DCC 250 Draft

Annex-A: Proposed Product for locally manufacture (Human)
Sl Name of the Name of the Drug Generic Name Therapeutic Indication Contra-indication & Side-effect Status USFDA/BNF/
Manufacturer Class (New Molecule/ MHRA
Existing) Reference
1. Incepta Minoxidil 5gm+ Finasteride Minoxidil USP 5gm+ Alopecia Agent This topical solution is indicated for the Contra-indication: Finasteride 1mg, cÖ‡qvRb
Pharmaceuticals 0.1gm/100ml Topical Solution Finasteride USP treatment of androgenic alopecia (male  Hypersensitivity to minoxidil, 5mg Tablet ‡bB
Ltd (Dhamrai 0.1gm/100ml finasteride or any of the constituents & weavq
Unit). pattern baldness) in men in the age group of Av‡e`b
of the solution. Minoxidil 20
18 to 60 years. bvgÄyi
 Pregnancy. mg/ml, 50 mg/ml
Kiv †h‡Z
Scalp Lotion, cv‡i|
Side-effect:
 The most common side effects are
itching and skin irritation of the
treated area of the scalp.
 Other adverse effects include
hypertrichosis, local erythema, and
dry skin/scalp.
2. Ziska Minoxidil 10% Topical Solution Minoxidil INN Alopecia Agent Androgenic alopecia & alopecia areata Contraindications: Hypersensitivity, local Minoxidil 2% &
Pharmaceuticals 10gm/100ml irritation, use with caution in patient with 5% topical
Ltd. severe renal impairment. solution
Side effects: Common side effects
includes Headache, Unusual hair growth,
on the face, arm, and back, Redness,
irritation and itching at the site of
application.
3. Square Mesalamine 800.00mg Mesalamine USP Aminosalicylates It is a locally acting aminosalicylate indicated Contra-indication: History of Mesalazine USFDA Aby‡g
Pharmaceuticals Delayed Release Tablet 800.00mg for the treatment of moderately active hypersensitivity to salicylates or (Mesalamine) v`b
Ltd., Pabna Unit, ulcerative colitis. aminosalicylates 1000 mg Kiv
Salgaria, Pabna Suppository & †h‡Z
Adverse reactions: The most common 400mg DR cv‡i|
adverse reactions (observed in >2% of Tablet
patients) were headache, nausea,
nasopharyngitis, abdominal pain, and
worsening of ulcerative colitis.
1|Page
Existing) Reference
4. Incepta Parecoxib sodium 40mg/Vial Parecoxib Sodium Analgesic For a single peri-operative dose for the Contraindications: contraindicated in New BNF75 cÖ‡qvRb
Pharmaceutics Poeder for solution for INN 42.3600 mg Eq. management of post-operative pain. patients undergoing cardiac or major Page: 1268 ‡bB
Ltd.; Zirabo, Injection to 40mg The decision to prescribe PARECOXIB vascular surgery, patients who have weavq
Savar, Dhaka. Parecoxib/Vial should be based on an assessment of the previously had a myocardial infarction or Av‡e`b
bvgÄyi
individual patient's overall risks and the stroke, patients with known
Kiv †h‡Z
potential risk/benefit profile of alternative hypersensitivity to parecoxib sodium, cv‡i|
parenteral therapies. valdecoxib or to any other ingredient of the
As the cardiovascular risks of the selective product.
COX-2 inhibitors may increase with dose
and duration of exposure, the shortest Side-effects:
duration possible and the lowest effective 1. Ulcer and gastrointestinal bleeding,
daily dose should be used. 2. Jaundice and abnormal liver function,
3. Heart failure, heart attack, slow heart
rate, high/low blood pressure and
abnormal heart rhythm,
4. Swelling, rash, itching and difficulty in
breathing.
5. Back pain, low platelet counts,
agitation, disturbed sleeping and
decreased urination.
5. Eskayef Paracetamol 2.167gm + Paracetamol BP Analgesic + It is indicated for Dry or unproductive cough, Contraindications: This is contraindicated New cÖ‡qvRb
Pharmaceuticals Dextromethorphan 2.167gm + Antitussive + Fever, Body aches, Watery eyes, Sneezing. in patients hypersensitive to any of the ‡bB
Limited, Tongi, Hydrobromide 0.1gm + Dextromethorphan Antihistamine ingredients. weavq
Gazipur. Doxylamine Succinate Hydrobromide USP Av‡e`b
bvgÄyi
0.042gm/100ml Syrup 0.1gm + Doxylamine Side effects: Most common side effects
Kiv †h‡Z
Succinate USP include: Constipation; diarrhea; dizziness; cv‡i|
0.042gm/100ml drowsiness; excitability; headache; loss of
appetite; nausea; nervousness or anxiety;
trouble sleeping; upset stomach; vomiting;
weakness.
6. Eskayef Paracetamol 3.25gm + Paracetamol BP Analgesic + It relieving congestion, cough, and throat Contraindications: Any known allergies to New cÖ‡qvRb
Pharmaceuticals Dextromethorphan 3.25gm + Antitussive + and airway irritation due to colds, flu, or hay any of the ingredients. ‡bB
Limited, Tongi, Hydrobromide 0.1gm + Dextromethorphan Expectorant + fever. weavq
Gazipur. Guaifenesin 2.0gm + Hydrobromide USP Sympathomimetic Side effects: Constipation; diarrhea; Av‡e`b
0.1gm + Guaifenesin bvgÄyi
Phenylephrine Hydrochloride dizziness; drowsiness; dry mouth, nose, or
USP 2.0gm + Kiv †h‡Z
0.05gm/100ml Syrup throat; excitability; headache; cv‡i|
Phenylephrine nervousness; trouble sleeping; upset
2|Page
Existing) Reference
Hydrochloride USP stomach.
0.05gm/100ml
7. Eskayef Paracetamol 2.167gm + Paracetamol BP Analgesic + It is indicated for Headache, Fever, Body Contraindications: This is contraindicated New cÖ‡qvRb
Pharmaceuticals Dextromethorphan 2.167gm + Antitussive + aches, Cough, Stuffy nose & Sinus in patients hypersensitive to any of the ‡bB
Limited, Tongi, Hydrobromide 0.067gm + Dextromethorphan Sympathomimeti congestion caused by allergies, the common ingredients. weavq
Gazipur. Phenylephrine Hydrochloride Hydrobromide USP c cold, or the flu. Av‡e`b
bvgÄyi
0.033gm/100ml Syrup 0.067gm + Side effects: General side effects of Brand
Kiv †h‡Z
Phenylephrine Name have included pallor, dizziness; cv‡i|
Hydrochloride USP excitability; headache; nausea;
0.033gm/100ml nervousness or anxiety; trouble sleeping;
weakness.
8. Incepta Sodium alginate 250mg + Sodium alginate BP Antacid 1. Gastric reflux Contraindications: This medicinal product New BNF- 75 DCC-249
Pharmaceutics Sodium bicarbonate 250mg + Sodium 2. Heartburn is contraindicated in patients with known Page No: 82 Rejected
Ltd.; Zirabo, 133.5mg + Calcium bicarbonate BP 3. Flatulence associated with gastric or suspected hypersensitivity to the active
Savar, Dhaka. bicarbonate 80mg/5ml 133.5mg + Calcium reflux substances or to any of the excipients
suspension bicarbonate BP 4. Heartburn of pregnancy including methyl parahydrobenzoate and
80mg/5ml 5. All cases of epigastric and propyl parahydrobenzoate. Each 10 ml
retrosternal distress where the dose has a sodium content of 141 mg (6.2
underlying cause is gastric reflux mmol). This shoul be taken into account
when a highly restricted salt diet is
recommended. E.g. in some cases of
congestive cardiac failure and renal
impairment.
Side-effects: Care needs to be taken in
treating patients with hypercalcaemia,
nephrocalcinosis and recurrent calcium
containing renal calculi.
9. Incepta Dicycloverine Hydrochloride Dicycloverine Antacid Treatment and prophylaxis of the symptoms Contraindications: BNF75 cÖ‡qvRb
Pharmaceutics INN 0.05gm + Simeticone BP Hydrochloride INN of peptic ulcer, functional dyspepsia, irritable Patients who are allergic to any of the Page:84 ‡bB
Ltd.; Zirabo, 0.4gm + Magnesium Oxide BP 0.05gm + bowel syndrome, oesophagitis, hiatus ingredients of Dicycloverine weavq
Savar, Dhaka. 2.0gm + Aluminium Hydroxid Simeticone BP hernia, gastritis and iatrogenic gastritis. Hydrochloride, Simeticone, Magnesium Av‡e`b
bvgÄyi
BP 4.0gm/100ml 0.4gm + Magnesium Oxide, and Aluminium Hydroxide
Kiv †h‡Z
suspension Oxide BP 2.0gm + Suspension cv‡i|
Aluminium Hydroxid Patients who have difficulty passing urine
BP 4.0gm/100ml because of an enlarged prostate or other
condition
patients who have ulcerative colitis or
3|Page
Existing) Reference
other conditions affecting movement of
food through the gastro-intestinal tract
patients who have myasthenia gravis (a
very rare muscle disease)
patients who have glaucoma (a condition
involving increased pressure within the
eye resulting in poor vision).
Side-effects: Most medicines can cause
some side-effects but not everyone taking
the same medicine will get the same side-
effects.
The following side-effects have been
associated with people taking this
medicine: atropine-like effects such as dry
mouth, blurred vision, urinary retention or
constipation phosphorus deficiency - this
may happen in people who are on a low
phosphorus diet.
10. Square Sodium Alginate 250mg + Sodium Alginate Antacid It is indicated for the treatment of gastro- Contraindications: Hypersensitivity to the Potassium MHRA cÖ‡qvRb
Pharmaceuticals Sodium Bicarbonate USP 250mg + oesophageal reflux i.e. acid regurgitation, active substances or to any of the Bicarbonate 100 ‡bB
Ltd., Pabna Unit, 106.50mg + Calcium Sodium Bicarbonate heartburn, indigestion (for example following excipients, including the esters of mg + Sodium weavq
Salgaria, Pabna Carbonate (Heavy) 187.50mg BP 106.50mg + meals or during pregnancy) and for hydroxybenzoates (parabens). Alginate 500 mg Av‡e`b
bvgÄyi
Tablet Calcium Carbonate symptoms of excess stomach acid Side effects: Very rarely (<1/10,000) Tablet
Kiv †h‡Z
(Heavy) BP (hyperacidity) patients sensitive to the ingredients may cv‡i|
187.50mg develop allergic manifestations such as
It acts in a dual mechanism mood, quickly urticaria or bronchospasm, anaphylactic or
neutralizes excess stomach acid and also anaphylactoid reactions
forms a protective layer over stomach
content
11. Square Sodium Alginate 5.0 gm + Sodium Alginate BP Antacid It is indicated for the treatment of gastro- Contraindications: Hypersensitivity to the Potassium MHRA cÖ‡qvRb
Pharmaceuticals Sodium Bicarbonate 2.13gm 5.0gm + Sodium oesophageal reflux i.e. acid regurgitation, active substances or to any of the Bicarbonate ‡bB
Ltd., Pabna Unit, + Calcium Carbonate (light) Bicarbonate BP heartburn, indigestion (for example following excipients, including the esters of 100mg + weavq
Salgaria, Pabna 3.25gm/100ml Oral 2.13gm + Calcium meals or during pregnancy) and for hydroxybenzoates (parabens). Sodium Alginate Av‡e`b
bvgÄyi
Suspension Carbonate BP symptoms of excess stomach acid Side effects: Very rarely (<1/10,000) 500mg/5ml
Kiv †h‡Z
3.25gm / 100ml (hyperacidity) patients sensitive to the ingredients may cv‡i|
develop allergic manifestations such as
It acts in a dual mechanism mood, quickly urticaria or bronchospasm, anaphylactic or
4|Page
Existing) Reference
neutralizes excess stomach acid and also anaphylactoid reactions
forms a protective layer over stomach
content
12. Incepta Salicylic Acid 2gm/100gm Salicylic acid BP/Ph. Antiacne It is indicated for the treatment of acne and Contraindications: It should not be used in Salicylic Acid Aby‡g
Pharmaceuticals lotion EUR 2gm/100gm oil control. any patient known to be sensitive to 0.5%, 6%, v`b
Ltd (Dhamrai Salicylic Acid or any other listed 12%, 25% Cream Kiv
Unit). ingredients. †h‡Z
cv‡i|
Side-effects/Toxicity : An allergic reaction
(shortness of breath, closing of the throat,
swelling of the lips, face or tongue or
hives) or severe skin irritation.
13. UniMed & Procainamide HCl 500mg Procainamide HCl Antiarrhythmic It is indicated for the treatment of Contra-indication : Complete Heart Block, New USFDA cÖ‡qvRb
UniHealth Tablet USP 500mg documented ventricular arrhythmias, such Idiosyncratic Hypersensitivity, Lupus ‡bB
Manufacturers Ltd. as sustained ventricular tachycardia, that in Erythematosus, Torsades De Pointes, weavq
B.K Bari, Gazipur the judgment of the physician are life- Digitalis Intoxication, First Degree Heart Av‡e`b
Sadar, Gazipur bvgÄyi
threatening Block, Predigitalization for Atrial Flutter or
Kiv †h‡Z
Fibrillation, Congestive Heart Failure, cv‡i|
Concurrent Other Antiarrhythmic Agents,
Renal Insufficiency, Myasthenia Gravis
14. a) Navana Doxofylline 400mg SR + Doxofylline INN Antiasthma & It is used for the treatment, control, Contraindication: Doxophylline cÖ‡qvRb
Pharmaceuticals, Montelukast 10mg Tablet 400mg SR + COPD prevention, & improvement of the following Contraindicated in patients who are 400 mg SR ‡bB
Narayanganj Montelukast Sodium diseases, conditions and symptoms: hypersensitive to any component of this Tablet, weavq
USP 10 mg Av‡e`b
 Asthma product or to any of its ingredients. It
b) Square bvgÄyi
Formulations Ltd.,  Hay fever should not be used if you have the Montelukast
Kiv †h‡Z
Gorai, Tangail  Exercise-induced asthma following conditions: 10mg Tablet cv‡i|
 Chronic asthma  Allergic reactions
 Seasonal allergic rhinitis  Asthma exacerbations
 Perennial allergic rhinitis  Hypersensitivity
 Lactation
 Pregnancy
Side effect: The following is a list of
possible side-effects that may occur
from all constituting ingredients of this
tablet. This is not a comprehensive
list. These side effects are possible,
5|Page
Existing) Reference
but do not always occur.
 Nausea, Vomiting, Epigastric pain,
Palpitations, Headache, Insomnia
15. Navana Doxofylline 100 mg Doxofyllin Anti-asthma & It is indicated in bronchial asthma, Chronic Contraindication: Do not take if patients 200 cÖ‡qvRb
Pharmaceuticals, Injection e INN 100mg/10ml COPD asthmatic bronchitis, other breathing are allergic to doxofylline or xanthine mg Tablet, ‡bB
Narayanganj problems caused by spasms. derivatives and those who have acute weavq
400
myocardial infarction. Av‡e`b
mg Tablet, 400 bvgÄyi
SR Tablet & 100 Kiv †h‡Z
mg/5ml syrup. cv‡i|
Side Effects: Using xanthine derivatives
may cause nausea, vomiting, upper
abdominal pain, headache, insomnia,
irritability, tachycardia, premature systole,
shortness of breath, high blood glucose.
16. Incepta Benralizumab Benralizumab Antiasthmatic  Benralizumab is indicated for the add- Contraindications: Benralizumab is New USFDA Aby‡g
Pharmaceutics 30 mg/ml solution in a single- 30mg/ml on maintenance treatment of patients contraindicated in patients who have v`b
Ltd.; Zirabo, dose prefilled syringe with severe asthma aged 12 years and known hypersensitivity to benralizumab or Kiv
Savar, Dhaka. any of its excipients.
older, and with an eosinophilic †h‡Z
phenotype. cv‡i|
 Benralizumab is not indicated for
treatment of other eosinophilic Side Effects: Allergic (hypersensitivity)
conditions. reactions, including anaphylaxis. Serious
Benralizumab is not indicated for the relief of allergic reactions can happen after getting
acute bronchospasm or status asthmaticus benralizumab injection. Allergic reactions
can sometimes happen hours or days
after you get your injection. Tell your
healthcare provider or get emergency help
right away if someone has any of the
following
symptoms of an allergic reaction:

 swelling of your face, mouth and
tongue
 breathing problems
 fainting, dizziness, feeling
6|Page
Existing) Reference
lightheaded (low blood pressure)
 rash
 hives
17. UniMed & Umeclidinium Bromide, Umeclidinium Antiasthmatic is a combination of umeclidinium, an Contra-indication: Severe hypersensitivity New USFDA Aby‡g
UniHealth Micronized 62.5mcg + Bromide, Micronized anticholinergic, and vilanterol, a long-acting to milk proteins or any ingredients. v`b
Manufacturers Ltd. Vilanterol (as Vilanterol INN 0.0625mg + beta2-adrenergic agonist (LABA), indicated Kiv
B.K Bari, Gazipur Trifenatate), Micronized Vilanterol (as for the long-term, once-daily, maintenance Adverse Reactions: Most common †h‡Z
Sadar, Gazipur
25mcg Dry Powder Inhaler Vilanterol treatment of airflow obstruction in patients adverse reactions (incidence ≥1% and cv‡i|
Capsule Trifenatate), with chronic obstructive pulmonary disease more common than placebo) include
Micronized INN (COPD). pharyngitis, sinusitis, lower respiratory
0.025mg tract infection, constipation, diarrhea, pain
Important limitations: Not indicated for the in extremity, muscle spasms, neck pain,
relief of acute bronchospasm or for the and chest pain.
treatment of asthma.
18. UniMed & Fluticasone Furoate, Fluticasone Furoate, Antiasthmatic It is a combination of fluticasone furoate, an Contraindication: Severe hypersensitivity Fluticasone USFDA Aby‡g
UniHealth Micronized 100mcg + Micronized INN inhaled corticosteroid (ICS), and vilanterol, a to milk proteins or any ingredients. Furoate v`b
Manufacturers Ltd. Vilanterol (as Vilanterol 0.100mg + Vilanterol long-acting beta2-adrenergic agonist 50mcg/100mcg/ Kiv
B.K Bari, Gazipur Trifenatate), Micronized (as Vilanterol (LABA), indicated for long-term, once-daily, Adverse Reactions: Most common 200mcg/250mcg †h‡Z
Sadar, Gazipur
25mcg Dry Powder Inhaler Trifenatate), maintenance treatment of airflow obstruction adverse reactions (incidence ≥3%) are / 500mcg Dry cv‡i|
Capsule Micronized INN and for reducing exacerbations in patients nasopharyngitis, upper respiratory tract Powder
0.025mg with chronic obstructive pulmonary disease infection, headache, and oral candidiasis. Inhalation
(COPD). Capsule
Important limitations: Not indicated for relief

of acute bronchospasm or for treatment of
asthma.
UniHealth Micronized 200mcg + Micronized INN inhaled corticosteroid (ICS), and vilanterol, a to milk proteins or any ingredients. Furoate v`b
Manufacturers Ltd. Vilanterol (as Vilanterol 0.200mg + Vilanterol long-acting beta2-adrenergic agonist 50mcg/100mcg/ Kiv
B.K Bari, Gazipur Trifenatate), Micronized (as Vilanterol (LABA), indicated for long-term, once-daily, Adverse Reactions: Most common 200mcg/250mcg †h‡Z
Sadar, Gazipur
25mcg Dry Powder Inhaler Trifenatate), maintenance treatment of airflow obstruction adverse reactions (incidence ≥3%) are / 500mcg Dry cv‡i|
Capsule Micronized INN and for reducing exacerbations in patients nasopharyngitis, upper respiratory tract Powder
0.025mg with chronic obstructive pulmonary disease infection, headache, and oral candidiasis. Inhalation
(COPD). Capsule
7|Page
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Important limitations: Not indicated for relief

of acute bronchospasm or for treatment of
asthma.
UniHealth Micronized 100mcg + Micronized INN inhaled corticosteroid (ICS); umeclidinium, to milk proteins or any ingredients Furoate v`b
Manufacturers Ltd. Umeclidinium Bromide, 0.100mg + an anticholinergic; and vilanterol, a long- 50mcg/100mcg/ Kiv
B.K Bari, Gazipur Micronized 62.5mcg + Umeclidinium acting beta2-adrenergic agonist (LABA), Adverse Reactions : Most common 200mcg/250mcg †h‡Z
Sadar, Gazipur
Vilanterol (as Vilanterol Bromide, Micronized indicated for the long-term, once-daily, adverse reactions (incidence ≥1%) are / 500mcg Dry cv‡i|
Trifenatate), Micronized INN 0.0625mg + maintenance treatment of airflow obstruction upper respiratory tract infection, Powder
25mcg Dry Powder Inhaler Vilanterol (as in patients with chronic obstructive pneumonia, bronchitis, oral candidiasis, Inhalation
Capsule Vilanterol pulmonary disease (COPD). It is also headache, back pain, arthralgia, influenza, Capsule
Trifenatate), indicated to reduce exacerbations of COPD sinusitis, pharyngitis, rhinitis, dysgeusia,
Micronized INN in patients with a history of exacerbations. constipation, urinary tract infection,
0.025mg diarrhea, gastroenteritis, oropharyngeal
Important limitations of use: Not indicated for pain, cough, and dysphonia.
relief of acute bronchospasm or the
treatment of asthma.
21. a) Beximco Fosfomycin 4 gm/vial powder Fosfomycin Sodium & Antibiotic Fosfomycin is indicated for the treatment of Contraindications: 3gm/Vial powder BNF75 kZ©
Pharmaceuticals for solution for infusion Succinic Acid sterile the following infections in adults and children Hypersensitivity to fosfomycin. for oral Page: 549 mv‡c‡
Ltd. Mixture 5.38gm including neonates : Side effects: suspension ÿ
containing Fosfomycin - Osteomyelitis GI disturbances (e.g. nausea, diarrhoea), MHRA Aby‡g
b) Incepta Sodium BP 5.28 gm
Pharmaceutics eq. to 4.00gm
- Complicated urinary tract infections transient increase in aminotransferase v`b
Ltd.; Zirabo, Fosfomycin/Vial - Nosocomial lower respiratory tract levels, headache, visual disturbances, skin Kiv
Savar, Dhaka. infections rashes, eosinophilia, angioedema, aplastic †h‡Z
- Bacterial meningitis anaemia, exacerbation of asthma, cv‡i|
- Bacteraemia that occurs in association cholestatic jaundice, hepatic necrosis,
with, or is suspected to be associated with, toxic megacolon.
any of the infections listed above Potentially Fatal: Anaphylactic shock,
antibiotic-associated colitis and
pseudomembranous colitis.
22. a) Navana Faropenem 200 mg Tablet Faropenem Sodium Antibiotic Lower respiratory tract infections: CONTRAINDICATION: Faropenem is New cÖ‡qvRb
Pharmaceutical, INN 215.40mg eq. Eg, acute bronchitis, pneumonia, pulmonary contraindicated in patients with known ‡bB
Narayanganj to 200mg suppuration. hypersensitivity to any of the components weavq
Faropenem Ear, nose and throat (ENT) infections: Eg, of this product or to other drugs in the Av‡e`b
b) Square bvgÄyi
Pharmaceuticals
otitis externa, tympanitis, sinusitis. same class, or in patients who have
8|Page
Existing) Reference
ltd., Dhaka Unit Genito-urinary infections: Eg, pyelonephritis, demonstrated anaphylactic reactions to Kiv †h‡Z
cystitis, prostatitis, seminal gland beta-lactams. cv‡i|
inflammation.
Upper respiratory tract infections: Eg, ADVERSE EFFECTS: Faropenem is
pharyngitis, tonsillitis. generally welltolerated. The most
Skin and skin structure infections: Eg, frequently reported adverse reactions are
pustular acne, folliculitis, contagious diarrhea, abdominal pain, loose bowel
impetigo, erysipelas, lymphangitis, movements, nausea and rash.
suppurative nail inflammation, subcutaneous The following adverse reactionshave also
abscess, hidradenitis (sweat gland been observed:
inflammation), infective sebaceous cyst,  Shock, pseudoanaphylactic
chronic pyoderma, secondary infection of symptoms: Feeling of discomfort,
external wounds or surgical wound. wheezing, breathing trouble,
Gynecological infections: Eg, adnexitis, dizziness, feeling a need to evacuate
bartholingland inflammation the bowel, ringing in the ear,
sweating, flushing of the whole body,
vascular edema, low blood pressure.
 Acute renal impairment.
 Serious colitis accompanied by
pseudomembranous colitis: Bloody
stool, stomachache, frequent
diarrhea.
 Mucocutaneous ocular syndrome
(Stevens-Johnson syndrome), toxic
epidermal necrosis (Lyell syndrome).
 Interstitial pneumonia: Pyrexia,
cough, breathing trouble,
abnormalities in the chest X-ray. If
these symptoms appear, appropriate
measures should be taken, such as
administration of an adrenal cortical
hormone.
 Liver function disorder, jaundice: An
increase in AST (SGOT), ALT
(SGPT), ALP, etc.
 Agranulocytosis.
 Striated muscle softening: Muscular
9|Page
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pain, feeling of exhaustion, increase
in CK (CPK), increase in myoglobinin
the blood and in the urine, and
subsequently, acute renal
impairment.
 Pulmonary infiltration with
eosinophilia (PIE) syndrome: Pyrexia,
cough, breathing trouble,
abnormalities in the chest X-ray and
eosinophilia. If these symptoms
appear, appropriate measures should
be taken, such as administration of
an adrenal cortical hormone.
 Hypersensitivity reactions: Rash,
pyrexia, redness, hives, red spots on
the skin, etc.
 Abnormal laboratory findings: Eg,
increases in liver function tests (ALT,
AST, bilirubin, LDH, etc.),
eosinophilia, increase in BUN-
creatinine, changes in granulocyte
and platelets.
 Vitamin deficiency: Symptoms of
vitamin K deficiency (low
prothrombin, tendency of
hemorrhage, etc). Symptoms of
vitamin B-group deficiency
(inflammation of the tongue,
stomatitis, lack of appetite, neuritis,
etc.) might occur rarely.
 Gastrointestinal disorders: Vomiting,
stomachache, diarrhea, lack of
appetite, gastritis, constipation,
inflammation of the corners of the
mouth and lips, stomatitis.
 Others: Burning sensation,
headache, dizziness, drowsiness,
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edema, dryness of the mouth and
lips, change in nail color, and a
washed-out feeling, all of them can
occur rarely.
23. Acme Cefcapene Film Coated Tablet Cefcapene Pivoxil Antibiotic It is indicated in superficial skin infection, Contraindication: This drug is New cÖ‡qvRb
Laboratories Ltd., Hydrochloride deep skin infection, lymphangitis, contraindicated in patients with known ‡bB
Dhamrai, Dhaka Hydrate INN 137.20 lymphadentitis, chronic pyoderma. allergy to penicllin or cephalosporin class weavq
mg eq. to 100mg -Secondary infections in trauma, burns, of antibiotics or any of the components of Av‡e`b
bvgÄyi
Cefcapene surgical wounds etc., mastitis, periproctic this formulation. Patients with a history of
Kiv †h‡Z
abscess. shock following exposure to any of the cv‡i|
-Pharyngolaryngitis, tonsillitis (including ingredients in this product. Patients with a
peritonsillitis and peritonsillar abscess), history of hypersensitivity to any of the
acute bronchitis, pneumonia, secondary ingredients in this product or to other
infections in chronic respiratory diseases cephalosporin antibiotics.
-Cystitis, pyelonephritis Side Effects: Clinically significant adverse
-Urethritis, cervicitis reactions are given below.
 Shock, anaphylactoid reaction, Acute
renal failure
 Agranulocytosis, thrombocytopenia,
hemolytic anemia
 Pseudomembranous colitis,
hemorrhagic colitis
 Toxic epidermal necrolysis (TEN),
Stevens-Johnson syndrome,
erythroderma.
24. Beximco Fosfomycin 8 gm/vial powder Fosfomycin sodium Antibiotic Fosfomycin is indicated for the treatment of Contraindications: Fosfomycin 3g MHRA cÖ‡qvRb
Pharmaceuticals for solution for infusion BP 10.56 gm eq. to the following infections in adults and children Hypersensitivity to fosfomycin. powder for oral ‡bB
Ltd. 8 gm including neonates : suspension weavq
Fosfomycin/vial. - Osteomyelitis Av‡e`b
Side effects: bvgÄyi
- Complicated urinary tract infections GI disturbances (e.g. nausea, diarrhoea), Kiv †h‡Z
- Nosocomial lower respiratory tract transient increase in aminotransferase
11 | P a g e
Existing) Reference
infections levels, headache, visual disturbances, skin cv‡i|
- Bacterial meningitis rashes, eosinophilia, angioedema, aplastic
- Bacteraemia that occurs in association anaemia, exacerbation of asthma,
with, or is suspected to be associated with, cholestatic jaundice, hepatic necrosis,
any of the infections listed above toxic megacolon.
Potentially Fatal: Anaphylactic shock,
25. Beximco Fosfomycin 2 gm/vial powder Fosfomycin Sodium Antibiotic Fosfomycin is indicated for the treatment of Contraindications: Fosfomycin BNF75 cÖ‡qvRb
Pharmaceuticals for solution for infusion BP 2.64 gm eq. to the following infections in adults and children Hypersensitivity to fosfomycin. 3g/Vial powder Page: 549 ‡bB
Ltd., Tongi, 2.0 gm including neonates : Side effects: for oral weavq
Gazipur Fosfomycin/Vial - Osteomyelitis GI disturbances (e.g. nausea, diarrhoea), suspension MHRA Av‡e`b
bvgÄyi
- Complicated urinary tract infections transient increase in aminotransferase
Kiv †h‡Z
- Nosocomial lower respiratory tract levels, headache, visual disturbances, skin cv‡i|
infections rashes, eosinophilia, angioedema, aplastic
- Bacterial meningitis anaemia, exacerbation of asthma,
- Bacteraemia that occurs in association cholestatic jaundice, hepatic necrosis,
with, or is suspected to be associated with, toxic megacolon.
any of the infections listed above Potentially Fatal: Anaphylactic shock,
26. Eskayef Azithromycin 500mg + Azithromycin BP Antibiotic It is indicated for the treatment of patients Contraindications: Azithromycin Plus is New DCC-249 cÖ‡qvRb
Pharmaceuticals Ambroxol 500mg + Ambroxol and with mild to moderate infections caused by contraindicated in patients with known Rejected ‡bB
Limited, Tongi, HCl 75mg Sustained Release HCl BP 75mg Expectorant susceptible strains of the designated hypersensitivity to ambroxol, azithromycin, weavq
Gazipur. Tablet microorganisms in the specific conditions erythromycin, or any macrolide antibiotic. Av‡e`b
bvgÄyi
listed below. Upper Respiratory Tract
Kiv †h‡Z
Infections Pharyngitis/Tonsillitis Acute Side effects: In clinical trials, most of the cv‡i|
Bacterial Sinusitis Otitis Media Lower reported side effects with Azithromycin
Respiratory Tract Infections Acute Bacterial were mild to moderate in severity and
Exacerbations of Chronic Obstructive were related to the gastrointestinal tract,
Pulmonary Disease Community-Acquired e.g., nausea, vomiting, diarrhea, or
Pneumonia [CAP]. abdominal pain. Rarely but potentially
serious side effects were angioedema and
cholestatic jaundice. Ambroxol: The side
effects on account of ambroxol include
gastrointestinal side effects, skin rashes,
12 | P a g e
Existing) Reference
headache, dizziness and sweating.
27. Eskayef Azithromycin 250mg + Azithromycin BP Antibiotic It is indicated for the treatment of patients Contraindications: Azithromycin Plus is New cÖ‡qvRb
Pharmaceuticals Ambroxol 250mg + Ambroxol and with mild to moderate infections caused by contraindicated in patients with known ‡bB
Limited, Tongi, Hydrochloride 75mg Sustained Hydrochloride BP Expectorant susceptible strains of the designated hypersensitivity to ambroxol, azithromycin, weavq
Gazipur. Release Tablet 75mg microorganisms in the specific conditions erythromycin, or any macrolide antibiotic. Av‡e`b
bvgÄyi
listed below. Upper Respiratory Tract
Kiv †h‡Z
Infections Pharyngitis/Tonsillitis Acute Side effects: In clinical trials, most of the cv‡i|
Bacterial Sinusitis Otitis Media Lower reported side effects with Azithromycin
Respiratory Tract Infections Acute Bacterial were mild to moderate in severity and
Exacerbations of Chronic Obstructive were related to the gastrointestinal tract,
Pulmonary Disease Community-Acquired e.g., nausea, vomiting, diarrhea, or
Pneumonia [CAP]. abdominal pain. Rarely but potentially
serious side effects were angioedema and
cholestatic jaundice. Ambroxol: The side
effects on account of ambroxol include
gastrointestinal side effects, skin rashes,
headache, dizziness and sweating.
28. Eskayef Fusidic Acid 480mg/Vial Sodium Fusidate BP Antibiotic It is indicated in the treatment of all Contraindications: Hypersensitivity, This New cÖ‡qvRb
Pharmaceuticals Powder for Injection 500mg eq. to 480mg staphylococcal infections due to susceptible product should not be infused with amino ‡bB
Limited, Tongi, Fusidic Acid/Vial organisms such as: osteomyelitis, acid solutions or in whole blood, Due to weavq
Gazipur. pneumonia, septicemia, wound infections, local tissue injury, this product should not Av‡e`b
bvgÄyi
endocarditis, superinfected cystic fibrosis, be administered intramuscularly or
Kiv †h‡Z
cutaneous infections. It should be subcutaneously. cv‡i|
administered intravenously whenever oral
therapy is inappropriate, which includes Side effects: Drowsiness, Dizziness,
cases where absorption from the gastro- Hyperbilirubinaemia, Venous intolerance,
intestinal tract is unpredictable. Thrombophlebitis.
29. Eskayef Fusidic Acid BP 5gm/100ml Fusidic Acid BP Antibiotic It is indicated in the treatment of all Contraindications: Hypersensitivity, This New cÖ‡qvRb
Pharmaceuticals Suspension 5gm/100ml staphylococcal infections due to susceptible product should not be infused with amino ‡bB
Limited, Tongi, organisms such as: osteomyelitis, acid solutions or in whole blood, Due to weavq
Gazipur. pneumonia, septicemia, wound infections, local tissue injury, this product should not Av‡e`b
bvgÄyi
endocarditis, superinfected cystic fibrosis, be administered intramuscularly or
Kiv †h‡Z
cutaneous infections. subcutaneously. cv‡i|
Side effects: Drowsiness, Dizziness,
13 | P a g e
Existing) Reference
Hyperbilirubinaemia, Venous intolerance,
Thrombophlebitis.
30. Incepta Ozenoxacin 10mg/1gm Cream Ozenoxacin INN Antibiotic Ozenoxacin is a quinolone antimicrobial Contra-indication: None New USFDA Aby‡g
Pharmaceuticals 10mg/1gm indicated for the topical treatment of v`b
Ltd (Dhamrai impetigo due to Staphylococcus aureus or Side-effect: Adverse reactions (rosacea Kiv
Unit). Streptococcus pyogenes in adult and and seborrheic dermatitis) were reported †h‡Z
pediatric patients 2 months of age and older in 1 adult patient treated with ozenoxacin. cv‡i|
31. Incepta Colistimethate Sodium 2 Colistimethate Antibiotic Treatment of the following infections where Contraindications: Hypersensitivity to Colistimethate BNF-75 kZ©
Pharmaceutics million IU/Vial Powder for Sodium USP 2 sensitivity testing suggests that they are colistimethate sodium (colistin) or to Sodium, 1 Page: 512 mv‡c‡
Ltd.; Zirabo, Solution for million IU eq. to 68 caused by susceptible bacteria: Treatment polymyxin B. Patients with myasthenia Million ÿ
Savar, Dhaka. Injection or Infusion mg colistin by inhalation of Pseudomonas aeruginosa gravis. International Aby‡g
lung infection in patient swith cysticfibrosis Side-effects: Units v`b
(CF). Intravenous administration for the Systemic Treatment: The likehood of (IU) Powder for Kiv
treatment of some serious infections caused adverse events may be related to the age, Solution for †h‡Z
by gram-negative bacteria, including those renal function and condition of the patient. Injection or cv‡i|
of the lower respiratory tract and urinary In cystic fibrosis patients, neurological Infusion
tract, when more commonly used systemic events have been reported in up to 27% of
antibacterial agents may be contraindicated patients. These are generally mild and
or may be ineffective because of bacterial resolve during or shortly after treatment.
resistance. Neurotoxicity may be associated with
overdose, failure to reduce the dose in
patients with renal insufficiency and
concomitant use of either neuromuscular-
blocking drugs or other drugs with similar
neurological effects. Reducing the dose
may alleviate symptoms. Effects may
include apnoea, transient sensory
disturbances (eg, facial paraesthesia and
vertigo) and rarely, vasomotor instability,
slurred speech, visual disturbances,
confusion or psychosis.
Adverse effects on renal function have
been reported, usually following use of
higher than recommended doses in
patients with normal renal function, or
14 | P a g e
Existing) Reference
failure to reduce the dosage in patients
with renal impairment or during
concomitant use of other nephrotoxic
drugs. The effects are usually reversible
on discontinuation of therapy. In cystic
fibrosis patients treated within the
recommended dosage limits,
nephrotoxicity appears to be rare (<1%).
In seriously ill hospitalised non-CF
patients, signs of nephrotoxicity have been
reported in approximately 20% of patients.
Hypersensitivity reactions including skin
rash and drug fever have been reported. If
these occur treatment should be
withdrawn. Local irritation at the site of
injection may occur.
Inhalation Treatment: Inhalation may

