropulsives. Used in the treatment of
diarrhea.
fever.


Vitamins &/or Minerals A11BA - Multivitamins, plain ; Used as dietary

supplements.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) M01AE03 - ketoprofen ; Belongs to the class of

propionic acid derivatives of non-steroidal
antiinflammatory and antirheumatic products.
Antacids, Antireflux Agents & Antiulcerants A02AG - Antacids with antispasmodics ; Used in
Antiasthmatic & COPD Preparations R03AB03 - orciprenaline ; Belongs to the class of

adrenergic inhalants, non-selective beta-
adrenoreceptor agonists. Used in the treatment
of obstructive airway diseases.
Antivirals J05AE - Protease inhibitors ; Used in the systemic
Other Drugs Acting on the Respiratory System R07AA02 - natural phospholipids ; Belongs to the
class of lung surfactants. Used in the treatment of
respiratory diseases.

Cephalosporins J01DB05 - cefadroxil ; Belongs to the class of first-

Oestrogens, Progesterones & Related Synthetic Drugs G03DC01 - allylestrenol ; Belongs to the class of
estren derivative progestogens used in
progestogenic hormone preparations.

dementia.

Vitamins &/or Minerals A11JA - Combinations of vitamins ; Used as

Antidiabetic Agents A10BD02 - metformin and sulfonylureas ; Belongs
diabetes.
Penicillins J01CA01 - ampicillin ; Belongs to the class of

penicillins with extended spectrum. Used in the
Anorectal Preparations C05AA01 - hydrocortisone ; Belongs to the class

of products containing corticosteroids for topical
use. Used in the treatment of hemorrhoids and
anal fissures.
Cough & Cold Preparations R05CB06 - ambroxol ; Belongs to the class of




Antidiarrheals A07DA03 - loperamide ; Belongs to the class of

antipropulsives. Used in the treatment of
diarrhea.
Other Drugs Acting on the Genito-Urinary System A13A - TONICS ; Used as tonics.
Parenteral Nutritional Products B05BA01 - amino acids ; Belongs to the class of

solutions for parenteral nutrition used in I.V.
solutions.
Cholagogues, Cholelitholytics & Hepatic Protectors A05BA - Liver therapy ; Used in liver therapy.

solutions.

solutions.
solutions.
Enteral/Nutritional Products V06DB -

Antiasthmatic & COPD Preparations R03DA05 - aminophylline ; Belongs to the class of

xanthines. Used in the systemic treatment of
obstructive airway diseases.
Other Drugs Acting on the Genito-Urinary System V06DE - Amino

acids/carbohydrates/minerals/vitamins,

solutions.

solutions.

solutions.
solutions.
Aminoglycosides J01GB06 - amikacin ; Belongs to the class of other

aminoglycosides. Used in the systemic treatment
of infections.
solutions.
Parenteral Nutritional Products V06DE - Amino








solutions.
Penicillins J01CA04 - amoxicillin ; Belongs to the class of










Corticosteroid Hormones H02AB08 - triamcinolone ; Belongs to the class of

glucocorticoids. Used in systemic corticosteroid
preparations.
Corticosteroid Hormones H02AB08 - triamcinolone ; Belongs to the class of

glucocorticoids. Used in systemic corticosteroid
preparations.
Phlebitis & Varicose Preparations / Anorectal A11AB - Multivitamins, other combinations ; Used
Preparations as dietary supplements.
Vitamins & Minerals (Paediatric) A11JC - Vitamins, other combinations ; Used as

Vitamins &/or Minerals A11AA03 - multivitamins and other minerals, incl.

supplements.
Cough & Cold Preparations R01BA51 - phenylpropanolamine, combinations ;

Phlebitis & Varicose Preparations / Anorectal C05CA53 - diosmin, combinations ; Belongs to the
Preparations class of bioflavonoids used as capillary stabilizing
agents.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) M01AE01 - ibuprofen ; Belongs to the class of


Antidepressants N06AA04 - clomipramine ; Belongs to the class of

non-selective monoamine reuptake inhibitors.
Used in the management of depression.
Cough & Cold Preparations R05FA02 - opium derivatives and expectorants ;

Belongs to the class of combinations of opium
derivatives cough suppressants and expectorants.
Used in the treatment of cough.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) N02BB72 - metamizole sodium, combinations

with psycholeptics ; Belongs to the class of
pyrazolone preparations. Used to relieve pain and
fever.
Analgesics (Opioid) N02AX52 - tramadol, combinations ; Belongs to
the class of other opioids. Used to relieve pain.

Antipsychotics N05AB02 - fluphenazine ; Belongs to the class of

phenothiazine antipsychotics with piperazine
structure.
Vitamins & Minerals (Paediatric) A11AA03 - multivitamins and other minerals, incl.
supplements.
Cephalosporins J01DC02 - cefuroxime ; Belongs to the class of

second-generation cephalosporins. Used in the
Macrolides J01FA06 - roxithromycin ; Belongs to the class of

infections.

Depot Contraceptives G03AC06 - medroxyprogesterone ; Belongs to the

class of progestogens. Used as systemic
contraceptives.
Oral Contraceptives G03FB09 - levonorgestrel and estrogen ; Belongs

to the class of progestogens and estrogens in
sequential preparations.
Analgesics (Opioid) N02AX02 - tramadol ; Belongs to the class of

other opioids. Used to relieve pain.
Topical Antihistamines/Antipruritics D04AA22 - isothipendyl ; Belongs to the class of

topical antihistamines used in the treatment of
pruritus.
Antidepressants N06AB03 - fluoxetine ; Belongs to the class of

selective serotonin reuptake inhibitors. Used in
the management of depression.


suppressant.
Androgens & Related Synthetic Drugs G03BA03 - testosterone ; Belongs to the class of
3-oxoandrosten (4) derivative androgens used in
androgenic hormone preparations.
Cancer Hormone Therapy / Other Drugs Affecting G03HA01 - cyproterone ; Belongs to the class of
Hormonal Regulation antiandrogen preparations.
Androgens & Related Synthetic Drugs G03BB01 - mesterolone ; Belongs to the class of
5-androstanon (3) derivative androgens used in
androgenic hormone preparations.
Vitamins & Minerals (Pre & Post Natal) / Antianemics B03BB01 - folic acid ; Belongs to the class of folic
acid and derivatives. Used in the treatment of
anemia.
Vitamins & Minerals (Pre & Post Natal) / Antianemics B03BB01 - folic acid ; Belongs to the class of folic
acid and derivatives. Used in the treatment of
anemia.

infections.
Hypnotics & Sedatives N05CD08 - midazolam ; Belongs to the class of

benzodiazepine derivatives. Used as hypnotics
and sedatives.
Anaesthetics - Local & General N01AX03 - ketamine ; Belongs to the class of

other general anesthetics.
Antidotes & Detoxifying Agents V03AB25 - flumazenil ; Belongs to the class of

antidotes. Used in the management of hypnotics
and sedatives overdose.
ACE Inhibitors/Direct Renin Inhibitors C09AA05 - ramipril ; Belongs to the class of ACE
Antidepressants N06AB06 - sertraline ; Belongs to the class of

Antifungals J02AB02 - ketoconazole ; Belongs to the class of

imidazole derivatives. Used in the systemic
treatment of mycotic infections.
Topical Antifungals & Antiparasites D01AC08 - ketoconazole ; Belongs to the class of

imidazole and triazole derivatives. Used in the
topical treatment of fungal infection.
Oestrogens, Progesterones & Related Synthetic Drugs G03CA03 - estradiol ; Belongs to the class of
natural and semisynthetic estrogens used in
estrogenic hormone preparations.
Anti-Anginal Drugs C01EB15 - trimetazidine ; Belongs to the class of

Angiotensin II Antagonists C09CA01 - losartan ; Belongs to the class of


disease (GERD).

Other Antibiotics / Antiamoebics P01AB01 - metronidazole ; Belongs to the class of

nitroimidazole derivatives antiprotozoals. Used in
the treatment amoebiasis and other protozoal
diseases.






Oestrogens, Progesterones & Related Synthetic Drugs G03AC01 - norethisterone ; Belongs to the class
of progestogens. Used as systemic contraceptives.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) M01AE03 - ketoprofen ; Belongs to the class of


Supplements & Adjuvant Therapy A07XA - Other antidiarrheals ; Used in the

treatment of diarrhea.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) N02BB02 - metamizole sodium ; Belongs to the

class of pyrazolone preparations. Used to relieve
pain and fever.

pain and fever.

pain and fever.

pain and fever.
Antacids, Antireflux Agents & Antiulcerants A02BA53 - famotidine, combinations ; Belongs to

the class of H2-receptor antagonists. Used in the
treatment of peptic ulcer and gastro-oesophageal
reflux disease (GERD).
Psoriasis, Seborrhea & Ichthyosis Preparations D05AC01 - dithranol ; Belongs to the class of
topical antracen derivative agent used in the
treatment of psoriasis.
Emollients, Cleansers & Skin Protectives D02 - EMOLLIENTS AND PROTECTIVES ; Used as
skin emollients and protectants.
Antacids, Antireflux Agents & Antiulcerants A02BA03 - famotidine ; Belongs to the class of
H2-receptor antagonists. Used in the treatment of
disease (GERD).
Nootropics & Neurotonics/Neurotrophics N06BX03 - piracetam ; Belongs to the class of

other psychostimulants and nootropics.

supplements.

Antidepressants N06AB06 - sertraline ; Belongs to the class of




pain and fever.
Supplements & Adjuvant Therapy A07XA - Other antidiarrheals ; Used in the

treatment of diarrhea.


products.
Antiemetics A11HA02 - pyridoxine (vit B6) ; Belongs to the

class of other plain vitamin preparations. Used as
Anxiolytics N05BA09 - clobazam ; Belongs to the class of

Cytotoxic Chemotherapy L01CD01 - paclitaxel ; Belongs to the class of plant
alkaloids and other natural products, taxanes.
Used in the treatment of cancer.

Appetite Enhancers A15 - APPETITE STIMULANTS ; Used as appetite

stimulants.


supplements.
Insulin Preparations A10AB06 - insulin glulisine ; Belongs to the class
of fast-acting insulins and analogues. Used in the
treatment of diabetes.
Anti-Obesity Agents A03AC02 - dimethylaminopropionylphenothiazine

; Belongs to the class of synthetic antispasmodics,
amides with tertiary amines. Used in the
treatment of functional bowel disorders.
Topical Corticosteroids D07AB08 - desonide ; Belongs to the class of

moderately potent (group II) corticosteroids. Used
in the treatment of dermatological diseases.
Topical Anti-Infectives with Corticosteroids D07BB02 - desonide and antiseptics ; Belongs to

the class of moderately potent (group II)
corticosteroids, in combination with antiseptics.
Used in the treatment of dermatological diseases.
Anticonvulsants N03AX16 - pregabalin ; Belongs to the class of
other antiepileptics.
Angiotensin II Antagonists C09CA04 - irbesartan ; Belongs to the class of

Cholagogues, Cholelitholytics & Hepatic Protectors A05BA03 - silymarin ; Belongs to the class of
drugs used in liver therapy.
Other Drugs Acting on Musculo-Skeletal System M01BX - Other antiinflammatory/antirheumatic

agents in combination with other drugs ; Used in
the treatment of inflammation and rheumatism.
Vitamins &/or Minerals M09AX - Other drugs for disorders of the
musculo-skeletal system ; Used in the treatment
of musculo-skeletal disorders.
Analgesics (Non-Opioid) & Antipyretics / B01AC06 - acetylsalicylic acid ; Belongs to the

Anticoagulants, Antiplatelets & Fibrinolytics class of platelet aggregation inhibitors excluding
(Thrombolytics) heparin. Used in the treatment of thrombosis.

products.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) / L04AA13 - leflunomide ; Belongs to the class of

Disease-Modifying Anti-Rheumatic Drugs (DMARDs) selective immunosuppressive agents. Used to
induce immunosuppression.
Angiotensin II Antagonists C09CA04 - irbesartan ; Belongs to the class of

Nootropics & Neurotonics/Neurotrophics A11DA02 - sulbutiamine ; Belongs to the class of

vitamin B1. Used as dietary supplements.

Tetracyclines J01AA02 - doxycycline ; Belongs to the class of

tetracyclines. Used in the systemic treatment of
infections.
Antihistamines & Antiallergics R06AA02 - diphenhydramine ; Belongs to the

class of aminoalkyl ethers used as systemic
antihistamines.
Vitamins & Minerals (Pre & Post Natal) / Antianemics B03BA01 - cyanocobalamin ; Belongs to the class
of vitamin B12 (cyanocobalamin and analogues).
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) M01AH05 - etoricoxib ; Belongs to the class of
products, coxibs.
Phlebitis & Varicose Preparations C05CA - Bioflavonoids ; Used as capillary

stabilizing agents.
Phlebitis & Varicose Preparations C05CA - Bioflavonoids ; Used as capillary

stabilizing agents.
Anorectal Preparations C05CA - Bioflavonoids ; Used as capillary

stabilizing agents.

supplements.
Agents Affecting Bone Metabolism M05BA03 - pamidronic acid ; Belongs to the class
bone diseases.
Vasoconstrictors C01CA03 - norepinephrine ; Belongs to the class

of adrenergic and dopaminergic cardiac
stimulants excluding glycosides. Used in the
treatment of heart failure.

Topical Anti-Infectives with Corticosteroids D07BC01 - betamethasone and antiseptics ;

corticosteroids, in combination with antiseptics.
Other Drugs Acting on the Respiratory System R07AX - Other respiratory system products ; Used
in the treatment of respiratory diseases.

dementia.

dementia.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) M01AC06 - meloxicam ; Belongs to the class of

products, oxicams.
Cancer Hormone Therapy L02BG03 - anastrozole ; Belongs to the class of
enzyme inhibitors. Used in endocrine therapy.

Anticoagulants, Antiplatelets & Fibrinolytics B01AX05 - fondaparinux ; Belongs to the class of
(Thrombolytics) other antithrombotic agents.
Antiparkinsonian Drugs N04AA01 - trihexyphenidyl ; Belongs to the class

of tertiary amines anticholinergic agents. Used in
the management of Parkinson's disease.
Topical Anti-Infectives with Corticosteroids D06AX02 - chloramphenicol ; Belongs to the class

of other topical antibiotics used in the treatment
of dermatological diseases.
Quinolones J01MA12 - levofloxacin ; Belongs to the class of

of infections.
supplements.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) M01AX17 - nimesulide ; Belongs to the class of

Cancer Hormone Therapy L02BG06 - exemestane ; Belongs to the class of

enzyme inhibitors. Used in endocrine therapy.

Analgesics (Non-Opioid) & Antipyretics N02BB52 - metamizole sodium, combinations

excl. psycholeptics ; Belongs to the class of
pyrazolone preparations. Used to relieve pain and
fever.
Anti-TB Agents J04AK02 - ethambutol ; Belongs to the class of

other drugs used in the systemic treatment of
tuberculosis.
Macrolides J01FA01 - erythromycin ; Belongs to the class of

infections.
Antiparkinsonian Drugs N04AA01 - trihexyphenidyl ; Belongs to the class

of tertiary amines anticholinergic agents. Used in
the management of Parkinson's disease.
Antimalarials P01BE02 - artemether ; Belongs to the class of
artemisinin and derivative antimalarials.
Antiglaucoma Preparations S01ED05 - carteolol ; Belongs to the class of beta

blocking agents. Used in the treatment of
glaucoma.
Anticoagulants, Antiplatelets & Fibrinolytics B01AC04 - clopidogrel ; Belongs to the class of


Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) M01AE51 - ibuprofen, combinations ; Belongs to

products.
Other Drugs Acting on Musculo-Skeletal System M01AX21 - diacerein ; Belongs to the class of

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) M01AC02 - tenoxicam ; Belongs to the class of

products, oxicams.

products, oxicams.
Haemostatics B02AA02 - tranexamic acid ; Belongs to the class

of amino acid antifibrinolytics. Used in the
Anticoagulants, Antiplatelets & Fibrinolytics B01AC06 - acetylsalicylic acid ; Belongs to the

(Thrombolytics) class of platelet aggregation inhibitors excluding
heparin. Used in the treatment of thrombosis.
Anthelmintics P02CB01 - piperazine ; Belongs to the class of

piperazine and derivatives agents. Used as
antinematodal.
Anthelmintics P02CB01 - piperazine ; Belongs to the class of

piperazine and derivatives agents. Used as
antinematodal.
Vitamins &/or Minerals A11EB - Vitamin B-complex with vitamin C ; Used

supplements.

Intravenous & Other Sterile Solutions B05BB01 - electrolytes ; Belongs to the class of
solutions affecting the electrolyte balance used in
I.V. solutions.
Antacids, Antireflux Agents & Antiulcerants A02AF01 - magaldrate and antiflatulents ; Belongs
to the class of antacids with antiflatulents.
Vitamin C A11GA01 - ascorbic acid (vit C) ; Belongs to the

class of ascorbic acid (vitamin C). Used as dietary
supplements.
Antiasthmatic & COPD Preparations R03CC02 - salbutamol ; Belongs to the class of
adrenergics for systemic use, selective beta-2-
Antiasthmatic & COPD Preparations R03DB04 - theophylline and adrenergics ; Belongs

to the class of xanthines and adrenergics. Used in
the systemic treatment of obstructive airway
diseases.

diseases.

diseases.
Electrolytes A12BA - Potassium ; Used as dietary supplements.
Cephalosporins J01DC07 - cefotiam ; Belongs to the class of

second-generation cephalosporins. Used in the
Analgesics (Non-Opioid) & Antipyretics / B01AC06 - acetylsalicylic acid ; Belongs to the

Anticoagulants, Antiplatelets & Fibrinolytics class of platelet aggregation inhibitors excluding
(Thrombolytics) heparin. Used in the treatment of thrombosis.
Analgesics (Non-Opioid) & Antipyretics N02BA01 - acetylsalicylic acid ; Belongs to the

class of salicylic acids and derivatives agents.
Used to relieve pain and fever.


Vitamins &/or Minerals A11JC - Vitamins, other combinations ; Used as

Antiasthmatic & COPD Preparations R03AC02 - salbutamol ; Belongs to the class of

adrenergic inhalants, selective beta-2-

diseases.

Cough & Cold Preparations R05DB24 - tipepidine ; Belongs to the class of

other cough suppressants.
Antiasthmatic & COPD Preparations R03AC16 - procaterol ; Belongs to the class of

Anxiolytics N05BA06 - lorazepam ; Belongs to the class of


Emollients, Cleansers & Skin Protectives D11AX - Other dermatologicals ; Used in the



Cardiac Drugs C01EB10 - adenosine ; Belongs to the class of

Neuromuscular Blocking Agents M03AC04 - atracurium ; Belongs to the class of

other quaternary ammonium-containing agents
used as peripherally-acting muscle relaxants.
Neuromuscular Blocking Agents M03AC04 - atracurium ; Belongs to the class of

other quaternary ammonium-containing agents
used as peripherally-acting muscle relaxants.
products.

products, oxicams.
Antiasthmatic & COPD Preparations R03BB01 - ipratropium bromide ; Belongs to the

class of other inhalants used in the treatment of
obstructive airway diseases, anticholinergics.


Antidepressants N06AG02 - moclobemide ; Belongs to the class of

monoamine oxidase A inhibitors. Used in the
management of depression.

Acne Treatment Preparations / Emollients, Cleansers & D10AX03 - azelaic acid ; Belongs to the class of
Skin Protectives other topical preparations used in the treatment
of acne.
Nasal Decongestants & Other Nasal Preparations R01AD12 - fluticasone furoate ; Belongs to the
class of topical corticosteroids used for
prophylaxis and treatment of allergic rhinitis.
Antidiabetic Agents A10BD03 - metformin and rosiglitazone ; Belongs

diabetes.
Antidiabetic Agents A10BD04 - glimepiride and rosiglitazone ; Belongs

diabetes.
Antidiabetic Agents A10BG02 - rosiglitazone ; Belongs to the class of
thiazolidinediones. Used in the treatment of
diabetes.
Vaccines, Antisera & Immunologicals J07BC02 - hepatitis A, inactivated, whole virus ;

Belongs to the class of hepatitis viral vaccines.
Quinolones J01MA14 - moxifloxacin ; Belongs to the class of

of infections.
Supportive Care Therapy D06BX - Other chemotherapeutics ; Used in the

Antihistamines & Antiallergics R06AB05 - pheniramine ; Belongs to the class of

substituted alkylamines used as systemic
antihistamines.
Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / P01BA01 - chloroquine ; Belongs to the class of

Antimalarials aminoquinoline antimalarials.
Antihistamines & Antiallergics R06AE09 - levocetirizine ; Belongs to the class of

piperazine derivatives used as systemic
antihistamines.
Drugs for Bladder & Prostate Disorders G04CB02 - dutasteride ; Belongs to the class of
testosterone-5-alpha reductase inhibitors. Used in
the treatment of benign prostatic hypertrophy.
Supplements & Adjuvant Therapy A11HA - Other plain vitamin preparations ; Used

Acne Treatment Preparations D10AX03 - azelaic acid ; Belongs to the class of
other topical preparations used in the treatment
of acne.
Immunosuppressants / Disease-Modifying Anti- L04AX01 - azathioprine ; Belongs to the class of

Rheumatic Drugs (DMARDs) other immunosuppressants.
Macrolides J01FA10 - azithromycin ; Belongs to the class of

infections.

Androgens & Related Synthetic Drugs G03XA01 - danazol ; Belongs to the class of
antigonadotropins and similar agents.
infections.
Antiglaucoma Preparations S01EC04 - brinzolamide ; Belongs to the class of

carbonic anhydrase inhibitors. Used in the
treatment of glaucoma.

infections.

supplements.
Eye Anti-Infectives & Antiseptics S01AA26 - azithromycin ; Belongs to the class of

antibiotics. Used in the treatment of eye
infections.
Anti-TB Agents J04AM03 - ethambutol and isoniazid ; Belongs to

the class of combination drugs used in the
systemic treatment of tuberculosis.
Anti-TB Agents J04AK02 - ethambutol ; Belongs to the class of

other drugs used in the systemic treatment of
tuberculosis.
Cephalosporins J01DD62 - cefoperazone, combinations ; Belongs

to the class of third-generation cephalosporins.
Used in the systemic treatment of infections.
Penicillins J01CR01 - ampicillin and enzyme inhibitor ;
Surgical Dressings & Wound Care D09AA12 - chlorhexidine ; Belongs to the class of
ointment dressings with antiinfectives.
Quinolones J01MA02 - ciprofloxacin ; Belongs to the class of

of infections.

Topical Antibiotics D06AX09 - mupirocin ; Belongs to the class of

Antibacterial Combinations J01EE01 - sulfamethoxazole and trimethoprim ;

Belongs to the class of combinations of
sulfonamides and trimethoprim, including
derivatives. Used in the systemic treatment of
infections.

infections.
infections.
Topical Antibiotics D06AX09 - mupirocin ; Belongs to the class of

Other Cardiovascular Drugs M02AX10 - various ; Belongs to the class of other

topical products used in the treatment of joint
and muscular pains.
Topical Antibiotics D06AX07 - gentamicin ; Belongs to the class of

Drugs for Neuropathic Pain / Anticonvulsants N03AF01 - carbamazepine ; Belongs to the class
of carboxamide derivatives antiepileptic.
Cephalosporins J01DD13 - cefpodoxime ; Belongs to the class of

Eye Anti-Infectives & Antiseptics S01AE03 - ciprofloxacin ; Belongs to the class of

quinolone antiinfectives. Used in the treatment of
eye infections.

of infections.
Antivirals J05AF10 - entecavir ; Belongs to the class of
infections.
Peripheral Vasodilators & Cerebral Activators / N07CA03 - flunarizine ; Belongs to the class of
Antiemetics antivertigo preparations.
Anticonvulsants N03AF02 - oxcarbazepine ; Belongs to the class of

carboxamide derivatives antiepileptic.
Topical Antifungals & Antiparasites D01AE14 - ciclopirox ; Belongs to the class of

other antifungals for topical use.
Supplements & Adjuvant Therapy G04BX - Other urologicals ; Used in the treatment
of urological problems.

Cephalosporins J01DD01 - cefotaxime ; Belongs to the class of
Topical Anti-Infectives with Corticosteroids D01AC20 - imidazoles/triazoles in combination

with corticosteroids ; Belongs to the class of
Beta-Blockers C07AB07 - bisoprolol ; Belongs to the class of

selective beta-blocking agents. Used in the
treatment of cardiovascular diseases.

Enteral/Nutritional Products V06DF - Milk substitutes ; Used as general

nutrients.



Infant Nutritional Products V06DF - Milk substitutes ; Used as general
nutrients.

nutrients.

nutrients.
Antacids, Antireflux Agents & Antiulcerants A02BX - Other drugs for peptic ulcer and gastro-
oesophageal reflux disease (GORD) ; Used in the
treatment of peptic ulcer and gastro-oesophageal
reflux disease (GERD).
Vitamins &/or Minerals A11JA - Combinations of vitamins ; Used as


Antiasthmatic & COPD Preparations R01AD01 - beclometasone ; Belongs to the class

of topical corticosteroids used for prophylaxis and
treatment of allergic rhinitis.
Nasal Decongestants & Other Nasal Preparations A07EA07 - beclometasone ; Belongs to the class
of corticosteroids acting locally. Used in the
treatment of intestinal inflammation.
Nootropics & Neurotonics/Neurotrophics / Peripheral N06BX06 - citicoline ; Belongs to the class of

Vasodilators & Cerebral Activators other psychostimulants and nootropics.
supplements.
Vitamin B-Complex / with C A11DB - Vitamin B1 in combination with vitamin

B6 and/or vitamin B12 ; Used as dietary
supplements.
Vitamin B-Complex / with C A11EC - Vitamin B-complex with minerals ; Used

Vitamins &/or Minerals A11EB - Vitamin B-complex with vitamin C ; Used


supplements.
Nasal Decongestants & Other Nasal Preparations R01AD01 - beclometasone ; Belongs to the class
of topical corticosteroids used for prophylaxis and
treatment of allergic rhinitis.
Vitamins & Minerals (Pre & Post Natal) / Antianemics B03BB51 - folic acid, combinations ; Belongs to
the class of folic acid and derivatives. Used in the

supplements.
Antidiarrheals A07BA01 - medicinal charcoal ; Belongs to the

class of charcoal preparations. Used as intestinal
adsorbents.

Antimigraine Preparations N02CA72 - ergotamine, combinations with

psycholeptics ; Belongs to the class of ergot
alkaloids preparations. Used to relieve migraine.
Supportive Care Therapy / Analgesics (Opioid) N02AX02 - tramadol ; Belongs to the class of
Vitamins & Minerals (Paediatric) B03AB03 - sodium feredetate ; Belongs to the

class of oral iron trivalent preparations. Used in
the treatment of anemia.


cough.
Antihistamines & Antiallergics R06AA02 - diphenhydramine ; Belongs to the

class of aminoalkyl ethers used as systemic
antihistamines.

cough.

suppressant.
Supplements & Adjuvant Therapy C10AX - Other lipid modifying agents ; Used in the
Anti-TB Agents J04AC51 - isoniazid, combinations ; Belongs to the

class of hydrazides. Used in the systemic
treatment of tuberculosis.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) M01AB01 - indometacin ; Belongs to the class of

products.

Antacids, Antireflux Agents & Antiulcerants A02BX02 - sucralfate ; Belongs to the class of
other drugs used in the treatment of peptic ulcer
and gastro-oesophageal reflux disease (GERD).
Antidiabetic Agents A10BA02 - metformin ; Belongs to the class of

biguanides. Used in the treatment of diabetes.
Antihistamines & Antiallergics R06AB05 - pheniramine ; Belongs to the class of

substituted alkylamines used as systemic
antihistamines.
Antacids, Antireflux Agents & Antiulcerants A02BA01 - cimetidine ; Belongs to the class of H2-
disease (GERD).
Corticosteroid Hormones H02AB01 - betamethasone ; Belongs to the class

of glucocorticoids. Used in systemic corticosteroid
preparations.
Topical Anti-Infectives with Corticosteroids D07CC01 - betamethasone and antibiotics ;

corticosteroids, in combination with antibiotics.




supplements.

Digestives A09AA02 - multienzymes (lipase, protease etc.) ;
Belongs to the class of enzyme preparations used
as digestives.
Parenteral Nutritional Products V06DE - Amino

Acne Treatment Preparations D10AE01 - benzoyl peroxide ; Belongs to the class

of topical peroxide preparations used in the
treatment of acne.
Acne Treatment Preparations D10AE51 - benzoyl peroxide, combinations ;

Belongs to the class of topical peroxide
preparations used in the treatment of acne.
Skin Antiseptics & Disinfectants D08AJ04 - cetrimide ; Belongs to the class of

quaternary ammonium compound antiseptics.
Emollients, Cleansers & Skin Protectives D11AX13 - monobenzone ; Belongs to the class of
Emollients, Cleansers & Skin Protectives D03AX03 - dexpanthenol ; Belongs to the class of
other cicatrizants. Used in the treatment of
wounds and ulcers.
Topical Corticosteroids D07XC01 - betamethasone ; Belongs to the class

of potent (group III) corticosteroids in other
combinations. Used in the treatment of

Haemostatics B02BB - Fibrinogen ; Used in the treatment of

hemorrhage.
Topical Corticosteroids D07AA02 - hydrocortisone ; Belongs to the class

of weak (group I) corticosteroids. Used in the



Topical Antifungals & Antiparasites D01AC01 - clotrimazole ; Belongs to the class of

Vitamin B-Complex / with C A11EA - Vitamin B-complex, plain ; Used as

of infections.

supplements.
Antiasthmatic & COPD Preparations R03AL01 - fenoterol and ipratropium bromide ;

Belongs to the class of adrenergics in combination
with anticholinergics. Used in the treatment of
Antiasthmatic & COPD Preparations R03AC04 - fenoterol ; Belongs to the class of
Supplements & Adjuvant Therapy B05XC - Vitamins ; Used in I.V. solutions.
Topical Corticosteroids D07AD01 - clobetasol ; Belongs to the class of

very potent (group IV) corticosteroids. Used in the
Nootropics & Neurotonics/Neurotrophics B03BA05 - mecobalamin ; Belongs to the class of

vitamin B12 (cyanocobalamin and analogues).
Digestives A09AA02 - multienzymes (lipase, protease etc.) ;

Belongs to the class of enzyme preparations used
as digestives.
Antihistamines & Antiallergics N05BB01 - hydroxyzine ; Belongs to the class of
diphenylmethane derivatives anxiolytics. Used in

Vitamin B-Complex / with C A11DA01 - thiamine (vit B1) ; Belongs to the class
of vitamin B1. Used as dietary supplements.

of infections.
Beta-Blockers / Calcium Antagonists C07FB03 - atenolol and other antihypertensives ;

Belongs to the class of selective beta-blocking
agents in combination with other
antihypertensives. Used in the treatment of
cardiovascular diseases.
Beta-Blockers C07AB03 - atenolol ; Belongs to the class of



Preparations for Oral Ulceration & Inflammation R02AA15 - povidone-iodine ; Belongs to the class
of antiseptics used in throat preparations.
Psoriasis, Seborrhea & Ichthyosis Preparations D11AC06 - povidone-iodine ; Belongs to the class
of medicated shampoos.
Preparations for Vaginal Conditions G01AX11 - povidone-iodine ; Belongs to the class

of other antiinfectives and antiseptics. Used in
the treatment of gynecological infections.
Vaccines, Antisera & Immunologicals L03AB08 - interferon beta-1b ; Belongs to the

class of interferons. Used as immunostimulants.
Quinolones J01MA01 - ofloxacin ; Belongs to the class of

of infections.

supplements.
Eye Antiseptics with Corticosteroids S01CA05 - betamethasone and antiinfectives ;

Belongs to the class of corticosteroids in
combination with antiinfectives. Used in the
treatment of eye diseases.
Antacids, Antireflux Agents & Antiulcerants A02BC03 - lansoprazole ; Belongs to the class of
proton pump inhibitors. Used in the treatment of
disease (GERD).