induce coughing or bronchospasm. Sore
throat or mouth has been reported and
may be due to Candida albicans infection
or hypersensitivity.
Skin rash may also indicate
hypersensitivity, if this occurs treatment
should be withdrawn
32. Navana Cefixime Trihydrate 500 mg/5 Cefixime Trihydrate Antibiotic It is a cephalosporin antibacterial drug Side Effects: Diarrhea or loose stools, 200mg, 400mg USFDA cÖ‡qvRb
Pharmaceuticals, ml Powder for Suspension BP 500 mg/ 5ml indicated for Uncomplicated Urinary Tract nausea, abdominal pain, headache, Tablet/Capsule ‡bB
Narayanganj Infections vomiting, dyspepsia, dry mouth, flatulence, weavq
Av‡e`b
 Otitis Media loss of appetite, oral lesions, dizziness, 100mg/5 ml,
bvgÄyi
 Pharyngitis and Tonsillitis insomnia, confusion, fungal infection, 200 mg/5ml
Kiv †h‡Z
 Acute Exacerbations of Chronic Bronchitis anxiety, cough, urticaria, rash, dry skin, cv‡i|
 Uncomplicated Gonorrhea sun burn may occur. Other side effects
(cervical/urethral) reported eosinophilia and blood disorder,
reversible interstitial nephritis,
nervousness.
Contraindication: Cefixime is
15 | P a g e
Existing) Reference
contraindicated in patients with a known
allergy to Cefixime or to the Cephalosporin
group of antibiotic.
33. Popular Cefixime 50mg + Clavulanic Cefixime BP 50mg + Antibiotic Cefixime-Clavulanic Acid should be used Contraindications: Cefixime is Cefixime 100 cÖ‡qvRb
Pharmaceuticals Acid 31.25mg Tablet Diluted Clavulanate only to treat or prevent infections that are contraindicated in patients with known mg, 200mg & ‡bB
Ltd. Potassium BP proven or strongly suspected to be caused allergy to the Cephalosporin class of 400mg Capsule weavq
164 Tongi I/A, 74.460mg eq. to by susceptible bacteria. Cefixime-Clavulanic antibiotics. Clavulanic Acid does not Av‡e`b
Tongi, Gazipur bvgÄyi
Clavulanic Acid Acid is indicated for the treatment of – 1) inactivate all β-Lactamases. Most Cefixime
Kiv †h‡Z
31.25mg Uncomplicated Urinary Tract Infections. 2) chromosomally mediated β- 200mg/5ml cv‡i|
Otitis Media. 3) Pharyngitis and Tonsillitis. 4) Lactamases,e.g. the enzyme produced by Powder For
Acute Bronchitis and Acute Exacerbations of pseudomonas aeruginosa, are resistant to Suspension
Chronic Bronchitis. 5) Uncomplicated its action. Other organism have different
gonorrhea etc. mechanisms of acquired resistance to β-
Lactam antibiotics, against which Cefixime
clavulanic acid is ineffective. 2.5gm/100 ml
Side effects: Cefixime-Clavulanic Acid are Paediatric Drop
diarrhea and stool changes. Events like
nausea/vomiting, transient elevation in
liver transaminases, alkaline phosphatase
and jaundice can also occur.
Thrombocytosis, thrombocytopenia,
leucopenia, hypereosinophilia,
neutropenia and agranulocytosis may also
occur. Other adverse events that may
occur are abdominal pain, abdominal
cramps, flatulence, indigestion, headache,
vaginitis, vulvar itch, rash, hives, itch,
dysuria, chills, chest pain, shortness of
breath, mouth ulcers, swollen tongue,
sleepiness, thirst, anorexia.
34. Popular Cefixime 100mg + Clavulanic Cefixime BP 100mg Antibiotic Cefixime-Clavulanic Acid should be used Contraindications: Cefixime is Cefixime 100 cÖ‡qvRb
Pharmaceuticals Acid 62.5mg Tablet + Diluted only to treat or prevent infections that are contraindicated in patients with known mg, 200mg & ‡bB
Ltd. Clavulanate proven or strongly suspected to be caused allergy to the Cephalosporin class of 400mg Capsule weavq
164 Tongi I/A, Potassium BP by susceptible bacteria. Cefixime-Clavulanic antibiotics. Clavulanic Acid does not Av‡e`b
148.920mg eq. to Acid is indicated for the treatment of – 1) inactivate all β-Lactamases. Most Cefixime
Kiv †h‡Z
Clavulanic Acid Uncomplicated Urinary Tract Infections. 2) chromosomally mediated β- 200mg/5ml cv‡i|
62.5mg Otitis Media. 3) Pharyngitis and Tonsillitis. 4) Lactamases,e.g. the enzyme produced by Powder For
16 | P a g e
Existing) Reference
gonorrhea etc. mechanisms of acquired resistance to β-
Lactam antibiotics, against which Cefixime
clavulanic acid is ineffective. 2.5gm/100 ml
Side effects: Cefixime-Clavulanic Acid are Paediatric Drop
35. Popular Cefixime 200mg + Clavulanic Cefixime BP 200mg Antibiotic Cefixime-Clavulanic Acid should be used Contraindications: Cefixime is Cefixime 100 cÖ‡qvRb
Pharmaceuticals Acid 125mg Tablet + Diluted only to treat or prevent infections that are contraindicated in patients with known mg, 200mg & ‡bB
Ltd. Clavulanate proven or strongly suspected to be caused allergy to the Cephalosporin class of 400mg Capsule weavq
164 Tongi I/A, Potassium BP by susceptible bacteria. Cefixime-Clavulanic antibiotics. Clavulanic Acid does not Av‡e`b
297.840mg eq. to Acid is indicated for the treatment of – 1) inactivate all β-Lactamases. Most Cefixime
Kiv †h‡Z
Clavulanic Acid Uncomplicated Urinary Tract Infections. 2) chromosomally mediated β- 200mg/5ml cv‡i|
125mg Otitis Media. 3) Pharyngitis and Tonsillitis. 4) Lactamases,e.g. the enzyme produced by Powder For
gonorrhea etc. mechanisms of acquired resistance to β- Cefixime
Lactam antibiotics, against which 2.5gm/100 ml
clavulanic acid is ineffective. Paediatric Drop
Side effects: Cefixime-Clavulanic Acid are
17 | P a g e
Existing) Reference
36. Renata Limited Cefcapene 100mg Tablet Cefcapene Pivoxil Antibiotic Cefcapene exerts antibacterial action by Contraindication: Cefcapene is New cÖ‡qvRb
Rajendrapur, Hydrochloride inhibiting the synthesis of the bacterial cell- contraindicated in the following patients’ ‡bB
Gazipur Hydrate INN wall, and its action is bactericidal. patients with a history of shock following weavq
137.18mg eq. to Cefcapene showed high binding affinity to all exposure to any of the ingredients in this Av‡e`b
bvgÄyi
Cefcapene 100mg of the subtypes 1, 2 and 3 of PBP (penicillin product.
Kiv †h‡Z
binding protein), which are known to be Side effects : Few major adverse events cv‡i|
target molecules lethal to Staphylococcus have been observed. The adverse events
aureus. Furthermore, it showed high binding found during trial are Urticaria, pruritus,
affinity to PBP3, which is an enzyme redness, erythema, swelling, fever,
essential to the synthesis of bacterial cell- Proteinuria, hematuria, increased
wall. creatinine, edema.
37. Renata Limited Ertapenem 500mg/Vial Ertapenem Sodium Antibiotic Ertapenem is bactericidal and act by binding Contraindication : Ertapenem is 1 gm/vial cÖ‡qvRb
Rajendrapur, Powder for Infusion INN 523mg eq. to to penicillin binding proteins (PBPs). This contraindicated in patients with known Injection ‡bB
Gazipur 500mg binding inactivates the PBPs, and prevents hypersensitivity to any component of this weavq
Ertapenem/Vial the transpeptidation (crosslinking) of product or to other drugs in the same Av‡e`b
bvgÄyi
peptidoglycan strands, which is essential for class or in patients who have
Kiv †h‡Z
the synthesis of intact bacterial demonstrated anaphylactic reactions to cv‡i|
peptidoglycan. betalactams. Due to the use of lidocaine
HCl as a diluent, ERTAPENEM
administered intramuscularly is
contraindicated in patients with a known
hypersensitivity to local anesthetics of the
amide type.
Side effects : The most common drug-
related adverse experiences in patients
treated with Ertapenem, including those
who were switched to therapy with an oral
18 | P a g e
Existing) Reference
antimicrobial, were diarrhea (5.5%),
infused vein complication (3.7%), nausea
(3.1%), headache (2.2%), vaginitis in
females (2.1%), phlebitis/thrombophlebitis
(1.3%), and vomiting (1.1%).
38. Ziska Telavancin 250mg/Vial Telavancin HCl Antibiotic Telavancin is a lipoglycopeptide antibacterial Contraindications: None New USFDA Aby‡g
Pharmaceuticals Sterile Lyophilized indicated for the treatment of adult patients Side effects: Most common adverse v`b
Ltd. Injection
Powder INN with complicated skin and skin structure reactions (≥10% of patients treated with Kiv
265.59mg eq. to infections (cSSSI) caused by susceptible Telavancin) include: taste disturbance, †h‡Z
250mg Telavancin Gram-positive bacteria. nausea, vomiting, and foamy urine cv‡i|
39. Ziska Telavancin 750 mg/Vial Telavancin HCl Antibiotic Telavancin is a lipoglycopeptide antibacterial Contraindications: New USFDA Aby‡g
Pharmaceuticals Injection Sterile Lyophilized indicated for the treatment of adult patients None v`b
Ltd. Powder INN with complicated skin and skin structure Side effects: Kiv
796.78mg eq. to infections (cSSSI) caused by susceptible Most common adverse reactions (≥10% of †h‡Z
750mg Telavancin Gram-positive bacteria. patients treated with Telavancin) include: cv‡i|
taste disturbance, nausea, vomiting, and
foamy urine
40. Beacon Rucaparib 200mg Tablet Rucaparib Camslate Anticancer It is a poly (ADP-ribose) polymerase (PARP) Contra-indication : None 300mg Tablet USFDA Aby‡g
Pharmaceuticals INN 344.00mg eq. to inhibitor indicated as monotherapy for the v`b
Ltd, 200mg Rucaparib treatment of patients with deleterious BRCA Side-effect: Most common adverse Kiv
Kathali, Bhaluka, mutation (germline and/or somatic) reactions (≥ 20%) were nausea, fatigue †h‡Z
Mymensingh
associated advanced ovarian cancer who (including asthenia), vomiting, anemia, cv‡i|
have been treated with two or more abdominal pain, dysgeusia, constipation,
chemotherapies. Select patients for therapy decreased appetite, diarrhea,
based on an FDA-approved companion thrombocytopenia, and dyspnea.
diagnostic for Rucaparib • Most common laboratory abnormalities
This indication is approved under (≥ 35%) were increase in creatinine,
accelerated approval based on objective increase in ALT, increase in AST,
response rate and duration of response. decrease in hemoglobin, decrease in
Continued approval for this indication may lymphocytes, increase in cholesterol,
be contingent upon verification and decrease in platelets, and decrease in
description of clinical benefit in confirmatory absolute neutrophil count
trials.
41. Beacon Rucaparib 250mg Tablet Rucaparib Anticancer It is a poly (ADP-ribose) polymerase (PARP) Contra-indication : None 300mg Tablet USFDA Aby‡g
Pharmaceuticals Camslate INN inhibitor indicated as monotherapy for the v`b
Ltd, 430.000mg eqv. To treatment of patients with deleterious BRCA Side-effect: Most common adverse Kiv
19 | P a g e
Existing) Reference
Kathali, Bhaluka, Rucaparib 250mg mutation (germline and/or somatic) reactions (≥ 20%) were nausea, fatigue †h‡Z
Mymensingh associated advanced ovarian cancer who (including asthenia), vomiting, anemia, cv‡i|
have been treated with two or more abdominal pain, dysgeusia, constipation,
chemotherapies. Select patients for therapy decreased appetite, diarrhea,
based on an FDA-approved companion thrombocytopenia, and dyspnea.
diagnostic for Rucaparib • Most common laboratory abnormalities
This indication is approved under (≥ 35%) were increase in creatinine,
accelerated approval based on objective increase in ALT, increase in AST,
response rate and duration of response. decrease in hemoglobin, decrease in
Continued approval for this indication may lymphocytes, increase in cholesterol,
be contingent upon verification and decrease in platelets, and decrease in
description of clinical benefit in confirmatory absolute neutrophil count
trials.
42. Beacon Olaparib 100mg Tablet Olaparib INN 100mg Anticancer It is a poly (ADP-ribose) polymerase Contra-indication : None New USFDA Aby‡g
Pharmaceuticals (PARP) inhibitor indicated: v`b
Ltd, • for the maintenance treatment of adult Side-effect: Kiv
Kathali, Bhaluka, patients with recurrent epithelial ovarian,  Most common adverse reactions (≥20%) †h‡Z
Mymensingh
fallopian tube or primary peritoneal cancer, in clinical trials were anemia, nausea, cv‡i|
who are in a complete or partial response to fatigue (including asthenia),
platinum-based chemotherapy. vomiting,nasopharyngitis/upper
• for the treatment of adult patients with respiratory tract infection/influenza,
deleterious or suspected deleterious diarrhea,thralgia/myalgia, dysgeusia,
germline BRCA-mutated advanced ovarian headache, dyspepsia, decreased
cancer who have been treated with three or appetite, constipation. and stomatitis.
more prior lines of chemotherapy. Select • Most common laboratory abnormalities
patients for therapy based on an FDA- (≥25%) were decrease in hemoglobin,
approved companion diagnostic for increase in mean corpuscular volume,
Lynparza. decrease in lymphocytes, decrease in
leukocytes, decrease in absolute
neutrophil count, increase in serum
creatinine and decrease in platelets.
43. Beacon Olaparib 150mg Tablet Olaparib INN 150mg Anticancer It is a poly (ADP-ribose) polymerase Contra-indication : None New USFDA Aby‡g
Pharmaceuticals (PARP) inhibitor indicated: v`b
Ltd, • for the maintenance treatment of adult Side-effect: Kiv
Kathali, Bhaluka, patients with recurrent epithelial ovarian,  Most common adverse reactions (≥20%) †h‡Z
Mymensingh
fallopian tube or primary peritoneal cancer, in clinical trials were anemia, nausea, cv‡i|
who are in a complete or partial response to fatigue (including asthenia),
20 | P a g e
Existing) Reference
platinum-based chemotherapy. vomiting,nasopharyngitis/upper
• for the treatment of adult patients with respiratory tract infection/influenza,
deleterious or suspected deleterious diarrhea,thralgia/myalgia, dysgeusia,
germline BRCA-mutated advanced ovarian headache, dyspepsia, decreased
cancer who have been treated with three or appetite, constipation. and stomatitis.
more prior lines of chemotherapy. Select • Most common laboratory abnormalities
patients for therapy based on an FDA- (≥25%) were decrease in hemoglobin,
approved companion diagnostic for increase in mean corpuscular volume,
Lynparza. decrease in lymphocytes, decrease in
leukocytes, decrease in absolute
neutrophil count, increase in serum
creatinine and decrease in platelets.
44. Beacon Enzalutamide 160mg Enzalutamide Anticancer It is an androgen receptor inhibitor Contra-indication : Pregnancy New cÖ‡qvRb
Pharmaceuticals Capsule INN 160mg indicated for the treatment of patients ‡bB
Ltd, with metastatic castration-resistant Side-effect: The most common adverse weavq
Kathali, Bhaluka, prostate cancer who have previously reactions (≥ 5%) are asthenia/fatigue, Av‡e`b
Mymensingh bvgÄyi
received docetaxel back pain, diarrhea, arthralgia, hot flush,
Kiv †h‡Z
peripheral edema, musculoskeletal pain, cv‡i|
headache, upper respiratory infection,
muscular weakness, dizziness, insomnia,
lower respiratory infection, spinal cord
compression and cauda equina syndrome,
hematuria, paresthesia, anxiety, and
hypertension
45. Drug International Apalutamide 60mg Tablet Apalutamide INN 60 Anticancer Apalutamide is an androgen receptor Contraindications: Pregnancy New USFDA Aby‡g
Ltd. UNIT-2 mg inhibitor indicated for the treatment of Adverse Reactions: The most common v`b
Plot# 13A & 14A, patients with non-metastatic castration- adverse reactions (≥10%) are fatigue, Kiv
Tongi Industrial resistant prostate cancer. hypertension, rash, diarrhea, nausea, †h‡Z
Area,
Tongi, Gazipur
weight decreased, arthralgia, fall, hot cv‡i|
flush, decreased appetite, fracture, and
peripheral edema
46. Drug International Venetoclax 10mg Tablet Venetoclax INN Anticancer It is a BCL-2 inhibitor indicated for the Contraindications: Concomitant use of New USFDA Aby‡g
Ltd. UNIT-2 10mg treatment of patients with chronic VENCLEXTA with strong inhibitors of v`b
Plot# 13A & 14A, lymphocytic leukemia (CLL) or small CYP3A at initiation and during ramp-up Kiv
Tongi Industrial lymphocytic lymphoma (SLL), with or without phase is contraindicated. †h‡Z
Area,
Tongi, Gazipur
17p deletion, who have received at least one cv‡i|
21 | P a g e
Existing) Reference
prior therapy. Adverse Reactions: The most common
adverse reactions (≥20%) with Venetoclax
in combination with rituximab were
neutropenia, diarrhea, upper respiratory
tract infection, fatigue, cough, and nausea.
(6.1) The most common adverse reactions
(≥20%) with VENCLEXTA in the
monotherapy studies were neutropenia,
diarrhea, nausea, upper respiratory tract
infection, anemia, fatigue,
thrombocytopenia, musculoskeletal pain,
edema, and cough.
Ltd. UNIT-2 50mg treatment of patients with chronic Venetoclax with strong inhibitors of v`b
Area,
Tongi, Gazipur
prior therapy.
Adverse Reactions: The most common
(≥20%) with Venetoclax in the
edema, and cough.
Ltd. UNIT-2 100mg treatment of patients with chronic Venetoclax with strong inhibitors of v`b
Area,
Tongi, Gazipur,
Bangladesh. prior therapy. Adverse Reactions: The most common
22 | P a g e
Existing) Reference
(≥20%) with Venetoclax in the
edema, and cough.
49. Healthcare Dasatinib 140 mg film coated Dasatinib Anticancer treatment of Contraindications: Known hypersensitivity 20mg, 50mg and USFDA Aby‡g
Pharmaceutical tablet Monohydrate INN 1.newly diagnosed adults with Philadelphia to Dasatinib INN or any excipients in 100mg Tablet v`b
ltd., Rajendrapur , 145.166mg eq. to chromosome-positive (Ph+) chronic myeloid formulation Kiv
Gazipur 140.0mg Dasatinib leukemia (CML) in chronic phase. The trial †h‡Z
is ongoing and further data will be required Side-Effects: Most common adverse cv‡i|
to determine long-term outcome. reactions (≥10%) in patients with newly
2.adults with chronic, accelerated, or diagnosed chronic phase CML included
myeloid or lymphoid blast phase Ph+ CML myelosuppression, fluid retention,
with resistance or intolerance to prior diarrhea, headache, musculoskeletal pain,
therapy including imatinib. and rash. Most common adverse reactions
3.adults with Philadelphia chromosome- (≥20%) in patients with resistance or
positive acute lymphoblastic leukemia (Ph+ intolerance to prior imatinib therapy
ALL) with resistance or intolerance to prior included myelosuppression, fluid retention
therapy events, diarrhea, headache, dyspnea, skin
rash, fatigue, nausea, and hemorrhage.
50. Incepta Abemaciclib Abemaciclib INN Anticancer Abemaciclib is a kinase inhibitor indicated: Contraindications: None. New USFDA Aby‡g
Pharmaceutics 150 mg Tablet 150 mg v`b
Ltd.; Zirabo, • in combination with fulvestrant for the Side Effects: Kiv
Savar, Dhaka. treatment of women with hormone receptor Diarrhea: Diarrhea is common with †h‡Z
(HR)-positive, human epidermal growth abemaciclib treatment and may cv‡i|
factor receptor 2 (HER2)-negative advanced sometimes be severe. Diarrhea may
or metastatic breast cancer with disease cause to develop dehydration or an
progression following endocrine therapy. infection. The most common time to
develop diarrhea is during the first month
• as monotherapy for the treatment of adult of abemaciclib treatment. If anyone
23 | P a g e
Existing) Reference
patients with HR-positive, HER2-negative develop diarrhea during treatment with
advanced or metastatic breast cancer with abemaciclib, healthcare provider may tell
disease progression following endocrine to temporarily stop taking abemaciclib,
therapy and prior chemotherapy in the stop treatment, or decrease dose.
metastatic setting.
-If have any loose stools, right away tell
healthcare provider, start taking an
antidiarrheal medicine (such as
loperamide), and drink more fluids.
Low white blood cell counts

(neutropenia):
Low white blood cell counts are common
during treatment with abemaciclib and
may cause serious infections that can lead
to death. Healthcare provider should
check white blood cell counts before and
during treatment. If develop low white
blood cell counts during treatment with
abemaciclib, healthcare provider may tell
to temporarily stop taking abemacicliob,
decrease dose, or wait before starting next
month of treatment.
Tell healthcare provider right away if have
signs and symptoms of low white blood
cell counts or infections, such as fever and
chills.
Liver problems:
Abemaciclib can cause serious liver
problems. Healthcare provider should do
blood tests to check liver before and
during treatment with abemaciclib. If
develop liver problems during treatment
with abemaciclib, healthcare provider may
reduce dose or stop treatment. Tell
healthcare provider right away if have any
24 | P a g e
Existing) Reference
of the following signs and symptoms of
liver problems:
-feeling very tired
-pain on the upper right side of your
stomach area (abdomen)
-loss of appetite
-bleeding or bruising more easily than
normal
Blood clots in veins, or in the arteries of
lungs.abemaciclib may cause serious
blood clots that have led to death. Tell
healthcare provider right away if get any of
the following signs and symptoms of a
blood clot:
-pain or swelling in your arms or legs
-shortness of breath
-chest pain
-rapid breathing
-rapid heart rate
51. Incepta Abemaciclib Abemaciclib INN Anticancer Abemaciclib is a kinase inhibitor indicated: Contraindications: None. New USFDA Aby‡g
Pharmaceutics 200 mg Tablet 200 mg v`b
Ltd.; Zirabo, • in combination with fulvestrant for the Side Effects: Kiv
Savar, Dhaka. treatment of women with hormone receptor Diarrhea: Diarrhea is common with †h‡Z
(HR)-positive, human epidermal growth abemaciclib treatment and may cv‡i|
factor receptor 2 (HER2)-negative advanced sometimes be severe. Diarrhea may
or metastatic breast cancer with disease cause to develop dehydration or an
progression following endocrine therapy. infection. The most common time to
develop diarrhea is during the first month
• as monotherapy for the treatment of adult of abemaciclib treatment. If anyone
patients with HR-positive, HER2-negative develop diarrhea during treatment with
advanced or metastatic breast cancer with abemaciclib, healthcare provider may tell
disease progression following endocrine to temporarily stop taking abemaciclib,
therapy and prior chemotherapy in the stop treatment, or decrease dose.
metastatic setting.
-If have any loose stools, right away tell
healthcare provider, start taking an
antidiarrheal medicine (such as
25 | P a g e
Existing) Reference
loperamide), and drink more fluids.
Low white blood cell counts