Eye Corticosteroids S01BA06 - betamethasone ; Belongs to the class

of corticosteroids. Used in the treatment of
inflammation of the eye.
Antihistamines & Antiallergics R06AE07 - cetirizine ; Belongs to the class of

antihistamines.
Antivertigo Drugs N07CA01 - betahistine ; Belongs to the class of

antivertigo preparations.
Supplements & Adjuvant Therapy A16AX - Various alimentary tract and metabolism
products ; Used in treatment of alimentary tract
and metabolism problems.
Corticosteroid Hormones H02AB01 - betamethasone ; Belongs to the class

preparations.
Antivertigo Drugs N07CA01 - betahistine ; Belongs to the class of

Emollients, Cleansers & Skin Protectives D02AX - Other emollients and protectives ; Used
as skin emollients and protectants.



Miotic Drugs S01ED02 - betaxolol ; Belongs to the class of beta

blocking agents. Used in the treatment of
glaucoma.


Vitamins &/or Minerals A13A - TONICS ; Used as tonics.

supplements.

supplements.

supplements.

supplements.
Dyslipidaemic Agents C10AB02 - bezafibrate ; Belongs to the class of
fibrates. Used in the treatment of hyperlipidemia.
Other Antibiotics J01XD01 - metronidazole ; Belongs to the class of

imidazole derivative antibacterials. Used in the
Laxatives, Purgatives A06AG02 - bisacodyl ; Belongs to the class of

enemas. Used in the treatment of constipation.
Macrolides J01FA09 - clarithromycin ; Belongs to the class of

infections.


supplements.
Cephalosporins J01DD12 - cefoperazone ; Belongs to the class of

Peripheral Vasodilators & Cerebral Activators A13A - TONICS ; Used as tonics.

Antidiarrheals A12CB01 - zinc sulfate ; Belongs to the class of

zinc-containing preparations. Used as dietary
supplements.


infections.

Acne Treatment Preparations D10AX30 - various combinations ; Belongs to the

class of other topical preparations used in the
treatment of acne.
Vaccines, Antisera & Immunologicals J06AA01 - diphtheria antitoxin ; Belongs to the

class of immune sera. Used in the treatment of
acute infectious diseases caused by toxigenic
strains.
Other Cardiovascular Drugs C01EB10 - adenosine ; Belongs to the class of

Supplements & Adjuvant Therapy V01AA08 - food ; Belongs to the class of allergen
extracts. Used as antigenic substances capable of
producing immediate-type hypersensitivity.
Calcium/with Vitamins A11AA02 - multivitamins and calcium ; Belongs to
the class of multivitamins with minerals. Used as

supplements.
Other Dermatologicals / Emollients, Cleansers & Skin D02AX - Other emollients and protectives ; Used
Protectives as skin emollients and protectants.

infections.
Topical Antibiotics D06AX07 - gentamicin ; Belongs to the class of

Antidiarrheals A07BC04 - attapulgite ; Belongs to the class of

other intestinal adsorbents.

Vitamins A, D & E A11HA03 - tocopherol (vit E) ; Belongs to the class

of other plain vitamin preparations. Used as
Vitamins & Minerals (Pre & Post Natal) / Antianemics B03AD - Iron in combination with folic acid ; Used
in the treatment of anemia
Oral Care A01AD11 - various ; Belongs to the class of other

agents for local oral treatment.

fever.
GIT Regulators, Antiflatulents & Anti-Inflammatories G01AX14 - lactobacillus fermentum ; Belongs to

the class of other antiinfectives and antiseptics.
Used in the treatment of gynecological infections.
Antifungals D01BA01 - griseofulvin ; Belongs to the class of

antifungals for systemic use.
Supplements & Adjuvant Therapy A02AA - Magnesium compounds ; Used in the

treatment of acid-related disorders.
supplements.
supplements.
supplements.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) A11EX - Vitamin B-complex, other combinations ;

Used as dietary supplements.

supplements.

Surgical Dressings & Wound Care D11AX - Other dermatologicals ; Used in the
Other Dermatologicals / Surgical Dressings & Wound D03AX05 - hyaluronic acid ; Belongs to the class
Care of other cicatrizants. Used in the treatment of
wounds and ulcers.
Vitamins & Minerals (Pre & Post Natal) / Antianemics B03AE02 - iron, multivitamins and folic acid ;

supplements.
Vitamins & Minerals (Paediatric) A11AA02 - multivitamins and calcium ; Belongs to

Emollients, Cleansers & Skin Protectives D11AX - Other dermatologicals ; Used in the
Topical Antibiotics D06AX04 - neomycin ; Belongs to the class of

Surgical Dressings & Wound Care B02BC08 - calcium alginate ; Belongs to the class
of local hemostatics. Used in the treatment of
hemorrhage.
Topical Antibiotics D06AX04 - neomycin ; Belongs to the class of

ACE Inhibitors/Direct Renin Inhibitors C09AA04 - perindopril ; Belongs to the class of
ACE inhibitors. Used in the treatment of
Diuretics / ACE Inhibitors/Direct Renin Inhibitors C09BA04 - perindopril and diuretics ; Belongs to
the class of ACE inhibitors in combination with
diuretics. Used in the treatment of cardiovascular
disease.
Other Dermatologicals D11AX11 - hydroquinone ; Belongs to the class of


Vitamins A, D & E V04CB01 - vitamin A concentrates ; Belongs to the

class of diagnostic agents used to test for fat
absorption.

Vitamins & Minerals (Pre & Post Natal) / Antianemics B03AE10 - various combinations ; Belongs to the
class of iron in other combinations. Used in the
Vaccines, Antisera & Immunologicals J06AA02 - tetanus antitoxin ; Belongs to the class
of immune sera. Used in the treatment of acute
infectious diseases caused by toxigenic strains.
Vaccines, Antisera & Immunologicals J06AA03 - snake venom antiserum ; Belongs to

the class of immune sera. Used in the treatment
of acute infectious diseases caused by toxigenic
strains.
Macrolides J01FA06 - roxithromycin ; Belongs to the class of

infections.
supplements.
Vitamin B-Complex / with C A11DA03 - benfotiamine ; Belongs to the class of

vitamin B1. Used as dietary supplements.
Chloramphenicols J01BA02 - thiamphenicol ; Belongs to the class of

amphenicols. Used in the systemic treatment of
infections.
Emollients, Cleansers & Skin Protectives A11HA01 - nicotinamide ; Belongs to the class of
other plain vitamin preparations. Used as dietary
supplements.


supplements.
Oral Care A01AD11 - various ; Belongs to the class of other

agents for local oral treatment.

Cough & Cold Preparations R05DA09 - dextromethorphan ; Belongs to the

class of opium alkaloids and derivatives. Used as
cough suppressant.
Cough & Cold Preparations R05CB02 - bromhexine ; Belongs to the class of








Diuretics / Beta-Blockers C07BB07 - bisoprolol and thiazides ; Belongs to

the class of selective beta-blocking agents in
combination with thiazides. Used in the
Nasal Decongestants & Other Nasal Preparations R01AX30 - combinations ; Belongs to the class of
other nasal preparations for topical use.
Ear Antiseptics with Corticosteroids G01BD - Antiseptics and corticosteroids ; Used in

Eye Antiseptics with Corticosteroids G01BD - Antiseptics and corticosteroids ; Used in

Drugs Acting on the Uterus G02AB01 - methylergometrine ; Belongs to the

class of ergot alkaloids. Used to induce abortion
or augment labour and to minimize blood loss
from the placental site.
Cytotoxic Chemotherapy L01DC01 - bleomycin ; Belongs to the class of

other cytotoxic antibiotics. Used in the treatment
of cancer.
Cytotoxic Chemotherapy L01DC01 - bleomycin ; Belongs to the class of

other cytotoxic antibiotics. Used in the treatment
of cancer.
Other Eye Preparations S01XA - Other ophthalmologicals ; Used in

ophthalmic preparations.
Trophic Hormones & Related Synthetic Drugs G03GB02 - clomifene ; Belongs to the class of
synthetic agents used as ovulation stimulants.
Calcium Antagonists C08CA04 - nicardipine ; Belongs to the class of

Other Cardiovascular Drugs A13A - TONICS ; Used as tonics.
Angiotensin II Antagonists C09CA06 - candesartan ; Belongs to the class of

Diuretics / Angiotensin II Antagonists C09DA06 - candesartan and diuretics ; Belongs to
the class of angiotensin II antagonists in
combination with diuretics. Used in the treatment
Beta-Blockers C07AG02 - carvedilol ; Belongs to the class of

alpha and beta blocking agents. Used in the
Psoriasis, Seborrhea & Ichthyosis Preparations D11AX - Other dermatologicals ; Used in the
Psoriasis, Seborrhea & Ichthyosis Preparations D02AB - Zinc products ; Used as skin emollients
and protectants.





Analgesics (Non-Opioid) & Antipyretics M01AE51 - ibuprofen, combinations ; Belongs to
products.
Cough & Cold Preparations / Analgesics (Non-Opioid) & R01BA52 - pseudoephedrine, combinations ;
Antipyretics Belongs to the class of systemic sympathomimetic
Cough & Cold Preparations / Analgesics (Non-Opioid) & R01BA52 - pseudoephedrine, combinations ;
Antipyretics Belongs to the class of systemic sympathomimetic

fever.

Analgesics (Non-Opioid) & Antipyretics N02BA01 - acetylsalicylic acid ; Belongs to the

class of salicylic acids and derivatives agents.
Used to relieve pain and fever.

fever.
Cough & Cold Preparations / Analgesics (Non-Opioid) & N02BE51 - paracetamol, combinations excl.
Antipyretics psycholeptics ; Belongs to the class of anilide

Other Drugs Acting on Musculo-Skeletal System M01AX21 - diacerein ; Belongs to the class of
Agents Affecting Bone Metabolism M05BA02 - clodronic acid ; Belongs to the class of
bisphosphonates. Used in the treatment of bone
diseases.
Agents Affecting Bone Metabolism M05BX - Other drugs affecting bone structure and
mineralization ; Used in the treatment of bone
diseases.
Supportive Care Therapy / Agents Affecting Bone M05BA06 - ibandronic acid ; Belongs to the class
Metabolism of bisphosphonates. Used in the treatment of
bone diseases.
Agents Affecting Bone Metabolism A11CC03 - alfacalcidol ; Belongs to the class of

vitamin D and analogues. Used as dietary
supplements.
Other Drugs Acting on Musculo-Skeletal System M01AX - Other antiinflammatory and
antirheumatic agents, non-steroids ; Used in the
treatment of inflammation and rheumatism.
Vaccines, Antisera & Immunologicals J07AJ52 - pertussis, purified antigen,

combinations with toxoids ; Belongs to the class
of pertussis bacterial vaccines.
Anorectal Preparations C05AD03 - benzocaine ; Belongs to the class of

local anesthetics. Used in the topical treatment of
hemorrhoids and anal fissures.
Anorectal Preparations C05AA04 - prednisolone ; Belongs to the class of

products containing corticosteroids for topical
use. Used in the treatment of hemorrhoids and
anal fissures.
Other Dermatologicals / Muscle Relaxants / Other Eye M03AX01 - botulinum toxin ; Belongs to the class
Preparations of other agents used as peripherally-acting
muscle relaxants.


supplements.
Eye Anti-Infectives & Antiseptics J01GB01 - tobramycin ; Belongs to the class of

other aminoglycosides. Used in the systemic
Eye Antiseptics with Corticosteroids S01CA01 - dexamethasone and antiinfectives ;

Belongs to the class of corticosteroids in
combination with antiinfectives. Used in the
treatment of eye diseases.

Trophic Hormones & Related Synthetic Drugs G03GA04 - urofollitropin ; Belongs to the class of
gonadotropins. Used as ovulation stimulants.
Topical Corticosteroids D07AC04 - fluocinolone acetonide ; Belongs to

the class of potent (group III) corticosteroids.
Topical Anti-Infectives with Corticosteroids D07CC02 - fluocinolone acetonide and

antibiotics ; Belongs to the class of potent (group
III) corticosteroids, in combination with
antibiotics. Used in the treatment of
Antispasmodics A03CA02 - clidinium and psycholeptics ; Belongs

to the class of synthetic anticholinergic
antispasmodics, in combination with
psycholeptics. Used in the treatment of functional
Peripheral Vasodilators & Cerebral Activators N07CA02 - cinnarizine ; Belongs to the class of
Nasal Decongestants & Other Nasal Preparations R01AX10 - various ; Belongs to the class of other
nasal preparations for topical use.

Peripheral Vasodilators & Cerebral Activators N06DX02 - Ginkgo folium ; Belongs to the class of
other anti-dementia drugs.
Cytotoxic Chemotherapy L01CD02 - docetaxel ; Belongs to the class of

plant alkaloids and other natural products,
taxanes. Used in the treatment of cancer.
Antiasthmatic & COPD Preparations R03AC03 - terbutaline ; Belongs to the class of

Antiasthmatic & COPD Preparations R03CC53 - terbutaline, combinations ; Belongs to

the class of adrenergics for systemic use, selective
beta-2-adrenoreceptor agonists. Used in the
treatment of obstructive airway diseases.
Anticoagulants, Antiplatelets & Fibrinolytics B01AC24 - ticagrelor ; Belongs to the class of

Cough & Cold Preparations R05DA09 - dextromethorphan ; Belongs to the

class of opium alkaloids and derivatives. Used as
cough suppressant.


Cough & Cold Preparations A08AA56 - ephedrine, combinations ; Belongs to

the class of centrally acting antiobesity products.
Used in the treatment of obesity.
Cough & Cold Preparations R05CB03 - carbocisteine ; Belongs to the class of

Antiasthmatic & COPD Preparations R03DA04 - theophylline ; Belongs to the class of



Other Drugs Acting on the Respiratory System J07AX - Other bacterial vaccines ; Used for active
immunizations.







Anaesthetics - Local & General N01BB01 - bupivacaine ; Belongs to the class of

amides. Used as local anesthetics.
GIT Regulators, Antiflatulents & Anti-Inflammatories A07EA06 - budesonide ; Belongs to the class of
corticosteroids acting locally. Used in the
treatment of intestinal inflammation.


Preparations for Oral Ulceration & Inflammation D07AB09 - triamcinolone ; Belongs to the class of
moderately potent (group II) corticosteroids. Used
in the treatment of dermatological diseases.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) D11AX18 - diclofenac ; Belongs to the class of


Antihistamines & Antiallergics R06AB02 - dexchlorpheniramine ; Belongs to the

class of substituted alkylamines used as systemic
antihistamines.


Topical Antibiotics D06BA01 - silver sulfadiazine ; Belongs to the

class of topical sulfonamides used in the
Antispasmodics A03BB01 - butylscopolamine ; Belongs to the

class of belladonna alkaloids, semisynthetic,
quaternary ammonium compounds. Used in the
treatment of functional gastrointestinal disorders.
Antispasmodics A03DB04 - butylscopolamine and analgesics ;

Belongs to the class of belladonna and derivatives
antispasmodics in combination with analgesics.
Used in the treatment of functional
Antispasmodics A03BB01 - butylscopolamine ; Belongs to the
class of belladonna alkaloids, semisynthetic,
quaternary ammonium compounds. Used in the
treatment of functional gastrointestinal disorders.
Anxiolytics N05BE01 - buspirone ; Belongs to the class of

azaspirodecanedione derivatives anxiolytics. Used
in the management of anxiety, agitation or
tension.





Calcium/with Vitamins A12AX - Calcium, combinations with vitamin D

and/or other drugs ; Used as dietary
supplements.
Dyslipidaemic Agents / Anti-Anginal Drugs / Calcium C10BX03 - atorvastatin and amlodipine ; Belongs
Antagonists to the class of HMG CoA reductase inhibitors,
other combinations.

Antimigraine Preparations N02CA52 - ergotamine, combinations excl.

psycholeptics ; Belongs to the class of ergot
alkaloids preparations. Used to relieve migraine.

Topical Corticosteroids D07AA02 - hydrocortisone ; Belongs to the class

of weak (group I) corticosteroids. Used in the
fever.
Electrolytes A12AA02 - calcium glubionate ; Belongs to the

class of calcium-containing preparations. Used as
Calcium/with Vitamins A11AA03 - multivitamins and other minerals, incl.

supplements.

Calcium/with Vitamins A12AA - Calcium ; Used as dietary supplements.

supplements.


supplements.

supplements.


Agents Affecting Bone Metabolism A11CC04 - calcitriol ; Belongs to the class of

vitamin D and analogues. Used as dietary
supplements.
supplements.
Supportive Care Therapy V03AF03 - calcium folinate ; Belongs to the class

of detoxifying agents used in antineoplastic
treatment.
Calcium/with Vitamins A12AA05 - calcium lactate ; Belongs to the class

of calcium-containing preparations. Used as
Antidotes & Detoxifying Agents V03AF04 - calcium levofolinate ; Belongs to the

class of detoxifying agents used in antineoplastic
treatment.
Calcium/with Vitamins A11JB - Vitamins with minerals ; Used as dietary

supplements.
Vitamins &/or Minerals A11AA02 - multivitamins and calcium ; Belongs to


supplements.
Vitamins & Minerals (Paediatric) A11AB - Multivitamins, other combinations ; Used

Vitamins & Minerals (Pre & Post Natal) / Antianemics B03AE02 - iron, multivitamins and folic acid ;
Calcium/with Vitamins A12AA04 - calcium carbonate ; Belongs to the


supplements.

supplements.

fever.
Calcium/with Vitamins A02AC01 - calcium carbonate ; Belongs to the

class of calcium-containing antacids.

supplements.
Vitamins &/or Minerals A11JC - Vitamins, other combinations ; Used as

Calcium/with Vitamins A11JC - Vitamins, other combinations ; Used as



supplements.

Calcium/with Vitamins A11GB01 - ascorbic acid (vit C) and calcium ;

Belongs to the class of ascorbic acid (vitamin C),
with other combinations. Used as dietary
supplements.

supplements.
supplements.

supplements.

Cephalosporins J01DD02 - ceftazidime ; Belongs to the class of


supplements.
Calcium/with Vitamins A11JB - Vitamins with minerals ; Used as dietary

supplements.


products, oxicams.
Corticosteroid Hormones H02AB02 - dexamethasone ; Belongs to the class

preparations.
Analgesics (Opioid) N02AX02 - tramadol ; Belongs to the class of

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) M01AC01 - piroxicam ; Belongs to the class of
products, oxicams.
Cytotoxic Chemotherapy L01XX19 - irinotecan ; Belongs to the class of

other antineoplastic agents. Used in the
Topical Anti-Infectives with Corticosteroids D01AC - Imidazole and triazole derivatives ; Used
in the topical treatment of fungal infection.


Antifungals J02AC01 - fluconazole ; Belongs to the class of

triazole derivatives. Used in the systemic
treatment of mycotic infections.
Antifungals A07AA02 - nystatin ; Belongs to the class of

antibiotics. Used in the treatment of intestinal
infections.


supplements.
Supplements & Adjuvant Therapy V06DB -



Preparations for Vaginal Conditions G01AF02 - clotrimazole ; Belongs to the class of
imidazole derivative antiinfectives. Used in the
treatment of gynecological infections.
Chloramphenicols J01BA02 - thiamphenicol ; Belongs to the class of

amphenicols. Used in the systemic treatment of
infections.
Antispasmodics A03AB12 - mepenzolate ; Belongs to the class of

synthetic anticholinergics, quaternary ammonium
compounds. Used in the treatment of functional
bowel disorders.
Antacids, Antireflux Agents & Antiulcerants A02BC03 - lansoprazole ; Belongs to the class of
disease (GERD).
Drugs for Erectile Dysfunction & Ejaculatory Disorders G04BE03 - sildenafil ; Belongs to the class of
drugs used in erectile dysfunction.
Other Beta-Lactams J01DH02 - meropenem ; Belongs to the class of
carbapenems. Used in the systemic treatment of
infections.

Antihistamines & Antiallergics R06AE07 - cetirizine ; Belongs to the class of

antihistamines.

Antacids, Antireflux Agents & Antiulcerants A02BC02 - pantoprazole ; Belongs to the class of
disease (GERD).
Cholagogues, Cholelitholytics & Hepatic Protectors A05B - LIVER THERAPY, LIPOTROPICS ; Used in
liver therapy.

Analgesics (Non-Opioid) & Antipyretics N01BX04 - capsaicin ; Belongs to the class of

other agents used as local anesthetics.
Drugs for Neuropathic Pain / Anticonvulsants N03AF01 - carbamazepine ; Belongs to the class
of carboxamide derivatives antiepileptic.
Beta-Blockers C07AG02 - carvedilol ; Belongs to the class of

alpha and beta blocking agents. Used in the






ACE Inhibitors/Direct Renin Inhibitors C09AA05 - ramipril ; Belongs to the class of ACE

supplements.

Cardiac Drugs C01CA07 - dobutamine ; Belongs to the class of

heart failure.

supplements.
Other Cardiovascular Drugs C01EX - Other cardiac combination products ;

Used in cardiac therapy.
Cardiac Drugs C01CA07 - dobutamine ; Belongs to the class of

heart failure.
Calcium Antagonists C08DA01 - verapamil ; Belongs to the class of

phenylalkylamine derivative selective calcium-
channel blockers with direct cardiac effects. Used
in the treatment of cardiovascular diseases.

Anti-Anginal Drugs C01DA14 - isosorbide mononitrate ; Belongs to

the class of organic nitrate vasodilators. Used in
the treatment of cardiac disease.

Other Antihypertensives / Drugs for Bladder & Prostate C02CA04 - doxazosin ; Belongs to the class of
Disorders alpha-adrenoreceptor antagonists, peripherally-
acting antiadrenergic agents. Used in the
treatment of hypertension.
Calcium Antagonists C08DB01 - diltiazem ; Belongs to the class of

benzothiazepine derivative selective calcium-
channel blockers with direct cardiac effects. Used
in the treatment of cardiovascular diseases.
Antiasthmatic & COPD Preparations R03DA - Xanthines ; Used in the systemic

treatment of obstructive airway diseases.
Emollients, Cleansers & Skin Protectives D02AE01 - carbamide ; Belongs to the class of
carbamide preparations used as skin emollients
and protectants.
Anti-Obesity Agents V06A - DIET FORMULATIONS FOR TREATMENT OF

OBESITY ; Used as general nutrients in diet
formulations for treatment of obesity.

Supplements & Adjuvant Therapy A16AA01 - levocarnitine ; Belongs to the class of
amino acids and derivatives products. Used in
treatment of alimentary tract and metabolism
problems.

Other Beta-Lactams J01DH02 - meropenem ; Belongs to the class of

carbapenems. Used in the systemic treatment of
infections.
Diuretics C03DA01 - spironolactone ; Belongs to the class

of aldosterone antagonists. Used as potassium-
sparing diuretics.
Other Cardiovascular Drugs C01EX - Other cardiac combination products ;

Used in cardiac therapy.
Other Cardiovascular Drugs A16AA01 - levocarnitine ; Belongs to the class of

amino acids and derivatives products. Used in
treatment of alimentary tract and metabolism
problems.
Calcium Antagonists C08CA04 - nicardipine ; Belongs to the class of

Other Drugs Acting on Musculo-Skeletal System M01AX25 - chondroitin sulfate ; Belongs to the
class of other non-steroidal antiinflammatory and

Cancer Hormone Therapy L02BB03 - bicalutamide ; Belongs to the class of

anti-androgens.
Cough & Cold Preparations R01BA51 - phenylpropanolamine, combinations ;

products.

products.

products.
Other Eye Preparations S01XA - Other ophthalmologicals ; Used in

ophthalmic preparations.

products.
Other Antihypertensives C02AC01 - clonidine ; Belongs to the class of
imidazoline receptor agonists, centrally-acting
antiadrenergic agents. Used in the treatment of
hypertension.

supplements.
Ophthalmic Lubricants S01KA - Viscoelastic substances ; Used as

ophthalmologic surgical aids.

supplements.
Vitamins &/or Minerals A11AA02 - multivitamins and calcium ; Belongs to
Antifungals A07AA02 - nystatin ; Belongs to the class of

antibiotics. Used in the treatment of intestinal
infections.

supplements.

supplements.
blood substitutes.

Other Dermatologicals / Emollients, Cleansers & Skin D02AX - Other emollients and protectives ; Used
Protectives as skin emollients and protectants.
supplements.
Supportive Care Therapy / Antiemetics A04AA01 - ondansetron ; Belongs to the class of

serotonin (5HT3) antagonists. Used for the
prevention of nausea and vomiting.
Anti-Anginal Drugs C01DA08 - isosorbide dinitrate ; Belongs to the

class of organic nitrate vasodilators. Used in the
treatment of cardiac disease.

supplements.
Cephalosporins J01DB01 - cefalexin ; Belongs to the class of first-




Cephalosporins J01DD01 - cefotaxime ; Belongs to the class of




Cephalosporins J01DB04 - cefazolin ; Belongs to the class of first-


Cephalosporins J01DD02 - ceftazidime ; Belongs to the class of





Cephalosporins J01DD07 - ceftizoxime ; Belongs to the class of




Regulatory Classification Presentation/Packing Off-Market
W 2-4 Zalf topical application
15 g x 1's (Rp2340.00/tube)
G 3TC tab 150 mg
60's (Rp436,364/pak)
G 3TC-HBV FC tab 100 mg
28's (Rp395,564/pak)
G 8Y inj 250 IU/10 mL 8Y inj 250 IU/10

mL
1's (Rp1,200,000/vial)
8Y inj 500 IU/20 mL 8Y inj 500 IU/20
mL
1's (Rp2,200,000/vial)
G Aafact inj 1000 IU

10 mL x 1's (Rp4,670,000/vial)
Aafact inj 500 IU
5 mL x 1's (Rp2,345,455/vial)
G A-B Vask tab 10 mg
30's (Rp195,000/pak)
A-B Vask tab 5 mg
30's (Rp105,000/pak)
G Abbotic Granule dry syr 125 mg/5 mL

Abbotic Granule dry syr 125 mg/5 mL
30 mL x 1's (Rp64,570/botol)
60 mL x 1's (Rp114,455/botol)
50 mL x 1's
Abbotic FC tab 500 mg
3 10's (Rp718,355/boks)
Abbotic XL MR tab 500 mg Abbotic XL
MR tab 500 mg
5 2's (Rp285,120/boks)
G Abilify Discmelt orally disintegrating tab
10 mg
1 10's
Abilify Discmelt orally disintegrating tab
15 mg
1 10's
G Abilify Oral Solution 1 mg/mL

150 mL x 1's (Rp512,250/botol)
G Abilify tab 10 mg
10's (Rp385,880/pak)
Abilify tab 15 mg
10's (Rp446,500/pak)
Abilify tab 5 mg
10's (Rp202,130/pak)
Abirom powd for inj 1 g

1's (Rp200,000/vial)
G Abixim cap 100 mg

3 10's (Rp360,000/boks)
Abixim cap 200 mg
1 10's (Rp180,000/boks)
Abixim dry syr 100 mg/5 mL
30 mL x 1's (Rp53,000/botol)
G Accolate FC tab 20 mg Accolate FC tab
20 mg
2 14's (Rp283,727/boks)
G Acdat cream 2%
5 g x 1's
X
G Acetensa tab 50 mg
3 10's (Rp255,000/boks)
G Acetin 600 effervescent tab 600 mg

1 10's (Rp82,000/boks)
G Acetram film-coated tab

10's (Rp49,500/pak)
G Acetylcysteine Yarindo infusion 200

mg/mL
25 mL x 1's
G Acifar caplet 200 mg button/view.png
10 10's (Rp83,600/boks)
Acifar caplet 400 mg button/view.png
3 10's (Rp46,860/boks)
G Acifar cream 5 % button/view.png

5 g x 1's (Rp9,926/tube)
G Aclam dry syr button/view.png

60 mL x 1's (Rp41,000/botol)
Aclam Forte dry syr button/view.png
60 mL x 1's (Rp60,000/botol)
Aclam FC caplet button/view.png
15's (Rp133,500/pak)
G Aclasta infusion 5 mg/100 mL

1's (Rp4,212,000/botol)
B Acna Care Plus softcap
3 10's (Rp143,000/boks)
B Acna-Care softcap
30's (Rp115,500/pak)
B Acne Feldin lotion 6.6 %

button/view.png
110 mL x 1's (Rp34,650/kontainer)
G Acpulsif 5 tab 5 mg
5 10's (Rp132,500/boks)
G Acran FC caplet 300 mg

3 10's (Rp195,000/boks)
Acran FC tab 150 mg
3 10's (Rp133,500/boks)
Acran inj 50 mg/2 mL
5 1's (Rp94,250/boks)
G Actabone inj 60 mg/mL

5 mL x 1's (Rp120,000/vial)
G Actalipid FC tab 10 mg
3 10's (Rp240,000/boks)
Actalipid FC tab 20 mg
3 10's (Rp240,000/boks)
Actalipid FC tab 40 mg
3 10's (Rp240,000/boks)
G Actapin tab 10 mg
3 10's (Rp195,000/boks)
Actapin tab 5 mg
3 10's (Rp105,000/boks)
G Actaryl tab 1 mg
3 10's (Rp45,000/boks)
Actaryl tab 2 mg
3 10's (Rp81,000/boks)
G Actatecan infusion conc 20 mg/mL