(neutropenia):
Low white blood cell counts are common
during treatment with abemaciclib and
may cause serious infections that can lead
to death. Healthcare provider should
check white blood cell counts before and
during treatment. If develop low white
blood cell counts during treatment with
abemaciclib, healthcare provider may tell
to temporarily stop taking abemacicliob,
decrease dose, or wait before starting next
month of treatment.
Tell healthcare provider right away if have
signs and symptoms of low white blood
cell counts or infections, such as fever and
chills.
Liver problems:
Abemaciclib can cause serious liver
problems. Healthcare provider should do
blood tests to check liver before and
during treatment with abemaciclib. If
develop liver problems during treatment
with abemaciclib, healthcare provider may
reduce dose or stop treatment. Tell
healthcare provider right away if have any
of the following signs and symptoms of
liver problems:
-feeling very tired
-pain on the upper right side of your
stomach area (abdomen)
-loss of appetite
-bleeding or bruising more easily than
normal
26 | P a g e
Existing) Reference
Blood clots in veins, or in the arteries of
lungs.abemaciclib may cause serious
blood clots that have led to death. Tell
healthcare provider right away if get any of
the following signs and symptoms of a
blood clot:
-pain or swelling in your arms or legs
-shortness of breath
-chest pain
-rapid breathing
-rapid heart rate
52. Incepta Daratumumab Daratumumab INN Anticancer Daratumumab is indicated as monotherapy Contraindications: None. New USFDA Aby‡g
Pharmaceutics 100mg/5ml 100mg/5ml for the treatment of adult patients with v`b
Ltd.; Zirabo, Injection relapsed and refractory multiple myeloma, Side Effects: Kiv
Savar, Dhaka. whose prior therapy included a proteasome Infusion reactions: Infusion reactions are †h‡Z
inhibitor and an immunomodulatory agent common with daratamumab and can be cv‡i|
and who have demonstrated disease severe. Your healthcare provider may
progression on the last therapy. temporarily stop your infusion or
completely stop treatment with
daratamumab if you have infusion
reactions. Tell healthcare provider right
away if get any of the following symptoms:
b) shortness of breath or trouble
breathing
c) dizziness or lightheadedness
(hypotension)
d) cough
e) wheezing
f) throat tightness
g) runny or stuffy nose
h) headache
i) itching
j) nausea
k) vomiting
27 | P a g e
Existing) Reference
l) chills
m) fever
Changes in blood tests: Daratamumab
can affect the results of blood tests to
match blood type. These changes can last
for up to 6 months after final dose of
daratamumab. Healthcare provider will do
blood tests to match blood type before
start treatment with daratamumab.
Decreases in blood cell counts:
Daratamumab can decrease white blood
cell counts which help fight infections and
blood cells called platelets which help to
clot blood.
53. Incepta Daratumumab Daratumumab INN Anticancer Daratumumab is indicated as monotherapy Contraindications: None. New USFDA Aby‡g
Pharmaceutics 400mg/20ml 400mg/20ml for the treatment of adult patients with v`b
Ltd.; Zirabo, Injection relapsed and refractory multiple myeloma, Side Effects: Kiv
Savar, Dhaka. whose prior therapy included a proteasome Infusion reactions: Infusion reactions are †h‡Z
inhibitor and an immunomodulatory agent common with daratamumab and can be cv‡i|
and who have demonstrated disease severe. Your healthcare provider may
progression on the last therapy. temporarily stop your infusion or
completely stop treatment with
daratamumab if you have infusion
reactions. Tell healthcare provider right
away if get any of the following symptoms:
n) shortness of breath or trouble
breathing
o) dizziness or lightheadedness
(hypotension)
p) cough
q) wheezing
r) throat tightness
s) runny or stuffy nose
t) headache
u) itching
v) nausea
w) vomiting
28 | P a g e
Existing) Reference
x) chills
y) fever
Changes in blood tests: Daratamumab
can affect the results of blood tests to
match blood type. These changes can last
for up to 6 months after final dose of
daratamumab. Healthcare provider will do
blood tests to match blood type before
start treatment with daratamumab.
Decreases in blood cell counts:
Daratamumab can decrease white blood
cell counts which help fight infections and
blood cells called platelets which help to
clot blood.
54. Incepta Atezolizumab Atezolizumab INN Anticancer Locally Advanced or Metastatic Urothelial Contraindications: None New USFDA Aby‡g
Pharmaceutics 1200mg/20ml Injection for 1200mg/20ml Carcinoma v`b
Ltd.; Zirabo, Intravenous Use Atezolizumab is indicated for the treatment Side Effects: The most common side Kiv
Savar, Dhaka. of patients with locally advanced or effects of atezolizumab in people with †h‡Z
metastatic urothelial carcinoma who: urothelial carcinoma include: cv‡i|
 feeling tired
 are not eligible for cisplatin-containing  decreased appetite
chemotherapy, or  nausea
 have disease progression during or  constipation
following any platinum-containing  urinary tract infection
chemotherapy, or within 12 months of  diarrhea
neoadjuvant or adjuvant  fever
chemotherapy
The most common side effects of
This indication is approved under atezolizumab in people with non-small cell
accelerated approval based on tumor lung cancer include:
response rate and durability of response.  feeling tired
Continued approval for this indication may
 decreased appetite
be contingent upon verification and
 shortness of breath
description of clinical benefit in confirmatory
trials.  cough
 nausea
Metastatic Non-Small Cell Lung Cancer  muscle or bone pain
29 | P a g e
Existing) Reference
Atezolizumab is indicated for the treatment  constipation
of patients with metastatic non-small cell Atezolizumab may cause fertility problems
lung cancer (NSCLC) who have disease in females, which may affect the ability to
progression during or following platinum- have children. Patients should talk to their
containing chemotherapy. Patients with healthcare provider if they have concerns
EGFR or ALK genomic tumor aberrations about fertility.
should have disease progression on FDA- These are not all the possible side effects
approved therapy for these aberrations prior of atezolizumab. Patients should ask their
to receiving atezolizumab. healthcare provider or pharmacist for more
information.
55. General Fluvoxamine Maleate BP Fluvoxamine Antidepressants Fluvoxamine Maleate Tablets are indicated Contra-indication : Coadministration of 50mg Tablet USFDA Aby‡g
Pharmaceutical 100mg Tablet Maleate BP 100mg for the treatment of obsessions and tizanidine, thioridazine, alosetron, v`b
Ltd., Gazipur compulsions in patients with obsessive pimozide Serotonin Syndrome and Kiv
compulsive disorder (OCD) MAOIs: Do not use MAOIs intended to †h‡Z
treat psychiatric disorders with cv‡i|
Fluvoxamine Maleate Tablets or within
14 days of stopping treatment with
Fluvoxamine Maleate Tablets. Do not
use Fluvoxamine Maleate Tablets within
14 days of stopping an MAOI intended to
treat psychiatric disorders. In addition, do
not start Fluvoxamine Maleate Tablets in
a patient who is being treated with
linezolid or intravenous methylene blue
Side –Effects: Most reactions in
controlled trails with adult OCD and
depression patients were nausea,
somnolence, insomnia, asthenia,
nervousness, dyspepsia, abnormal
ejaculation, sweating, anorexia, termor
and vomiting. Using the above rule, the
following events were also identified:
anorgasmia, deacresed libido, dry
30 | P a g e
Existing) Reference
mouth, rhinitis, taste perbversion, and
urinary frequiency in patients with OCD
and agitation, depression dysmenorrhea,
flatulence, hyperkinesia and rash in
pediatric patients with OCD
56. Ziska L-tryptophan 500 mg Capsule L-tryptophan USP Antidepressants Treatment resistant depression (used alone Contraindications: History of eosinophilia New BNF-75 Aby‡g
Pharmaceuticals 500mg or as adjunct to other antidepressant drugs) myalgia syndrome following use of Page-370 v`b
Ltd. Tryptophan Kiv
Side effects: Asthenia, dizziness, †h‡Z
eosinophilia myalgia syndrome, headache, cv‡i|
myalgia, myopathy, nausea, oedema,
somnolence, suicidal ideation & behavior
57. a) Pacific Empagliflozin 25mg + Empagliflozin INN Antidiabetic It is indicated as an adjunct to diet and Contraindications: Empagliflozin & New USFDA cÖ‡qvRb
Pharmaceuticals Linagliptin 5mg 25 mg + Linagliptin exercise to improve glycemic control in Linagliptin INN Tablet is contraindicated in DCC-248 ‡bB
Limited Tablet INN 5 mg adults with type 2 diabetes mellitus when patients with Severe renal impairment, Rejected weavq
BSCIC, Kanchpur, treatment with both Empagliflozin and end-stage renal disease, or dialysis. A Av‡e`b
Sonargaon, bvgÄyi
Narayangonj
Linagliptin is appropriate. history of serious hypersensitivity reaction
Kiv †h‡Z
Empagliflozin is indicated to reduce the risk to Empagliflozin, Linagliptin, or any of the cv‡i|
b) Square of cardiovascular death in adults with type 2 excipients in this product such as
Formulations Ltd., diabetes mellitus and established anaphylaxis, angioedema, exfoliative skin
Gorai, Tangail cardiovascular disease. However, the conditions, urticaria, or bronchial
effectiveness of Combination of hyperreactivity.
Empagliflozin and Linagliptin on reducing
c) Aristopharma the risk of cardiovascular death in adults Side Effects : The common adverse
Ltd. with type 2 diabetes mellitus and effect reported associated with the
Plot No.21, Road
No.11,
cardiovascular disease has not been treatment of combination of Empagliflozin
Shampur- established. & Linagliptin are pancreatitis, heart failure,
Kadamtali I/A hypotension, ketoacidosis, acute kidney
Dhaka-1204 injury and impairment in renal function,
urosepsis and pyelonephritis,
hypoglycemia with concomitant use with
insulin and insulin secretagogues, genital
mycotic infections, hypersensitivity
reactions, increased low-density
lipoprotein cholesterol (ldl-c), severe and
31 | P a g e
Existing) Reference
disabling arthralgia, bullous pemphigoid.
58. a) Pacific Empagliflozin 10mg + Empagliflozin INN Antidiabetic It is indicated as an adjunct to diet and Contraindications: Empagliflozin & New USFDA cÖ‡qvRb
Pharmaceuticals Linagliptin 5 mg 10 mg + Linagliptin exercise to improve glycemic control in Linagliptin INN Tablet is contraindicated in ‡bB
Limited Tablet INN 5 mg adults with type 2 diabetes mellitus when patients with Severe renal impairment, weavq
BSCIC, Kanchpur, treatment with both Empagliflozin and end-stage renal disease, or dialysis. A Av‡e`b
Sonargaon, bvgÄyi
Narayangonj
Linagliptin is appropriate. history of serious hypersensitivity reaction
Kiv †h‡Z
Empagliflozin is indicated to reduce the risk to Empagliflozin, Linagliptin, or any of the cv‡i|
b) Square of cardiovascular death in adults with type 2 excipients in this product such as
Formulations Ltd., diabetes mellitus and established anaphylaxis, angioedema, exfoliative skin
Gorai, Tangail cardiovascular disease. However, the conditions, urticaria, or bronchial
effectiveness of Combination of hyperreactivity.
c) Aristopharma Empagliflozin and Linagliptin on reducing Side Effects : The common adverse
Ltd. the risk of cardiovascular death in adults effect reported associated with the
Plot No.21, Road with type 2 diabetes mellitus and treatment of combination of Empagliflozin
No.11,
Shampur-
cardiovascular disease has not been & Linagliptin are pancreatitis, heart failure,
Kadamtali I/A established. hypotension, ketoacidosis, acute kidney
Dhaka-1204 injury and impairment in renal function,
urosepsis and pyelonephritis,
hypoglycemia with concomitant use with
insulin and insulin secretagogues, genital
mycotic infections, hypersensitivity
reactions, increased low-density
lipoprotein cholesterol (ldl-c), severe and
disabling arthralgia, bullous pemphigoid.
59. Eskayef Teneligliptin 20mg Film Teneligliptin INN Antidiabetic It is a Type 2 diabetes mellitus- Contraindications: Hypersensitivity, New cÖ‡qvRb
Pharmaceuticals Coated Tablet 20mg The drug product should be used only in Severe ketosis, diabetic coma or history of ‡bB
Limited, Tongi, patients who have not sufficiently responded diabetic coma, type 1 diabetic patient, weavq
Gazipur. to either of the following treatments: Patients with severe infection, surgery, Av‡e`b
bvgÄyi
 Diet and/or exercise therapy alone. severe trauma (blood sugar control should
Kiv †h‡Z
 Use of sulfonylureas in addition to diet preferably be done by insulin). cv‡i|
and/or exercise therapy.
 Use of thiazolidinediones in addition to Side effects: Abdominal bloating,
diet and/or exercise therapy. abdominal discomfort, nausea, abdominal
pain, flatulence, Proteinuria, urine ketone-
positive, Eczema, rash, itching, allergic
dermatitis.
60. Incepta Semaglutide 1.34mg/ml Semaglutide INN Antidiabetic It is a glucagon-like peptide 1 (GLP-1) Contraindications: New USFDA Aby‡g
32 | P a g e
Existing) Reference
Pharmaceutics Pre-filled Pen for Injection 1.34mg/ml receptor agonist indicated as an adjunct to 1. Personal or family history of medullary v`b
Ltd.; Zirabo, diet and exercise to improve glycemic thyroid carcinoma or in patients Kiv
Savar, Dhaka. control in adults with type 2 diabetes with Multiple Endocrine Neoplasia †h‡Z
mellitus. syndrome type cv‡i|
2. Known hypersensitivity to this or any of
Limitations of Use: the product components
1. Not recommended as first-line therapy for
patients inadequately controlled on diet and Side-effects/Toxicity: The most common
exercise. adverse reactions, reported in ≥5% of
2. Has not been studied in patients with a patients treated with this are: nausea,
history of pancreatitis. Consider another vomiting, diarrhea, abdominal pain and
antidiabetic therapy. constipation.
3. Not indicated for use in type 1 diabetes
mellitus or treatment of diabetic ketoacidosis
61. Popular Gliclazide 80mg + Metformin Gliclazide BP 80mg Antidiabetic Gliclazide + Metformin is indicated as an Contraindications: Gliclazide cÖ‡qvRb
Pharmaceuticals Hydrochloride 500mg Film + Metformin adjunct to diet and exercise to improve Type-1 diabetes mellitus, renal or hepatic 60mg Tablet ‡bB
Ltd. Coated Tablet Hydrochloride BP glycemic control in adults with type failure, alcoholism, type-2 diabetes weavq
164 Tongi I/A, 500mg 2diabetes mellitus. complicated by severe ketosis and Metformin Av‡e`b
acidosis, diabetic precoma and coma, HCl BP 500mg
Kiv †h‡Z
patients undergoing surgery, after severe Tablet cv‡i|
trauma or during infections, chronic
obstructive pulmonary disease, coronary
heart disease, cardiac failure, peripheral
vascular disease, known hypersensitivity
to any of the ingredients.
Side effects:
Gastrointestinal disturbances - Nausea,
diarrhea, gastric pain, constipation,
vomiting, metallic taste in mouth.
Dermatological effects - Rash, pruritus,
urticaria, erythema and flushing.
Miscellaneous - Headache and dizziness.
Gliclazide appears to be associated with a
low incidence of hypoglycaemia. Impaired
gastrointestinal absorption of vitamin B 12
33 | P a g e
Existing) Reference
and folic acid has been associated with
long term Metformin therapy.
62. Square Empagliflozin 5mg + Empagliflozin INN Antidiabetic It is a combination of empagliflozin, a Hypersensitivity to the active substances Empagliflozin USFDA cÖ‡qvRb
Formulations Ltd., Metformin Hydrochloride 5mg + Metformin sodium-glucose co-transporter 2 (SGLT2) or to any of the excipients. 10mg & 25 mg ‡bB
Gorai, Tangail Extended Release 1000mg Hydrochloride EP inhibitor and metformin hydrochloride, a • Any type of acute metabolic acidosis Tablet weavq
Tablet 1000mg biguanide, indicated as an adjunct to diet (such as lactic acidosis, diabetic Av‡e`b
bvgÄyi
and exercise to improve glycemic control in ketoacidosis) Metformin
Kiv †h‡Z
adults with type 2 diabetes mellitus when • Diabetic pre-coma. Hydrochloride cv‡i|
treatment with both empagliflozin and • Severe renal failure (GFR <30 ml/min). 500mg, 850mg,
metformin hydrochloride is appropriate. • Acute conditions with the potential to 1000mg Tablet
Empagliflozin is indicated to reduce the risk alter renal function such as: dehydration,
of cardiovascular death in adults with type 2 severe infection, shock.
diabetes mellitus and established • Disease which may cause tissue hypoxia
cardiovascular disease. However, the (especially acute disease, or worsening of
effectiveness of SYNJARDY on reducing the chronic disease) such as: decompensated
risk of cardiovascular death in adults with heart failure, respiratory failure, recent
type 2 diabetes mellitus and cardiovascular myocardial infarction, shock.
disease has not been established. • Hepatic impairment, acute alcohol
intoxication, alcoholism
Limitations of Use: Not recommended for
patients with type 1 diabetes or for the Adverse reactions: Most common adverse
treatment of diabetic ketoacidosis reactions associated with empagliflozin
(5% or greater incidence) were urinary
tract infection and female genital mycotic
infections.
Most common adverse reactions
associated with metformin (>5%) are
diarrhea, nausea/vomiting, flatulence,
abdominal discomfort, indigestion,
asthenia, and headache
63. Square Empagliflozin 10 mg + Empagliflozin INN Antidiabetic It is a combination of empagliflozin, a Hypersensitivity to the active substances Empagliflozin USFDA
Formulations Ltd., Metformin Hydrochloride 10 mg + Metformin sodium-glucose co-transporter 2 (SGLT2) or to any of the excipients. 10mg & 25 mg
Gorai, Tangail Extended Release 1000 mg Hydrochloride EP inhibitor and metformin hydrochloride, a • Any type of acute metabolic acidosis Tablet
Tablet 1000 mg biguanide, indicated as an adjunct to diet (such as lactic acidosis, diabetic
adults with type 2 diabetes mellitus when • Diabetic pre-coma. Hydrochloride
34 | P a g e
Existing) Reference
infections.
64. Square Empagliflozin 12.5 mg + Empagliflozin INN Antidiabetic It is a combination of empagliflozin, a Hypersensitivity to the active substances Empagliflozin USFDA cÖ‡qvRb
Formulations Ltd., Metformin Hydrochloride 12.5mg + Metformin sodium-glucose co-transporter 2 (SGLT2) or to any of the excipients. 10mg & 25 mg ‡bB
Gorai, Tangail Extended Release 1000 mg Hydrochloride EP inhibitor and metformin hydrochloride, a • Any type of acute metabolic acidosis Tablet weavq
film coated Tablet 1000mg biguanide, indicated as an adjunct to diet (such as lactic acidosis, diabetic Av‡e`b
bvgÄyi
Kiv †h‡Z
35 | P a g e
Existing) Reference
infections.
65. Square Empagliflozin 25 mg + Empagliflozin INN Antidiabetic It is a combination of empagliflozin, a Hypersensitivity to the active substances Empagliflozin USFDA cÖ‡qvRb
Formulations Ltd., Metformin Hydrochlorude 25 mg + Metformin sodium-glucose co-transporter 2 (SGLT2) or to any of the excipients. 10mg & 25 mg ‡bB
Gorai, Tangail Extended Release 1000 mg Hydrochlorude EP inhibitor and metformin hydrochloride, a • Any type of acute metabolic acidosis Tablet weavq
Tablet 1000mg biguanide, indicated as an adjunct to diet (such as lactic acidosis, diabetic Av‡e`b
bvgÄyi
Kiv †h‡Z
36 | P a g e
Existing) Reference
infections.
66. Square Ertugliflozin 5 mg Film Coated Ertugliflozin L- Antidiabetic It is a sodium glucose co-transporter 2 Contraindication: New USFDA cÖ‡qvRb
Formulations Ltd., Tablet Pyroglutamic Acid (SGLT2) inhibitor indicated as an adjunct to  Severe renal impairment, end-stage ‡bB
Gorai, Tangail INN 6.48mg eq. to diet and exercise to improve glycemic control renal disease, or dialysis. weavq
Ertugliflozin 5 mg in adults with type 2 diabetes mellitus. Av‡e`b
 History of serious hypersensitivity
bvgÄyi
reaction to the active substances. Kiv †h‡Z
Limitations of Use: Not for the treatment of Adverse Reaction: The most common cv‡i|
type 1 diabetes mellitus or diabetic adverse reactions associated with
ketoacidosis. Ertugliflozin (incidence ≥ 5%) were female
genital mycotic infections
67. Square Ertugliflozin 15 mg Film Ertugliflozin L- Antidiabetic It is a sodium glucose co-transporter 2 Contraindication: New USFDA cÖ‡qvRb
Formulations Ltd., Coated Tablet Pyroglutamic Acid (SGLT2) inhibitor indicated as an adjunct to  Severe renal impairment, end-stage ‡bB
Gorai, Tangail INN 19.43mg eq. to diet and exercise to improve glycemic control renal disease, or dialysis. weavq
Ertugliflozin 15 mg in adults with type 2 diabetes mellitus. Av‡e`b
 History of serious hypersensitivity
bvgÄyi
reaction to the active substances. Kiv †h‡Z
Limitations of Use: Not for the treatment of Adverse Reaction: cv‡i|
type 1 diabetes mellitus or diabetic The most common adverse reactions
ketoacidosis. associated with Ertugliflozin (incidence ≥
5%) were female genital mycotic infections
68. Square Ertugliflozin 2.5 mg + Ertugliflozin L- Antidiabetic It is a combination of ertugliflozin, a sodium Contraindication: Metformin USFDA cÖ‡qvRb
Formulations Ltd., Metformin Hydrochloride Pyroglutamic Acid glucose cotransporter 2 (SGLT2) inhibitor, • Severe renal impairment, end stage Hydrochloride ‡bB
Gorai, Tangail 500mg Film Coated Tablet INN 3.24mg eq. to and metformin, a biguanide, indicated as an renal disease, or dialysis. 500mg, 850mg weavq
Ertugliflozin 2.5 mg adjunct to diet and exercise to improve • Metabolic acidosis, including diabetic & 1000mg Tablet Av‡e`b
bvgÄyi
+ Metformin glycemic control in adults with type 2 ketoacidosis.
Kiv †h‡Z
Hydrochloride EP diabetes mellitus who are not adequately • History of serious hypersensitivity cv‡i|
500 mg controlled on a regimen containing reaction to ertugliflozin or metformin.
ertugliflozin or metformin, or in patients who
are already treated with both ertugliflozin Adverse reactions:
and metformin. • The most common adverse reactions
associated with ertugliflozin (incidence
Limitations of Use: Not for the treatment of ≥5%) were female genital mycotic
type 1 diabetes mellitus or diabetic infections.
37 | P a g e
Existing) Reference
ketoacidosis. • Most common adverse reactions
associated with metformin (incidence ≥5%):
diarrhea, nausea, vomiting, flatulence,
abdominal discomfort, indigestion, asthenia,
and headache.
Formulations Ltd., Metformin Hydrochloride pyroglutamic acid glucose cotransporter 2 (SGLT2) inhibitor, • Severe renal impairment, end stage Hydrochloride ‡bB
Gorai, Tangail 1000mg Film Coated Tablet INN 3.24mg eqv. to and metformin, a biguanide, indicated as an renal disease, or dialysis. 500mg, 850mg weavq
bvgÄyi
Kiv †h‡Z
ertugliflozin or metformin, or in patients who
are already treated with both ertugliflozin Adverse reactions:
and metformin. • The most common adverse reactions
associated with ertugliflozin (incidence
Limitations of Use: Not for the treatment of ≥5%) were female genital mycotic
type 1 diabetes mellitus or diabetic infections.
ketoacidosis. • Most common adverse reactions
associated with metformin (incidence ≥5%):
and headache.
Formulations Ltd., Metformin Hydrochloride Pyroglutamic Acid glucose cotransporter 2 (SGLT2) inhibitor, • Severe renal impairment, end stage Hydrochloride ‡bB
Gorai, Tangail 500mg Film Coated Tablet INN 9.71mg eqv. to and metformin, a biguanide, indicated as an renal disease, or dialysis. 500mg, 850mg weavq
bvgÄyi
Kiv †h‡Z
ertugliflozin or metformin, or in patients who Adverse reactions:
are already treated with both ertugliflozin • The most common adverse reactions
and metformin. associated with ertugliflozin (incidence
≥5%) were female genital mycotic
Limitations of Use: Not for the treatment of infections.
type 1 diabetes mellitus or diabetic • Most common adverse reactions
ketoacidosis. associated with metformin (incidence ≥5%):
38 | P a g e
Existing) Reference
and headache.
Formulations Ltd., Metformin Hydrochloride pyroglutamic acid glucose cotransporter 2 (SGLT2) inhibitor, • Severe renal impairment, end stage Hydrochloride ‡bB
Gorai, Tangail 1000mg Film Coated Tablet INN 9.71mg eqv. to and metformin, a biguanide, indicated as an renal disease, or dialysis.• Metabolic 500mg, 850mg weavq
Ertugliflozin 7.5 mg adjunct to diet and exercise to improve acidosis, including diabetic ketoacidosis. • & 1000mg Tablet Av‡e`b
bvgÄyi
+ Metformin glycemic control in adults with type 2 History of serious hypersensitivity reaction
Kiv †h‡Z
Hydrochloride EP diabetes mellitus who are not adequately to ertugliflozin or metformin. cv‡i|
1000 mg controlled on a regimen containing Adverse reactions:
ertugliflozin or metformin, or in patients who • The most common adverse reactions
are already treated with both ertugliflozin associated with ertugliflozin (incidence
and metformin. ≥5%) were female genital mycotic
infections.
Limitations of Use: Not for the treatment of • Most common adverse reactions
type 1 diabetes mellitus or diabetic associated with metformin (incidence ≥5%):
ketoacidosis. diarrhea, nausea, vomiting, flatulence,
and headache.
72. Square Ertugliflozin 5 mg + Sitagliptin Ertugliflozin L- Antidiabetic It is a combination of ertugliflozin, a sodium Contraindication: Sitagliptin 25 mg USFDA cÖ‡qvRb
Formulations Ltd., 100 mg Film Coated Tablet Pyroglutamic Acid glucose cotransporter 2 (SGLT2) inhibitor, , 50mg & 100mg ‡bB
Gorai, Tangail INN 6.47mg eqv. to and sitagliptin, a dipeptidyl peptidase-4 • Severe renal impairment, end stage renal Tablet weavq
Ertugliflozin 5 mg + (DPP-4) inhibitor, indicated as an adjunct to disease, or dialysis. Av‡e`b
bvgÄyi
Sitagliptin diet and exercise to improve glycemic • History of a serious hypersensitivity
Kiv †h‡Z
Phosphate control in adults with type 2 diabetes mellitus reaction to sitagliptin, such as anaphylaxis cv‡i|
Monohydrate INN when treatment with both ertugliflozin and or angioedema. • History of serious
128.5mg eqv. to sitagliptin is appropriate. hypersensitivity reaction to ertugliflozin.
Sitagliptin 100 mg
Tablet Limitations of Use: Adverse reactions:
• Not for the treatment of type 1 diabetes • Most common adverse reactions
mellitus or diabetic ketoacidosis. associated with ertugliflozin
• Has not been studied in patients with a (LQFLGHQFH•5%): female genital mycotic
history of pancreatitis. infections.
• Most common adverse reactions
associated with sitagliptin (LQFLGHQFH
•5%): upper respiratory tract infection,
nasopharyngitis and headache. In the add-
39 | P a g e
Existing) Reference
on to sulfonylurea and add-on to insulin
studies, hypoglycemia was also more
commonly reported in patients treated with
sitagliptin compared to placebo.
73. Square Ertugliflozin 15 mg + Sitagliptin Ertugliflozin L- Antidiabetic It is a combination of ertugliflozin, a sodium Contraindication: Sitagliptin 25 mg USFDA cÖ‡qvRb
Formulations Ltd., 100 mg Film Coated Tablet Pyroglutamic Acid glucose cotransporter 2 (SGLT2) inhibitor, , 50mg & 100mg ‡bB
Gorai, Tangail INN 19.42mg eqv. to and sitagliptin, a dipeptidyl peptidase-4 • Severe renal impairment, end stage renal Tablet weavq
Ertugliflozin 15 mg + (DPP-4) inhibitor, indicated as an adjunct to disease, or dialysis. Av‡e`b
bvgÄyi
Sitagliptin diet and exercise to improve glycemic • History of a serious hypersensitivity
Kiv †h‡Z
phosphate control in adults with type 2 diabetes mellitus reaction to sitagliptin, such as anaphylaxis cv‡i|
monohydrate INN when treatment with both ertugliflozin and or angioedema. • History of serious
128.5mg eqv. to sitagliptin is appropriate. hypersensitivity reaction to ertugliflozin.
Sitagliptin 100 mg
Tablet Limitations of Use: Adverse reactions:
• Not for the treatment of type 1 diabetes • Most common adverse reactions
mellitus or diabetic ketoacidosis. associated with ertugliflozin
• Has not been studied in patients with a (LQFLGHQFH•5%): female genital mycotic
history of pancreatitis. infections.
associated with sitagliptin (LQFLGHQFH
•5%): upper respiratory tract infection,
nasopharyngitis and headache. In the add-
on to sulfonylurea and add-on to insulin
studies, hypoglycemia was also more
commonly reported in patients treated with
sitagliptin compared to placebo.
74. Square Empagliflozin 5mg + Empagliflozin INN Antidiabetic It is a combination of empagliflozin and Contraindications: Metformin USFDA cÖ‡qvRb
Formulations Ltd., Metformin 500mg Film Coated 5mg + Metformin metformin HCl indicated as an adjunct to diet • Renal Impairment, ESRD, or on dialysis 500mg Tablet ‡bB
Gorai, Tangail Tablet Hydrochloride EP and exercise to improve glycemic control in • Metabolic acidosis, including diabetic weavq
500 mg adults with type 2 diabetes mellitus who are ketoacidosis Av‡e`b
bvgÄyi
not adequately controlled on a regimen • History of serious hypersensitivity
Kiv †h‡Z
containing empagliflozin or metformin, or in reaction to empagliflozin or metformin cv‡i|
patients already being treated with both Side effects:
empagliflozin and metformin. • Most common adverse reactions
Limitation of use: associated with empaglifloz in (5% or
It is not recommended for patients with type greater incidence) were urinary tract
1 diabetes or for the treatment of diabetic infection and female genital mycotic
40 | P a g e
Existing) Reference
ketoacidosis. infections.
asthenia, and headache.
75. Square Empagliflozin 5mg + Empagliflozin INN Antidiabetic It is a combination of empagliflozin, a Hypersensitivity to the active substances Empagliflozin USFDA cÖ‡qvRb
Formulations Ltd., Metformin Hydrochloride 5mg + Metformin sodium-glucose co-transporter 2 (SGLT2) or to any of the excipients. 10mg & 25 mg ‡bB
Gorai, Tangail 1000mg Tablet Hydrochloride BP inhibitor and metformin hydrochloride, a • Any type of acute metabolic acidosis Tablet weavq
1000mg biguanide, indicated as an adjunct to diet (such as lactic acidosis, diabetic Av‡e`b
bvgÄyi
and exercise to improve glycemic control in ketoacidosis)
Kiv †h‡Z
adults with type 2 diabetes mellitus when • Diabetic pre-coma. cv‡i|
treatment with both empagliflozin and • Severe renal failure (GFR <30 ml/min).
metformin hydrochloride is appropriate. • Acute conditions with the potential to
infections.
76. Square Empagliflozin 12.5mg + Empagliflozin INN Antidiabetic It is a combination of empagliflozin and Contraindications: Metformin USFDA cÖ‡qvRb
Formulations Ltd., Metformin 500 mg Film 12.5mg + Metformin metformin HCl indicated as an adjunct to diet • Renal Impairment, ESRD, or on dialysis 500mg Tablet ‡bB
Gorai, Tangail Coated Tablet EP 500 mg and exercise to improve glycemic control in • Metabolic acidosis, including diabetic weavq
41 | P a g e
Existing) Reference
adults with type 2 diabetes mellitus who are ketoacidosis Av‡e`b
not adequately controlled on a regimen • History of serious hypersensitivity bvgÄyi
containing empagliflozin or metformin, or in reaction to empagliflozin or metformin Kiv †h‡Z
patients already being treated with both Side effects: cv‡i|
empagliflozin and metformin. • Most common adverse reactions
Limitation of use: associated with empaglifloz in (5% or
It is not recommended for patients with type greater incidence) were urinary tract
1 diabetes or for the treatment of diabetic infection and female genital mycotic
ketoacidosis. infections.
asthenia, and headache.
77. Square Empagliflozin 12.5mg + Empagliflozin INN Antidiabetic It is a combination of empagliflozin, a Hypersensitivity to the active substances Empagliflozin USFDA cÖ‡qvRb
Formulations Ltd., Metformin Hydrochloride 12.5mg + Metformin sodium-glucose co-transporter 2 (SGLT2) or to any of the excipients. 10mg & 25 mg ‡bB
Gorai, Tangail 1000mg Tablet Hydrochloride EP inhibitor and metformin hydrochloride, a • Any type of acute metabolic acidosis Tablet weavq
1000mg biguanide, indicated as an adjunct to diet (such as lactic acidosis, diabetic Av‡e`b
bvgÄyi
and exercise to improve glycemic control in ketoacidosis)
Kiv †h‡Z
adults with type 2 diabetes mellitus when • Diabetic pre-coma. cv‡i|
treatment with both empagliflozin and • Severe renal failure (GFR <30 ml/min).
metformin hydrochloride is appropriate. • Acute conditions with the potential to
42 | P a g e
Existing) Reference
infections.
78. Incepta Desmopressin Acetate Desmopressin Antidiuretic IT is a vasopressin analog indicated for Contraindications: Desmopressin USFDA Aby‡g
Pharmaceutics 0.83mcg/0.1ml Acetate INN Hormone treatment of nocturia due to nocturnal 1 Hyponatremia or a history of 360mcg/1ml v`b
Ltd.; Zirabo, Nasal Spray 0.83mcg eq. to polyuria in adults who awaken at least 2 hyponatremia oral solution Kiv
Savar, Dhaka. desmopressin times per night to void. 2.Polydipsia †h‡Z
0.75mcg/0.1ml 3.Primary nocturnal enuresis cv‡i|
Spray Limitation of Use: Not studied in patients 4. Concomitant use with loop diuretics or
younger than 50 years of age. systemic or inhaled glucocorticoids
5.Estimated glomerular filtration rate
below 50 mL/min/1.73 m2
6.Syndrome of inappropriate antidiuretic
hormone secretion (SIADH)
7.During illnesses that can cause fluid or
electrolyte imbalance (4)
8.New York Heart Association (NYHA)
Class II-IV congestive heart failure
7.Uncontrolled hypertension
Side-effects/Toxicity: Common adverse

reactions in clinical trials (incidence >2%)
included nasal discomfort,
nasopharyngitis, nasal congestion,
sneezing, hypertension/ blood pressure
increased, back pain, epistaxis, bronchitis
and dizziness.
79. Incepta Desmopressin Acetate 1.66 Desmopressin Antidiuretic It is a vasopressin analog indicated for Contraindications: Desmopressin USFDA Aby‡g
Pharmaceutics Ltd.; mcg/0.1 ml Nasal Spray acetate INN Hormone treatment of nocturia due to nocturnal 1 Hyponatremia or a history of 360mcg/1ml v`b
Zirabo, Savar, 1.66mcg eq. to polyuria in adults who awaken at least 2 hyponatremia Oral solution Kiv
43 | P a g e
Existing) Reference
Dhaka. desmopressin times per night to void. 2.Polydipsia †h‡Z
1.5mcg/0.1ml 3.Primary nocturnal enuresis cv‡i|
Spray 4. Concomitant use with loop diuretics or
Limitation of Use: Not studied in patients systemic or inhaled glucocorticoids
younger than 50 years of age. 5.Estimated glomerular filtration rate
below 50 mL/min/1.73 m2
6.Syndrome of inappropriate antidiuretic
hormone secretion (SIADH)
7.During illnesses that can cause fluid or
electrolyte imbalance (4)
8.New York Heart Association (NYHA)
Class II-IV congestive heart failure
7.Uncontrolled hypertension
Side-effects/Toxicity: Common adverse