Actatecan infusion conc 20 mg/mL
5 mL x 1's (Rp1,400,000/boks)
G Actaxon powd for inj 1 g
(+ 1 amp sterile water for inj 10 mL) 1's
G Actazolam tab 0.5 mg

30's (Rp45,000/pak)
Actazolam tab 1 mg
30's (Rp65,000/pak)
W Actifed syr Actifed syr
60 mL x 1's (Rp44,600/botol)
W Actifed Plus Cough Suppressant syr

Actifed Plus Cough Suppressant syr
60 mL x 1's (Rp44,600/botol)
W Actifed Plus Expectorant syr Actifed

Plus Expectorant syr
60 mL x 1's (Rp44,600/botol)
X
G Actilyse infusion 50 mg Actilyse

infusion 50 mg
(+ vial 50 mL water for inj & Cannula
Transferx) 1's (Rp6,547,530/vial)
G Actonel FC tab 35 mg Actonel FC tab 35
mg
4's (Rp381,180/pak)
G Actoplatin infusion 150 mg/15 mL

Actoplatin infusion 150 mg/15 mL
1's (Rp500,000/vial)
1's (Rp1,350,000/vial)
G Actos tab 15 mg Actos tab 15 mg

2 7's (Rp94,080/boks)
Actos tab 30 mg Actos tab 30 mg
2 7's (Rp141,225/boks)
G Actosmet FC tab 15 mg/850 mg
Actosmet FC tab 15 mg/850 mg
2 7's
G Actrapid HM inj 100 IU/mL
button/view.png
(vial) 10 mL x 1's (Rp319,000/vial)
Actrapid Penfill for Inj 100 IU/mL
button/view.png
3 mL x 5 1's (Rp599,500/boks)
G Acuatim cream 10 g Acuatim cream 10
g
1's
X
G Adant Dispo inj 10 mg/mL
2.5 mL x 1's (Rp439,000/boks)
B Adfer cap
100's (Rp65,000/pak)
G Advantan cream 0.1%

10 g x 1's (Rp77,050/boks)
G Aerius FC tab 5 mg Aerius FC tab 5 mg
30's (Rp180,090/pak)
Aerius syr 0.5 mg/mL Aerius syr 0.5
mg/mL
60 mL x 1's (Rp64,170/boks)
G Aerius D-12 tab
2 5's (Rp60,500/boks)
B Afamed cap 320 ng

3 10's (Rp210,000/boks)
W Afrin nasal drops 0.25 mg/mL
10 mL x 1's
Afrin nasal spray 0.5 mg/mL
button/view.png
15 mL x 1's
G Agrelano FC tab 75 mg
30's (Rp249,000/pak)
G Akilen FC tab 200 mg
3 10's (Rp222,000/boks)
Akilen FC tab 400 mg
5 6's (Rp433,350/boks)
G Akilen ear drops 3 mg/mL

5 mL x 1's (Rp54,800/boks)
X
X
B Ala 600 FC caplet 600 mg

30's (Rp170,000/pak)
B Alabetic cap
5 6's (Rp112,500/boks)
W Alaxan FR cap
10 10's (Rp32,000/boks)
G Albapure 20 infusion 20 %
button/view.png
button/view.png
50 mL x 1's (Rp600,000/botol)
100 mL x 1's (Rp1,200,000/botol)
X
G Albothyl ovule 90 mg
6's (Rp101,640/pak)
Albothyl topical soln conc 360 mg/g
5 mL x 1's (Rp17,600/botol)
10 mL x 1's (Rp26,950/botol)
30 mL x 1's (Rp66,000/botol)
100 mL x 1's (Rp236,500/botol)
Albothyl vag gel 50 g
1's (Rp74,580/tube)
G Albuman infusion soln 20%

50 mL x 1's (Rp799,000/vial)
100 mL x 1's (Rp1,598,000/vial)
G Albuminar-25 infusion 25 %
button/view.png
50 mL x 1's (Rp750,000/vial)
100 mL x 1's (Rp1,500,000/vial)
G Alco oral drops 7.5 mg
15 mL x 1's (Rp36,850/botol)
Alco Plus DMP syr
100 mL x 1's (Rp25,300/botol)
Alco Plus syr
100 mL x 1's (Rp23,100/botol)
G Aldisa SR cap
5 10's (Rp195,000/boks)
G Aldomer film-coated tab 5 mg

30's (Rp421,500/pak)
G Alegi tab button/view.png
10 10's (Rp70,000/boks)
G Alerdex tab button/view.png

10 10's (Rp77,000/boks)
Aleros syr 0.5 mg/mL

60 mL x 1's (Rp45,000/botol)
G Alerson eye drops 1 mg/mL

B Alerten 100 mg softcap

3 30's (Rp321,200/pak)
Alerten 25 mg softcap
3 10's (Rp123,200/boks)
X
G Alimta powd for inj 100 mg Alimta
powd for inj 100 mg
1's (Rp3,753,981/boks)
Alimta powd for inj 500 mg Alimta
powd for inj 500 mg
1's (Rp15,015,000/vial)
Tab: B; inj: G Alinamin-F inj 25 mg/10 mL Alinamin-F
inj 25 mg/10 mL
10 mL x 5 1's (Rp56,243/boks)
Alinamin tab 5 mg Alinamin tab 5 mg
100's (Rp36,425/pak)
1000's (Rp348,096/pak)
Alinamin-F tab Alinamin-F tab
100's (Rp75,758/pak)
W Allerin oral liqd

60 mL x 1's (Rp10,000/botol)
120 mL x 1's (Rp17,500/botol)
B Allevyn Adhesive foam

(7.5 cm x 7.5 cm) 10 1's
(12.5 cm x 12.5 cm) 10 1's
Allevyn Non Adhesive foam
(10 x 10 cm) 10 1's
(10 x 20 cm) 10 1's
X
G Alloris syr 5 mg/5 mL

60 mL x 1's (Rp48,750/boks)
Alloris tab 10 mg
10 10's (Rp415,000/boks)
G Alovell tab 10 mg
3 10's (Rp245,000/boks)
G Aloxtra tab 5 mg
30's (Rp577,500/botol)
X
G Alpentin cap 100 mg

5 10's (Rp170,000/boks)
Alpentin cap 300 mg
5 10's (Rp315,000/boks)
X
G Alprazolam OGB Mersi tab 0.5 mg
100's
Alprazolam OGB Mersi tab 1 mg
100's
G Altofen inj 50 mg/mL

2 mL x 5 1's (Rp121,000/boks)
B Aludonna D chewable tab

button/view.png
160's (Rp78,000/pak)
Aludonna D susp
150 mL x 1's (Rp37,500/botol)
X
Alveofact endotracheopulmonary
instillation 45 mg/mL
1's
G Alviz tab 0.5 mg

3 10's (Rp72,600/boks)
Alviz tab 1 mg
3 10's (Rp108,900/boks)
G Alynol tab 5 mg
30's (Rp93,500/pak)
G Alzim tab 5 mg
3 10's (Rp450,000/boks)
G Amadiab caplet 1 mg button/view.png

50's (Rp67,500/pak)
Amadiab caplet 2 mg button/view.png
50's (Rp125,000/pak)
50's (Rp170,000/pak)
50's (Rp217,500/pak)
B Amaropo Plus caplet button/view.png

10 10's (Rp207,900/boks)
G Amaryl tab 1 mg Amaryl tab 1 mg
50's (Rp137,118/pak)
Amaryl tab 2 mg Amaryl tab 2 mg
50's (Rp243,000/pak)
50's (Rp305,373/pak)
30's (Rp208,933/pak)
G Amaryl M FC tab 1/250 mg Amaryl M
FC tab 1/250 mg
30's (Rp82,223/pak)
Amaryl M FC tab 2/500 mg
30's (Rp145,719/pak)
G Ambiopi FC caplet 500 mg

10 10's (Rp110,000/boks)
X
X
G Amcor tab 10 mg Amcor tab 10 mg

5 10's (Rp330,000/boks)
Amcor tab 5 mg
3 10's (Rp138,600/boks)
X
G Aminefron FC caplet
25 4's (Rp595,000/boks)
G Aminofluid infusion Aminofluid

infusion
Aminofluid infusion
500 mL x 1's
1000 mL x 1's
G Aminoleban Infusion Aminoleban
Infusion
500 mL x 12 1's (Rp145,147/boks)
G Aminosteril Infant infusion 6 %

100 mL x 10 1's (Rp66,000/botol)
G Aminovel 600 infusion Aminovel 600
infusion
500 mL x 1's
G Amiosin inj (vial) 1 g/4 mL

4 mL x 5 1's
Amiosin inj (vial) 250 mg/2 mL
2 mL x 5 1's
Amiosin inj (vial) 500 mg/2 mL
2 mL x 5 1's
G Amiparen infusion Amiparen infusion
500 mL x 12 1's
G Amiten infusion
200 mL x 1's (Rp86,100/botol)
G Amlogal tab 5 mg
3 10's (Rp85,800/boks)
G Amnorel 600 infusion

(glass bottle) 500 mL x 1's
(Rp50,000/botol)
X
X
G Amoxsan cap 250 mg
10 10's (Rp147,500/boks)
Amoxsan cap 500 mg
10 10's (Rp302,000/boks)
Amoxsan dispersible tab 250 mg
10 10's (Rp130,000/boks)
Amoxsan dry syr 125 mg/5 mL
60 mL x 1's (Rp20,710/botol)
Amoxsan Forte dry syr 250 mg/5 mL
60 mL x 1's (Rp29,535/botol)
Amoxsan infusion 1 g
10 1's (Rp207,100/boks)
Amoxsan Paed oral drops 100 mg/mL
15 mL x 1's (Rp20,710/botol)
G Amtocort Injection inj 40 mg/mL

1 mL x 1's
G Amtocort Tablet tab 4 mg

5 10's (Rp121,000/boks)
B Amvar FC caplet
5 6's (Rp142,500/boks)
G Analsik FC caplet
10 10's (Rp110,000/boks)
G Analtram FC caplet
3 10's (Rp180,000/boks)
G Anbacim FC caplet 500 mg

5 4's (Rp381,000/boks)
Anbacim powd for inj 1 g
(vial) 1's (Rp69,300/boks)
G Anbiolid FC tab 150 mg

5 10's (Rp230,000/boks)
G Ancefa dry susp 125 mg/5 mL

60 mL x 1's (Rp38,000/botol)
Ancefa Forte dry susp 250 mg/5 mL
60 mL x 1's (Rp65,000/botol)
Ancefa FC tab 500 mg
5 6's (Rp270,000/boks)
G Ancla Forte dry susp
60 mL x 1's (Rp63,000/botol)
Ancla FC tab
5 6's (Rp330,000/boks)
W Andantol jelly 7.5 mg

10 g x 1's (Rp28,350/tube)
X
B Anelat caplet 1000 mcg
10 10's
B Anemolat tab 1 mg
10 10's (Rp14,545/boks)
G Anesfar inj 1 mg/mL

5 mL x 5 1's
Anesfar inj 5 mg/mL
(amp) 3 mL x 5 1's (Rp65,000/boks)
G Anexia tab 10 mg
30's (Rp300,000/boks)
Anexia tab 2.5 mg
30's (Rp117,000/boks)
Anexia tab 5 mg
30's (Rp172,500/boks)
X
G Anfix cap 100 mg
30's (Rp450,000/boks)
Anfix caplet 200 mg
10's (Rp210,000/boks)
Anfix dry syr 100 mg/5 mL
30 mL x 1's (Rp65,000/boks)
G Angintriz MR FC tab 35 mg
30's
X
X
G Anpiride tab 1 mg
5 10's (Rp100,000/boks)
Anpiride tab 2 mg
5 10's (Rp187,500/boks)
Anpiride tab 3 mg
5 10's (Rp250,000/boks)
Anpiride tab 4 mg
5 10's (Rp105,000/boks)
X
X
G Antiplat tab 50 mg
30's (Rp150,000/pak)
G Antiprestin cap 10 mg
3 10's (Rp105,600/boks)
Antiprestin cap 20 mg
3 10's (Rp164,450/boks)
W Antiza drag
10 10's (Rp95,000/boks)
Antiza syr
60 mL x 1's (Rp15,300/boks)
G Anuva 50 mg dispersible tab

5 10's
G Anvomer B6 sugar-coated tab

60's (Rp108,000/pak)
B Apecur syr
100 mL x 1's (Rp26,000/botol)
B Apialys oral drops button/view.png

10 mL x 1's (Rp20,000/botol)
Apialys syr button/view.png
100 mL x 1's (Rp18,500/botol)
G Apidra infusion 100 IU/mL Apidra
infusion 100 IU/mL
10 mL x 1's
Apidra solostar 100 IU/mL Apidra
solostar 100 IU/mL
5 1's (Rp769,002/boks)
G Apolar cream 0.5 mg/g

10 g x 1's (Rp28,000/boks)
G Apolar-N cream
10 g x 1's (Rp32,000/boks)
G Aprion cap 150 mg
10's
Aprion cap 300 mg
10's
Aprion cap 75 mg
10's
G Aprovel FC tab 150 mg Aprovel FC tab

150 mg
28's (Rp316,289/pak)
Aprovel FC tab 300 mg Aprovel FC tab
300 mg
28's (Rp426,881/pak)
G Araclof sugar-coated tab 50 mg
button/view.png
5 10's (Rp65,000/boks)
G Arcalion 200 sugar-coated tab 200 mg

button/view.png
60's (Rp258,000/pak)
G Arcamox cap 250 mg button/view.png
100's (Rp129,000/pak)
Arcamox cap 500 mg button/view.png
100's (Rp179,000/pak)
Arcamox dry syr 125 mg/5 mL
60 mL x 1's (Rp25,500/botol)
Arcamox Forte dry syr 250 mg/5 mL
60 mL x 1's (Rp33,000/botol)
Arcamox FC caplet 500 mg
button/view.png
25 4's (Rp179,000/boks)
B Arcapec dry syr

60 mL x 1's (Rp15,000/botol)
Arcapec tab
10 10's (Rp95,000/boks)
X
G Arcoxia FC tab 120 mg
30's (Rp363,000/pak)
Arcoxia FC tab 60 mg
30's (Rp257,400/pak)
Arcoxia FC tab 90 mg
30's (Rp280,500/pak)
G Ardium 500 tab 500 mg

60's (Rp422,100/pak)
X
G Arespin soln for infusion 4 mg/4 mL

(amp) 1's (Rp350,000/boks)
G Arfen caplet 400 mg

10 10's (Rp86,600/boks)
B Argensol cream
5 g x 1's (Rp32,000/tube)
W Argomed FC tab 20 mg
5 6's (Rp105,000/boks)
G Aricept tab 5 mg Aricept tab 5 mg

2 14's (Rp481,423/blister)
G Aricept Evess orodispersible tab 10 mg

Aricept Evess orodispersible tab 10 mg
2 14's (Rp577,707/boks)
G Arimed tab 15 mg
2 10's (Rp120,000/boks)
G Arimidex FC tab 1 mg
2 14's (Rp1,922,127/boks)
Ariski tab 10 mg
10's (Rp289,000/strip)
Ariski tab 15 mg
10's (Rp335,000/strip)
G Arixtra inj 2.5 mg/0.5 mL Arixtra inj 2.5
mg/0.5 mL
2 1's (Rp655,500/boks)
Arixtra inj 7.5 mg/0.6 mL Arixtra inj 7.5
mg/0.6 mL
2 1's (Rp690,000/pak)
G Arkine caplet 2 mg
10 10's (Rp62,500/boks)
250's (Rp145,000/pak)
G Armolev 500 film-coated tab 500 mg

button/view.png
10's (Rp99,000/pak)
B Armovit cap button/view.png
6 5's (Rp52,000/boks)
G Aromasin sugar-coated tab 25 mg

2 15's (Rp1,789,695/boks)
X
G Arteoptic LA eye soln 2% Arteoptic LA
eye soln 2/
2.5 mL x 1's (Rp130,000/boks)
G Artepid film-coated tab 75 mg

10 3's (Rp396,000/boks)
G Arthrifen oral susp 100 mg/5 mL

60 mL x 1's (Rp19,500/boks)
Arthrifen tab 200 mg button/view.png
100's (Rp53,000/pak)
G Arthrifen Plus tab button/view.png

25 4's (Rp76,000/boks)
X
Ascavin cap 4 mg
2 6's
B Asedas syr
60 mL x 1's (Rp35,000/botol)
G Asering-5 infusion Asering-5 infusion

500 mL x 1's
G Asimat FC caplet 500 mg

10 10's (Rp66,000/boks)
W Asmasolon tab
25 4's (Rp28,754/boks)
G Aspil inj 1 g
(vial) 1's (Rp99,000/vial)
B Aspilets chewable tab 80 mg

button/view.png
100's (Rp36,700/pak)
X
B Astaplus FC caplet
5 6's (Rp180,000/boks)
Astar-C FC caplet
3 10's
B Astatin soft-gelatin cap 4 mg

2 10's (Rp100,000/boks)
G Astharol syr 2 mg/5 mL

60 mL x 1's (Rp13,600/boks)
Astharol tab 4 mg
10 10's (Rp105,000/boks)
B Astina cap 4 mg
18's (Rp103,950/pak)
B Astria softcap 4 mg
2 10's (Rp120,000/boks)
G Atarax film-coated tab 0.5 mg
10 10's (Rp130,000/boks)
G Ataroc syr 5 mcg/mL Ataroc syr 5

mcg/mL
60 mL x 1's (Rp34,500/botol)
Ataroc tab 25 mcg
10 10's (Rp180,000/boks)
Ataroc tab 50 mcg
10 10's (Rp150,000/boks)
G Atofar film-coated tab 10 mg

3 10's (Rp240,000/boks)
Atofar film-coated tab 20 mg
3 10's (Rp240,000/boks)
Atofar film-coated tab 40 mg
3 10's (Rp240,000/boks)
G Atopiclair cream
10 mL x 1's (Rp75,000/tube)
G Atorvastatin Yarindo FC tab 10 mg

3 10's
Atorvastatin Yarindo FC tab 20 mg
3 10's (Rp120,000/boks)
Atorvastatin Yarindo FC tab 40 mg
3 10's
G Atorwin FC tab 10 mg Atorwin FC tab
10 mg
3 10's (Rp234,000/boks)
Atorwin FC tab 20 mg Atorwin FC tab
20 mg
3 10's (Rp270,000/boks)
G Atrocox 15 tab 15 mg
2 10's (Rp140,000/boks)
Atrocox 7.5 tab 7.5 mg
2 10's (Rp88,000/boks)
G Atrovent aerosol 0.02 mg/dose

(200 dose) 10 mL x 1's
Atrovent inhalation soln 0.025 %
Atrovent inhalation soln 0.025 /
20 mL x 1's (Rp172,590/botol)
Atrovent MDI 20 mcg/puff
(200 puffs) 10 mL x 1's
(Rp135,300/canister)
X
X
G Augmentin Forte oral susp

60 mL x 1's (Rp53,818/botol)
Augmentin oral susp
60 mL x 1's (Rp40,053/botol)
Augmentin 1 g tab
14's (Rp131,016/pak)
Augmentin 625 mg tab
60's (Rp415,508/pak)
X
W AV F AZA Acne Foundation cream 20%
AV F AZA Acne Foundation cream 20/
30 g x 1's (Rp58,000/kontainer)
G Avamys nasal spray 27.5 mcg/spray

120 1's (Rp109,900/boks)
X
X
G Avemar powd for oral liqd

17 g x 30 1's (Rp1,800,000/boks)
G Aviter powd for oral liqd

6 g x 21 1's (Rp284,130/boks)
G Avocel FC tab 5 mg
3 10's
G Avodart cap 0.5 mg
30's (Rp257,728/pak)
B Avogin FC caplet button/view.png

5 6's (Rp66,000/boks)
B Axamed liqd-filled cap 4 mg

(blister) 3 10's (Rp199,500/boks)
B Axamed Plus cap

5 6's (Rp252,000/boks)
B Axtan cap 4 mg
3 10's (Rp257,400/boks)
B Axtan Syr syr 2 mg/5 mL

60 mL x 1's (Rp55,000/botol)
G Azmacon tab 2 mg button/view.png
10 10's (Rp55,000/boks)
Azmacon tab 4 mg button/view.png
10 10's (Rp70,000/boks)
G Azol cap 200 mg Azol cap 200 mg

30's (Rp385,000/pak)
G Azomax cap 250 mg
1 10's
3 10's
Azomax FC caplet 500 mg
button/view.png
1 10's
3 10's
G Aztrin cap 250 mg

6's (Rp86,790/pak)
Aztrin cap 500 mg
6's
Aztrin DS syr 200 mg/5 mL
15 mL x 1's (Rp88,000/botol)
G bacbutINH Forte tab button/view.png

100's (Rp237,000/pak)
bacbutINH tab button/view.png
160's (Rp197,000/pak)
G Bacbutol tab 500 mg button/view.png

160's (Rp271,000/pak)
G Bactesyn powd for inj 1.5 g
1's (Rp125,000/vial)
Bactesyn powd for inj 750 mg
1's (Rp65,000/vial)
Bactesyn tab 375 mg
30's (Rp410,000/pak)
G Bactiprox film-coated tab 500 mg

button/view.png
2 10's (Rp193,600/boks)
G Bactirom powd for inj 1 g

1's (Rp268,550/boks)
G Bactoderm cream 2% Bactoderm

cream 2/
Bactoderm cream 2/
5 g x 1's (Rp37,500/tube)
10 g x 1's (Rp54,000/tube)
Bactoderm oint 2% Bactoderm oint 2/
10 g x 1's (Rp54,000/tube)
G Bactroban cream 2 % Bactroban cream
2/
5 g x 1's (Rp35,000/tube)
10 g x 1's (Rp54,000/tube)
Bactroban oint 2 % Bactroban oint 2 /
5 g x 1's (Rp35,000/tube)
10 g x 1's (Rp54,000/tube)
G Bamgetol FC caplet 200 mg

10 10's (Rp180,000/boks)
X
G Bantif Child syr

60 mL x 1's (Rp9,450/boks)
G Baquinor eye drops 3 mg/mL

5 mL x 1's (Rp31,250/boks)
G Baquinor Forte FC caplet 500 mg

2 10's (Rp252,000/boks)
Baquinor FC tab 250 mg
2 10's (Rp119,000/boks)
Baquinor infusion 200 mg/100 mL
100 mL x 1's (Rp215,100/kantung infus)
G Baraclude tab 0.5 mg Baraclude tab 0.5
mg
30's
Baraclude tab 1 mg Baraclude tab 1 mg
30's (Rp2,648,700/pak)
G Barzepin FC tab 300 mg

3 10's (Rp180,000/boks)
Barzepin FC tab 600 mg
3 10's (Rp300,000/boks)
G Baxcef inj
1 g x 1's (Rp215,000/boks)
B Bd-GARD cap
30's (Rp230,000/pak)
X
X
Bebelove 1 milk powd
200 g x 1's (Rp28,400/pak)
400 g x 1's (Rp55,900/pak)
800 g x 1's (Rp108,800/kaleng)
1800 g x 1's (Rp227,500/pak)
Bebelove 2 milk powd

200 g x 1's (Rp26,600/pak)
400 g x 1's (Rp51,900/pak)
800 g x 1's (Rp101,300/kaleng)
1800 g x 1's (Rp212,000/pak)
Bebelove FL milk powd

400 g x 1's (Rp65,000/kaleng)
Bebemama powd
((softpack)) 400 g x 1's (Rp60,800/pak)
G Becantex film-coated tab 100 mg

10 10's (Rp250,000/boks)
B Becefort syr button/view.png

1's (Rp22,809/botol)
Becefort tab button/view.png
100's (Rp134,063/pak)
G Beclov inj 125 mg/mL

(amp) 2 mL x 5 1's (Rp158,500/boks)
X
B Becom-C FC caplet
10 10's (Rp120,000/boks)
W Becom-Zet FC caplet
10 10's (Rp160,000/boks)
X
X
Belvin Drops
15 mL x 1's
X
X
X
X
X
G Benutrion VE infusion
(glass bottle) 250 mL x 1's
(Rp98,200/botol)
G Bepanthen oint 5 %
20 g x 1's
G Berea syr 15 mg/5 mL Berea syr 15
mg/5 mL
60 mL x 1's (Rp24,871/botol)
Berea tab 30 mg Berea tab 30 mg
10 10's (Rp117,040/boks)
G Beriplast P Combi-Set topical

application button/view.png
1 mL x 1's (Rp2,255,000/vial)
X
Berocca Performance effervescent tab
((orange flavor)) 15's
G Berodual inhaler Berodual inhaler

(200 puffs) 10 mL x 1's
(Rp152,130/canister)
G Berotec inhalation soln 0.1 %
50 mL x 1's (Rp207,020/canister)
Berotec MDI 100 mcg/puff Berotec
MDI 100 mcg/puff
(200 puffs) 10 mL x 1's
(Rp123,860/boks)
B Berry Vision dispersible tab

10 10's (Rp190,000/boks)
Berry Vision tab
10 10's (Rp285,000/boks)
G Bestalin syr 10 mg/5 mL
button/view.png
100 mL x 1's (Rp22,500/botol)
Bestalin tab 25 mg button/view.png
100's (Rp160,000/pak)
G Bestypro FC tab 500 mg

3 10's (Rp324,000/boks)
X
G Betagentam ophth drops
5 mL x 1's (Rp49,650/boks)
G Betalans tab 30 mg
20's (Rp215,000/pak)
G Betam-Ophtal eye drops 0.1 %

5 mL x 1's (Rp49,650/boks)
G Betarhin oral drops 10 mg/mL
30 mL x 1's (Rp36,000/botol)
Betarhin syr 5 mg/5 mL
60 mL x 1's (Rp33,000/botol)
Betarhin tab 10 mg
20's (Rp60,000/pak)
G Betaserc tab 24 mg
20's (Rp107,000/pak)
Betaserc tab 8 mg
100's (Rp130,650/boks)
B Betaslim FC caplet button/view.png

30's (Rp60,000/pak)
G Betaver tab 6 mg
10 10's (Rp220,000/boks)
G Betopic cream 0.1 %

10 g x 1's (Rp25,000/tube)
G Betrix powd for inj 1 g

1's (Rp155,000/vial)
B Bevita syr
120 mL x 1's (Rp23,500/botol)
W Bevizil FC caplet
25 4's (Rp135,000/boks)
X
G Bezalip Retard tab 400 mg
100's (Rp700,000/pak)
Bezalip tab 200 mg
100's (Rp227,500/pak)
G Biatron FC tab 500 mg

5 10's (Rp68,200/boks)
Biatron infusion 500 mg/100 mL
1's
W Bicolax tab 5 mg button/view.png

18's (Rp19,000/pak)
G Bicrolid FC caplet 250 mg

3 10's (Rp262,500/boks)
Bicrolid FC caplet 500 mg
3 10's (Rp667,500/boks)
B Biferce effervescent tab 1000 mg

1 10's (Rp21,300/boks)
G Bifotik powd for inj 1 g

(vial) 1's (Rp158,800/boks)
Binapro softcap
6 10's (Rp420,000/boks)
Binomic dispersible tab 20 mg

10 10's (Rp198,000/boks)
B Bioacne cream
10 g x 48 1's (Rp15,500/boks)
G Bioads (Anti Difteri Serum 20,000 IU)

inj
10 mL x 10 1's (Rp1,193,500/vial)
G Bio-ATP tab button/view.png

100's (Rp203,981/pak)
X
FC tab: B; amp: G Biocombin film-coated tab

10 10's (Rp125,000/boks)
Biocombin 5000 inj
3 mL x 10 1's (Rp50,000/boks)
B Biocream cream Biocream cream

20 g x 1's (Rp18,040/tube)
G Biodasin cap 300 mg

5 10's (Rp285,000/boks)
G Bioderm cream 0.1 % button/view.png

5 g x 1's (Rp17,600/boks)
B Bioferron chewable tab

10 3's (Rp30,000/boks)
B Biofos oral susp
60 mL x 1's (Rp55,000/botol)
120 mL x 1's (Rp65,000/botol)
B Biogesic oral liqd 160 mg/5 mL

60 mL x 1's (Rp13,500/botol)
Biogesic tab 500 mg
100's (Rp26,100/pak)
Biolectra effervescent tab 240 mg

5 4's (Rp120,000/boks)
Biolectra effervescent tab 365 mg
2 10's (Rp150,000/boks)
W Biolite cream Biolite cream

30 g x 1's (Rp85,000/kontainer)
Bionect cream 0.2%
15 g x 1's
Bionect gauze pad
(10 cm x 10 cm) 10's
B Bionemi cap
5 10's (Rp42,500/boks)
G Bioprexum FC tab 10 mg
30's (Rp385,000/pak)
Bioprexum FC tab 5 mg
30's (Rp280,000/pak)
G Bioprexum Plus FC tab
30's (Rp308,000/pak)
2% cream:W; 4% Forte cream:G Bioquin cream 2% Bioquin cream 2/

14.2 g x 48 1's (Rp15,500/boks)
Bioquin Forte cream 4% Bioquin Forte
cream 4/
15 g x 48 1's (Rp29,000/boks)
Bioquinone softcap
5 10's (Rp675,000/boks)
B Biosan tab 275 mg

3 6's (Rp160,200/boks)
B Biosanbe cap
10 10's (Rp90,000/boks)
G Biosat 1.5 (Serum Anti Tetanus 1,500

IU) inj
1 mL x 10 1's (Rp158,125/ampul)
G Biosave (Snake Anti Venom/Abu

Polivalen I) soln for inj/infusion
5 mL x 10 1's (Rp591,250/vial)
B Biostrum syr button/view.png

100 mL x 1's (Rp32,000/botol)
G Biothicol cap 250 mg

10 10's (Rp165,000/boks)
Biothicol cap 500 mg
10 10's (Rp330,000/boks)
Biothicol dry syr 125 mg/5 mL
60 mL x 1's (Rp18,900/boks)
Biothicol Forte dry syr 250 mg/5 mL
60 mL x 1's (Rp52,250/boks)
Biotopix Eye Bag & Dark Circle cream

Biotopix Eye Bag /amp/ Dark Circle
cream
15 g x 1's (Rp175,000/boks)
Biotopix Specific Lifting Cream Biotopix
Specific Lifting Cream
15 g x 1's (Rp250,000/boks)
G Bipro film-coated tab 5 mg

3 10's
B Bital oint
40 g x 1's (Rp28,600/tube)
G Blecidex ear drops

5 mL x 1's (Rp37,950/boks)
G Blecidex eye drops

5 mL x 1's (Rp37,950/boks)
G Bledstop inj 200 mcg/mL

(amp) 1 mL x 10 1's (Rp66,500/boks)
Bledstop sugar-coated tab 125 mcg
10 10's (Rp45,000/boks)
G Bleocin inj 15 mg
1's (Rp420,000/ampul)
G Blesifen tab 50 mg
2 10's (Rp228,000/boks)
G Blistra inj 10 mg/10 mL