reactions in clinical trials (incidence >2%)
included nasal discomfort, nasopharyngitis,
nasal congestion, sneezing, hypertension /
blood pressure increased, back pain,
epistaxis, bronchitis and dizziness
80. Incepta Lamotrigine 2 mg Chewable Lamotrigine BP 2 Antiepileptic Epilepsy—adjunctive therapy in patients Contraindication: Hypersensitivity to the 25mg, 50mg & USFDA Aby‡g
Pharmaceutics Dispersible Tablet mg aged 2 years and older: drug or its ingredients 100mg Tablet v`b
Ltd.; Zirabo, partial-onset seizures. Kiv
Savar, Dhaka. primary generalized tonic-clonic seizures. †h‡Z
generalized seizures of Lennox-Gastaut Side Effects: Epilepsy: Most common cv‡i|
syndrome. adverse reactions (incidence ≥10%) in
Epilepsy—monotherapy in patients aged 16 adults were dizziness, headache, diplopia,
years and older: Conversion to monotherapy ataxia, nausea, blurred vision,
in patients with partial-onset seizures who somnolence, rhinitis, pharyngitis, and
are receiving treatment with carbamazepine, rash. Additional adverse reactions
phenytoin, phenobarbital, primidone, or (incidence ≥10%) reported in children
valproate as the single AED. included vomiting, infection, fever,
accidental injury, diarrhea, abdominal
Bipolar disorder: Maintenance treatment of pain, and tremor. Bipolar disorder: Most
bipolar I disorder to delay the time to common adverse reactions (incidence
occurrence of mood episodes in patients >5%) in adults were nausea, insomnia,
treated for acute mood episodes with somnolence, back pain, fatigue, rash,
44 | P a g e
Existing) Reference
standard therapy. rhinitis, abdominal pain, and xerostomia.
Limitations of Use: Treatment of acute

manic or mixed episodes is not
recommended. Effectiveness of Lamotrigine
in the acute treatment of mood episodes has
not been established.
81. Incepta Lamotrigine 5 mg Chewable Lamotrigine BP 5 Antiepileptic Epilepsy—adjunctive therapy in patients Contraindication:Hypersensitivity to the 25mg, 50mg & USFDA Aby‡g
Pharmaceutics dispersible tablet mg aged 2 years and older: drug or its ingredients 100mg Tablet v`b
Ltd.; Zirabo, 1. partial-onset seizures. Side Effects: Epilepsy: Most common Kiv
Savar, Dhaka. 2. primary generalized tonic-clonic adverse reactions (incidence ≥10%) in †h‡Z
seizures. adults were dizziness, headache, diplopia, cv‡i|
3. generalized seizures of Lennox- ataxia, nausea, blurred vision,
Gastaut syndrome. somnolence, rhinitis, pharyngitis, and
Epilepsy—monotherapy in patients aged 16 rash. Additional adverse reactions
years and older: Conversion to monotherapy (incidence ≥10%) reported in children
in patients with partial-onset seizures who are included vomiting, infection, fever,
receiving treatment with carbamazepine, accidental injury, diarrhea, abdominal
phenytoin, phenobarbital, primidone, or pain, and tremor. Bipolar disorder: Most
valproate as the single AED. common adverse reactions (incidence
>5%) in adults were nausea, insomnia,
Bipolar disorder: Maintenance treatment of somnolence, back pain, fatigue, rash,
bipolar I disorder to delay the time to rhinitis, abdominal pain, and xerostomia.
occurrence of mood episodes in patients
treated for acute mood episodes with
standard therapy.
Limitations of Use: Treatment of acute manic

or mixed episodes is not recommended.
Effectiveness of LAMICTAL in the acute
treatment of mood episodes has not been
established.
82. Acme Brivaracetam 25mg Film Brivaracetam INN Anti-epileptic It is indicated in the treatment of partial- Contraindication: It is contraindicated in New USFDA Aby‡g
Laboratories Ltd., Coated Tablet 25 mg onset seizures in patients 4 years of age & hypersensitivity to Brivaracetam or any of v`b
Dhamrai, Dhaka older. the inactive ingredients. Kiv
†h‡Z
Side Effects: Adults: Most common cv‡i|
45 | P a g e
Existing) Reference
adverse reactions (at least 5% for
Brivaracetam and at Least 2% more
frequently than placebo) are
somnolence/sedation, dizziness, fatigue,
and nausea/vomiting.
Pediatric Patients: Most common adverse

reactions are similar to those seen in adult
patients.
WARNINGS AND PRECAUTIONS:

- Suicidal Behavior and Ideation: Monitor
patients for suicidal behavior and ideation.
- Neurological Adverse Reactions:
Monitor for somnolence and fatigue, and
advise patients not to drive or operate
machinery until they have gained sufficient
experience on it.
- Psychiatric Adverse Reactions:
Behavioral reactions including psychotic
symptoms, irritability, depression,
aggressive behavior, and anxiety; monitor
patients for symptoms.
- Hypersensitivity: Bronchospasm and
Angioedema: Advise patients to seek
Immediate medical care. Discontinue and
do not restart BRIVIACT if hypersensitivity
occurs.
Withdrawal of Antiepileptic Drugs: this
drug should be gradually withdrawn.
83. Acme Brivaracetam 50 mg Film Brivaracetam INN Anti-epileptic It is indicated in the treatment of partial- Contraindication: It is contraindicated in New USFDA Aby‡g
Laboratories Ltd., Coated Tablet 50 mg onset seizures in patients 4 years of age & hypersensitivity to Brivaracetam or any of v`b
Dhamrai, Dhaka older. the inactive ingredients. Kiv
†h‡Z
Side Effects: Adults: Most common cv‡i|
adverse reactions (at least 5% for
Brivaracetam and at Least 2% more
46 | P a g e
Existing) Reference
frequently than placebo) are

patients.
experience on it.
occurs.
84. Acme Brivaracetam 10mg/ml Oral Brivaracetam INN Anti-epileptic It is indicated for the treatment of partial- Contraindication: It is contraindicated in New USFDA Aby‡g
Laboratories Ltd., Solution 10mg/ml onset seizures in patients 4 years of age hypersensitivity to Brivaracetam or any of v`b
Dhamrai, Dhaka and older. the inactive ingredients. Kiv
As the safety of this injection in pediatric †h‡Z
patients has not been established, This Side Effects: Adults: Most common cv‡i|
injection is indicated for the treatment of adverse reactions (at least 5% for
partial-onset seizures only in adult patients Brivaracetam and at Least 2% more
(16 years of age and older) frequently than placebo) are
47 | P a g e
Existing) Reference

patients.
experience on it.
occurs.
85. Navana Itraconazole 10 mg/mL oral Itraconazole USP 10 Antifungal It is indicated for the treatment of the CONTRAINDICATIONS: 100 mg capsule USFDA Aby‡g
Pharmaceuticals, solution mg/mL oral solution following fungal infections in  Itraconazole oral solution is v`b
Narayanganj immunocompromised and non- contraindicated in patients with a Kiv
immunocompromised patients: known hypersensitivity to the drug or †h‡Z
1. Blastomycosis, pulmonary and its excipients. cv‡i|
extrapulmonary  Caution should be used in
2. Histoplasmosis, including chronic cavitary prescribing itraconazole to patients
pulmonary disease and disseminated, with hypersensitivity to other azoles.
nonmeningeal histoplasmosis, and
3. Aspergillosis, pulmonary and  Itraconazole oral solution should not
extrapulmonary, in patients who are be administered to patients with
intolerant of or who are refractory to evidence of ventricular dysfunction
amphotericin B therapy. Specimens for such as congestive heart failure
48 | P a g e
Existing) Reference
fungal cultures and other relevant laboratory (CHF) or a history of CHF except for
studies (wet mount, histopathology, the treatment of life-threatening or
serology) should be obtained before therapy other serious infections
to isolate and identify causative organisms.
Therapy may be instituted before the results  Itraconazole is contraindicated in
of the cultures and other laboratory studies pregnant women except for the
are known; however, once these results treatment of life-threatening cases of
become available, antiinfective therapy systemic mycoses, where the
should be adjusted accordingly. It is also potential benefits outweigh the
indicated for the treatment of the following potential harm to the foetus.
fungal infections in non-
immunocompromised patients: Side Effect: dizziness, headache, nausea,
1. Onychomycosis of the toenail, with or vomiting, diarrhoea, abdominal pain,
without fingernail involvement, due to constipation, dyspepsia .
dermatophytes (tinea unguium), and
2. Onychomycosis of the fingernail due to
dermatophytes (tinea unguium). Prior to
initiating treatment, appropriate nail
specimens for laboratory testing (KOH
preparation, fungal culture, or nail biopsy)
should be obtained to confirm the diagnosis
of onychomycosis.
86. Ziska Ketoconazole 2%, Zinc Ketoconazole BP Antifungal and In the treatment of anti-dandruff, seberrhoeic Contraindications: The drug is Ketoconazole 20 cÖ‡qvRb
Pharmaceuticals Pyrithione 1% and Aloe-vera 2% + Zinc Pyrithione anti-seborrheic dermatitis, candidiasis, candidura infections, contraindicated in patients who are taking mg/ml Shampoo ‡bB
Ltd. 10% Lotion INN 1% + Aloe-vera agent sperificial, and deep mycosis, dry scalp Skin terfenadine or astemizole, cisapride, weavq
USP 10% and psoriasis triazolam and hypersensitivity. Av‡e`b
bvgÄyi
Side effects: Possible side effects are
Kiv †h‡Z
Dizziness, Headache, Nausea, Vomiting, cv‡i|
Diarrhea, Anorexia, Gynecomastia, Loss
of hair, Libido, Leucopenia, Pruritis,
Psychiatric problems etc.
.
87. Beacon Voriconazole 200mg/Vial Voriconazole Anti-fungal It is an azole antifungal indicated for use Contra-indication : Hypersensitivity to 50mg, 200mg, USFDA Aby‡g
Pharmaceuticals Injection USP 200mg/Vial Drugs in the treatment of: voriconazole or its excipients Tablet v`b
Ltd, • Invasive aspergillosis • Coadministration with terfenadine, Kiv
Kathali, Bhaluka, •Candidemia (nonneutropenics) and astemizole, cisapride, pimozide or & †h‡Z
Mymensingh
disseminated candidiasis in skin, quinidine, sirolimus due to risk of serious cv‡i|
49 | P a g e
Existing) Reference
abdomen, kidney, bladder wall, and adverse reactions 200mg/5ml
wounds • Coadministration with rifampin, suspension
• Esophageal candidiasis carbamazepine, long-acting barbiturates,
• Serious infections caused by efavirenz, ritonavir, rifabutin, ergot
Scedosporium apiospermum and alkaloids, and St. John’s Wort due to risk
Fusarium species including Fusarium of loss of efficacy
solani, in patients intolerant of, or
refractory to, other therapy Side-effect: Most common adverse
reactions (incidence ≥2%): visual
disturbances, fever, nausea, rash,
vomiting, chills, headache, liver function
test abnormal, tachycardia, hallucinations
88. a) Eskayef Latanoprostene Bunod Latanoprostene Antiglaucoma It is a prostaglandin analog indicated for the Contraindications: None. Latanoprost USFDA Aby‡g
Pharmaceuticals 0.024% Ophthalmic Solution Bunod INN reduction of intraocular pressure in patients 0.005% Eye v`b
Limited, Tongi, 0.024gm/100ml with open-angle glaucoma or ocular Side effects: Most common ocular adverse Drops Kiv
Gazipur hypertension. reactions with incidence ≥ 2% are †h‡Z
b) Incepta
Pharmaceutics
conjunctival hyperemia (6%), eye irritation cv‡i|
Ltd.; Zirabo, (4%), eye pain (3%), and instillation site
Savar, Dhaka. pain (2%).
89. Eskayef Netarsudil 0.02% Ophthalmic Netarsudil INN Antiglaucoma It is a Rho kinase inhibitor indicated for the Contraindications: None. New USFDA Aby‡g
Pharmaceuticals Solution 0.02gm/100ml reduction of elevated intraocular pressure in v`b
Limited, Tongi, patients with open-angle glaucoma or ocular Side effects: The most common adverse Kiv
Gazipur. hypertension. reaction is conjunctival hyperemia (53%). †h‡Z
Other common adverse reactions, cv‡i|
approximately 20% include: corneal
verticillata, instillation site pain, and
conjunctival hemorrhage.
90. Incepta Netarsudil 0.2mg/ml Netarsudil Antiglaucoma It is indicated for the reduction of elevated Contraindications: None New USFDA Aby‡g
Pharmaceutics Ophthalmic solution Dimesylate INN intraocular pressure (IOP) in patients with Side Effects : The most common adverse v`b
Ltd.; Zirabo, 0.0280mg eq. to open-angle glaucoma or ocular reaction is conjunctival hyperemia (53%). Kiv
Savar, Dhaka 0.2mg Netarsudil /ml hypertension. Other common adverse reactions, †h‡Z
approximately 20% include: corneal cv‡i|
verticillata, instillation site pain, and
conjunctival hemorrhage.
91. Eskayef Phenylephrine 1.016% + Phenylephrine USP Antihistamin + It is an alpha 1-adrenergic receptor agonist Contraindications: None. Phenylephrine USFDA Aby‡g
50 | P a g e
Existing) Reference
Pharmaceuticals Ketorolac 0.288% Intraocular 1.016gm + NSAIDS and nonselective cyclooxygenase inhibitor Hydrochloride v`b
Limited, Tongi, Solution Ketorolac USP indicated for : Side effects: The most common reported 5% + Kiv
Gazipur. 0.2888gm/100ml  Maintaining pupil size by preventing adverse reactions (≥2%) are eye irritation, Tropicamide †h‡Z
intraoperative miosis. posterior capsule opacification, increased 0.8% Eye Drops cv‡i|
 Reducing postoperative pain. intraocular pressure, and anterior chamber
inflammation.
92. ACI Ltd. (Brompheniramine Maleate (Brompheniramine Antihistamine It is indicated for relieves of symtomps Contraindications: This combination is New cÖ‡qvRb
0.020 g + Dextromethorphan Maleate USP 0.020 including nasal sinus congestion, contraindicated in patients with known ‡bB
Hydrobromide 0.100 g + g+ blocked/runny nose,itchy water eyes, hypersensitivity to any of the ingredients. weavq
Phenylephrine Hydrochloride Dextromethorphan sneezing, dry irritating cough Av‡e`b
bvgÄyi
0.050 g) / 100 ml Syrup Hydrobromide BP Side Effects :The common side effects of
Kiv †h‡Z
0.100 g + this combination are dizziness, feeling cv‡i|
Phenylephrine nervous and excitable, not able to sleep
Hydrochloride USP and feeling sleepy,hives, difficult
0.050g) / 100 ml breathing;swelling of the face,lips, tongue
or throat.
93. Concord Bilastine 20 mg Tablet Bilastine INN 20 mg Antihistamine Bilastine is a non-sedating, long-acting Contraindicaion: Bilastine is New BNF-75 Aby‡g
Pharmaceuticals histamine antagonist with selective contraindicated in patients with: Page: 275 v`b
Ltd. peripheral H1 receptor antagonist affinity and  hypersensitivity to bilastine or to any Kiv
no affinity for muscarinic receptors. indicated ingredient in the formulation or component †h‡Z
in allergic rhino-conjunctivitis (seasonal and of the container. For a complete listing of cv‡i|
perennial) and urticaria. ingredients and components .
 a history of QT prolongation and/or
torsade de pointes, including congenital
long QT syndromes
Adverse Reactions: The most common

treatment-emergent adverse reactions
reported in the double-blind Phase 3
studies involving 931 subjects treated with
bilastine 20 mg were related to the central
nervous
51 | P a g e
Existing) Reference
system (headache, dizziness and
somnolence) and the gastrointestinal
system (abdominal pain upper).
94. Popular Ebastine 10mg + Montelukast Ebastine BP 10mg + Antihistamine Ebastine and Montelukast combination is Contraindications: Hypersensitivity to the Ebastine 10 mg DCC-248 cÖ‡qvRb
Pharmaceuticals 10mg Tablet Montelukast Sodium indicated for the prophylaxis and chronic combination of Ebastine & Montelucast is Tablet Rejected ‡bB
Ltd. BP 10.40mg eq. to treatment of Asthma, Exercise-Induced a contraindication. In addition, the & weavq
164 Tongi I/A, Montelukast 10mg Bronchoconstriction & Hay fever Allergic combination of Ebastine & Montelucast 5mg/5ml Syrup Av‡e`b
Rhinitis shuld not be used in the conditions of,
Kiv †h‡Z
cardiac arrhythmias, lactation and cv‡i|
pregnancy. any component of this product.
Side effects: The common side effects of

the combination are nausea, diarrhea,
diarrhea, dryness in mouth, vomiting, skin
rash,, headache, drowsiness, flu-like
symptoms.
95. Incepta Phenylephrine HCl 10 mg + Phenylephrine Antihistamine + Nasal congestion associated with the Contraindications: It is contraindicated for Phenylephrine cÖ‡qvRb
Pharmaceutics Pyrilamine Maleate 16 mg Hydrochloride BP 10 Nasal common cold, sinusitis allergic rhinitis and use in the treatment of lower respiratory Hydrochloride ‡bB
Ltd.; Zirabo, Chewable Tablet mg+ Pyrilamine decongestant other respiratory tract infections tract symptoms, including asthma. 5% + weavq
Savar, Dhaka. Maleate INN 16 mg Phenylephrine is contraindicated in Tropicamide Av‡e`b
bvgÄyi
patients with hypertension or with 0.8% Eye Drops
Kiv †h‡Z
peripheral vascular insufficiency cv‡i|
Side Effects: Drowsiness sedation,
dryness of mucous membranes, and
gastrointestinal effects.
96. a) Eskayef Bisoprolol Fumarate Bisoprolol Fumarate Antihypertensive It is indicated for the treatment of Contraindications: Combination of Bisoprolol cÖ‡qvRb
Pharmaceuticals 5.00mg + Amlodipine USP 5.00mg + hypertension, alone or with other Amlodipine and Bisoprolol is 5.00mg & 10mg ‡bB
Limited, Tongi, 5mg Film Coated Tablet Amlodipine Besilate Antihypertensive agents. contraindicated in patients who are Tablet weavq
Gazipur BP 6.935mg eq. to (Amlodipine+Bisoprolol) may also be used hypersensitive to any component of this Av‡e`b
bvgÄyi
b) Square
5mg Amlodipine as initial therapy in patients who are likely to product or to any of its ingredients. Amlodipine 5mg
Kiv †h‡Z
Pharmaceuticals need multiple Tablet cv‡i|
Ltd., Pabna Unit, Antihypertensive agents to achieve their Side effects: The common side effects
52 | P a g e
Existing) Reference
Salgaria, Pabna blood pressure goals. It is also used to treat include edema, upper respiratory tract
angina pectoris, stable chronic heart failure. infection, hypotension, dizziness,
c) Aristopharma headache, nausea, vomiting, diarrhoea,
Ltd.; Plot No.21, constipation, hypersensitivity reactions
Road No.11,
Shampur-
(itching, flush, rash) etc.
Kadamtali I/A
Dhaka-1204
97. Square Amlodipine 5 mg + Valsartan Amlodipine Besilate Antihypertensive Amlodipine, a dihydropyridine calcium Contraindications: Anuria, Amlodipine USFDA cÖ‡qvRb
Pharmaceuticals 160 mg + Hydrochlorothiazide BP 7mg eqv. to 5mg channel blocker (DHP CCB), valsartan, an Hypersensitivity to sulfonamide-derived 10mg + ‡bB
Ltd., Pabna Unit, 12.5mg Tablet Amlodipine + angiotensin II receptor blocker (ARB), and drugs, Known hypersensitivity to any Hydrochlorothiaz weavq
Salgaria, Pabna Valsartan USP 160 hydrochlorothiazide, a thiazide diuretic. This component, Do not coadminister aliskiren ide 25mg + Av‡e`b
bvgÄyi
mg + combination is indicated for the treatment of with this product in patients with diabetes. Valsartan
Kiv †h‡Z
Hydrochlorothiazide hypertension to lower blood pressure. 160mg Tablet cv‡i|
BP 12.5 mg Lowering blood pressure reduces the risk of Side-effect: Most common adverse events
fatal and nonfatal cardiovascular events, (≥2% incidence) are dizziness, peripheral
primarily strokes, and myocardial infarctions edema, headache, dyspepsia, fatigue,
muscle spasms, back pain, nausea and
nasopharyngitis
98. Sun Olmesartan Medoxomil 20mg Olmesartan Antihypertensive Olmesartan medoxomil, amlodipine and Contraindications: Anuria; New USFDA cÖ‡qvRb
Pharmaceutical + Amlodipine 5mg + Medoxomil BP 20 hydrochlorothiazide tablets is a combination Hypersensitivity to sulfonamide-derived ‡bB
(Bangladesh) Ltd. Hydrochlorothi azide 12.5mg mg + Amlodipine of an angiotensin 2 receptor blocker, a drugs (4). Do not co administer aliskiren weavq
Tablet Besylate 6.940 mg dihydropyridine calcium channel blocker, with olmesartan medoxomil, amlodipine Av‡e`b
bvgÄyi
eq. to Amlodipine 5 and a thiazide diuretic indicated for the and hydrochlorothiazide in patients with
Kiv †h‡Z
mg + treatment of hypertension, to lower blood diabetes cv‡i|
Hydrochlorothiazide pressure. Lowering blood pressure reduces
BP 12.5 mg the risk of fatal and nonfatal cardiovascular Side Effects: Most common adverse
events, primarily strokes and myocardial reactions (incidence ≥2%) are dizziness,
infarctions. Olmesartan medoxomil, peripheral edema, headache, fatigue,
amlodipine and hydrochlorothiazide tablets nasopharyngitis, muscle spasms, nausea,
is not indicated for initial therapy. upper respiratory tract infection, diarrhea,
urinary tract infection, and joint swelling
99. Sun Olmesartan Medoxomil 40mg Olmesartan Antihypertensive Olmesartan medoxomil, amlodipine and Contraindications: Anuria; New USFDA cÖ‡qvRb
Pharmaceutical + Amlodipine 5mg + Medoxomil BP 20 hydrochlorothiazide tablets is a combination Hypersensitivity to sulfonamide-derived ‡bB
(Bangladesh) Ltd. Hydrochlorothi azide 12.5mg mg + Amlodipine of an angiotensin 2 receptor blocker, a drugs (4). Do not co administer aliskiren weavq
Tablet Besylate 6.940 mg dihydropyridine calcium channel blocker, with olmesartan medoxomil, amlodipine Av‡e`b
53 | P a g e
Existing) Reference
eqv. to Amlodipine and a thiazide diuretic indicated for the and hydrochlorothiazide in patients with bvgÄyi
5 mg + treatment of hypertension, to lower blood diabetes Kiv †h‡Z
Hydrochlorothiazide pressure. Lowering blood pressure reduces cv‡i|
BP 12.5 mg the risk of fatal and nonfatal cardiovascular Side Effects: Most common adverse
events, primarily strokes and myocardial reactions (incidence ≥2%) are dizziness,
infarctions. Olmesartan medoxomil, peripheral edema, headache, fatigue,
amlodipine and hydrochlorothiazide tablets nasopharyngitis, muscle spasms, nausea,
is not indicated for initial therapy. upper respiratory tract infection, diarrhea,
urinary tract infection, and joint swelling
100. Drug International Cilnidipine 10 mg + Cilnidipine INN 10 Anti- It is used in the treatment of high blood Contraindication: It is contraindicated for New cÖ‡qvRb
Ltd Olmesartan Medoxomil 20mg mg + Olmesartan Hypertensive pressure the patients with hypersensitivity to ‡bB
252,Tongi I/A Tablet Medoxomil BP Cilnidipine&Olmesartan or any other weavq
Tongi, Gazipur 20mg components of this product. Cardiogenic Av‡e`b
bvgÄyi
Shock; Recent MI Or Acute Unstable
Kiv †h‡Z
Angina; Severe Aortic Stenosis. cv‡i|
Side effect/ Toxicity: Dizziness; Flushing;