(amp) 10 1's (Rp1,650,000/boks)
G Blopress tab 16 mg Blopress tab 16 mg
14's (Rp199,760/pak)
28's
Blopress tab 8 mg Blopress tab 8 mg
14's (Rp151,780/pak)
28's
G Blopress Plus tab Blopress Plus tab
14's (Rp190,250/pak)
G Blorec film-coated tab 25 mg

3 10's (Rp150,000/boks)
BMT Gold milk powd BMT Gold milk
powd
200 g x 1's (Rp42,000/pak)
400 g x 1's (Rp79,900/kaleng)
800 g x 1's (Rp153,500/boks)
BMT P-HP milk powd BMT P-HP milk

powd
400 g x 1's (Rp115,300/pak)
800 g x 1's (Rp229,200/kaleng)
BMT Platinum milk powd BMT
Platinum milk powd
400 g x 1's (Rp111,950/kaleng)
800 g x 1's (Rp216,000/kaleng)
BMT Soya milk powd BMT Soya milk

powd
300 g x 1's (Rp79,100/kaleng)
X
X
X
G Bonevell infusion conc 6 mg/6 mL

1's (Rp900,000/boks)
G Bon-One tab 0.25 mcg

30's (Rp191,500/pak)
Bon-One tab 0.5 mcg
30's (Rp336,500/pak)
Bon-One tab 1 mcg
30's (Rp495,000/pak)
B Bonvit caplet
30's (Rp84,000/pak)
G Borraginol-N rectal oint Borraginol-N

rectal oint
15 g x 1's (Rp32,078/tube)
Borraginol-N supp Borraginol-N supp
10's (Rp58,086/pak)
G Borraginol-S rectal oint Borraginol-S

rectal oint
15 g x 1's (Rp43,197/tube)
Borraginol-S supp Borraginol-S supp
10's (Rp66,560/pak)
G Botox powd for inj 100 u

1's
G Brainact caplet 1000 mg
30's (Rp430,000/pak)
Brainact O-dis tab 500 mg
3 10's (Rp294,000/boks)
Brainact inj 1,000 mg/8 mL
5 1's (Rp410,000/boks)
Brainact inj 250 mg/2 mL
5 1's (Rp171,000/boks)
Brainact inj 500 mg/4 mL
5 1's (Rp279,000/boks)
Brainact powd for oral liqd 1000 mg
(sachet) 2 g x 5 1's (Rp68,000/boks)
Brainact tab 500 mg
30's (Rp310,000/pak)
G Brainolin caplet 500 mg

(amp) 30's (Rp235,000/pak)
Brainolin inj 250 mg/2 mL
5 1's (Rp115,000/boks)
B Brainvit syr
60 mL x 1's (Rp30,000/botol)
G Bralifex eye drops 0.3 %

5 mL x 1's (Rp30,350/boks)
G Bralifex Plus eye susp

5 mL x 1's (Rp42,000/boks)
Bravelle inj 75 IU
10 1's (Rp4,200,000/boks)
G Bravoderm cream 0.025% Bravoderm

cream 0.025/
5 g x 1's (Rp18,288/boks)
G Bravoderm-N cream Bravoderm-N

cream
5 g x 1's (Rp20,482/tube)
G Braxidin FC tab
10 10's (Rp80,000/boks)
G Brazine caplet 25 mg
10 10's (Rp140,000/boks)
W Breathy nasal drops 6.5 mg/mL Breathy

nasal drops 6.5 mg/mL
Breathy nasal spray 6.5 mg/mL
30 mL x 1's
G Brexel infusion 20 mg/0.5 mL
1's (Rp1,600,000/vial)
Brexel infusion 80 mg/2 mL
1's (Rp4,900,000/vial)
G Bricasma inj 0.5 mg/mL Bricasma inj

0.5 mg/mL
1 mL x 5 1's (Rp101,598/boks)
Bricasma inhalation powd 0.5 mg
Bricasma inhalation powd 0.5 mg
100 dose x 1's (Rp110,000/boks)
Bricasma respules 2.5 mg/mL Bricasma
respules 2.5 mg/mL
2 5's (Rp104,386/karton)
Bricasma tab 2.5 mg Bricasma tab 2.5
mg
10 10's (Rp237,424/boks)
X
G Brilinta FC tab 90 mg Brilinta FC tab 90
mg
4 14's (Rp805,605/boks)
G Broadced IV infusion 1 g
(+ 0.9% NaCl 50 mL) 1's
(Rp165,000/vial)
Broadced IM inj 1 g
W Brochifar caplet
10's
Brochifar Plus caplet
10's
G, W Bromifar caplet 8 mg
10 10's (Rp21,542/boks)
Bromifar Plus syr
60 mL x 1's
Bromifar Plus tab
100's
G Brommer 30 tab 30 mg
10 10's (Rp55,000/boks)
Broncho-Vaxom Adult cap 7 mg

10's
30's
Broncho-Vaxom Childn cap 3.5 mg
Broncho-Vaxom Childn cap 3.5 mg
10's
30's
G Brufen susp 100 mg/5 mL Brufen susp
100 mg/5 mL
60 mL x 1's (Rp25,000/boks)
Brufen Forte tab 600 mg
10 10's (Rp300,000/boks)
Brufen tab 200 mg
25 4's (Rp55,000/boks)
G Budenofalk cap 3 mg
50's (Rp1,045,000/pak)
G Bufabron cap 100 mg Bufabron cap 100

mg
10 10's (Rp124,355/boks)
Bufabron syr 43.33 mg/5 mL Bufabron
syr 43.33 mg/5 mL
100 mL x 1's (Rp17,556/botol)
G Bufacardo caplet 10 mg Bufacardo

caplet 10 mg
3 10's (Rp364,287/boks)
Bufacardo caplet 5 mg Bufacardo
caplet 5 mg
3 10's (Rp197,505/boks)
G Bufacomb IOB cream 5 g Bufacomb IOB

cream 5 g
1's (Rp21,214/boks)
G Bufaflam Emulgel 20 g Bufaflam

Emulgel 20 g
1's (Rp29,260/boks)
G Bufamoxy cap 500 mg Bufamoxy cap

500 mg
10 10's (Rp351,120/boks)
Bufamoxy dry syr 125 mg/5 mL
Bufamoxy dry syr 125 mg/5 mL
60 mL x 1's (Rp24,871/botol)
G Bufaramine cap 2 mg Bufaramine cap 2

mg
10 10's (Rp80,465/boks)
G Bufect FC tab 200 mg
25 4's (Rp60,000/boks)
Bufect Forte oral susp 200 mg/5 mL
50 mL x 1's (Rp18,500/boks)
Bufect oral susp 100 mg/5 mL
60 mL x 1's (Rp13,100/boks)
G Bunascan inj 5 mg/mL

20 mL x 5 1's
G Bunascan Spinal 0.5% Heavy inj 0.5 %

4 mL x 5 1's (Rp225,000/boks)
G Burnazin cream 10 mg/g

35 g x 1's (Rp36,500/tube)
500 mg x 1's (Rp325,000/kontainer)
X
B Cado effervescent tab

10's (Rp20,000/pak)
G Caduet FC tab 10 mg/10 mg Caduet FC
tab 10 mg/10 mg
30's (Rp289,476/pak)
Caduet FC tab 10 mg/20 mg Caduet FC
tab 10 mg/20 mg
30's (Rp490,886/pak)
tab 5 mg/10 mg
30's (Rp289,476/pak)
tab 5 mg/20 mg
30's (Rp490,886/pak)
B Cal-95 FC caplet button/view.png

30's (Rp75,000/pak)
G Calacort cream 2.5 % button/view.png

10 g x 1's (Rp16,500/tube)
X
B Calbon caplet
30's (Rp74,000/botol)
G Calcianta tab 10 mg button/view.png

10 10's (Rp102,000/boks)
Calcianta tab 5 mg button/view.png
10 10's (Rp65,000/boks)
B CalciD tab
30's (Rp30,000/pak)
Calcido FC caplet
3 10's
B Calcimega cap
10 10's (Rp71,100/boks)
B Calcium Ad chewable tab
100's (Rp41,000/pak)
B Caldece effervescent tab

1 10's (Rp25,000/boks)
W Caldetri tab button/view.png

30's (Rp23,000/pak)
B Calix oral susp

100 mL x 1's (Rp40,000/botol)
B Calnic caplet 400 mg

3 10's (Rp60,000/boks)
Calnic oral susp 200 mg/5 mL
100 mL x 1's (Rp40,000/botol)
B Caloma Plus soft-gelatin cap
60's (Rp88,000/pak)
W Calos caplet
60's (Rp48,000/pak)
B Calostrum oral susp

100 mL x 1's (Rp42,000/botol)
B Calplex caplet
30's (Rp87,000/pak)
B Calporosis D 500 caplet

30's (Rp25,000/pak)
Calporosis D 800 caplet
30's (Rp45,000/pak)
X
G Calsivas tab 10 mg
3 10's (Rp210,000/boks)
Calsivas tab 5 mg
3 10's (Rp120,000/boks)
B CalSource Forte effervescent tab

10's (Rp35,500/pak)
CalSource Plus Vitamin C effervescent
tab
(lemon/orange) 10's (Rp19,000/pak)
CalSource syr CalSource syr
120 mL x 1's (Rp46,000/botol)
CalSource Junior Growth tab
(orange) 30's
CalSource Junior Strength tab 625 mg
(chocolate) 30's (Rp15,000/pak)
60's (Rp24,800/pak)
B Caltrate 600 +D tab Caltrate 600 /D tab

1 30's (Rp52,929/boks)
1 60's (Rp100,670/boks)
B Caltrate 600 Plus tab Caltrate 600 Plus
tab
1 30's (Rp64,345/boks)
1 60's (Rp118,313/boks)
B Caltrax effervescent tab

10's (Rp30,000/pak)
B Caltron caplet
50's (Rp125,000/pak)
B Calvit-D coated tab

10 10's
G Campto infusion 100 mg/5 mL Campto
infusion 100 mg/5 mL
1's (Rp2,779,635/vial)
Campto infusion 40 mg/2 mL Campto
infusion 40 mg/2 mL
1's (Rp1,270,910/vial)
G Canderin tab 16 mg
3 10's
Canderin tab 8 mg
3 10's
G Candistin oral drops 100000 u/mL
12 mL x 1's (Rp32,450/botol)
G Candotens tab 16 mg
1 10's
Candotens tab 8 mg
1 10's
B Canergy FC tab
15's (Rp97,500/pak)
W Canesten cream 1 %
3 g x 1's (Rp9,700/tube)
5 g x 1's (Rp12,105/tube)
10 g x 1's (Rp28,100/tube)
G Canesten SD vag tab 500 mg
1's (Rp54,375/pak)
Canesten VT vag tab 100 mg
6's (Rp54,375/pak)
G Canicol cap 500 mg

10 10's (Rp306,500/boks)
G Caprazol cap 30 mg
2 10's (Rp208,900/boks)
G Caprenafil FC caplet 100 mg

1 4's (Rp285,000/boks)
Caprenafil FC caplet 50 mg
1 4's (Rp217,000/boks)
G Caprenem powd for inj 0.5 g
1's (Rp220,765/boks)
Caprenem powd for inj 1 g
1's (Rp419,445/boks)
G Caprifim inj 1 g
1's (Rp249,460/boks)
G Capritazin FC caplet 10 mg
3 10's (Rp72,600/boks)
Capritazin oral drops 10 mg/mL
20 mL x 1's (Rp45,000/boks)
Capritazin syr 5 mg/5 mL
60 mL x 1's (Rp40,000/boks)
G Caprocef inj 1 g
1's (Rp226,280/boks)
B Caproliv FC caplet
6 10's (Rp264,900/boks)
G Capsinat dry syr
60 mL x 1's (Rp44,075/boks)
Capsinat Forte dry syr
60 mL x 1's (Rp57,985/boks)
Capsinat FC caplet
5 6's (Rp302,400/boks)
G Capsinat Injection 1 g
6 1's (Rp441,270/boks)
G Carboplatin Kalbe infusion 150 mg/15
mL
1's (Rp546,000/vial)
Carboplatin Kalbe infusion 450 mg/45
mL
1's (Rp1,575,000/vial)
G Carcinocin inj 10 mg/5 mL

1's
Carcinocin inj 50 mg/25 mL
1's
G Cardace tab 10 mg Cardace tab 10 mg
30's (Rp302,778/pak)
Cardace tab 2.5 mg Cardace tab 2.5 mg
60's (Rp294,698/pak)
Cardace tab 5 mg Cardace tab 5 mg
60's (Rp434,606/pak)
G Cardicap tab 10 mg
5 10's (Rp446,750/boks)
Cardicap tab 5 mg
5 10's (Rp255,500/boks)
W Cardiomin softcap button/view.png
5 4's (Rp42,000/boks)
G Cardiotone soln for inj 250 mg/5 mL

(amp) 5 mL x 1's (Rp110,000/boks)
G Cardisan tab 10 mg
5 10's (Rp465,000/boks)
Cardisan tab 5 mg
5 10's (Rp262,500/boks)
G Cardismo tab 20 mg button/view.png

10 10's (Rp246,675/boks)
G Cardura tab 1 mg Cardura tab 1 mg
50's (Rp395,630/pak)
Cardura tab 2 mg Cardura tab 2 mg
50's (Rp677,111/pak)
X
B Carniten softcap
30's (Rp135,000/boks)
G Caronem powd for inj 1 g

G Carpiaton-100 tab 100 mg

100's (Rp320,000/pak)
Carpiaton-25 tab 25 mg
100's (Rp115,000/pak)
B Car-Q100 FC caplet
3 10's (Rp285,000/boks)
G Carsive inj 10 mg/10 mL

10's (Rp1,700,000/ampul)
B Cartiflex caplet
20's (Rp115,500/pak)
B Cartogen cap
5 6's (Rp231,000/boks)
B Cartos effervescent tab 1500 mg

(tube) 10's (Rp70,000/tube)
G Casodex FC tab 150 mg

2 14's (Rp4,381,696/boks)
Casodex FC tab 50 mg
2 14's (Rp2,700,078/boks)
G Cataflam D dispertab 50 mg
5 10's (Rp173,525/boks)
Cataflam sugar-coated tab 25 mg
5 10's (Rp93,265/boks)
Cataflam sugar-coated tab 50 mg
5 10's (Rp177,995/boks)
X
G Catapres infusion 0.15 mg/mL
10 1's (Rp390,060/boks)
Catapres tab 0.075 mg Catapres tab
0.075 mg
100's (Rp256,080/pak)
Catapres tab 0.15 mg Catapres tab 0.15
mg
100's (Rp337,700/pak)
B Cataro effervescent tab

1 10's (Rp31,000/boks)
W Cavit D3 tab Cavit D3 tab

100's (Rp134,200/pak)
G Cazetin oral susp 100000 IU
button/view.png
15 mL x 1's (Rp33,264/botol)
B CDR effervescent tab

10's (Rp18,690/pak)
20's (Rp35,450/pak)
B CDR Fortos caplet

5's
CDR Fortos effervescent tab
10's (Rp20,790/pak)
G Cebactam powd for inj

1's
Cebelia Intensive Anti-Aging cream

1's (Rp588,500/tube)
Cebelia LCE Balm

1's (Rp418,000/kontainer)
Cebelia Reinforced Depigmenting

cream
1's (Rp867,000/tube)
X
G Cedocard IV infusion 1 mg/mL

button/view.png
10 mL x 10 1's (Rp64,800/boks)
Cedocard 10 tab 10 mg
button/view.png
60's (Rp79,800/pak)
Cedocard 20 tab 20 mg
button/view.png
60's (Rp127,000/pak)
Cedocard 5 tab 5 mg button/view.png
60's (Rp53,500/pak)
Cedocard Retard 20 tab 20 mg
button/view.png
60's (Rp132,500/pak)
G Cefacef cap 100 mg

3 10's (Rp502,500/boks)
Cefacef dry syr 100 mg/5 mL
30 mL x 1's (Rp69,580/boks)
G Cefarin powd for inj 1 g
1's (Rp110,000/vial)
G Cefarox cap 100 mg

2 10's (Rp280,000/boks)
Cefarox dry syr 100 mg/5 mL
30 mL x 1's (Rp60,000/botol)
G Cefat cap 250 mg

10 10's (Rp490,000/boks)
Cefat cap 500 mg
10 10's (Rp965,000/boks)
Cefat dry syr 125 mg/5 mL
60 mL x 1's (Rp39,700/boks)
Cefat forte dry syr 250 mg/5 mL
60 mL x 1's (Rp68,300/boks)
G Cefazol powd for inj 1 g

1's (Rp82,000/vial)
(Hospital Pack) 3 1's (Rp65,000/boks)
3 1's (Rp195,000/boks)
G Cefila cap 100 mg button/view.png
30's (Rp330,000/pak)
Cefila cap 200 mg
10's (Rp170,000/pak)
Cefila cap 50 mg button/view.png
30's (Rp165,000/pak)
Cefila dry syr 100 mg/5 mL
30 mL x 1's (Rp58,000/botol)
G Cefim powd for inj 1 g

1's (Rp150,000/vial)
G Cefinov powd for inj 1000 mg

1's (Rp220,000/boks)
G Cefir powd for inj 1 g
1's (Rp200,000/vial)
Captured Time
6/2/2015 22:54
3/28/2017 12:15
3/28/2017 12:19
3/28/2017 12:21
2/25/2017 17:39
2/25/2017 17:41
2/25/2017 17:44
2/25/2017 17:47
2/25/2017 17:52
2/25/2017 17:56
2/25/2017 17:58
2/25/2017 18:18
2/25/2017 18:19
2/25/2017 18:23
2/25/2017 18:27
2/25/2017 18:30
2/25/2017 18:33
2/25/2017 18:38
2/25/2017 18:39
2/25/2017 18:42
2/25/2017 18:45
2/25/2017 18:47
2/25/2017 18:49
2/25/2017 18:50
2/25/2017 18:54
2/25/2017 19:52
2/25/2017 19:56
2/25/2017 19:58
2/25/2017 20:01
2/25/2017 20:03
2/25/2017 20:06
2/25/2017 20:09
2/25/2017 20:42
2/25/2017 20:45
2/25/2017 20:48
2/25/2017 20:51
2/25/2017 22:36
2/25/2017 22:39
2/25/2017 22:42
2/25/2017 22:44
2/26/2017 6:48
2/26/2017 6:50
2/26/2017 6:53
2/26/2017 6:56
2/26/2017 6:57
2/26/2017 7:01
2/26/2017 7:02
2/26/2017 7:04
2/26/2017 7:08
2/26/2017 7:11
2/26/2017 7:14
2/26/2017 7:18
3/3/2017 17:56
3/3/2017 18:01
2/26/2017 7:22
2/26/2017 7:24
2/26/2017 7:26
2/26/2017 7:30
2/26/2017 7:33
2/26/2017 7:36
2/26/2017 7:38
2/26/2017 7:42
2/26/2017 7:44
2/26/2017 7:45
2/26/2017 8:43
2/26/2017 8:45
2/26/2017 8:48
2/26/2017 8:52
2/26/2017 8:56
2/26/2017 9:00
2/26/2017 9:03
2/26/2017 9:05
2/26/2017 9:07
2/26/2017 9:09
2/26/2017 9:11
2/26/2017 9:13
2/26/2017 9:14
2/26/2017 9:16
2/26/2017 11:11
2/26/2017 11:25
2/26/2017 11:27
2/26/2017 11:29
2/26/2017 11:32
2/26/2017 11:34
2/26/2017 11:36
2/26/2017 11:38
2/26/2017 13:56
2/26/2017 13:59
2/26/2017 14:03
2/26/2017 14:06
2/26/2017 14:08
2/26/2017 14:11
2/26/2017 14:13
2/26/2017 14:15
2/26/2017 14:17
2/26/2017 14:19
2/26/2017 14:22
2/26/2017 14:24
2/26/2017 14:26
2/26/2017 14:28
2/26/2017 14:31
2/26/2017 14:33
2/26/2017 14:35
2/26/2017 14:37
2/26/2017 14:39
2/26/2017 14:42
2/26/2017 14:45
2/26/2017 14:47
2/26/2017 14:49
2/26/2017 14:51
2/26/2017 14:53
2/26/2017 14:55
2/26/2017 14:57
2/26/2017 14:59
2/26/2017 15:02
2/26/2017 15:14
2/26/2017 15:18
2/26/2017 15:21
2/26/2017 15:25
2/26/2017 15:26
2/26/2017 15:39
2/26/2017 15:44
2/26/2017 15:46
2/26/2017 15:52
2/26/2017 15:55
2/26/2017 16:01
2/26/2017 16:38
2/26/2017 16:40
2/26/2017 16:43
2/26/2017 16:45
2/26/2017 16:47
2/26/2017 18:13
2/26/2017 18:15
2/26/2017 18:18
2/26/2017 18:19
2/26/2017 18:23
2/26/2017 18:26
2/26/2017 18:28
2/26/2017 18:31
2/26/2017 18:33
2/26/2017 18:35
2/26/2017 18:50
2/26/2017 18:54
2/26/2017 18:57
2/26/2017 18:59
2/26/2017 19:02
2/26/2017 19:05
2/26/2017 19:09
2/26/2017 19:11
2/26/2017 19:13
2/26/2017 19:14
2/26/2017 19:16
2/26/2017 19:18
2/26/2017 19:21
2/26/2017 19:22
2/26/2017 19:26
3/3/2017 18:06
2/26/2017 19:29
2/26/2017 19:31
2/26/2017 19:34
2/26/2017 19:39
2/26/2017 19:47
2/26/2017 19:49
2/26/2017 19:51
2/26/2017 19:53
2/26/2017 19:55
2/26/2017 19:56
2/26/2017 19:59
2/26/2017 20:01
2/26/2017 20:03
2/26/2017 20:05
2/26/2017 20:07
2/26/2017 20:08
2/26/2017 20:10
2/26/2017 20:14
2/26/2017 20:17
2/26/2017 20:21
2/26/2017 20:23
2/26/2017 20:26
2/26/2017 20:28
2/26/2017 20:31
2/26/2017 20:33
2/26/2017 20:35
2/26/2017 20:37
2/26/2017 20:40
2/26/2017 20:42
2/26/2017 20:44
2/26/2017 20:46
2/26/2017 20:48
2/26/2017 20:51
2/26/2017 20:55
2/26/2017 21:06
2/26/2017 21:14
2/26/2017 21:23
2/26/2017 21:33
2/26/2017 21:35
2/26/2017 21:38
2/26/2017 21:40
2/26/2017 21:43
2/26/2017 21:46
2/26/2017 21:48
2/26/2017 21:51
2/26/2017 21:54
2/26/2017 21:57
2/26/2017 22:00
2/26/2017 22:03
2/26/2017 22:07
2/27/2017 1:43
2/27/2017 1:47
2/27/2017 5:10
2/27/2017 5:14
2/27/2017 5:16
2/27/2017 5:17
2/27/2017 5:19
2/27/2017 5:21
2/27/2017 5:25
2/27/2017 5:28
2/27/2017 5:30
2/27/2017 5:33
2/27/2017 5:36
2/27/2017 5:38
2/27/2017 5:40
2/27/2017 5:42
2/27/2017 5:45
2/27/2017 5:47
2/27/2017 5:49
2/27/2017 5:51
2/27/2017 5:53
2/27/2017 5:55
2/27/2017 5:57
2/27/2017 6:01
2/27/2017 6:04
2/27/2017 6:07
2/27/2017 6:10
2/27/2017 6:12
2/27/2017 6:14
2/27/2017 6:16
2/27/2017 6:18
2/27/2017 6:19
2/27/2017 6:23
2/27/2017 6:25
2/27/2017 6:27
2/27/2017 6:30
2/27/2017 6:32
2/27/2017 6:34
2/27/2017 6:36
2/27/2017 6:38
2/27/2017 6:39
2/27/2017 6:41
2/27/2017 6:43
2/27/2017 6:47
2/27/2017 6:49
2/27/2017 6:51
2/27/2017 6:53
3/3/2017 18:10
3/3/2017 18:14
2/27/2017 7:00
2/27/2017 7:02
2/27/2017 7:04
2/27/2017 7:06
2/27/2017 7:08
2/27/2017 7:09
2/27/2017 7:11
2/27/2017 7:13
2/27/2017 7:15
2/27/2017 7:17
2/27/2017 7:20
2/27/2017 7:22
2/27/2017 7:25
2/27/2017 7:27
2/27/2017 7:29
2/27/2017 7:30
2/27/2017 7:34
2/27/2017 7:37
2/27/2017 7:40
2/27/2017 7:43
2/27/2017 7:45
2/27/2017 7:47
2/27/2017 10:50
2/27/2017 19:54
2/28/2017 5:14
2/28/2017 19:42
2/28/2017 19:46
2/28/2017 19:48
2/28/2017 19:49
2/28/2017 19:54
2/28/2017 19:57
2/28/2017 20:00
2/28/2017 20:02
2/28/2017 20:07
2/28/2017 20:09
2/28/2017 20:11
2/28/2017 21:13
2/28/2017 21:15
2/28/2017 21:18
2/28/2017 21:19
2/28/2017 21:21
2/28/2017 21:23
2/28/2017 21:25
2/28/2017 21:28
2/28/2017 21:30
2/28/2017 21:31
2/28/2017 21:33
2/28/2017 21:36
2/28/2017 21:38
2/28/2017 21:40
2/28/2017 21:42
2/28/2017 21:43
2/28/2017 21:45
2/28/2017 21:47
2/28/2017 21:49
2/28/2017 21:50
2/28/2017 21:52
2/28/2017 21:54
2/28/2017 21:56
2/28/2017 21:58
2/28/2017 22:01
2/28/2017 22:03
2/28/2017 22:05
2/28/2017 22:06
2/28/2017 22:08
2/28/2017 22:10
2/28/2017 22:12
2/28/2017 22:14
2/28/2017 22:16
2/28/2017 22:17
2/28/2017 22:19
2/28/2017 22:21
2/28/2017 22:23
2/28/2017 22:25
2/28/2017 22:27
2/28/2017 22:30
2/28/2017 22:31
2/28/2017 22:34
2/28/2017 22:38
2/28/2017 22:41
2/28/2017 22:43
2/28/2017 22:45
2/28/2017 22:47
2/28/2017 22:50
2/28/2017 22:53
2/28/2017 22:55
2/28/2017 22:56
2/28/2017 22:58
2/28/2017 23:01
2/28/2017 23:03
2/28/2017 23:05
2/28/2017 23:09
2/28/2017 23:11
2/28/2017 23:14
2/28/2017 23:17
2/28/2017 23:20
2/28/2017 23:24
2/28/2017 23:26
2/28/2017 23:28
2/28/2017 23:29
2/28/2017 23:49
2/28/2017 23:52
2/28/2017 23:54
2/28/2017 23:55
2/28/2017 23:59
3/1/2017 0:02
3/1/2017 0:05
3/1/2017 0:07
3/1/2017 0:09
3/1/2017 0:11
3/1/2017 0:14
3/1/2017 0:17
3/1/2017 0:19
3/1/2017 0:21
3/1/2017 0:23
3/1/2017 0:25
3/1/2017 0:28
3/1/2017 4:18
3/1/2017 3:34
3/1/2017 3:39
3/1/2017 3:42
3/1/2017 4:22
3/1/2017 6:06
3/1/2017 6:10
3/1/2017 6:13
3/1/2017 6:17
3/1/2017 6:21
3/1/2017 6:22
3/1/2017 6:27
3/1/2017 6:30
3/1/2017 6:32
3/1/2017 6:35
3/1/2017 6:37
3/1/2017 6:39
3/1/2017 6:41
3/1/2017 6:43
3/1/2017 6:45
3/1/2017 6:46
3/1/2017 6:50
3/1/2017 6:53
3/1/2017 6:57
3/1/2017 7:00
3/1/2017 7:02
3/1/2017 7:04
3/1/2017 7:06
3/1/2017 7:08
3/1/2017 7:10
3/1/2017 7:11
3/1/2017 7:13
3/1/2017 7:15
3/1/2017 7:17
3/1/2017 7:19
3/1/2017 7:20
3/1/2017 7:22
3/1/2017 7:24
3/1/2017 7:27
3/1/2017 7:28
3/1/2017 7:30
3/1/2017 7:32
3/1/2017 7:35
3/1/2017 7:36
3/1/2017 7:40
3/1/2017 7:41
3/1/2017 7:45
3/1/2017 7:46
3/1/2017 7:48
3/1/2017 7:50
3/1/2017 7:52
3/1/2017 7:55
3/1/2017 7:57
3/1/2017 7:58
3/1/2017 8:01
3/1/2017 8:04
3/1/2017 8:06
3/1/2017 8:08
3/1/2017 8:10
3/1/2017 8:12
3/1/2017 8:14
3/1/2017 8:17
3/1/2017 8:20
3/1/2017 8:21
3/1/2017 8:23
3/1/2017 8:26
3/1/2017 8:28
3/1/2017 8:30
3/1/2017 8:33
3/1/2017 8:36
3/1/2017 8:37
3/1/2017 8:41
3/1/2017 8:44
3/1/2017 8:46
3/1/2017 8:48
3/1/2017 8:51
3/1/2017 8:54
3/1/2017 8:56
3/1/2017 8:59
3/1/2017 9:03
3/1/2017 9:04
3/1/2017 9:06
3/1/2017 9:08
3/1/2017 9:10
3/1/2017 9:12
3/1/2017 9:15
3/1/2017 9:19
3/1/2017 9:21
3/1/2017 9:22
3/1/2017 9:26
3/1/2017 9:28
3/1/2017 9:30
3/1/2017 9:33
3/1/2017 9:37
3/1/2017 9:38
3/1/2017 9:40
3/1/2017 9:42
3/1/2017 9:44
3/1/2017 9:46
3/1/2017 9:48
3/1/2017 9:50
3/1/2017 9:53
3/1/2017 9:55
3/1/2017 9:58
3/1/2017 10:02
3/1/2017 10:04
3/1/2017 10:07
3/1/2017 10:10
3/1/2017 10:12
3/1/2017 10:14
3/1/2017 10:17
3/1/2017 10:19
3/1/2017 10:20
3/1/2017 10:22
3/1/2017 10:25
3/3/2017 18:19
3/1/2017 10:30
3/1/2017 10:32
3/1/2017 10:35
3/1/2017 10:37
3/1/2017 10:39
3/1/2017 10:42
3/1/2017 10:45
3/1/2017 10:47
3/1/2017 10:50
3/1/2017 10:52
3/1/2017 10:55
3/1/2017 10:58
3/1/2017 11:01
3/1/2017 11:03
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