Headache; Hypotension; Peripheral
Oedema; Tachycardia; Palpitations; GI
Disturbances; Increased Micturition
Frequency; Lethargy; Eye Pain;
Depression; Ischaemic Chest Pain;
Cerebral Or Myocardial Ischaemia;
Transient Blindness; Rashes; Fever;
Abnormal Liver Function; Gingival
Hyperplasia; Myalgia; Tremor; Impotence
101. Healthcare Apremilast 20 mg Film coated Apremilast INN Anti- Indicated for the treatment of 1. Adult Contraindications: Known hypersensitivity 10mg & 30mg USFDA Aby‡g
Pharmaceutical tablet 20mg Inflammatory patients with active psoriatic arthritis to apremilast or any excipients in Tablet v`b
ltd., Rajendrapur , 2.Patients with moderate to severe plaque formulation Kiv
Gazipur psoriasis who are candidates for †h‡Z
phototherapy or systemic therapy Side-Effects: cv‡i|
1. InPsoriatic Arthritis: The most common
adverse reactions (≥5%) are
Diarrhea, nausea, and headache.
2. In Psoriasis: The most common
adverse reactions (≥5%) are diarrhea,
nausea,
54 | P a g e
Existing) Reference
upper respiratory tract infection, and
headache, including tension headache
102. Eskayef Etoricoxib 60mg + Etoricoxib INN 60mg Anti- It is used medically to treat orthopedic, Contraindication: Inflammatory bowel Etoricoxib 60mg cÖ‡qvRb
Pharmaceuticals Thiocolchicoside 4mg Film + Thiocolchicoside inflammatory and traumatological and rheumatologic disorders disease, severe kiere congestive heart Tablet ‡bB
Limited, Tongi, Coated Tablet INN 4mg Muscle Relaxant as well as to treat muscular spasms. It is failure, Active peptic ulceration, weavq
Gazipur. also used to control the pain and swelling cerebrovascular disease, Lactation child, Etoricoxib 90mg Av‡e`b
bvgÄyi
suffered by individuals with four medical Adolescent < 16 years. Tablet
Kiv †h‡Z
conditions: cv‡i|
 Rheumatoid arthritis Side effects: Side effects of Etoricoxib and Etoricoxib
 Gout Thiocolchicoside are most likely to be 120mg
 Osteoarthritis minor. Like Constipation, diarrhea, Tablet
 Ankylosing spondylitis dizziness. If you suffer from serious side
effects, then concern your doctor as soon
as possible.
103. Eskayef Etoricoxib 60mg + Etoricoxib INN 60mg Anti- It is used medically to treat orthopedic, Contraindication: Inflammatory bowel Etoricoxib 60mg cÖ‡qvRb
Pharmaceuticals Thiocolchicoside 8mg Film + Thiocolchicoside inflammatory and traumatological and rheumatologic disorders disease, severe kiere congestive heart Tablet ‡bB
Limited, Tongi, Coated Tablet INN 8mg Muscle Relaxant as well as to treat muscular spasms. It is failure, Active peptic ulceration, weavq
Gazipur. also used to control the pain and swelling cerebrovascular disease, Lactation child, Etoricoxib 90mg Av‡e`b
bvgÄyi
suffered by individuals with four medical Adolescent < 16 years. Tablet
Kiv †h‡Z
conditions: cv‡i|
 Rheumatoid arthritis Side effects: Side effects of Etoricoxib and Etoricoxib
 Gout Thiocolchicoside are most likely to be 120mg
 Osteoarthritis minor. Like Constipation, diarrhea, Tablet
 Ankylosing spondylitis dizziness. If you suffer from serious side
effects, then concern your doctor as soon
as possible.
104. Incepta Glycerin 0.20gm + Glycerin BP 0.20gm Antiitching for the relief of discomfort and redness of Contraindication: Aby‡g
Pharmaceutics Hypromelloses 0.36gm + + Hypromelloses BP the eye due to minor eye irritations If patients have medical conditions, v`b
Ltd.; Zirabo, Polyethylene Glycol(400) 1.0 0.36gm + relieves dryness of the eye especially: glaucoma; heart disease, high Kiv
Savar, Dhaka. gm + Tetrahydrozoline Polyethylene for the temporary relief of burning and blood pressure; †h‡Z
Hydrochloride 0.05gm + Zinc Glycol(400) 1.0 gm irritation due to exposure to wind or sun diabetes; cv‡i|
Sulfate 0.25gm/100ml + Tetrahydrozoline for protection against further irritation a thyroid disorder; or
Ophthalmic solution Hydrochloride USP an eye injury or infection.
0.05gm + Zinc allergic to tetrahydrozoline and zinc.
Sulfate USP Side effects: ongoing or worsening eye
0.25gm/100ml redness; eye pain; changes in your vision;
chest pain, fast or uneven heart rate; or
55 | P a g e
Existing) Reference
Severe headache, buzzing in your ears,
anxiety, confusion, or feeling short of
breath. Common side effects may include:
mild burning or stinging of the eye; blurred
vision, watery eyes; or
dilated pupils.
105. Navana Sumatriptan Sumatriptan Antimigraine It is a combination of sumatriptan, a Contraindications: History of coronary Naproxen 250, USFDA cÖ‡qvRb
Pharmaceuticals, Succinate Succinate BP 119 serotonin (5-HT) 1b/1d receptor agonist artery disease or coronary vasospasm. 500 mg Tablet & ‡bB
Narayanganj 85mg+Naproxen Sodium 500 mg eq. to 85mg (triptan), and naproxen sodium, a non- History of coronary artery bypass graft Sumatriptan weavq
mg Tablet Sumatriptan + steroidal antiinflammatory drug, indicated for surgery.(Wolff-Parkinson-White syndrome 50mg Tablet Av‡e`b
bvgÄyi
Naproxen Sodium the acute treatment of migraine with or or other cardiac accessory conduction,
Kiv †h‡Z
BP 500 mg without aura in adults and pediatric patients pathway disorders. History of stroke, cv‡i|
12 years of age and older. Limitations of transient ischemic attack, or hemiplegic or
Use: Use only if a clear diagnosis of basilar migraine. Peripheral vascular
migraine headache has been established. disease. Ischemic bowel disease.
Not indicated for the prophylactic therapy of Uncontrolled hypertension.
migraine attacks. Not indicated for the
treatment of cluster headache. Side Effects: Dizziness, drowsiness,
. Somnolence, Paresthesia, Nausea,
Dyspepsia, dry mouth, chest pain or
pressure, tight feeling in neck or jaw, pain
spreading to arm or shoulder, sudden
numbness or weakness, confusion,
problems with vision, speech, or balance,
bloody or tarry stools.
106. Eskayef Fesoterodine Fumarate 8mg Fesoterodine Antimuscarinic It is indicated for the treatment of overactive Contraindications: It is contraindicated in New USFDA Aby‡g
Pharmaceuticals Extended Release Tablet Fumarate INN 8mg agent bladder with symptoms of urge urinary patients with urinary retention, gastric v`b
Limited, Tongi, incontinence, urgency, and frequency. retention, or uncontrolled narrow-angle Kiv
Gazipur. glaucoma. Toviaz is also contraindicated †h‡Z
in patients with known hypersensitivity to cv‡i|
the drug or its ingredients or to tolterodine
tartrate tablets or tolterodine tartrate
extended-release capsules.
Side effects: Dry mouth, Constipation,
Dyspepsia, Nausea.
107. Beacon Arsenic Trioxide 10mg/10ml Arsenic Trioxide INN Antineoplastic It is an arsenical indicated: Contra-indication : Hypersensitivity to New USFDA Aby‡g
Pharmaceuticals injection 10mg/10ml Agent  In combination with tretinoin for treatment arsenic v`b
56 | P a g e
Existing) Reference
Ltd, of adults with newly-diagnosed low-risk Kiv
Kathali, Bhaluka, acute promyelocytic leukemia (APL) whose Side-effect: The most common adverse †h‡Z
Mymensingh APL is characterized by the presence of the reactions (greater than 30%) were cv‡i|
t(15;17) translocation or PML/RAR-alpha leukocytosis, neutropenia,
gene expression. thrombocytopenia, nausea, vomiting,
 For induction of remission and diarrhea, abdominal pain, hepatic toxicity,
consolidation in patients with APL who are fever, rigors, fatigue, insomnia,
refractory to, or have relapsed from, retinoid tachycardia, QTc prolongation, edema,
and anthracycline chemotherapy, and hyperglycemia, hypokalemia,
whose APL is characterized by the presence hypomagnesemia, dyspnea, cough, rash
of the t(15;17) translocation or PML/RAR- or itching, sore throat, arthralgia,
alpha gene expression. headaches, paresthesia, and dizziness
108. Beacon Tretinoin 10mg capsule Tretinoin USP 10mg Antineoplastic Its indicated for the induction of Contra-indication: VESANOID is 0.025% Cream USFDA Aby‡g
Pharmaceuticals Agent remission in patients with acute contraindicated in patients with a known v`b
Ltd, hypersensitivity to VESANOID, any of its 0.05% Cream Kiv
Kathali, Bhaluka, promyelocytic leukemia (APL), French-
components, or other retinoids. †h‡Z
Mymensingh AmericanBritish (FAB) classification M3
VESANOID should not be given to cv‡i|
(including the M3 variant), characterized patients who are sensitive to parabens,
by the presence of the t(15;17) which are used as preservatives in the
translocation and/or the presence of the gelatin capsule
PML/RARα gene who are refractory to, Side effect: Virtually all patients
or who have relapsed from, experience some drug-related toxicity,
anthracycline chemotherapy, or for especially headache, fever, weakness,
and fatigue. These adverse effects are
whom anthracycline-based
seldom permanent or irreversible nor do
chemotherapy is contraindicated. they usually require interruption of
VESANOID is for the induction of therapy. Some of the adverse events are
remission only. The optimal common in patients with APL, including
consolidation or maintenance regimens hemorrhage, infections, gastrointestinal
have not been defined, but all patients hemorrhage, disseminated intravascular
should receive an accepted form of coagulation, pneumonia, septicemia, and
cerebral hemorrhage. The following
remission consolidation and/or
describes the adverse events, regardless
maintenance therapy for APL after of drug relationship, that were observed in
completion of induction therapy with patients treated with VESANOID
VESANOID
i. a) Nipro JMI Lorcaserin HCl 10mg Film Lorcaserin HCl Anti-Obesity Lorcaserin hydrochloride is indicated as an Contraindications: It is contraindicated in New USFDA cÖ‡qvRb
57 | P a g e
Existing) Reference
Pharma Ltd., Coated Tablet Hemihydrate INN adjunct to a reduced-calorie diet and Pregnancy. ‡bB
Comilla 10.40 mg eq. 10 mg increased physical activity for chronic weight weavq
Lorcaserin HCl management in adult patients with an initial Side Effects:Most common adverse Av‡e`b
body mass index (BMI) of: reactions (greater than 5%) in non-diabetic bvgÄyi
b) Aristopharm Kiv †h‡Z
a Ltd.  30 kg/m2 or greater (obese), or patients are headache, dizziness, fatigue,
cv‡i|
Plot No.21, Road  27 kg/m2 or greater (overweight) in the nausea, dry mouth, and constipation, and
No.11, presence of at least one weight related in diabetic patients are hypoglycemia,
Shampur- comorbid condition (e.g., hypertension, headache, back pain, cough, and fatigue.
Kadamtali I/A dyslipidemia, type 2 diabetes)
Dhaka-1204 Limitations of use:
The safety and efficacy of coadministration
of Lorcaserin hydrochloride with other
products intended for weight loss including
prescription drugs (e.g., phentermine), over-
the-counter drugs, and herbal preparations
have not been established
 The effect of Lorcaserin hydrochloride on
cardiovascular morbidity and mortality has
not been established
109. Ziska Naltrexone HCl 8.0mg + Naltrexone HCl USP Antiobesity agent Adjunct in obesity (in conjunction with Contraindications: Naltrexone 25 BNF-75 cÖ‡qvRb
Pharmaceuticals Bupropion HCl 90mg 8mg + Bupropion dietary measures and increased physical Uncontrolled hypertension mg & 50 mg Page-90 ‡bB
Ltd. Extended Release Tablet HCl USP 90 mg Side effects: tablet, weavq
activity in individuals with a body mass index Av‡e`b
Most common adverse reactions (greater
(BMI) of 30 kg/m2 or more or in individuals bvgÄyi
than or equal to 5%): nausea, Bupropion 150
with a BMI of 27 kg/m 2 or more in the Kiv †h‡Z
constipation, headache, vomiting, mg SR Tablet cv‡i|
presence of one or more weight related co- dizziness,insomnia, dry mouth and
morbidity) diarrhea.
110. ACI Ltd. Undenatured Type-2 Collagen Undenatured Type-2 Anti-Osteoporotic It is indicated for to treat joint pain Contraindications: It is contraindicated in New cÖ‡qvRb
40.00 mg Capsule Collagen INN 40.00 agent associated with many types of arthritis like patients with known hypersensitivity to any ‡bB
mg osteoarthritis and rheumatoid arthritis and of the ingredients. weavq
surgeryas well as back pain, neck pain and Av‡e`b
bvgÄyi
pain following injury. Side Effects: The most common sid
Kiv †h‡Z
effects include nausea, heartburn. cv‡i|
Diarrhea and constipation, drowsiness,
skin reactions and headache.
58 | P a g e
Existing) Reference
111. Incepta Astaxanthin 6mg+ Blueberry Astaxanthin Antioxidant Astaxanthin is indicated to- Contra-indication: Contraindicated for Astaxanthin cÖ‡qvRb
Pharmaceuticals extract 160mg + Lutein 6mg Oleoresin 5% INN 1. Strong antioxidant those with known allergies to Astaxanthin. 2mg, 4mg soft ‡bB
Ltd (Dhamrai Soft Gelatin Capsule 120mg eq. to 6mg 2. Improves cardiovascular health gelatin capsule weavq
Unit). Astaxanthin + (Atherosclerosis, reduce cholesterol). Side-effect: No severe side effects have Av‡e`b
bvgÄyi
Blueberry Extract 3. Improves immune function. been reported yet for astaxanthin.
Kiv †h‡Z
INN 160mg + Lutein 4. Improves condition of skin Possible side effects of ginkgo biloba cv‡i|
INN 6mg 5. Protects skin from damage caused by sun include: Nausea, Diarrhea, Dizziness,
(Reduce wrinkles, pimples and other signs Headaches, Stomach ache, Restlessness,
of aging) Vomiting
6. Improves recovery from central nervous
system injuries
7. Protects from Parkinson ’s disease,
Dementia and Alzheimer's
8. Protects eyes from cataracts and macular
degeneration.
9. Reduces inflammation (Arthritis)
10. Reduces risk of infertility
Also Astaxnthin effectively reduce oxidative
damage to DNA, decrease the risk for many
types of cancer and stabilize blood sugar.
Blueberry is used for preventing cataracts
and glaucoma and for treating ulcers,
urinary tract infections (UTIs), multiple
sclerosis (MS), chronic fatigue syndrome
(CFS), colic, fever, varicose veins, and
hemorrhoids. Blueberry is also used for
improving circulation, and as a laxative.
112. Incepta Trihexyphenidyl Hydrochloride Trihexyphenidyl Antiparkinsonian It is indicated as an adjunct in the treatment Contraindication: This is contraindicated in 2mg & 5mg Aby‡g
Pharmaceutics Ltd.; 1mg Tablet Hydrochloride USP of all forms of parkinsonism patients with hypersensitivity to Tablet v`b
Zirabo, Savar, 1mg (postencephalitic, arteriosclerotic, and trhexyphenidyl HCI or to any Of the tablet Kiv
Dhaka. idiopathic). It is often useful as adjuvant or elixir ingredients. It is also †h‡Z
therapy when treating these forms of contraindicated in patients with narrow cv‡i|
parkinsonism with-Ievodopa. Additionally, it angle glaucoma. Blindness after long-term
is indicated for the control of extrapyramidal use due to narrow angle glaucoma has
disorders caused by central nervous system been reported.
drgs such as the dibenzoxazepines,
phenothiazines, thioxanthenes, and Side- effect: Minor side effects, such as
59 | P a g e
Existing) Reference
butyophenones. dress of the mouth, blurred vision,
dizziness, mild nausea or nervousness, wil
be experienced by 30 tö 50 percent of all
patients. These sensations, however, are
much less troublesome with ARTANE than
with belladonna alkaloids and are usually
less disturbing than unalleviated
parkinsonism. Such reactions tend to
become less pronounced, and even to
disappear, as treatment continues. Even
before these reactions have remitted
spontaneously, they may often be
controlled by careful adjustnent of dosage
form, amount of
drg, or interval between doses.Isolated
instaces of suppurative parotitis secondar
to excessive dress of the mouth,
skin rashes, dilatation of the colon,
paralytic ileus, and certain psychiatrc
manifestations such as delusions,
hallucinations, and paranoia, all of which
iIay occur with any of the atropine-like
drugs, have been reported rarely with
ARTANEQ.
Potential side effects associated with the
use of any atropine-like drugs, including
ARTANE,
include cogntive dysfuctions, including
confusion and memory impairment;
constipation,
drowsiness, urnary hesitancy or retention,
tachycardia, dilation of the pupil, increased
intraocular pressure,' choreiform
movements, weakness, vomiting, and
headache. ,Exacerbation of
parkinsonism with abrupt treatment
withdrawal has been reported. Neuroleptic
60 | P a g e
Existing) Reference
malignant syndrome with abrupt treatment
withdrawal has been reported.The
occurence of angle-closure glaucoma in
patients receiving trhexyphenidyl Hei has
been reported (blindness has been
reported in some cases). Paradoxical
sinus bradycardia,
dry skin,and cycloplegia have been
reported.. In addition to adverse events
seen in adults, the following adverse
events have been reported in the literatue
in pediatrc patients: hyperkinesia,
psychosis, forgetfulness,
weightloss,restlessness, chorea, and
sleep alterations.
113. Eskayef Aspirin 81mg + Omeprazole Aspirin USP 81mg + Anti-platelet It is a combination of aspirin, an anti-platelet Contraindications: Aspirin 75mg cÖ‡qvRb
Pharmaceuticals 40mg Delayed Release Tablet Omeprazole USP agent agent, and omeprazole, a proton pump  History of asthma, urticaria, or other Tablet ‡bB
Limited, Tongi, 40mg and PPI inhibitor (PPI), indicated for patients who allergic-type reactions after taking weavq
Gazipur. require aspirin for secondary prevention of Omeprazole Av‡e`b
aspirin or other NSAIDs.
bvgÄyi
cardiovascular and cerebrovascular events  In pediatric patients with suspected viral 40mg Capsule
Kiv †h‡Z
and who are at risk of developing aspirin infections, with or without fever, cv‡i|
associated gastric ulcers. The aspirin because of the risk of Reye's syndrome.
component of this combination indicated for:  Known hypersensitivity to aspirin,
Reducing the combined risk of death and omeprazole, substituted benzimidazoles
nonfatal stroke in patients who have had or to any of the excipients of this
ischemic stroke or transient ischemia of the combination.
brain due to fibrin platelet emboli.  Patients receiving rilpivirine-containing
Reducing the combined risk of death and products.
nonfatal MI in patients with a previous MI or
unstable angina pectoris. Side effects: Most common adverse
Reducing the combined risk of MI and reactions in adults (≥2%) are: gastritis,
sudden death in patients with chronic stable nausea, diarrhea, gastric polyps, and non-
angina pectoris. cardiac chest pain.
Use in patients who have undergone
revascularization procedures (Coronary
Artery Bypass Graft [CABG] or
Percutaneous Transluminal Coronary
61 | P a g e
Existing) Reference
Angioplasty [PTCA]) when there is a pre-
existing condition for which aspirin is already
indicated.
Limitations of Use:
Not for use as the initial dose of aspirin
therapy during onset of acute coronary
syndrome, acute myocardial infarction or
before percutaneous coronary intervention.
Has not been shown to reduce the risk of
gastrointestinal bleeding due to aspirint.
It is not interchangeable with the individual
components of aspirin and Omeprazole.
114. Eskayef Aspirin 325mg + Omeprazole Aspirin USP 325mg Anti-Platelet It is a combination of aspirin, an anti-platelet Contraindications: Aspirin 75mg cÖ‡qvRb
Pharmaceuticals 40mg Delayed Release Tablet + Omeprazole USP agent and PPI agent, and omeprazole, a proton pump  History of asthma, urticaria, or other Tablet ‡bB
Limited, Tongi, 40mg inhibitor (PPI), indicated for patients who allergic-type reactions after taking weavq
Gazipur. require aspirin for secondary prevention of Omeprazole Av‡e`b
aspirin or other NSAIDs.
bvgÄyi
cardiovascular and cerebrovascular events  In pediatric patients with suspected viral 40mg Capsule
Kiv †h‡Z
and who are at risk of developing aspirin infections, with or without fever, cv‡i|
associated gastric ulcers. The aspirin because of the risk of Reye's syndrome.
component of this combination indicated for:  Known hypersensitivity to aspirin,
Reducing the combined risk of death and omeprazole, substituted benzimidazoles
nonfatal stroke in patients who have had or to any of the excipients of this
ischemic stroke or transient ischemia of the combination.
brain due to fibrin platelet emboli.  Patients receiving rilpivirine-containing
Reducing the combined risk of death and products.
unstable angina pectoris. Side effects: Most common adverse
Reducing the combined risk of MI and reactions in adults (≥2%) are: gastritis,
sudden death in patients with chronic stable nausea, diarrhea, gastric polyps, and non-
angina pectoris. cardiac chest pain.
Use in patients who have undergone
revascularization procedures (Coronary
Artery Bypass Graft [CABG] or
Percutaneous Transluminal Coronary
existing condition for which aspirin is already
62 | P a g e
Existing) Reference
indicated.
Limitations of Use:
Not for use as the initial dose of aspirin
therapy during onset of acute coronary
syndrome, acute myocardial infarction or
before percutaneous coronary intervention.
Has not been shown to reduce the risk of
gastrointestinal bleeding due to aspirint.
It is not interchangeable with the individual
components of aspirin and Omeprazole.
115. Drug International Ticagrelor Tablet Ticagerol INN 60 mg Anti-platelet drug Ticagrelor is indicated to reducetherate of Contraindication:Ticagrelor is 90 mg BNF-75 Aby‡g
Ltd thrombotic cardiovascular events in patients contraindicated in patients with active Page: 213 v`b
252,Tongi I/A with acute coronary syndrome (ACS) pathological bleeding such as peptic ulcer Kiv
Tongi,Gazipure (unstable angina, non-ST elevation or intracranial hemorrhage. It is also †h‡Z
myocardial infarction, or ST elevation contraindicated in patients with cv‡i|
myocardial infarction). It has been shown to hypersensitivity to Ticagrelor or any
reduce the rate of cardiovascular death, component of the product.
myocardial infarction or stroke compared to Side effect:Bleeding is the most commonly
clopidogrel. In patients treated with PCI, it reported adverse reaction. Others adverse
also reduces the rate of stent thrombosis. effects include hypertension, fatigue,
headache, back pain, dizziness, nausea
etc.
116. Popular Aspirin 81mg + Omeprazole Aspirin BP 81mg + Antiplatelet + The combination of aspirin and omeprazole, This combination is contraindicated in: Aspirin 75mg USFDA cÖ‡qvRb
Pharmaceuticals 40 mg Delayed release Tablet Omeprazole BP Anti-Ulserant is indicated for patients who require aspirin Tablet (Discontinue) ‡bB
Ltd. 40mg for secondary prevention of cardiovascular • Patients with known allergy to aspirin weavq
164 Tongi I/A, and cerebrovascular events and who are at and other nonsteroidal anti-inflammatory Omeprazole Av‡e`b
risk of developing aspirin associated gastric drug products (NSAIDs) and in patients 40mg Capsule
Kiv †h‡Z
ulcers. with the syndrome of asthma, rhinitis, and cv‡i|
nasal polyps. Aspirin may cause severe
The aspirin component is indicated for: urticaria, angioedema, or bronchospasm
(asthma).
• Reducing the combined risk of death and
nonfatal stroke in patients who have had • Pediatric patients with suspected viral
ischemic stroke or transient ischemia of the infections, with or without fever, because
brain due to fibrin platelet emboli of the risk of Reye's syndrome with
63 | P a g e
Existing) Reference
concomitant use of aspirin in certain viral
• Reducing the combined risk of death and illnesses.
unstable angina pectoris • This combination is contraindicated in
patients with known hypersensitivity to
• Reducing the combined risk of MI and aspirin, omeprazole, substituted
sudden death in patients with chronic stable benzimidazoles, or to any of the excipients
angina pectoris in the formulation.
• Use in patients who have undergone • Proton pump inhibitor (PPI)–containing

revascularization procedures (Coronary products, including this combination, are
Artery Bypass Graft [CABG] or contraindicated in patients receiving
Percutaneous Transluminal Coronary rilpivirine-containing products.
existing condition for which aspirin is already Side Effects
indicated. Because clinical trials are conducted
under widely varying conditions, adverse
The omeprazole component is indicated for reaction rates observed in the clinical trials
decreasing the risk of developing aspirin- of a drug cannot be directly compared to
associated gastric ulcers in patients at risk rates in the clinical trials of another drug
for developing aspirin-associated gastric and may not reflect the rates observed in
ulcers due to age (≥ 55) or documented practice. This combination 325 mg/40 mg
history of gastric ulcers. was studied primarily in two randomized,
double-blind controlled clinical trials
(n=524) of 6 months duration. Table 1 lists
adverse reactions that occurred in >2% of
patients in the this combination arm and
were more common than in the control
arm, consisting of 325 mg of enteric
coated (EC)-aspirin.
Preferred Aspirin EC-

Term +Omep Aspirin
razole 325 mg
325 once
mg/40 daily
mg (n=524)
64 | P a g e
Existing) Reference
once
daily
%
(n=521)
%
Gastritis 18 16
Nausea 3 2
Diarrhea 3 2
Gastric 2 1
Polyps
Non- 2 1
Cardiac
chest pain
*Adverse reactions occurring in ≥2% of
Aspirin+Omeprazole -treated patients and
more common than in the control arm
In Study 1 and Study 2 combined, 7% of

patients taking this combination
discontinued due to adverse reactions
compared to 11% of patients taking EC-
aspirin alone. The most common reasons
for discontinuations due to adverse
reactions in the this combination treatment
group were upper abdominal pain (<1%,
n=2), diarrhea (<1%, n=2) and dyspepsia
(<1%, n=2).
Less Common Adverse Reactions

In THIS COMBINATION-treated patients
in the clinical trials there were 2 patients
with upper GI bleeding (gastric or
duodenal) and 2 patients with lower GI
bleeding (hematochezia and large
intestinal hemorrhage) and one additional
patient experienced obstruction in the
small bowel.
65 | P a g e
Existing) Reference
117. Aristopharma Ltd. Levosulpiride Levosulpiride INN Antipsychotic It is a gastroprokinetic agent.. For the Contraindications: Levosulpiride is New cÖ‡qvRb
Plot No.21, Road 25mg Tablet 25mg treatment of gastroesophageal reflux contraindicated in conditions like epilepsy, ‡bB
No.11, disease, various forms of dyspepsia, hyperprolactinaemia, breast feeding, and weavq
Shampur- diabetic gastroparesis, vomiting and hypersensitivity to any component of Av‡e`b
Kadamtali I/A bvgÄyi
Dhaka-1204
nausea. product,gastrointestinal Hemorrhage and
Kiv †h‡Z
pheochromocytoma. cv‡i|
Side effects: The symptomatic adverse

reactions produced by Levosulpiride are
more or less tolerable and if they become
severe, they can be treated
symptomatically, these include sedation,
hypotension, and dyskinesia
hyperprolactinemia .
118. General Olanzapine 6mg + Fluoxetine Olanzapine BP 6mg Antipsychotic Ccombines olanzapine, an atypical Contra-indication : Do not use with an Olanzapine 5mg USFDA cÖ‡qvRb
Pharmaceutical Hydrochloride 25mg Capsule + Fluoxetine antipsychotic and fluoxetine, a selective MAOI or within 14 days of discontinuing 10mg Tablet ‡bB
Ltd., Gazipur Hydrochloride BP serotonin reuptake inhibitor, indicated for an MAOI due to risk of drug interaction. At weavq
27.95mg eq. to acute treatment of: least 5 weeks should be allowed after Fluoxetine 20mg Av‡e`b
bvgÄyi
25mg Fluoxetine Depressive Episodes Associated with stopping SYMBYAX before starting Capsule & 0.4%
Kiv †h‡Z
Bipolar I Disorder in adults (1.1) treatment with an MAOI (4, 7.1) Do not Oral Solution cv‡i|
Treatment Resistant Depression (Major use with pimozide due to risk of risk of
Depressive Disorder in adults who do not drug interaction or QTc prolongation (4,
respond to 2 separate trials of different 7.9)
antidepressants of adequate dose and Do not use with thioridazine due to QTc
duration in the current episode) interval prolongation or potential for
elevated thioridazine plasma levels. Do
not use thioridazine within 5 weeks of
discontinuing
Side –Effects:
Most common adverse reactions are
disturbance in attention, dry mouth,
fatigue, hypersomnia, increased
appetite, peripheral edema, sedation,
somnolence, termor, vision blurred, and
weight increased.
119. General Olanzapine 12mg + Fluoxetine Olanzapine BP 12.0 Antipsychotic Ccombines olanzapine, an atypical Contra-indication : Do not use with an Olanzapine 5mg USFDA cÖ‡qvRb
Pharmaceutical Hydrochloride 25mg Capsule mg + Fluoxetine antipsychotic and fluoxetine, a selective MAOI or within 14 days of discontinuing Tablet & 10mg ‡bB
66 | P a g e
Existing) Reference
Ltd., Gazipur Hydrochloride BP serotonin reuptake inhibitor, indicated for an MAOI due to risk of drug interaction. At Tablet weavq
27.95mg eq. to acute treatment of: least 5 weeks should be allowed after Fluoxetine 20mg Av‡e`b
25mg Fluoxetine Depressive Episodes Associated with stopping SYMBYAX before starting Capsule & Oral bvgÄyi
treatment with an MAOI (4, 7.1) Do not Solution Kiv †h‡Z
Bipolar I Disorder in adults (1.1)
cv‡i|
Treatment Resistant Depression (Major use with pimozide due to risk of risk of
Depressive Disorder in adults who do not drug interaction or QTc prolongation (4,
respond to 2 separate trials of different 7.9)
antidepressants of adequate dose and Do not use with thioridazine due to QTc
duration in the current episode) interval prolongation or potential for
elevated thioridazine plasma levels. Do
not use thioridazine within 5 weeks of
discontinuing
Side –Effects:
Most common adverse reactions are
disturbance in attention, dry mouth,
fatigue, hypersomnia, increased
appetite, peripheral edema, sedation,
somnolence, termor, vision blurred, and
weight increased.
120. Delta Pharma Ltd. Paracetamol 500 mg + Paracetamol BP Antipyretic & For relief of symptoms of colds and Contra-indications: Paracetamol MHRA cÖ‡qvRb
Phenylephrine HCl 6.10mg 500mg + Analgesic influenza, including the relief of aches and ▪ Hypersensitivity to any of the active 500mg + ‡bB
Tablet Phenylephrine HCl pains, sore throat, headache, nasal substances or any other ingredient. Caffeine 65mg weavq
BP 6.10 mg congestion and lowering of temperature. ▪ Severe coronary heart disease and Av‡e`b
bvgÄyi
cardiovascular disorders.
Kiv †h‡Z
▪ Hypertension. cv‡i|
▪ Hyperthyroidism.
▪ Contraindicated in patients currently
receiving or within two weeks of stopping
therapy with monoamine oxidase
inhibitors.
Side-effects: Adverse effects of

paracetamol are rare, but hypersensitivity
including skin rash may occur.
Phenylephrine HCl
High blood pressure with headache,
vomiting, probably only in overdosage.
67 | P a g e
Existing) Reference
Rarely, palpitations. Also, rare reports of
allergic reactions and occasionally urinary
retention in males.
121. Delta Pharma Ltd. Paracetamol 500mg + Paracetamol BP 500 Antipyretic & It is recommended for the relief of sinus pain Contra-indications: Paracetamol MHRA cÖ‡qvRb
Phenylephrine HCl 5mg + mg+ Phenylephrine Analgesic and the symptoms of colds and influenza, ▪ Concomitant use of other 500mg + ‡bB
Caffeine 25mg Tablet HCl 5 mg+ Caffeine . including fatigue and drowsiness. sympathomimetic decongestants Caffeine 65mg weavq
25 mg Tablet ▪ Phaeochromocytoma Av‡e`b
bvgÄyi
▪ Closed angle glaucoma
Kiv †h‡Z
▪ Known hypersensitivity to paracetamol cv‡i|
or any of the other constituents. Hepatic or
severe renal impairment, hypertension,
hyperthyroidism, diabetes, and heart
disease. Patients taking tricyclic
antidepressants, or beta-blocking drugs
and those who are taking or who have
taken within the last two weeks
monoamine oxidase inhibitors
Side-effects: Adverse effects of

paracetamol are rare, but hypersensitivity
including skin rash may occur.
Phenylephrine HCl
High blood pressure with headache,
vomiting, probably only in overdosage.
Rarely, palpitations. Also, rare reports of
allergic reactions and occasionally urinary
retention in males.
Caffeine
Adverse reactions identified through post-
marketing use with caffeine are
Nervousness and anxiety Irritability,
Restlessness and Excitability Dizziness.
The frequency of these reactions is
unknown.
122. Incepta Baricitinib Baricitinib INN 2 mg. Antirheumatic It is indicated for the treatment of adult Contraindications: None. New USFDA cÖ‡qvRb
Pharmaceutics 2 mg Tablet patients with moderately to severely active Approved ‡bB
Ltd.; Zirabo, rheumatoid arthritis who have had an Side Effects: Adverse reactions (greater 2018 weavq
68 | P a g e
Existing) Reference
Savar, Dhaka. inadequate response to one or more tumor than or equal to 1%) include: upper Av‡e`b
necrosis factor (TNF) antagonist therapies. respiratory tract infections, nausea, herpes bvgÄyi
simplex, and herpes zoster. Kiv †h‡Z
Limitation of Use: Use of OLUMIANT in cv‡i|
combination with other JAK inhibitors,
biologic disease-modifying antirheumatic
drugs (DMARDs), or with potent
immunosuppressants such as azathioprine
and cyclosporine is not recommended.
123. Incepta Baricitinib Baricitinib INN 4 mg Antirheumatic It is indicated for the treatment of adult Contraindications: None. New cÖ‡qvRb
Pharmaceutics 4 mg Tablet patients with moderately to severely active ‡bB
Ltd.; Zirabo, rheumatoid arthritis who have had an Side Effects: Adverse reactions (greater weavq
Savar, Dhaka. inadequate response to one or more tumor than or equal to 1%) include: upper Av‡e`b
bvgÄyi
necrosis factor (TNF) antagonist therapies. respiratory tract infections, nausea, herpes
Kiv †h‡Z
simplex, and herpes zoster. cv‡i|
Limitation of Use: Use of OLUMIANT in
combination with other JAK inhibitors,
biologic disease-modifying antirheumatic
drugs (DMARDs), or with potent
immunosuppressants such as azathioprine
and cyclosporine is not recommended.
124. Eskayef Phenol 1.4% Oral Liquid Spray Phenol BP Antiseptic It is indicated for sore throat, mouth irritation. Contraindications: Hypersensitivity New cÖ‡qvRb
Pharmaceuticals 1.4gm/100ml + ‡bB
Limited, Disinfectant Side effects: Rash, Hives, Itching, weavq
Tongi,Gazipur. Redness, Swollen, Blistered or peeling Av‡e`b
bvgÄyi
skin.
Kiv †h‡Z
cv‡i|
125. Ziska Alverine citrate 60 mg + Alverine citrate BP Antispasmodics Abdominal pain in irritable bowel syndrome Contraindications: Hypersensitivity to Alverine citrate BNF-75 cÖ‡qvRb
Pharmaceuticals Simeticone 300mg Capsule 60mg + Simeticone simethicone, alverine citrate or to any of BP 60mg Tablet Page-46 ‡bB
Ltd. BP 300 mg the excipients of Avarin. Patients with & 120mg weavq
intestinal obstruction or paralytic ileus. Capsule Av‡e`b
bvgÄyi
Pregnancy and lactation. Children <12
Kiv †h‡Z
years. Simethicone cv‡i|
Side effects: Dizziness, Headaches, 67mg/ml
Difficulty breathing, Swelling of the face, pediatric drops
69 | P a g e
Existing) Reference
wheeze, Dry mouth, Weakness,
Decreased blood pressure can occur. Simethicone 40
Rash (very rare) mg Chewable
Tablet
126. Eskayef Dextromethorphan Dextromethorphan Antitussive + It is used for the relief of coughs and upper Contraindications: Hypersensitivity, Dextromethorph - cÖ‡qvRb
Pharmaceuticals Hydrobromide 0.20gm + Hydrobromide USP Sympathomimeti respiratory symptoms, including nasal Monoamine oxidase (MAO) inhibitor an ‡bB
Limited, Tongi, Phenylephrine Hydrochloride 0.20gm + c + Antihistamine congestion, associated with allergy or the therapy. Hydrobromide weavq
Gazipur. 1.0gm + Chlorpheniramine Phenylephrine common cold. 0.40gm + Av‡e`b
bvgÄyi
Maleate 0.04gm/100ml Syrup Hydrochloride USP Side effects: Sedation, dizziness, diplopia, Phenylephrine
Kiv †h‡Z
1.0gm + vomiting, diarrhea, nausea, anorexia, HCl 0.20gm + cv‡i|
Chlorpheniramine heartburn, dry mouth, headache, Triprolidine HCl
Maleate USP nervousness, weakness, polyuria and 0.05gm/100ml
0.04gm/100ml dysuria. Syrup
127. Eskayef Dextromethorphan Dextromethorphan Antitussive + It Helps loosen phlegm (mucus) and thin Contraindications: Hypersensitivity, Dextromethorph cÖ‡qvRb
Pharmaceuticals Hydrobromide 0.1gm + Hydrobromide USP Expectorant + bronchial secretions to drain bronchial Concomitant use with MAO inhibitors. an ‡bB
Limited, Tongi, Guaifenesin 2.0gm + 0.1gm + Sympathomimeti tubes. Temporarily relieves these symptoms Hydrobromide weavq
Gazipur. Phenylephrine Hydrochloride Guaifenesin USP c occurring with a cold, nasal congestion, Side effects: Mood changes, Severe 0.40gm + Av‡e`b
bvgÄyi
0.05gm/100ml Syrup 2.0gm + cough due to minor throat and bronchial headache, Fast or uneven heart rate, Phenylephrine
Kiv †h‡Z
Phenylephrine irritation. Severe dizziness or anxiety. HCl 0.20gm + cv‡i|
Hydrochloride USP Triprolidine HCl
0.05gm/100ml 0.05gm/100ml
Syrup
128. Square Sucralfate 10gm/100ml Oral Sucralfate USP Antiulcerant It is indicated in the short-term (up to 8 Contraindications: 500mg USFDA cÖ‡qvRb
Pharmaceuticals Suspension 10gm/100ml weeks) treatment of active duodenal ulcer This product is contraindicated in patients and ‡bB
Ltd., Pabna Unit, with a known hypersensitivity to any of the 1.0gm Tablet weavq
Salgaria, Pabna ingredients. Av‡e`b
bvgÄyi
20gm/100ml
Kiv †h‡Z
Side Effects: the following signs or Oral Suspension cv‡i|
symptoms that may be related to a very
bad side effect:
Signs of an allergic reaction, like rash;
hives; itching; red, swollen, blistered, or
peeling skin with or without fever;
wheezing; tightness in the chest or throat;
trouble breathing or talking; unusual
hoarseness; or swelling of the mouth,
70 | P a g e
Existing) Reference
face, lips, tongue, or throat.
Signs of high blood sugar like confusion,
feeling sleepy, more thirst, more hungry,
passing urine more often, flushing, fast
breathing, or breath that smells like fruit.
129. Beacon Chloral Hydrate Chloral Hydrate BP Anxiolytics  Chloral Hydrate Oral Solution is used Contra-indication : Chloral Hydrate Oral cÖ‡qvRb
Pharmaceuticals 2.866gm/100ml Oral Solution 2.866gm /100ml for the short-term treatment of severe Solution should not be used in patients ‡bB
Ltd, insomnia which is interfering with with a marked hepatic or renal impairment, weavq
Kathali, Bhaluka, or in patients with severe cardiac disease. Av‡e`b
normal daily life and where other
Mymensingh bvgÄyi
therapies have failed . Should not be used in patients susceptible
Kiv †h‡Z
 Chloral Hydrate Oral Solution Should to acute attacks of porphyria. cv‡i|
be used as an adjunct to non-
Pharmacological therapies. Side-effect: Gastric irritation , abdominal
 In children aged 2-11 years treatment distension and flatulence may occur .
should be as an adjunct to behavioural Excitement, tolerance, allergic skin
therapy and sleep hygiene reactions,headache and ketonuria have
management , and usually for duration occasionally been reported. There is a
of less than 2 weeks. danger of abuse or chronic intoxication
The use of hypnotics in children and and the possibility that habituation may
adolescents is not generally recommended develop. In such patients gastritis and
and if used should be under the supervision parenchymatous renal injury may develop
of a medical specialist. . After long term use, sudden withdrawal
may result in delirium.
Elderly patients are more susceptible to
the undesirable effects of hypnotic
medications such as Chloral Hydrate Oral
Solution and are therefore more
susceptible to ataxia, Confusion , falls and
injuries.
130. Square Doxofylline 400mg + Doxofylline INN Bronchodilator It is used for the treatment, control, Contraindication: Doxophylline cÖ‡qvRb
Formulations Ltd., Montelukast 10mg Tablet 400mg + prevention, & improvement of the following Contraindicated in patients who are 400 mg Tablet, ‡bB
Gorai, Tangail Montelukast Sodium diseases, conditions and symptoms: hypersensitive to any component of this weavq
USP 10.400mg eq. Av‡e`b
 Asthma product or to any of its ingredients.It Montelukast bvgÄyi
to 10mg of should not be used if you have the 10mg Tablet
Montelukast
 Hay fever following conditions:
Kiv †h‡Z
 Exercise-induced asthma cv‡i|
 Allergic reactions
71 | P a g e
Existing) Reference
 Chronic asthma  Asthma exacerbations
 Seasonal allergic rhinitis  Hypersensitivity
 Perennial allergic rhinitis  Lactation
 Doxovent M Tablet may also be used  Pregnancy
for purposes not listed here.
Side effect: The following is a list of
possible side-effects that may occur from
all constituting ingredients of Doxovent M
Tablet. This is not a comprehensive list.
These side-effects are possible, but do not
always occur.
 Nausea
 Vomiting
 Epigastric pain
 Palpitations
 Headache
 Insomnia

131. Aristopharma Ltd. Nifedipine 0.30g + Lidocaine Nifedipine USP Ca Channel Lidocaine is a topical anesthetic and Contraindications: This combinateion is Nifedipine 5 mg, cÖ‡qvRb
Plot No.21, Road Hydrochloride 1.50 g /100g 0.30g + Lidocaine Blocker & Loacal Nifedipine works in a anal fissure by contraindicated in patients with a known 10mg & 20mg ‡bB
No.11, Cream Hydrochloride USP Anesthetic blocking the action of calcium on blood hypersensitivity to any of the ingredients Capsule weavq
Shampur- 1.50 g /100g vessels of anus. As a result. Blood vessels contained in this product. Av‡e`b
Dhaka-1204
are relaxed which allows fissure to relieves Side effects: During or immediately after Lidocaine
Kiv †h‡Z
pain. treatment , the skin at the site of treatment Hydrochloride cv‡i|
may develop erythema or edema or may 20mg/ml ,
be the locus of abnormal sensation. 40mg/ml
Injection
132. Beacon Etelcalcetide 5mg/ml Injection Etelcalcetide Calcimimetic It is a calcium-sensing receptor agonist Contra-indication: It is contraindicated in New USFDA Aby‡g
Pharmaceuticals Hydrochloride INN indicated for: Secondary patients with known hypersensitivity to v`b
Ltd, Kathali, 5.77mg eq. to 5mg hyperparathyroidism (HPT) in adult patients etelcalcetide or any of its excipients Kiv
Bhaluka, Etelcalcetide/ml with chronic kidney disease (CKD) on †h‡Z
Mymensingh
hemodialysis. Side-effect: The most common adverse cv‡i|
reactions (≥ 5%) were blood calcium
72 | P a g e
Existing) Reference
Limitations of Use: It has not been studied in decreased, muscle spasms, diarrhea,
adult patients with parathyroid carcinoma, nausea, vomiting, headache,
primary hyperparathyroidism, or with CKD hypocalcemia, and paresthesia
who are not on hemodialysis and is not
recommended for use in these populations.
133. Beacon Etelcalcetide 10mg/2ml Etelcalcetide Calcimimetic It is a calcium-sensing receptor agonist Contra-indication: It is contraindicated in New USFDA Aby‡g
Pharmaceuticals Injection Hydrochloride INN indicated for: Secondary patients with known hypersensitivity to v`b
Ltd, Kathali, 11.54mg eq. to hyperparathyroidism (HPT) in adult patients etelcalcetide or any of its excipients Kiv
Bhaluka, 10mg with chronic kidney disease (CKD) on †h‡Z
Mymensingh
Etelcalcetide/2ml hemodialysis. Side-effect: The most common adverse cv‡i|
reactions (≥ 5%) were blood calcium
Limitations of Use: It has not been studied in decreased, muscle spasms, diarrhea,
adult patients with parathyroid carcinoma, nausea, vomiting, headache,
primary hyperparathyroidism, or with CKD hypocalcemia, and paresthesia
who are not on hemodialysis and is not
recommended for use in these populations.
134. Eskayef Lisdexamfetamine Dimesylate Lisdexamfetamine CNS It is a central nervous system (CNS) Contraindications: Known hypersensitivity New USFDA cÖ‡qvRb
Pharmaceuticals 30mg Capsule Dimesylate INN Stimulant stimulant indicated for the treatment of : to amphetamine products and is also ‡bB
Limited, Tongi, 30mg • Attention Deficit Hyperactivity Disorder contraindicated with monoamine oxidase weavq
Gazipur. (ADHD) (MAO) inhibitor, or within 14 days of the Av‡e`b
bvgÄyi
• Moderate to Severe Binge Eating Disorder last MAO inhibitor dose.
Kiv †h‡Z
(BED) in adults. cv‡i|
Side effects: The most frequent adverse
Limitation of Use: It is not indicated for reactions leading to discontinuation were
weight loss. Use of other sympathomimetic insomnia, tachycardia, irritability,
drugs for weight loss has been associated hypertension, headache, anxiety and
with serious cardiovascular adverse events. dyspnea. The most common adverse
The safety and effectiveness of this drug for reactions (incidence ≥5% and at a rate at
the treatment of obesity have not been least twice placebo) reported in children,
established. adolescents, and/or adults were anorexia,
anxiety, decreased appetite, decreased
weight, diarrhea, dizziness, dry mouth,
irritability, insomnia, nausea, upper
abdominal pain, and vomiting.
135. a) Eskayef Flibanserin 100mg Film Flibanserin INN CNS Agent It is indicated for the treatment of Contraindications: Alcohol, Hepatic New USFDA cÖ‡qvRb
Pharmaceuticals Coated Tablet 100mg premenopausal women with acquired, impairment, Moderate or strong ‡bB
Limited, Tongi, generalized hypoactive sexual desire cytochrome P450 3A4 (CYP3A4) weavq
73 | P a g e
Existing) Reference
Gazipur disorder inhibitors. Av‡e`b
(HSDD) as characterized by low sexual bvgÄyi
b) Square desire that causes marked distress or Side effects: Most common adverse Kiv †h‡Z
Pharmaceuticals interpersonal difficulty and is NOT due to: reactions (incidence ≥2%) are dizziness, cv‡i|
Ltd., Pabna Unit,
Salgaria, Pabna  A co-existing medical or psychiatric somnolence, nausea, fatigue, insomnia,
condition, and dry mouth.
 Problems within the relationship, or
 The effects of a medication or other drug
substance.
Limitations of Use:
 It is not indicated for the treatment of
HSDD in postmenopausal women or in men.
 It is not indicated to enhance sexual
performance.
136. Incepta Triamcinolone Acetonide Triamcinolone Corticosteroid It is an extended-release synthetic Contraindications: Patients with 40 mg/ml USFDA Aby‡g
Pharmaceutics 32mg/vial extended-release Acetonide BP corticosteroid indicated as an intra-articular hypersensitivity to triamcinolone acetonide Injection v`b
Ltd.; Zirabo, injectable suspension for Intra- 32mg/vial injection for the management of or any component of the product. 0.1% Oral Paste Kiv
Savar, Dhaka. articular Use osteoarthritis pain of the knee. 4mg Tablet †h‡Z
Side-effects/Toxicity: Most commonly cv‡i|
Limitations of Use: It is not intended for reported adverse reactions (incidence
repeated use. ≥1%) in clinical studies include sinusitis,
cough and contusions.
137. Eskayef Levodropropizine 30mg/5ml Levodropropizine Cough It is indicated for the symptomatic treatment Contraindications: It should not be used in New cÖ‡qvRb
Pharmaceuticals Syrup BP 0.60gm/100ml suppressant of cough. those cases where it is known or ‡bB
Limited, Tongi, hypersensitivity is suspected to the active weavq
Gazipur. ingredient, or in patients with bronchial Av‡e`b
bvgÄyi
hypersecretion, where function mucociliary
Kiv †h‡Z
reduced syndrome (Kartagener, cv‡i|
dyskinesia ciliary) in severe liver or kidney
failure.
Side effects: The sometimes may occur

gastrointestinal disorders (nausea,
vomiting, heartburn, abdominal discomfort,
diarrhea), central nervous system
(exhaustion, dizziness, drowsiness,
74 | P a g e
Existing) Reference
mental confusion, numbness, dizziness
and headache), cardiovascular system
(palpitations) and, rarely, have been
observed dermatological allergic
reactions.
138. Eskayef Brimonidine Tartrate 0.025% Brimonidine Tartrate Decongestant It is an alpha adrenergic agonist indicated Contraindications: Neonates and infants Brimonidine USFDA Aby‡g
Pharmaceuticals Ophthalmic Solution BP 0.025gm/100ml for lowering intraocular pressure (IOP) in (under the age of 2 years). Tartrate 0.2 % v`b
Limited, Tongi, patients with open-angle glaucoma or ocular Eye Drops Kiv
Gazipur. hypertension. Side effects: Most common adverse †h‡Z
reactions occurring in approximately 10 to cv‡i|
30% of patients receiving brimonidine
ophthalmic solution 0.2% included oral
dryness, ocular hyperemia, burning and
stinging, headache, blurring, foreign body
sensation, fatigue/drowsiness, conjunctival
follicles, ocular allergic reactions, and
ocular pruritus.
139. Navana Oxymetazoline Hydrochloride Oxymetazoline Decongestant For the fast relief of stuffy noses due to head Contraindication: Hypersensitivity to any of 0.05% MHRA Aby‡g
Pharmaceuticals, 0.05% Nasal Spray Hydrochloride USP colds and hay fever. the ingredients, patients with & 0.025% Nasal v`b
Narayanganj 0.05% cardiovascular disease, hyperthyroidism, Drops Kiv
angle closure glaucoma or prostatic †h‡Z
enlargement cv‡i|
Side Effects: Occasionally may cause

local irritation and dryness of the mouth
and throat. Prolonged use may cause
rebound congestion and rhinitis
medicamentosa.
140. Ziska Alitretinoin 10 mg soft Gelatin Alitretinoin INN 10 Dermatological Severe chronic hand eczema refractory to Contraindications: Hypervitaminosis A, New BNF-75 Aby‡g
Pharmaceuticals capsule mg Agent high potency topical corticosteroids in adults uncontrolled hyperlipidemia, uncontrolled Page-1193 v`b
Ltd. hypothyroidism Kiv
Side effects: Alopecia, anaemia, †h‡Z
arthralgia, dry eyes, dryness of lips, cv‡i|
75 | P a g e
Existing) Reference
dryness of skin, erythema, eye kinase,
raised serum concentration, of
triglycerides and of cholesterol.
141. Ziska Alitretinoin 30 mg soft Gelatin Alitretinoin INN 30 Dermatological Severe chronic hand eczema refractory to Contraindications: Hypervitaminosis A, New BNF-75 Aby‡g
Pharmaceuticals capsule mg Agent high potency topical corticosteroids in adults uncontrolled hyperlipidemia, uncontrolled Page: 1193 v`b
Ltd. hypothyroidism Kiv
Side effects: Alopecia, anaemia, †h‡Z
arthralgia, dry eyes, dryness of lips, cv‡i|
dryness of skin, erythema, eye kinase,
raised serum concentration, of
triglycerides and of cholesterol.
142. Beacon Tolvaptan 30mg Tablet Tolvaptan INN 30mg Diuretic agent It is a selective vasopressin V2-receptor Contra-indication : New USFDA Aby‡g
Pharmaceuticals antagonist indicated for the treatment of Do not administer to patients requiring v`b
Ltd, clinically significant hypervolemic and urgent intervention to raise serum sodium Kiv
Kathali, Bhaluka, euvolemic hyponatremia [serum sodium < acutely †h‡Z
Mymensingh
125 mEq/L or less marked hyponatremia • Do not use in patients who are unable to cv‡i|
that is symptomatic and has resisted sense or to respond appropriately to thirst
correction with fluid restriction], including • Do not use in patients with hypovolemic
patients with heart failure, cirrhosis, and hyponatremia
Syndrome of Inappropriate Antidiuretic • Do not use with strong CYP 3A inhibitors
Hormone (SIADH) • Do not administer to patients who are
Limitations: anuric as no benefit is expected
• Patients requiring intervention to raise
serum sodium urgently to prevent or to treat Side-effect: Most common adverse
serious neurological symptoms should not reactions (≥ 5% placebo) are thirst, dry
be treated with Tolvaptan mouth, asthenia, constipation, pollakiuria
• It has not been established that Tolvaptan or polyuria, and hyperglycemia
provides a symptomatic benefit to patients
143. Beacon Tolvaptan 15mg Tablet Tolvaptan INN 15mg Diuretic agent It is a selective vasopressin V2-receptor Contra-indication : New USFDA Aby‡g
Pharmaceuticals antagonist indicated for the treatment of Do not administer to patients requiring v`b
Ltd, Kathali, clinically significant hypervolemic and urgent intervention to raise serum sodium Kiv
Bhaluka, euvolemic hyponatremia [serum sodium < 125 acutely †h‡Z
Mymensingh mEq/L or less marked hyponatremia that is • Do not use in patients who are unable to cv‡i|
76 | P a g e
Existing) Reference
symptomatic and has resisted correction with sense or to respond appropriately to thirst
fluid restriction], including patients with heart • Do not use in patients with hypovolemic
failure, cirrhosis, and Syndrome of hyponatremia
Inappropriate Antidiuretic Hormone (SIADH) • Do not use with strong CYP 3A inhibitors
Limitations: • Do not administer to patients who are
• Patients requiring intervention to raise serum anuric as no benefit is expected
sodium urgently to prevent or to treat serious
neurological symptoms should not be treated Side-effect: Most common adverse reactions
with Tolvaptan (≥ 5% placebo) are thirst, dry mouth,
• It has not been established that Tolvaptan asthenia, constipation, pollakiuria or
provides a symptomatic benefit to patients polyuria, and hyperglycemia
144. Eskayef Potassium Citrate 508.305mg Potassium Citrate Electrolytes It is a hydration solution specially formulated Contraindications: No information New cÖ‡qvRb
Pharmaceuticals + Sodium Citrate Anhydrous USP 508.305mg + with the optimal balace of sugar and ‡bB
Limited, Tongi, 197.80mg + Sodium Chloride Sodium Citrate electrolytes needed to help replenish vital Side effects: None weavq
Gazipur. 484.957mg + Anhydrous Anhydrous USP fluids, minerals, and nutrients, which, when Av‡e`b
bvgÄyi
Glucose (Dextrose) 197.80mg + Sodium lost, can lead to dehydration caused by
Kiv †h‡Z
5.7gm/Sachet Chloride BP vomiting, diarrhea, exercise, travel and heat cv‡i|
484.957 mg + exhaustion.
Anhydrous Glucose
(Dextrose) BP 5.7
gm/Sachet
145. Square Urea 10.00 gm + Liquid Urea BP 10.00 gm + Emollient & It is used for the treatment, control, prevention, Contraindications: Hypersensitivity, New cÖ‡qvRb
Pharmaceuticals Paraffin 10.00gm + Propylene Liquid Paraffin BP Protectives & improvement of the following diseases, perforation of tympanic membrane, ‡bB
Ltd., Pabna Unit, Glycol 10.00 gm + Lactic Acid 10.00gm + conditions and symptoms: premature infants weavq
Salgaria, Pabna 10.00 gm/100gm Cream Propylene Glycol  Wrinkles and lines Side-effects: Av‡e`b
 Dry skin conditions Common side effects may include: bvgÄyi
10.00 gm + Lactic
 Erosion Kiv †h‡Z
Acid BP 10.00  Mild to severe forms of dry, scaly skin
 Stinging cv‡i|
gm/100gm  Dry skin
 Psoriasis  Burning
 Burns  Itching
 Rough skin  Inflammation of chinchilla middle ears
 Hyperkeratotic surface lesions  Contact dermatitis
 Moisturex Cream may also be used for  Mild lactic acidosis
purposes not listed here  No known side effects
146. Beacon L-Asparaginase INN L-Asparaginase Enzyme It is an asparagine specific enzyme Contra-indication: Serious allergic New †idv‡i
Pharmaceuticals 5,000IU/vial (As Lyophilized INN 5,000IU/vial indicated as a component of a multi- reactions to Elspar or other Escherichia Ýmn
Ltd, Kathali, powder) (As Lyophilized coli-derived L-asparaginases ciewZ
Bhaluka, agent chemotherapeutic regimen for the
powder) Side effect: Most common adverse ©
77 | P a g e
Existing) Reference
Mymensingh treatment of patients with acute reactions are allergic reactions (including mfvq
lymphoblastic leukemia anaphylaxis), hyperglycemia, pancreatitis, Dc¯’v
central nervous system (CNS) thrombosis, c‡bi
coagulopathy, hyperbilirubinemia, and Rb¨
elevated transaminases. mycv
wik
Kiv
nBj|
147. Beacon L-Asparaginase INN L-Asparaginase INN Enzyme It is an asparagine specific enzyme Contra-indication: Serious allergic New USFDA Aby‡g
Pharmaceuticals 10,000IU/vial (As Lyophilized 10,000IU/vial (As indicated as a component of a multi- reactions to Elspar or other Escherichia v`b
Ltd, Kathali, powder) Lyophilized powder) coli-derived L-asparaginases Kiv
Bhaluka, agent chemotherapeutic regimen for the
Side effect: Most common adverse †h‡Z
Mymensingh treatment of patients with acute
reactions are allergic reactions (including cv‡i|
lymphoblastic leukemia anaphylaxis), hyperglycemia, pancreatitis,
central nervous system (CNS) thrombosis,
coagulopathy, hyperbilirubinemia, and
elevated transaminases.
148. Square Amylase 15,000 Units + Pancrelipase EC Enzymes It is a combination of porcine-derived Contraindication: None. New USFDA cÖ‡qvRb
Formulations Ltd., Lipase 3000 Units + Protease Pellets Ph. Grade lipases, proteases, and amylases indicated ‡bB
Gorai, Tangail 9,500 Units Capsule 83.67mg for the treatment of exocrine pancreatic Warnnigns: weavq
contains Amylase insufficiency due to cystic fibrosis, chronic Fibrosing colonopathy is associated with Av‡e`b
bvgÄyi
15,000 USP Units + pancreatitis, pancreatectomy, or other high-dose use of pancreatic enzyme
Kiv †h‡Z
Lipase 3000 USP conditions. replacement. Exercise caution when cv‡i|
Units + Protease doses of PANCREAZE exceed 2,500
9,500 USP Units lipase units/kg of body weight per meal (or
greater than 10,000 lipase units/kg of body
weight per day). To avoid irritation of oral
mucosa, do not chew PANCREAZE or
retain in the mouth
Exercise caution when prescribing
PANCREAZE to patients with gout, renal
impairment, or hyperuricemia. There is
theoretical risk of viral transmission with all
pancreatic enzyme products including
PANCREAZE.
149. Square Formulations Amylase 1,20,000 Units + Pancrelipase EC Enzymes It is a combination of porcine-derived Contraindication: None. New USFDA cÖ‡qvRb
78 | P a g e
Existing) Reference
Ltd., Gorai, Tangail Lipase 24000 Units + Protease Pellets Ph. Grade lipases, proteases, and amylases indicated ‡bB
76,000 Units Capsule 669.36mg for the treatment of exocrine pancreatic Warnnigns: weavq
(contains Amylase insufficiency due to cystic fibrosis, chronic Fibrosing colonopathy is associated with Av‡e`b
1,20,000 USP Units pancreatitis, pancreatectomy, or other high-dose use of pancreatic enzyme bvgÄyi
Kiv †h‡Z
+ Lipase 24,000 conditions. replacement. Exercise caution when
cv‡i|
USP Units + doses of PANCREAZE exceed 2,500
Protease 76,000 lipase units/kg of body weight per meal (or
USP Units) greater than 10,000 lipase units/kg of body
weight per day). To avoid irritation of oral
mucosa, do not chew PANCREAZE or
retain in the mouth
Exercise caution when prescribing
PANCREAZE to patients with gout, renal
impairment, or hyperuricemia. There is
theoretical risk of viral transmission with all
pancreatic enzyme products including
PANCREAZE.
150. Square Sildenafil 50 mg + Dapoxetine Sildenafil Citrate BP Erectile It is used to achieve and maintain erections Sildenafil & Dapoxetine combination was New cÖ‡qvRb
Pharmaceuticals 30 mg Tablet 70.25mg eq. to 50 dysfunction and delay premature ejaculation in men. shown to potentiate the hypotensive ‡bB
Ltd., Pabna Unit, mg Sildenafil + This medication is used to treat men with effects of nitrates and its administration to weavq
Salgaria, Pabna Dapoxetine persistent or recurrent ejaculation with patients who are using organic nitrates, Av‡e`b
bvgÄyi
Hydrochloride INN minimal sexual stimulation before, on, or either regularly and or intermittently, in any
Kiv †h‡Z
33.58mg eq. to 30 shortly after penetration and before the form is therefore contraindicated. Patients cv‡i|
mg Dapoxetine patient wishes and simultaneously have also with significant pathological cardiac
to be treated for erectile dysfunction (ED). conditions such as heart failure (NYHA
class II-IV), conduction abnormalities
(second or third degree AV block or sick
sinus syndrome) not treated with a
permanent pacemaker, significant
ischemic heart disease of significant
valvular disease. - Concomitant treatment
with monoamine oxidase inhibitors
(MAOIs), thioridazine. Similarly, MAOIs or
thioridazine should not be administered
within 7 days after Dapoxetine has been
discontinued. - Concomitant treatment
with serotonin reuptake inhibitors (SSRIs),
79 | P a g e
Existing) Reference
serotonin-norepinephrine reuptake
inhibitors (SNRIs), tricyclic
antidepressants (TCAs) or other
medicinal/herbal products with
serotonergic effects or within 14 days of
discontinuing treatment with these
medicinal/herbal products.
Side Effects: mmediate call your

emergency when you face sign of allergy
such as pimples; difficulty in breathing;
face swelling, lips, tongue, or gullet. If you
become faint or disgusted, or have pain,
anesthetized, or itchy in your chest, arms,
neck, or jaw during sexual activity, call
your doctor. You could have these serious
side effects of Suhagra Force: sudden
vision loss; ringingin you rears,or sudden
hearing loss; chest pain or heavy feeling,
pain spreading to the arm or shoulder,
nausea, sweating, general ill feeling;
irregular heartbeat; swelling in your hands,
ankles, or feet; shortness of breath; vision
changes; feeling light-headed, fainting; or
Penis erection that is painful or lasts 4
hours or longer.
151. Eskayef Patiromer 16.80gm/Sachet Patiromer Sorbitex Exchange It is a potassium binder indicated for the Contraindications: Known hypersensitivity New USFDA Aby‡g
Pharmaceuticals Powder For Suspension Calcium INN Resin treatment of hyperkalemia. to Veltassa or any of its components. v`b
Limited, Tongi, 33.60gm eq. to /Potassium Kiv
Gazipur. 16.80gm Binder Limitations of use: It should not be used as Side effects: Most common adverse †h‡Z
Patiromer/Sachet an emergency treatment for life-threatening reactions (incidence ≥2%) are cv‡i|
hyperkalemia because of its delayed onset constipation, hypomagnesemia, diarrhea,
of action. nausea, abdominal discomfort and
flatulence.
152. Eskayef Guaifenesin 2.0gm/100ml Guaifenesin USP Expectorant It helps loosen phlegm and thin bronchial Contraindications: Hypersensitivity New cÖ‡qvRb
80 | P a g e
Existing) Reference
Pharmaceuticals syrup 2.0gm/100ml secretions, symptomatic relief of deep (allergy) to the active substance or to any ‡bB
Limited, Tongi, chesty coughs, expectorant for productive of the ingredients. weavq
Gazipur. cough. Av‡e`b
Side effects: Occasionally been reported bvgÄyi
Kiv †h‡Z
to cause gastrointestinal (stomach)
cv‡i|
discomfort, nausea and vomiting,
particularly in high doses.
153. Incepta Dextromethorphan Dextromethorphan Expectorant This combination medication is used to Contraindications: Some medicines can Dextromethorph cÖ‡qvRb
Pharmaceutics Hydrobromide 0.40gm + Hydrobromide BP temporarily treat cough, chest congestion, cause unwanted or dangerous effects an ‡bB
Ltd.; Zirabo, Guaifenesin 4.0gm + 0.40gm + and stuffy nose symptoms caused by the when used together. Not all possible Hydrobromide weavq
Savar, Dhaka. Phenylephrine 0.10gm/100ml Guaifenesin BP common cold, flu, allergies, hay fever, or interactions are listed in this medication 0.40gm + Av‡e`b
bvgÄyi
Suspension 4.0gm + other breathing illnesses (e.g., sinusitis, guide. Taking this medicine with other Phenylephrine
Kiv †h‡Z
Phenylephrine HCl bronchitis). Guaifenesin is an expectorant drugs that make you sleepy or slow your HCl 0.20gm + cv‡i|
BP 0.1218gm eq. to that helps to thin and loosen mucus in the breathing can worsen these effects. Ask Triprolidine HCl
0.10gm/100ml lungs, making it easier to cough up the your doctor before taking this medicine 0.05gm/100ml
mucus. Dextromethorphan is a cough with a sleeping pill, narcotic pain medicine, Syrup
suppressant that affects a certain part of the muscle relaxer, or medicine for anxiety,
brain (cough center), reducing the urge to depression, or seizures.
cough. This product also contains a Side Effects: Dizziness, headache,
decongestant, which helps relieve stuffy nausea, nervousness, or trouble sleeping
nose symptoms. may occur. If any of these effects persist
This medication is usually not used for or worsen, contact your doctor or
ongoing coughs from smoking, asthma, pharmacist promptly.If your doctor has
other long-term breathing problems (e.g., prescribed this drug, remember that your
emphysema), or coughs with a lot of mucus, doctor has prescribed it because he or she
unless directed by your doctor. has judged that the benefit to you is
greater than the risk of side effects. Many
people using this medication do not have
serious side effects.Tell your doctor if any
of these unlikely but serious side effects
occur: mental/mood changes (e.g.,
confusion, hallucinations), shaking
(tremors), weakness.Tell your doctor if any
of these rare but very serious side effects
occur: fast/slow/irregular heartbeat.
154. Incepta Dextromethorphan Dextromethorphan Expectorant This combination medication is used to Contraindications: Some medicines can Dextromethorph cÖ‡qvRb
81 | P a g e
Existing) Reference
Pharmaceutics Hydrobromide 0.40gm + Hydrobromide BP temporarily treat cough, chest congestion, cause unwanted or dangerous effects an ‡bB
Ltd.; Zirabo, Guaifenesin 4.0gm + 0.40gm + and stuffy nose symptoms caused by the when used together. Not all possible Hydrobromide weavq
Savar, Dhaka. Phenylephrine 0.10gm/100ml Guaifenesin BP common cold, flu, allergies, hay fever, or interactions are listed in this medication 0.40gm + Av‡e`b
Pediatric Drop 4.0gm + other breathing illnesses (e.g., sinusitis, guide. Phenylephrine bvgÄyi
Kiv †h‡Z
Phenylephrine HCl bronchitis). Guaifenesin is an expectorant Taking this medicine with other drugs that HCl 0.20gm +
cv‡i|
BP 0.1218gm eq. to that helps to thin and loosen mucus in the make you sleepy or slow your breathing Triprolidine HCl
0.10gm/100ml lungs, making it easier to cough up the can worsen these effects. Ask your doctor 0.05gm/100ml
mucus. Dextromethorphan is a cough before taking this medicine with a sleeping Syrup
suppressant that affects a certain part of the pill, narcotic pain medicine, muscle
brain (cough center), reducing the urge to relaxer, or medicine for anxiety,
cough. This product also contains a depression, or seizures.
decongestant, which helps relieve stuffy
nose symptoms. Side Effects: Dizziness, headache,
This medication is usually not used for nausea, nervousness, or trouble sleeping
ongoing coughs from smoking, asthma, may occur. If any of these effects persist
other long-term breathing problems (e.g., or worsen, contact your doctor or
emphysema), or coughs with a lot of mucus, pharmacist promptly.
unless directed by your doctor. If your doctor has prescribed this drug,
remember that your doctor has prescribed
it because he or she has judged that the
benefit to you is greater than the risk of
side effects. Many people using this
medication do not have serious side
effects.
Tell your doctor if any of these unlikely but
serious side effects occur: mental/mood
changes (e.g., confusion, hallucinations),
shaking (tremors), weakness.
Tell your doctor if any of these rare but
very serious side effects occur:
fast/slow/irregular heartbeat.
155. Navana Guaifenesin BP 2.0gm + Guaifenesin BP 2.0g Expectorant It is indicated for the symptomatic relief of Contraindication: Diphenhydramin MHRA cÖ‡qvRb
82 | P a g e
Existing) Reference
Pharmaceuticals, Levomenthol BP + Levomenthol BP cough. This product is contraindicated in e Hydrochloride ‡bB
Narayanganj 22.0mg/100ml Syrup 22.0mg/100ml individuals with known hypersensitivity to 14mg + weavq
the product, or any of its components Guaifenesin Av‡e`b
Side Effects: 100mg + bvgÄyi
Kiv †h‡Z
Hypersensitivity, Rash, Diarrhoea, Nausea Levomenthol
cv‡i|
& Vomiting 1.10mg/5ml
syrup
156. Eskayef Bromhexine Hydrochloride Bromhexine Expectorant + It is indicated for the Secretolytic therapy in Contraindications: Children under 2 years New cÖ‡qvRb
Pharmaceuticals 0.08gm + Guaifenesin Hydrochloride BP Mucolytic Agent acute and chronic bronchopulmonary of age. ‡bB
Limited, Tongi, 2.0gm/100ml Syrup 0.08gm + diseases associated with abnormal mucus weavq
Gazipur. Guaifenesin USP secretion and impaired mucus transport. Side effects: Nausea, Vomiting, Av‡e`b
bvgÄyi
2.0gm/100ml Hypersensitivity.
Kiv †h‡Z
cv‡i|
157. a) Beacon Linaclotide 290mcg Capsule Linaclotide INN Gastrointestinal It is a guanylate cyclase-C agonist indicated Contra-indication : New USFDA cÖ‡qvRb
Pharmaceuticals 290mcg Agent in adults for treatment of: • Pediatric patients up to 6 years of age. ‡bB
Ltd, • Irritable bowel syndrome with constipation • Patients with known or suspected weavq
Kathali, Bhaluka, (IBS-C) mechanical gastrointestinal obstruction Av‡e`b
Mymensingh bvgÄyi
• Chronic idiopathic constipation (CIC)
Kiv †h‡Z
b) Incepta Side-effect: Most common adverse cv‡i|
Pharmaceutics reactions (incidence of at least 2%)
Ltd.; Zirabo, reported in IBS-C or CIC patients are
Savar, Dhaka diarrhea, abdominal pain, flatulence and
abdominal distension
c) Square
Pharmaceuticals
Ltd., Pabna Unit,
Salgaria, Pabna
158. Navana Domperidone 30mg SR Domperidone INN Gastroprokinetic 1. The dyspeptic symptom complex that is Contraindications: Known hypersensitivity 10 mg tablet cÖ‡qvRb
Pharmaceuticals, Capsule 30 mg often associated with delayed gastric to Domperidone or any of the excipients ‡bB
Narayanganj emptying, Gastrooesophageal reflux and • Prolactin-releasing pituitary tumour weavq
Eesophagitis: (prolactinoma) Av‡e`b
bvgÄyi
- Epigastric sense of fullness, early satiety, • Co-administration with medicines that
Kiv †h‡Z
feeling of abdominal distension, upper prolong the QTc interval. cv‡i|
abdominal pain; • It should not be used in the presence of
- Bloating, eructation, flatulence; gastrointestinal haemorrhage, mechanical
- Nausea and vomiting; obstruction, or perforation.
- Heartburn with or without regurgitations of
83 | P a g e
Existing) Reference
gastric contents in the mouth. Side-effects: Generally well tolerated.
2. Nausea and vomiting of functional, Most common side effects are
organic, infectious or dietetic origin or somnolence, dizziness, dry mouth and
induced by radiotherapy or drug therapy. A blurring of vision.
specific indication is nausea and vomiting
induced by dopamine agonists, as used in
Parkinson’s disease (such as L-dopa and
bromocriptine).
159. Square Deflazacort 1mg Tablet Deflazacort INN Glucocorticoid Asthma and other airway Contraindications: Systemic infection; live 6mg, 24mg, cÖ‡qvRb
Pharmaceuticals 1mg Diseases, Rheumatoid arthritis, juvenile virus vaccines in those receiving 30mg Tablet ‡bB
Ltd., Pabna Unit, chronic arthritis, pemphigus, uveitis, immunosuppressive doses. weavq
Salgaria, Pabna nephritic, syndrome,Immune suppression in & Av‡e`b
bvgÄyi
transplantation, anaphylaxis, Side Effects: GI disturbances, 120mg/100ml
Kiv †h‡Z
severe,hypersensitivity reactions, musculoskeletal, endocrine, Suspention cv‡i|
dermatomyositis, mixed connective, tissue neuropsychiatric, ophthalmic, fluid and
disease, polyarteritis nodosa, bullous electrolyte disturbances; susceptible to
pemphigoid, ulcerative colitis, optic neuritis, infection, impaired healing,
autoimmune haemolytic anaemia, idiopathic, hypersensitivity, skin atrophy, striae,
thrombocytopenic, purpura, acute and telangiectasia, acne, myocardial rupture
lymphatic leukaemia, malignant lymphoma. following recent MI, thromboembolism.
160. Square Deflazacort 18 mg Tablet Deflazacort INN Glucocorticoid Asthma and other airway Contraindications: Systemic infection; live 6mg, 24mg USFDA cÖ‡qvRb
Pharmaceuticals 18mg Diseases, Rheumatoid arthritis, juvenile virus vaccines in those receiving Tablet ‡bB
Ltd., Pabna Unit, chronic arthritis, pemphigus, uveitis, immunosuppressive doses. weavq
Salgaria, Pabna nephritic, syndrome,Immune suppression in & Av‡e`b
bvgÄyi
transplantation, anaphylaxis, Side Effects: GI disturbances, 120mg/100ml
Kiv †h‡Z
severe,hypersensitivity reactions, musculoskeletal, endocrine, Suspention cv‡i|
dermatomyositis, mixed connective, tissue neuropsychiatric, ophthalmic, fluid and
disease, polyarteritis nodosa, bullous electrolyte disturbances; susceptible to
pemphigoid, ulcerative colitis, optic neuritis, infection, impaired healing,
autoimmune haemolytic anaemia, idiopathic, hypersensitivity, skin atrophy, striae,
thrombocytopenic, purpura, acute and telangiectasia, acne, myocardial rupture
lymphatic leukaemia, malignant lymphoma. following recent MI, thromboembolism.
84 | P a g e
Existing) Reference
161. Popular Follicle Stimulating Hormone Follicle Stimulating Hormone Ovulation Induction Contraindications: Tumours of the ovary, FSH 50IU, 75IU, USFDA cÖ‡qvRb
Pharmaceuticals (FSH) (Urofollitropin) 150 Hormone (FSH) FSH administered IM or SC with HCG in a breast, uterus, pituitary or hypothalamus. 100IU ‡bB
Ltd. IU/Vial Lyophilized Injection (Urofollitropin) BP sequential manner, which is indicated for Pregnancy or lactation. Undiagnosed weavq
164 Tongi I/A, 150IU/Vial ovulation indication in patients who have vaginal bleeding. Hypersensitivity to the Av‡e`b
previously received pituitary suppression. active substance or to any of the
Kiv †h‡Z
Multi-follicular Development excipients. Primary ovarian failure. Fibroid cv‡i|
During ART FSH administered IM in tumors of the uterus incompatible with
conjunction with HCG is indicated for pregnancy. Primary testicular failure.
multiple follicular developments (controlled
ovarian stimulation) during ART cycles in Side effects: FSH sometimes excites the
patients who have previously received ovaries too much. This may cause pelvic
pituitary suppression. Polycystic Ovarian pain or breathing problems. It may also
Syndrome (OCOS). make you urinate less. In rare cases,
Used to treat Polycystic Ovarian Syndrome patients with this problem have had
(PCOS) related infertility. serious lung problems, including fluid in
IN Women; Starting dose of 150 to 225 the lungs, troublebreathing, and worsening
international units (IU) of FSH is of asthma blood clots and strokes, severe
administered intramuscularly for at least the pelvic pain, chest pain, or abdominal pain,
first 4 days of treatment. Subsequent doses Nausea, Vomiting, Sudden weight gain,
are adjusted based upon ovarian response Bloating, Trouble, breathing. FSH may
as determined by ultrasound evaluation of cause twins or multiple births.
follicular growth and serum estradiol levels. The most common side effects with FSH
Final Oocyte (egg) maturation is induced are headache, vaginal bleeding, nausea,
with a dose of 7500-10,000 international and hot flashes. Sometimes there is a
units of HCG Oocyte (egg) retrieval is reaction at the spot where you give
performed 34 to 36 hours later Polycystic yourself the injection. This can include
Ovarian Hyperstimulation (PCOS). bruising, pain, or redness.
FSH injections are therefore given each
morning as an intramuscular injection. It is
best to start with the lowest dose of FSH per
day (using 75 IU per day). There doses are
used for 4 to 6 days at a time. The ovarian
response is determined by measuring
oestrogen levels in the blood. When the
oestrogen beings to rise, the FSH is
successfully growing an egg or eggs. If there
85 | P a g e
Existing) Reference
is no response to a dose of FSH in 5-6 days
of injections the dose will be increased. The
normal dose increments are 75 units, 112
units, 150 units and 225 units per day. Most
patients respond with 50 to 150 IU per day.
However it is very important that increments
are only made cautiously.
162. Healthcare Diacerein capsule Diacerein 50mg Interleukin-1 Treatment of Osteoarthritis & Rheumatoid Contraindications: Should not be New cÖ‡qvRb
Pharmaceutical capsule receptor arthritis. administered to patients with known ‡bB
ltd., Rajendrapur , antagonist, hypersensitivity to weavq
Gazipur Antirheumatic the drug or those with previous episodes Av‡e`b
agent bvgÄyi
of hypersensitivity to Anthraquinone
Kiv †h‡Z
derivatives cv‡i|
Side-Effects: May cause mild to moderate

laxative effects in few patients which is
transient and goes once the patients is
accustomed to the medication
163. Beacon (Sodium Picosulfate 10.00mg+ (Sodium Laxative it is a combination of sodium picosulfate, a Contra-indication : Patients with severely New USFDA Aby‡g
Pharmaceuticals Magnesium Oxide 3.50gm + Picosulfate BP stimulant laxative, and magnesium oxide reduced renal function (creatinine v`b
Ltd, Kathali, Anhydrous Citric Acid 10.00mg+ and anhydrous citric acid, which form clearance less than 30 mL/minute) Kiv
Bhaluka, 12.0gm)/160ml Bottle Magnesium magnesium citrate, an osmotic laxative, • Gastrointestinal (GI) obstruction or ileus †h‡Z
Mymensingh
Oxide BP indicated for cleansing of the colon as a • Bowel perforation cv‡i|
3.50gm + preparation for colonoscopy in adul • Toxic colitis or toxic megacolon
Anhydrous Citric • Gastric retention
Acid BP • An allergy to any of the ingredients in
12.0gm)/160ml CLENPIQ
Side-effect: Most common adverse

reactions (>1%) are nausea, headache,
and vomiting
86 | P a g e
Existing) Reference
164. Incepta PEG-3350 210 gm + Sodium PEG-3350 BP/Ph. laxatives This preparation is indicated for cleansing of Contraindications: The PEG-3350, sodium New USFDA cÖ‡qvRb
Pharmaceutics chloride 5.6gm + Sodium EUR 210 gm + the colon as a preparation for colonoscopy chloride, sodium bicarbonate and ‡bB
Ltd.; Zirabo, Bicarbonate 2.86 gm + Sodium chloride in adults. potassium chloride and bisacodyl delayed- weavq
Savar, Dhaka. Potassium Chloride BP/Ph. EUR 5.6gm release tablet, is contraindicated in the Av‡e`b
bvgÄyi
0.74gm/Bottle Oral Solution + Sodium following conditions:
Kiv †h‡Z
and Bisacodyl 5mg Delayed- Bicarbonate BP/Ph. Gastrointestinal (GI) obstruction cv‡i|
Release Tablet EUR 2.86 gm + Bowel perforation
Potassium Chloride Toxic colitis and toxic megacolon
BP/Ph. EUR Gastric retention
0.74gm/Bottle and Ileus
Bisacodyl Extended Side-effects: Because clinical studies are
Release USP 5mg conducted under widely varying
conditions, adverse reaction rates
observed in the clinical studies of a drug
cannot be directly compared to rates in
clinical studies of another drug and may
not reflect the rates observed in practice.
In a clinical study of PEG-3350, sodium
chloride, sodium bicarbonate and
potassium chloride and (5 mg vs. 10 mg)
bisacodyl delayed-release tablet, overall
discomfort, abdominal fullness, abdominal
cramping, nausea, and vomiting, were the
most common adverse reactions (>3%). The
data in Table 1 reflects the 154 patients that
received PEG-3350, sodium chloride,
sodium bicarbonate and potassium chloride
and 5 mg bisacodyl tablet vs. the 154
patients that received PEG-3350, sodium
chloride, sodium bicarbonate and potassium
chloride and 10 mg bisacodyl tablets. The
PEG-3350, sodium chloride, sodium
bicarbonate and potassium chloride and 5
mg bisacodyl delayed-release tablet,
population was 29-87 years of age, 49%
male, 51% female, 13% African American,
83% White, 5% Hispanic requiring a
colonoscopy. The demographics of the
87 | P a g e
Existing) Reference
comparator group were similar.
165. Square Prucalopride 1mg Tablet Prucalopride Laxativves This is a selective serotonin (5-HT4) Contraindications: New BNF-75 Aby‡g
Pharmaceuticals succinate INN 1.049 receptor agonist which is indicated for - Hypersensitivity to the active substance Page: 59 v`b
Ltd., Pabna Unit, mg eqv. to 1.00mg symptomatic treatment of chronic or to any of the excipients listed in section Kiv
Salgaria, Pabna Prucalopride constipation in adults especially in women 6.1. - Renal impairment requiring dialysis. †h‡Z
when other laxatives fail to provide adequate - Intestinal perforation or obstruction due cv‡i|
relief. to structural or functional disorder of the
gut wall, obstructive ileus, severe
inflammatory conditions of the intestinal
tract, such as Crohn’s disease, and
ulcerative colitis and toxic
megacolon/megarectum.
Side Effects: The most frequently reported
adverse reactions associated with
Prucalopride therapy are headache
(17.8%) and gastrointestinal symptoms
(abdominal pain (13.7%), nausea (13.7%)
and diarrhoea (12.0%)
166. Square Prucalopride 2mg Tablet Prucalopride Laxativves This is a selective serotonin (5-HT4) Contraindications: New BNF-75 Aby‡g
Pharmaceuticals succinate INN 2.098 receptor agonist which is indicated for - Hypersensitivity to the active substance Page: 59 v`b
Ltd., Pabna Unit, mg eqv. to 2.00mg symptomatic treatment of chronic or to any of the excipients listed in section Kiv
Salgaria, Pabna Prucalopride constipation in adults especially in women 6.1. - Renal impairment requiring dialysis. †h‡Z
when other laxatives fail to provide adequate - Intestinal perforation or obstruction due cv‡i|
relief. to structural or functional disorder of the
gut wall, obstructive ileus, severe
inflammatory conditions of the intestinal
tract, such as Crohn’s disease, and
ulcerative colitis and toxic
megacolon/megarectum.
Side Effects: The most frequently reported
adverse reactions associated with
Prucalopride therapy are headache
(17.8%) and gastrointestinal symptoms
(abdominal pain (13.7%), nausea (13.7%)
and diarrhoea (12.0%)
88 | P a g e
Existing) Reference
167. Popular Ferric Pyrophosphate Citrate Ferric Mineral It is indicated for the replacement of iron to None. New USFDA Aby‡g
Pharmaceuticals eq. to Iron (III) 27.20 mg/5ml Pyrophosphate maintain hemoglobin in adult patients with v`b
Ltd. IV Infusion Citrate Solution INN hemodialysis-dependent chronic kidney PREGNANCY: Kiv
164 Tongi I/A, eq. to Iron (III) disease (HDD-CKD). Pregnancy Category C. There are no †h‡Z
Tongi, Gazipur
27.20mg/5ml adequate and well-controlled studies of cv‡i|
Ferric Pyrophosphate Citrate in pregnant
women. Use of Ferric Pyrophosphate
Citrate during pregnancy only if the
potential benefit justifies the potential risk
to the fetus.
LACTATION: It is not known if ferric

pyrophosphate citrate is present in human
milk. Because many drugs are excreted in
human milk and because of the potential
for adverse events in nursing infants, a
decision should be made whether to
discontinue nursing or to avoid it, taking
into account the importance of iron to the
mother and the known benefits of nursing.
Side Effects: The most common adverse

reactions in controlled clinical studies
include: headache, peripheral edema,
asthenia, AV fistula thrombosis, urinary
tract infection, AV fistula site hemorrhage,
pyrexia, fatigue, procedural hypotension,
muscle spasms, pain in extremity, back
pain, and dyspnea.
89 | P a g e
Existing) Reference
168. Square Calcium L-5 Calcium L-5 Mineral Folic acid is the man-made form of folate. Contraindications: New cÖ‡qvRb
Formulations Ltd., Methyltetrahydrofolate 1.00mg Methyltetrahydrofola Folate is a B-vitamin naturally found in some This product is contraindicated in patients ‡bB
Gorai, Tangail Tablet te USP 1.00mg foods. It is needed to form healthy cells, with a known hypersensitivity to weavq
especially red blood cells. pregabalin or any of it’s component. Av‡e`b
bvgÄyi
Folic acid supplements may come in
Kiv †h‡Z
different forms (such as L-methylfolate, cv‡i|
levomefolate, methyltetrahydrofolate). They
are used to treat or prevent low folate levels.
Low folate levels can lead to certain types
of anemia. Conditions that can cause low
folate levels include poor
diet, pregnancy, alcoholism, liver disease,
certain stomach/intestinal problems, kidney
dialysis, among others. Women of
childbearing age should receive adequate
amounts of folic acid either through their diet
or supplements to prevent infant spinal
cord birth defects.
169. Beacon Elemental Zinc 0.4gm/100ml Zinc Gluconate USP Minerals It is a nutrient that people need to stay Contra-indication: The following drugs can 10 mg/5 ml cÖ‡qvRb
Pharmaceuticals Syrup 2.80gm eqv. to healthy. Zinc is found in cells throughout interact with or be made less effective by Syrup ‡bB
Ltd, Kathali, Elemental Zinc zinc gluconate. Tell your doctor if you are weavq
Bhaluka, the body. It helps the immune Av‡e`b
0.4gm/100ml using any of these:
Mymensingh system fight off 20 mg/5 ml bvgÄyi
a blood thinner such as warfarin
invading bacteria and viruses. The body Syrup Kiv †h‡Z
(Coumadin); cv‡i|
also needs zinc to methyltestosterone (Android, Methitest,
make proteins and DNA, Oreton);
the genetic material in all cells. During penicillamine (Cuprimine, Depen);
pregnancy, infancy, and childhood, the risedronate (Actonel);
body needs zinc to grow and develop a tetracycline antibiotic such as
demeclocycline (Declomycin), doxycycline
properly. Zinc also helps wounds heal
(Adoxa, Doryx, Oracea, Vibramycin),
and is important for proper senses of minocycline (Dynacin, Minocin, Solodyn,
taste and smell. Vectrin), or tetracycline (Brodspec,
Panmycin, Sumycin, Tetracap); or
90 | P a g e
Existing) Reference
an antibiotic such as ciprofloxacin (Cipro),
ofloxacin (Floxin), norfloxacin (Noroxin),
levofloxacin (Levaquin), and others.
Side-effect: Frequency not defined; may
vary with different salts. Adverse reactions
reported with excess dietary zinc (IOM,
2001).
Central nervous system: Headache
Endocrine & metabolic: Copper deficiency,
decreased HDL cholesterol, decreased
LDL cholesterol
Gastrointestinal: Abdominal cramps,
decreased appetite, diarrhea, epigastric
pain, gastrointestinal distress, nausea,
vomiting
Hematologic & oncologic:
Immunodeficiency
170. Eskayef Iron 14 mg + Folic Acid 200 Dried Ferrous Minerals + It is indicated for the treatment of all Contraindications: Hypersensitivity, New cÖ‡qvRb
Pharmaceuticals mcg + Cyanocobalamin 3mcg Sulphate USP Vitamins anemias that are responsive to oral iron Hemolytic anemia, Hemochromatosis, ‡bB
Limited, Tongi, + Ascorbic Acid 100 mg 43.523mg eq. to therapy. These include: hypochromic Haemosiderosis. weavq
Gazipur. Effervescent Tablet Elemental Iron 14 anemia associated with pregnancy, chronic Av‡e`b
bvgÄyi
mg + Folic Acid USP and/or acute blood loss, metabolic disease, Side effects: Adverse reactions with iron
Kiv †h‡Z
200 mcg + post-surgical convalescence, and dietary therapy may include GI irritation, cv‡i|
Cyanocobalamin needs. constipation, diarrhea, nausea, vomiting,
USP 3mcg + and dark stools. Adverse reactions with
Ascorbic Acid USP iron therapy are usually transient. Allergic
100 mg sensitization has been reported following
both oral and parenteral administration of
folic acid.
171. Aristopharma Ltd. Erdosteine Erdosteine INN Mucolytic Erdosteine is priparily indicated in conditions to any of the excipients or to free SH – 300mg Capsule cÖ‡qvRb
Plot No.21, Road 175mg/5ml 175mg/5ml like acute exacerbation of chronic group containing products. Hepatic ‡bB
No.11, Powder for bronchitis, and can also be given in disorders and abnormalities (e.g. increase weavq
Shampur- Suspension adjunctive therapy as an alternative drug of of serum alkaline phosphatase, Av‡e`b
Dhaka-1204
choice in respiratory tract disorders. transaminases, etc.). Renal insufficiency
Kiv †h‡Z
91 | P a g e
Existing) Reference
(creatinine clearance <25mL/min). cv‡i|
Homocystinuria (the active substance is
partially metabolised to homocysteine and
there are no data concerning
administration of erdosteine in case of
congenital errors of the Metabolism of
aminoacids, especially in those patients
obliged to follow a methionine-free
dietary regimen). Phenylketonuria (only for
powder for suspension due to the
presence of aspartame in this
presentation).
Side effects: Gastric burning, nausea and
rarely diarrhea.
172. Ziska Vitamin C 500 mg + Vitamin Vitamin C BP 500 Multivitamin Nutritional supplement to help promote Contraindications: Ascorbic Acid cÖ‡qvRb
Pharmaceuticals B1 (Thiamine Mononitrate) 50 mg + Vitamin B1 increased energy & enhance the immune If the patient is allergic to any ingredient of 175 mg + ‡bB
Ltd. mg + Vitamin B2 (Riboflavin) (Thiamine system. Treatment of vit B-complex & vit C the product. Calcium d- weavq
25 mg + Vitamin B6 Mononitrate) BP 50 deficiencies. Side effects: Pantothenate 25 Av‡e`b
bvgÄyi
(Pyridoxine HCl) 10 mg + mg + Vitamin B2 Nausea, flushing of the face, arms & mg +
Kiv †h‡Z
Vitamin B12 5 mcg + (Riboflavin) BP 25 chest, itching, abdominal cramps, diarrhea Cynocobalamin cv‡i|
Niacinamide 50 mg + Calcium mg + Vitamin B6 & nose bleeds. 5 mcg + Folic
Pantothenate 20 mg Tablet (Pyridoxine HCl) BP Acid 500 mcg +
10 mg + Vitamin Nicotinamide100
B12 BP 5mcg + mg + Pyridoxine
Niacinamide BP 50 Hydrochloride
mg + Calcium 10 mg +
Pantothenate BP 20 Riboflavin 25 mg
mg + Vitamin B 150
mg
173. Opsonin Phatrma Firmvit Syrup Vitamin (A+D3) Multi-Vitamin Promotes muscle growth. Weight gain and The Products are contraindicated in Folic Acid 250 cÖ‡qvRb
Ltd Vitamin (A+D3) Water Miscible Water Miscible Type calcium retention: Helps to enhance body patients with a know hypersensitivity to mcg + L-Lysine ‡bB
Type 100/20 10 mg (eq. to 100/20 BP 10 mg geight and weight gain: Ensures good eye any of the ingredients of the products. 50 mg + weavq
Vitamin A 1000 IU & Vitamin (equivalent to sight: Necessary for the normal process in Nicotinamide 2.5 Av‡e`b
bvgÄyi
D3 200 IU) + Ascorbic Acid Vitamin A 1000 IU & protein, fat carbohydrate metabolism: for Side effects: Generally well tolerated mg + Vitamin A
Kiv †h‡Z
15mg + dl-Alpha Tocopheryl Vitamin D3 200 IU)+ RBC formation and correct functioning of 1500 IU + cv‡i|
Acetate USP 5 mg (eq. to Ascorbic Acid BP nervous system & proper food assimilation Vitamin B1 250
Vitamin E 5IU) + Pyridoxine 15mg +dl-Alpha and for proper cell functioning and pretect mcg + Vitamin
92 | P a g e
Existing) Reference
HCl 500mcg + Thiamine HCl Tocopheryl Acetate body cell from free radical B12 2 mcg +
500mcg + Riboflavin Sodium USP 5 mg Vitamin B2 250
Phosphate 500mcg + (equivalent to mcg + Vitamin
Nicotinamide 6mg + Vitamin E 5 IU) + B6 250 mcg +
Cyanocobalamin 0.9mcg + Pyridoxine Vitamin C 50 mg
Calcium Pantothenate Hydrochloride BP + Vitamin D3
2.174mg + L-Lysine 100mg/ 500 mcg + Thiamine 100 IU + Vitamin
5ml Syrup Hydrochloride BP E 10 IU Tablet
500 mcg +Riboflavin
Sodium
PhosphateBP 500
mcg +Nicotinamide
BP 6mg
+Cyanocobalamin
BP 0.9 mcg +
Calcium
Pantothenate
BP2.174 mg + L-
Lysine USP
100mg/5ml
174. Square Eperisone Hydrochloride Eperisone Muscle Relaxat Improvement of muscular hypertonic It is contraindicated in patients with 50 mg Tablet cÖ‡qvRb
Formulations Ltd., 150mg Sustained Release Hydrochloride symptoms in the following diseases Cervical known hypersensitivity to the drug. ‡bB
Gorai, Tangail Capsule sustained release syndrome, periarthritis of the shoulder, Warnings : Interaction with alcohol is weavq
pellets 50% w/w Ph. lumbago. Spastic paralysis in the following unknown Eprisan 150mg Capsule SR may Av‡e`b
bvgÄyi
Grade 300mg eqv. disease: Cerebrovascular disease, spastic be unsafe to use during pregnancy. Drug
Kiv †h‡Z
to Eperisone spinal paralysis, cervical spondylosis, should not be used during lactation. cv‡i|
Hydrochloride INN postoperative sequelae (including
150mg cerebrospinal tumor), sequelae to trauma
(spinal trauma, head injury),amyotrophic
lateral sclerosis, cerebral palsy,
spinocerebellar degeneration, spinal vascular
diseases and other encephalomyelopathies.
175. Aristopharma Ltd.; Atropine Sulfate 0.01g/100 ml Atropine Sulfate Mydriatic and Atropine Sulfate Ophthalmic Solution 0.01% Contraindications: Patients with glaucoma Atropine cÖ‡qvRb
Plot No.21, Road Ophthalmic Solution USP 0.01g/100 ml Cycloplegic is indicated to control progression of myopia. or a tendency toward glaucoma, and with Sulphate ‡bB
No.11, Agent It is used to widen the pupil before an eye hypersensitivity to belladonna alkaloids. 1 mg/ml weavq
Shampur- exam or eye surgery. It is used to treat eye Side effects: May be occasional with 0.6 mg/ml Av‡e`b
93 | P a g e
Existing) Reference
Kadamtali I/A swelling. It is used to treat lazy eye stinging sensation on instillation. May Injection bvgÄyi
Dhaka-1204 (amblyopia). cause allergy (itch, irritation and redness), Injection Kiv †h‡Z
blurring of near vision and glare in some cv‡i|
children. 1% Eye Drops
176. Popular Pregabalin 82.5mg SR Tablet Pregabalin BP Neuropathic Pain Pregabalin extended-release tabletis Known hypersensitivity to Pregabalin or Pregabalin USFDA cÖ‡qvRb
Pharmaceuticals 82.5mg Agent indicated for the management of: any of its components. 25mg, 50mg, ‡bB
Ltd. • Neuropathic pain 75mg, 100mg, weavq
164 Tongi I/A, Most common adverse reactions reported 150mg Capsule Av‡e`b
Tongi, Gazipur associated with diabetic bvgÄyi
peripheral neuropathy in greater than or equal to 4% of patients
Kiv †h‡Z
• Postherpetic neuralgia treated with Pregabalin extended-release cv‡i|
tabletare dizziness, somnolence,
Pregabalin extended-release tabletshould
headache, fatigue, peripheral edema,
be administered once daily after an evening
meal. Pregabalin extended-release nausea, blurred vision, dry mouth, and
tabletshould be swallowed whole and should weight gain.
not be split, crushed, or chewed. When
discontinuing Pregabalin extended-release
tablet, taper gradually over a minimum of 1
week.
Neuropathic Pain Associated with Diabetic

Peripheral Neuropathy
Begin dosing at 165 mg once daily and
increase to 330 mg once daily within 1 week
based on individual patient response and
tolerability. The maximum recommended
dose of Pregabalin extended-release tabletis
330 mg once daily.
Although Pregabalinwas studied at 600
mg/day, there was no evidence that this
dose conferred additional significant
benefit and this dose was less well
tolerated. In view of the dose -dependent
adverse reactions with Pregabalin,
treatment with doses above 330 mg/day
is not recommended for Pregabalin
extended-release tablet.
94 | P a g e
Existing) Reference
Postherpetic Neuralgia
tolerability.
Patients who do not experience
sufficient pain relief following 2 to 4
weeks of treatment with 330 mg once
daily and who are able to tolerate
Pregabalin extended-release tablet,
may be treated with up to 660 mg once
daily. In view of the dose-dependent
adverse reactions and the higher rate
of treatment discontinuation due to
adverse reactions,dosing above 330
mg/day should be reserved only for
those patients who have on-going pain
and are tolerating 330 mg daily. The
maximum recommended dose of
Pregabalin extended-release tablet is
660 mg once daily.
177. Popular Pregabalin 165mg SR Tablet Pregabalin BP Neuropathic Pain Pregabalin extended-release tabletis Known hypersensitivity to Pregabalin or Pregabalin USFDA cÖ‡qvRb
Pharmaceuticals 165mg Agent indicated for the management of: any of its components. 25mg, 50mg, ‡bB
Ltd. • Neuropathic pain 75mg, 100mg, weavq
164 Tongi I/A, Most common adverse reactions reported 150mg Capsule Av‡e`b
Tongi, Gazipur associated with diabetic bvgÄyi
peripheral neuropathy in greater than or equal to 4% of patients
Kiv †h‡Z
• Postherpetic neuralgia treated with Pregabalin extended-release cv‡i|
tabletare dizziness, somnolence,
Pregabalin extended-release tabletshould
headache, fatigue, peripheral edema,
be administered once daily after an evening
meal. Pregabalin extended-release nausea, blurred vision, dry mouth, and
tabletshould be swallowed whole and should weight gain.
not be split, crushed, or chewed. When
discontinuing Pregabalin extended-release
tablet, taper gradually over a minimum of 1
95 | P a g e
Existing) Reference
week.
Neuropathic Pain Associated with Diabetic

Peripheral Neuropathy
tolerability. The maximum recommended
dose of Pregabalin extended-release tabletis
330 mg once daily.
Although Pregabalinwas studied at 600
mg/day, there was no evidence that this
dose conferred additional significant
benefit and this dose was less well
tolerated. In view of the dose -dependent
adverse reactions with Pregabalin,
treatment with doses above 330 mg/day
is not recommended for Pregabalin
extended-release tablet.
Postherpetic Neuralgia
tolerability.
Patients who do not experience
sufficient pain relief following 2 to 4
weeks of treatment with 330 mg once
daily and who are able to tolerate
Pregabalin extended-release tablet,
may be treated with up to 660 mg once
daily. In view of the dose-dependent
adverse reactions and the higher rate
of treatment discontinuation due to
adverse reactions,dosing above 330
mg/day should be reserved only for
those patients who have on-going pain
96 | P a g e
Existing) Reference
and are tolerating 330 mg daily. The
maximum recommended dose of
Pregabalin extended-release tablet is
660 mg once daily.
178. Eskayef Paracetamol 250mg + Aspirin Paracetamol BP NSAID + It is used for the treatment of mild to Contraindications: Hypersensitivity to the New
Pharmaceuticals 250mg + Caffeine 65mg Film 250mg + Aspirin Analgesic + moderate pain including headache, active ingredients or any of the other
Limited, Tongi, Coated Tablet USP 250mg + CNS Stimulant migraine, neuralgia, toothache, sore throat, constituents. Peptic ulceration and those
Gazipur. Caffeine USP 65mg period pains, symptomatic relief of sprains, with a history of peptic ulceration;
strains, rheumatic pain, sciatica, lumbago, haemophilia, concurrent anti-coagulant
fibrositis, muscular aches and pains, joint therapy; children under 16 years and
swelling and stiffness, influenza, when breast feeding because of possible
feverishness and feverish colds. risk of Reyes Syndrome.
Side effects: Side effects are mild and

infrequent, but there is a high incidence of
gastro-intestinal irritation with slight
asymptomatic blood loss. Increased
bleeding time. Aspirin may precipitate
bronchospasm and induce asthma attacks
or other hypersensitivity reactions, such as
skin reactions (including angioedema and
face oedema) in susceptible individuals.
Aspirin may induce gastro-intestinal
haemorrhage, occasionally major.
179. Navana Ferric Citrate 1 gm Tablet Ferric Citrate INN Phosphate It is a phosphate binder indicated for the Contraindication: Iron overload syndromes New USFDA Aby‡g
Pharmaceuticals, 1.0gm eq. to 210 mg binder control of serum phosphorus levels in v`b
Narayanganj Iron patients with chronic kidney disease (CKD) Side Effect: Diarrhea, discolored feces, Kiv
on dialysis. constipation, nausea and vomiting †h‡Z
cv‡i|
180. Beacon Sodium Zirconium Sodium Potassium It is a potassium binder indicated for the Contra-indication : None New USFDA Aby‡g
Pharmaceuticals Cyclosilicate INN Zirconium binder treatment of hyperkalemia in adults. v`b
Ltd, 5gm/Sachet Powder for Cyclosilicate INN Side-effect: Most common adverse Kiv
Kathali, Bhaluka, Oral suspension 5gm/Sachet Limitation of Use: It should not be used reactions with it: mild to moderate edema †h‡Z
97 | P a g e
Existing) Reference
Mymensingh as an emergency treatment for life- cv‡i|
threatening hyperkalemia because of its
delayed onset of action
181. Beacon Sodium Zirconium Sodium Potassium It is a potassium binder indicated for the Contra-indication : None New USFDA Aby‡g
Pharmaceuticals Cyclosilicate Zirconium binder treatment of hyperkalemia in adults. v`b
Ltd, 10.000g/Sachet Powder for Cyclosilicate INN Limitation of Use: It should not be used Side-effect: Most common adverse Kiv
Kathali, Bhaluka, Oral suspension 10.000g/Sachet as an emergency treatment for life- reactions with LOKELMA: mild to †h‡Z
Mymensingh
threatening hyperkalemia because of its moderate edema cv‡i|
delayed onset of action
182. Eskayef Patiromer 8.40gm/Sachet Patiromer Sorbitex Potassium It is a potassium binder indicated for the Contraindications: Known hypersensitivity New USFDA Aby‡g
Pharmaceuticals Powder For Suspension Calcium INN Binder treatment of hyperkalemia. to Veltassa or any of its components. v`b
Limited, Tongi, 16.80gm eq. to Side effects: Most common adverse Kiv
Gazipur. 8.40gm Limitations of use: It should not be used as reactions (incidence ≥2%) are †h‡Z
Patiromer/Sachet an emergency treatment for life-threatening constipation, hypomagnesemia, diarrhea, cv‡i|
hyperkalemia because of its delayed onset nausea, abdominal discomfort and
of action. flatulence.
183. Eskayef Patiromer 25.20gm/Sachet Patiromer Sorbitex Potassium It is a potassium binder indicated for the Contraindications: Known hypersensitivity New USFDA Aby‡g
Pharmaceuticals Powder For Suspension Calcium INN Binder treatment of hyperkalemia. to Veltassa or any of its components. v`b
Limited, Tongi, 50.40gm eq. to Side effects: Most common adverse Kiv
Gazipur. 25.20gm Limitations of use: It should not be used as reactions (incidence ≥2%) are †h‡Z
Patiromer/Sachet an emergency treatment for life-threatening constipation, hypomagnesemia, diarrhea, cv‡i|
hyperkalemia because of its delayed onset nausea, abdominal discomfort and
of action. flatulence.
184. a) Eskayef Vonoprazan 10mg Film Vonoprazan INN Potassium- Vonoprazan Fumarate is a first-in-clas Contraindications: Caution is necessary New cÖ‡qvRb
Pharmaceuticals Coated Tablet 10mg Competitive Acid potassium-competitive acid blocker. It when oral vonoprazan Fumarate is used in ‡bB
Limited, Tongi, Blocker inhibits H+, K+-ATPase activities in a patients with the following conditions and weavq
Gazipur reversible and potassium-competitive frequent monitoring is necessary: Av‡e`b
bvgÄyi
b) Aristopharma
manner with potency of inhibition Liver/Renal disorders, allergic rections
Kiv †h‡Z
Ltd.; Plot No.21, approximately 350 times higher than the (itch, rash, etc.) or cv‡i|
Road No.11, proton pump inhibitor, Lansoprazole. in those who are taking any other
Shampur- Vonoprazan Fumarate tablet is indicated in medicinal products, over-the-counter
Kadamtali I/A the treatment of Gastroduodenal Ulcer, medicines & dietary supplements as well
Dhaka-1204 Secondary prevention of Reflux Esophagitis, as other prescription medicines. Caution is
Secondary prevention of lowdose aspirin or also necessary for women who are
non-steroidal antiinflammatory drug induced pregnant & breastfeeding.
98 | P a g e
Existing) Reference
Peptic Ulcer, in combination with Side-effects: The most commonly reported
Clarithromycin and Amoxicillin for the adverse reactions include constipation,
eradication of Hlicobacter pylori. diarrhea, enlarged feeling
185. a) Eskayef Vonoprazan 20mg Film Vonoprazan INN Potassium- Vonoprazan Fumarate is a first-in-clas Contraindications: Caution is necessary New cÖ‡qvRb
Pharmaceuticals Coated Tablet 20mg Competitive Acid potassium-competitive acid blocker. It when oral vonoprazan Fumarate is used in ‡bB
Limited, Tongi, Blocker inhibits H+, K+-ATPase activities in a patients with the following conditions and weavq
Gazipur reversible and potassium-competitive frequent monitoring is necessary: Av‡e`b
bvgÄyi
b) Square
manner with potency of inhibition Liver/Renal disorders, allergic rections
Kiv †h‡Z
Formulations Ltd., approximately 350 times higher than the (itch, rash, etc.) or cv‡i|
Gorai, Tangail proton pump inhibitor, Lansoprazole. in those who are taking any other
Vonoprazan Fumarate tablet is indicated in medicinal products, over-the-counter
c) Aristopharma the treatment of Gastroduodenal Ulcer, medicines & dietary supplements as well
Ltd. Secondary prevention of Reflux Esophagitis, as other prescription medicines. Caution is
Plot No.21, Road Secondary prevention of lowdose aspirin or also necessary for women who are
No.11, non-steroidal antiinflammatory drug induced pregnant & breastfeeding.
Shampur- Peptic Ulcer, in combination with
Kadamtali I/A
Dhaka
Clarithromycin and Amoxicillin for the Side-effects: The most commonly reported
eradication of Hlicobacter pylori. adverse reactions include constipation,
diarrhea, enlarged feeling
186. UniMed & Pirfenidone 534 mg Tablet Pirfenidone BP 534 Respiratory It is a pyridone indicated for the treatment of Contraindication: None 267mg Capsule USFDA Aby‡g
UniHealth mg Agent idiopathic pulmonary fibrosis & v`b
Manufacturers Ltd. Adverse Reactions : The most common 801mg Tablet Kiv
B.K Bari, Gazipur adverse reactions (≥10%) are nausea, †h‡Z
Sadar, Gazipur
rash, abdominal pain, upper respiratory cv‡i|
tract infection, diarrhea, fatigue,
headache, dyspepsia, dizziness, vomiting,
anorexia, gastro-esophageal reflux
disease, sinusitis, insomnia, weight
decreased, and arthralgia
187. Incepta Rh0 (D) Immune Globulin Rh0 (D) Immune Rh Immune Suppression of rhesus (Rh) isoimmunization Contraindications: Anaphylactic or severe New USFDA Aby‡g
Pharmaceutics Intravenous (Human) Globulin (As Rho Globulin in: systemic reaction to human immune v`b
Ltd.; Zirabo, 1500 IU (300 mcg)/2ml (D) Immune • Pregnancy and obstetric conditions in non- globulin products Kiv
Savar, Dhaka. prefilled syringe for Globulin ready to fill sensitized, Rh0(D)-negative women †h‡Z
injection sterile solution) INN with an Rh-incompatible pregnancy, Side-effects: cv‡i|
1500 IU (300 including: Suppression of Rh Isoimmunization. Most
mcg)/2ml prefilled o Routine antepartum and postpartum Rh common adverse reactions are nausea,
syringe prophylaxis dizziness, headache, injection-site pain,
99 | P a g e
Existing) Reference
o Rh prophylaxis in obstetric complications and malaise
or invasive procedures Immune thrombocytopenic purpura (ITP) :
• Incompatible transfusions in Rh0(D)- Most common adverse reactions are
negative individuals transfused with blood chills, pyrexia/increased body
components containing Rh0(D)-positive red temperature, headache, and mild
blood cells (RBCs) extravascular hemolysis (increased
Immune thrombocytopenic purpura (ITP) bilirubin, decreased Hemoglobin.
Raising platelet counts in Rh0(D)-positive,
non-splenectomized adults with chronic ITP
188. Navana Loteprednol etabonate 0.5% + Loteprednol Steroid + It is indicated for – Hypersensitivity to Loteprednol / Loteprednol cÖ‡qvRb
Pharmaceuticals, Moxifloxacin 0.5% Eye Drops etabonate 0.5gm + Antibiotic  Ocular infection & inflammation Moxifloxacin is a contraindication. In 0.5% Eye Drops, ‡bB
Narayanganj Moxifloxacin HCl (steroid-responsive inflammation) addition, Loteprednol / Moxifloxacin should weavq
0.545gm eq. to not be used if you have the following Moxifloxacin Av‡e`b
 Prevents pre and post conjunctivitis
bvgÄyi
0.5gm  Reduces symptoms of bacterial conditions: 0.5% Eye Drops
Kiv †h‡Z
Moxifloxacin/100ml conjunctivitis  Allergic reactions cv‡i|
 Active against allergic conjuctivitis  Anxiety
 Fungal infections of ocular Loteprednol
structures Etabonate 0.5%
 Hypersensitivity + Tobramycin
 Insomnia 0.3% Eye Drops
 Mycobacterial eye infection
 Nervousness
 Viral infections of the cornea and
conjunctiva
189. Square Ketoconazole 2.00gm + Zinc Ketoconazole BP Topical Anti- It is used for the treatment, control, Contraindications: New cÖ‡qvRb
Pharmaceuticals Pyrithione 1.00gm + Aloe 2.00gm + Zinc Fungal prevention, & improvement of the following It is contra-indicated for use in the ‡bB
Ltd., Pabna Unit, extract 10.00gm/100gm Pyrithione Ph. diseases, conditions and symptoms: following conditions: weavq
Salgaria, Pabna Shampoo Grade 1.00gm + Av‡e`b
 Fungal infections  Astemizole bvgÄyi
Aloe extract BP  Seborrhoeic dermatitis of the scalp  Cisapride Kiv †h‡Z
10.00gm/100gm
 Dandruff  Hypersensitivity cv‡i|
 Dry skin  Porphyria
 Wounds  Preexisting liver disease
 Radiation induced skin damage  Terfenadine
Side effects:
 Skin aging
 lockade of synthesis of hormones
 Minor skin infections from adrenal glands
100 | P a g e
Existing) Reference
 Microbial infections of living surface  Itching of skin
 Indigestion
 Skin burning sensation
 Dryness
 Folliculitis
190. Square Hydrocortisone 0.50gm + Hydrocortisone BP Topical Effective preparation to reduce mixed Contraindications: New cÖ‡qvRb
Pharmaceuticals Dimeticone 350 10.00gm + 0.50gm + Corticosteroid infection with inflammation specially, in the It is contra-indicated for use in the ‡bB
Ltd., Pabna Unit, Nystatin 3.00gm + Dimeticone 350 BP Combinations folding areas of body following conditions: weavq
Salgaria, Pabna Av‡e`b
Benzalkonium chloride 10.00gm + Nystatin Suitable for children affected by mixed  Hypersensitivity to nystatin, bvgÄyi
0.20gm/100gm Cream BP 3.00gm + infections with inflammation (as hydrocortisone, dimeticone 350, Kiv †h‡Z
Benzalkonium Hydrocortisone is a mild steroid) benzalkonium cv‡i|
chloride BP Eases the soreness and treats the  rosacea
0.20gm/100gm infections in intertrigo and inflamed nappy  perioral dermatitis
rash.
 untreated bacterial, fungal or viral
Treats various skin diseases mixed with
skin infections
Candida infections: Eczema, Seborrhoeic
 ulcerated skin
dermatitis, Pruritis ani & vulvae etc.
Side effects: Thinning of the skin,
irreversible striae atrophicae,
telangiectasia, acne or worsening of acne,
rosacea, mild depigmentation
191. Beacon Selenium 100mcg/2ml Sodium Selenite Trace It is indicated Proven selenium Contra-indication : Hypersensitivity to any New BNF-75 Aby‡g
Pharmaceuticals Solution Injection Pentahydrate BP element deficiency that cannot be offset from component of the product Page: 1006 v`b
Ltd, Kathali, 333mcg eq. to food sources. Kiv
Bhaluka, 100mcg Side-effect: None to know. †h‡Z
Mymensingh
Selenium/2ml cv‡i|
192. Beacon Selenium 500mcg/10ml Sodium Selenite Trace It is indicated Proven selenium Contra-indication : Hypersensitivity to New BNF-75 Aby‡g
Pharmaceuticals Injection Pentahydrate BP element deficiency that cannot be offset from any component of the product Page: 1006 v`b
Ltd, Kathali, 1665mcg eqv. to food sources. Side-effect: General disorders and Kiv
Bhaluka, Selenium administration site conditions.After †h‡Z
Mymensingh
500mcg/10ml intramuscular administration local pain cv‡i|
has been reported.
193. Eskayef Fesoterodine Fumarate 4mg Fesoterodine Urinary It is indicated for the treatment of overactive Contraindications: It is contraindicated in New USFDA Aby‡g
Pharmaceuticals Extended Release Tablet Fumarate INN 4mg Antispasmodic bladder with symptoms of urge urinary patients with urinary retention, gastric v`b
Limited, Tongi, incontinence, urgency, and frequency. retention, or uncontrolled narrow-angle Kiv
Gazipur. glaucoma. Toviaz is also contraindicated †h‡Z
in patients with known hypersensitivity to
101 | P a g e
Existing) Reference
the drug or its ingredients or to tolterodine cv‡i|
tartrate tablets or tolterodine tartrate
extended-release capsules.
Side effects: Dry mouth, Constipation,

Dyspepsia, Nausea.
194. Incepta Phenylephrine Hydrochloride Phenylephrine Vasoconstrictor Nasal congestion, Hypotensive states, Contraindication: Hypertension, ventricular Phenylephrine
Pharmaceutics 10mg Tablet Hydrochloride BP 10 Paroxysmal supraventricular tachycardia, tachycardia. Oral: use with or within 14 Hydrochloride
Ltd.; Zirabo, mg Mydriasis, Conjunctival decongestant. days of MAOI therapy. Ophthalmic: 10mg/ml
Savar, Dhaka. narrow-angle glaucoma. Injection
Side Effects: Anxiety, reflex bradycardia,

tachycardia, arrhythmias, headache, cold
extremities/gangrene, hypertension,
nausea, vomiting, sweating, weakness,
fear, restlessness, insomnia, confusion,
irritability, psychotic states, dyspnoea,
anorexia, palpitations, extravasation
causing tissue necrosis and sloughing,
mydriasis, difficulty in micturition and
urinary retention, piloerection, increased
salivation, hyperglycaemia, lactic acidosis.
Ophthalmic solutions may liberate pigment
granules from the iris, corneal
clouding/damage.
Potentially Fatal: Increase in cardiac
contractility, which may lead to angina or
cardiac arrest; severe hypertension
leading to cerebral haemorrhage or
pulmonary oedema.
195. Incepta Phenylephrine Hydrochloride Phenylephrine Vasoconstrictor Nasal congestion, Hypotensive states, Contraindication: Hypertension, ventricular Phenylephrine cÖ‡qvRb
Pharmaceutics 2.5mg/5ml Paediatric drops Hydrochloride BP Paroxysmal supraventricular tachycardia, tachycardia. Oral: use with or within 14 Hydrochloride ‡bB
Ltd.; Zirabo, 2.5mg/5ml Mydriasis, Conjunctival decongestant. days of MAOI therapy. Ophthalmic: 10mg/ml weavq
Savar, Dhaka. narrow-angle glaucoma. Injection Av‡e`b
bvgÄyi
Kiv †h‡Z
Side Effects: Anxiety, reflex bradycardia, cv‡i|
tachycardia, arrhythmias, headache, cold
102 | P a g e
Existing) Reference
extremities/gangrene, hypertension,
nausea, vomiting, sweating, weakness,
fear, restlessness, insomnia, confusion,
irritability, psychotic states, dyspnoea,
anorexia, palpitations, extravasation
causing tissue necrosis and sloughing,
mydriasis, difficulty in micturition and
urinary retention, piloerection, increased
salivation, hyperglycaemia, lactic acidosis.
Ophthalmic solutions may liberate pigment
granules from the iris, corneal
clouding/damage.
Potentially Fatal: Increase in cardiac
contractility, which may lead to angina or
cardiac arrest; severe hypertension
leading to cerebral haemorrhage or
pulmonary oedema.
196. Concord Benfotiamine 100mg + alpha Benfotiamine BP Vitamin This Tablet is used for the treatment, Contraindication: This Tablet should not New cÖ‡qvRb
Pharmaceuticals lipoic acid 100 mg + 100 mg + alpha control, prevention, & improvement of the be used if you have the following ‡bB
Ltd. Mecobalamin 0.5mg + lipoic acid BP 100 following diseases, conditions and conditions: Allergic to Saw Palmetto , weavq
Pyridoxine hydrochloride mg + Mecobalamin symptoms: Adjunct therapy in severe Asthma or other breathing disorder , Heart Av‡e`b
bvgÄyi
50mg Tablet BP 0.5 mg + muscle tightness , Loss of sensation , disease , Heart rhythm disorder , History
Kiv †h‡Z
Pyridoxine Diabetic polyneuropathy, Inadequate dietary of stomach ulcer , Hypersensitivity , cv‡i|
Hydrochloride BP 50 intake , Pain in extremities , Eye diseases , Kidney or Liver problems , Liver disease ,
mg Decrease in muscle mass , Prevention of Low blood sugar , Thyroid disorder,
complications of diabetes , Thiamine sensitivity
deficiency , Weight loss , Burning mouth
syndrome , Low hemoglobin , Drug-induced Adverse Reactions: The most commonly
deficiency reported side-effects of tablet are
vomiting, diarrhea, biliousness, eczema,
moderate skin rash, and nausea.
197. Drug International Vitamin E Soft Capsule Vitamin E USP 600 Vitamin Vitamin E is indicated in the prevention and Contraindication: Vitamin E is 200 IU & 400 IU BNF-75 Aby‡g
Ltd IU treatment of vitamin E deficiency. There is a contraindicated in patients with known Soft Capsule Page: 1024 v`b
252,Tongi I/A possible need for supplimentation of Vitamin hypersensitivity to Vitamin E or any other Kiv
Tongi, Gazipur E in the diet of pregnant & lactating women components of this product. †h‡Z
and for new born infants where anemia can cv‡i|
arise as a result of insufficiency of Vitamin- Side effect: Nausea, flatulence or
103 | P a g e
Existing) Reference
E. Vitamin E has been tried in the treatment diarrhoea may occur. High dose Vitamin E
of various disorders including angina (generally more than 400 mg daily) has
pectoris, hypercholesterolemia, intermittent been associated with a variety of minor
claudicating, fibrocystic breast disease, side effects, including hypertension,
cancer, nocturnal leg cramps, osteoarthritis fatigue, diarrhoea, myopathy and
etc. Vitamin-E has also been claimed to thrombophlebitis.
enhance athletic performance.
198. Incepta Cholecalciferol equivalent to Dry Vitamin D3 100 Vitamin Colecalciferol Tablets are essential for Contraindication: Colecalciferol Tablets 1000IU, BNF-75 Aby‡g
Pharmaceutics vitamin D3 10000IU Tablet INN 110.00 mg eq. absorption of calcium and necessary for are contraindicated in patients with 2000IU Page: 1019 v`b
Ltd.; Zirabo, to 10000IU Vitamin healthy and strong bones. Cholecalciferol hypercalcemia, malabsorption syndrome, 4000IU Tablet Kiv
Savar, Dhaka. D3/Cholecalciferol Tablets are indicated for use in the abnormal sensitivity to the toxic effects of †h‡Z
USP treatment of hypoparathyroidism, refractory vitamin D, and hypervitaminosis D cv‡i|
rickets, also known as vitamin D resistant Side effects: Generally all nutrition
rickets, and familial hypophosphatemia. supplements are considered to be safe
and well tolerable. However, few side-
effects can generally occur including
hypercalcaemia syndrome or calcium
intoxication, occasional acute symptoms
include anorexia, headache, nausea,
vomiting, abdominal pain or stomach ache
and constipation with the administration of
colecalciferol.
199. Navana Beta-Carotene 1.6mg + Beta-Carotene BP Vitamin Vitamin-Mineral Supplement Contraindication: It is contraindicated in New cÖ‡qvRb
Pharmaceuticals, Vitamin B1 3 mg + Vitamin B2 1.6 mg + Vitamin B1 -Mineral Tablets for Prenatal/Postpartum use. patients with known hypersensitivity to any ‡bB
Narayanganj 3.4 mg + Nicotinamide 20mg + (As Thiamine of the ingredients in the formulation weavq
Pantothenic Acid 5 mg mononitrate) BP 3 Av‡e`b
bvgÄyi
+Vitamin B6 10 mg + Vitamin mg + Vitamin B2 (As Side Effect: Constipation, Nausea,
Kiv †h‡Z
C 120 mg + Vitamin E 13.8 Riboflavin) BP 3.4 Fatigue, diarrhea cv‡i|
mg + Copper 2 mg+ Iodine mg+
0.15mg+ Iron 35 mg+ Nicotinamide BP 20
Magnesium 50 mg+ Zinc 15 mg+
mg Morning Tablet Pantothenic Acid
(As Calcium D
pantothenate) USP
5 mg + Vitamin
B6(As Pyridoxine
HCl) BP 10 mg+
104 | P a g e
Existing) Reference
Vitamin C (As
Ascorbic acid) BP
120 mg + Vitamin E
(As alpha tocopheryl
acetate) USP 13.8
mg +
Copper Ph. Grade
(As Cupric oxide) 2
mg+
Iodine (As
Potassium iodide)
USP 0.15 mg+
Iron (As dried
ferrous fumarate)
BP 35 mg+
Magnesium (As
heavy Manganiese
oxide) BP 50 mg +
Zinc (As zinc oxide)
USP 15 mg
200. Navana Folic Acid 1.1 mg+ Folic Acid USP 1.1 Vitamin Vitamin-Mineral Supplement Contraindication:It is contraindicated in New cÖ‡qvRb
Pharmaceuticals, Vitamin B12 12μg + Vitamin mg+ -Mineral Tablets for Prenatal/Postpartum use. patients with known hypersensitivity to any ‡bB
Narayanganj D3 600 IU + Calcium 300 mg Vitamin B12 (As of the ingredients in the formulation weavq
Evening Tablet Cyanocobalamin) Av‡e`b
bvgÄyi
Ph. Gr. 12μg+ Side Effect: Constipation, Nausea,
Kiv †h‡Z
Vitamin D3 (As Fatigue, diarrhea cv‡i|
cholecalciferol)
USP 600 IU +
Calcium (As
Calcium carbonate)
USP 300 mg
201. Navana Folic Acid 5 mg+ Folic Acid USP 5 Vitamin Vitamin-Mineral Supplement Contraindication: It is contraindicated in New cÖ‡qvRb
Pharmaceuticals, Vitamin B12 12μg + Vitamin g+ -Mineral Tablets for Prenatal/Postpartum use. patients with known hypersensitivity to any ‡bB
Narayanganj D3 600 IU + Calcium 300 mg Vitamin B12 (As of the ingredients in the formulation weavq
Evening Tablet Cyanocobalamin) Av‡e`b
bvgÄyi
Ph. Gr 12μg+ Side Effect: Constipation, Nausea,
Kiv †h‡Z
105 | P a g e
Existing) Reference
Vitamin D3 (As Fatigue, diarrhea cv‡i|
Cholecalciferol)
USP 600 IU +
Calcium (As
Calcium carbonate)
USP 300 mg
202. Square Myo-inositol 2000mg + Myo-inositol BP Vitamin It is indicated for the treatment of women Contraindications: Inositol 500mg, cÖ‡qvRb
Pharmaceuticals Melatonin 1mg + Folic 2000mg + Melatonin suffers from PCOS (Polycystic Ovary This combination is contraindicated in 700mg Tablet ‡bB
Ltd., Pabna Unit, 0.20mg/Sachet BP 1mg + Folic BP Syndrome) and to improve fertility. patients who are hypersensitive to any weavq
Salgaria, Pabna 0.20mg component of this product or to any of its Melatonin 3 mg Av‡e`b
bvgÄyi
ingredients. Tablet
Kiv †h‡Z
cv‡i|
203. Square Elemental Calcium 800mg + Calcium Carbonate Vitamin It is indicated to support healthy bones, Contraindications: This product is Calcium 500mg TGA cÖ‡qvRb
Pharmaceuticals Colecalciferol 10mg + Vitamin CS 90 Ph. Grade & Vitamin D, Vitamin K or Calcium Deficiency contraindicated in patients with a known + Vitamin D3 ‡bB
Ltd., Pabna Unit, k2 180mcg Tablet 2222.22mg eq. to Minerals in adults and postmenopausal women. hypersensitivity to any of the ingredients. 200 IU weavq
Salgaria, Pabna 800mg of Elemental Moreover inerali Calcium Delivery.Vitamin Av‡e`b
bvgÄyi
Calcium + D is required for optimal calcium and Side effects: Allergic sensitization has
Kiv †h‡Z
Colecalciferol (1 lac phosphorous absorption. Vitamin D is been reported following administration of cv‡i|
IU/gm) BP 10mg required to maintain normal blood levels of folic acid.
(Dry Vitamin D3 calcium and phosphate, which are in turn
1000 IU) + Vitamin needed for the normal ineralization of bone,
K2 (menaquinone-7) muscle contraction, nerve conduction, and
general cellular function in all cells of the
Ph. Grade 90mg eq. body as well as bone growth and
to Vitamin k2 maintenance of bone density. Vitamin K is
180mcg responsible for the carboxylation of the bone
protein, osteocalcin, to its active form.
Osteocalcin regulates the function of
calcium in bone turnover /bone
ineralization/bone development. MK-7 may
play a role in bone health.; MK-7 may be
involved in (bone health/maintenance of
healthy bone/normal bone/bone health).
May help to increase bone mineral density.
For optimal delivery of calcium into the
106 | P a g e
Existing) Reference
bones. More than 99% of total body calcium
is stored in the bones and teeth. Clinically
trialled dose of Vitamin K2 (MK-7) which
may help decrease bone loss in
postmenopausal women Supplementation of
K2 (MK-7) may help decrease bone loss in
postmenopausal women; Maintaining
adequate Vitamin K2 (MK-7) levels may help
decrease bone loss in postmenopausal
women. Calcium is essential for bone
mineralisation. D3 is the preferred form of
vitamin D/ the form found in the human
body. Vitamin D is required for optimal
calcium and phosphorous absorption.
Adequate serum vitamin D level is required
for bone and muscle health. Vitamin D is
important for absorption of calcium and
phosphorous from the small intestine,
extracellular calcium homeostasis and
mineralisation of the skeleton.
204. Beximco Cholecalciferol (Vitamin D3) Each 0.5ml syrup Vitamins & Vitamin D is essential for normal bone Contraindications: Cholecalciferol BNF-75 cÖ‡qvRb
Pharmaceuticals 200IU / 0.5 ml contains minerals growth and development and to maintain ● Hypersensitivity to the active substance 40000 IU Page: 1020 ‡bB
Ltd. Cholecalciferol bone density. Vitamin D acts as a hormone (cholecalciferol) or to any of the excipients capsule, weavq
200IU USP and increases reabsorption of Calcium and • Hypercalcaemia and/or hypercalciuria Cholecalciferol Av‡e`b
bvgÄyi
equivalent to 5 mcg Phosphorus by the kidneys and increased ● Nephrolithiasis (Renal calculi) 20000 IU
Kiv †h‡Z
of vitamin D3. bone turnover. ● Hypervitaminosis capsule, cv‡i|
Prevention and Treatment of vitamin D ● Severe renal impairment Cholecalcigerol
deficiency states. Side effects: Few side-effects can 2000 IU tablet
generally occur including hypercalcaemia
syndrome or Calcium intoxication
(depending on the severity and duration of
hypercalcaemia), occasional acute
symptoms include anorexia, headache,
nausea, vomiting, abdominal pain or
stomach ache and constipation with the
administration of Cholecaciferol.
107 | P a g e
Existing) Reference
205. Beximco Cholecalciferol 50,000 IU Cholecalciferol (As Vitamins & Prevention and Treatment of vitamin D Contraindications: Cholecalciferol BNF-75 Aby‡g
Pharmaceuticals Capsule vitamin D3 1,00,000 minerals deficiency states. ● Hypersensitivity to the active substance 40000 IU Page: 1020 v`b
Ltd. IU/g) USP (cholecalciferol) or to any of the excipients • capsule, Kiv
500.000mg eq.to Hypercalcaemia and/or hypercalciuria Cholecalciferol MHRA †h‡Z
Vitamin D3 50, 000 ● Nephrolithiasis (Renal calculi) 20000 IU cv‡i|
IU ● Hypervitaminosis capsule,
● Severe renal impairment Cholecalciferol
Side effects: Few side-effects can generally 2000 IU tablet
occur including hypercalcaemia syndrome or
Calcium intoxication (depending on the
severity and duration of hypercalcaemia),
occasional acute symptoms include
anorexia, headache, nausea, vomiting,
abdominal pain or stomach ache and
constipation with the administration of
Cholecaciferol.
108 | P a g e
Existing) Reference
206. M/S Radiant Elemental Calcium 600mg + Calcium Carbonate Vitamin & Indicated for the prevention and treatment of Contraindication: The use of calcium New cÖ‡qvRb
Pharmaceuticals Colecalciferol 1000 IU + (Coral Calcium) USP Minerals vitamin & minerals deficiencies. supplement with Vitamins, minerals and ‡bB
Limited. Ascorbic Acid 45.0 mg + 1500.00mg eq. to Collagen (UC II) preparations tablets is weavq
Magnesium 50mg + Zinc 600mg of Calcium + contraindicated in patients with known Av‡e`b
Colecalciferol (Vitamin bvgÄyi
Tongi ,Gazipur 7.5mg + Manganese 1. + D3) BP 10.00mg eq. to
hypersensitivity to any of the ingredients of
Kiv †h‡Z
Copper 0.5mg + Collagen 1000 IU of the tablet. Periodic checks of plasma cv‡i|
10mg Tablet Colecalciferol + calcium levels and urinary calcium
Ascorbic Acid (Vitamin excertion should be made in patients with
C, coated) USP 45.0 mild to moderate renal failure or mild
mg + Magnesium hypercalciuria.
Oxide (Heavy) USP Side effects: This calcium supplement
82.50mg eq. to 50mg with vitamins, minerals and collagen
of Magnesium + Zinc (UCII) preparations is generally well
Oxide BP 9.33mg eq.
to 7.5mg of zinc +
tolerated. However, Mild and transient
Manganese Sulphate effect of gastrointestinal disturbance, like
USP 5.535mg eq.to constipation, flatulence, nausea, diarrhea
1.8mg of Manganese may be seen in some individuals.
+ Cupric Oxide USP Following administration of vitamin D
0.62575mg eq.to Supplements may cause skin rash in
0.5mg of Copper + some rare cases. Hypercalciuria has been
Collagen (UC-II) PH with long-term use at high dosage.
grade 10mg .
109 | P a g e

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Annex-A: Proposed Product for locally manufacture (Human)

symptoms of an allergic reaction:

Important limitations: Not indicated for relief

Important limitations: Not indicated for relief

Side effects: Drowsiness, Dizziness,

Inhalation Treatment: Inhalation may

Low white blood cell counts

Low white blood cell counts

Side-effects/Toxicity: Common adverse

Side-effects/Toxicity: Common adverse

Limitations of Use: Treatment of acute

Limitations of Use: Treatment of acute manic

Pediatric Patients: Most common adverse

WARNINGS AND PRECAUTIONS:

Pediatric Patients: Most common adverse

Pediatric Patients: Most common adverse

Adverse Reactions: The most common

Side effects: The common side effects of

Side effect/ Toxicity: Dizziness; Flushing;

• Use in patients who have undergone • Proton pump inhibitor (PPI)–containing

Preferred Aspirin EC-

In Study 1 and Study 2 combined, 7% of

Less Common Adverse Reactions

Side effects: The symptomatic adverse

Side-effects: Adverse effects of

Side-effects: Adverse effects of

Side effects: The sometimes may occur

Side Effects: Occasionally may cause

Side Effects: mmediate call your

Side-Effects: May cause mild to moderate

Side-effect: Most common adverse

LACTATION: It is not known if ferric

Side Effects: The most common adverse

Neuropathic Pain Associated with Diabetic

Neuropathic Pain Associated with Diabetic

Side effects: Side effects are mild and

Side effects: Dry mouth, Constipation,

Side Effects: Anxiety, reflex bradycardia,

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