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Mayamo lalLh C 092611

l AnLlpyreLlcs
AnLlpyreLlcs /nLlparrrrLrks/ anLeepahyreLlks from Lhe Creek anLl agalnsL and pyreLlcus (perLalnlng Lo
fever) are drugs or herbs LhaL reduce fever normally Lhey wlll noL lower body LemperaLure lf one does noL have a
fever AnLlpyreLlcs cause Lhe hypoLhalamus Lo overrlde an lnLerleuklnlnduced lncrease ln LemperaLure 1he body
Lhen works Lo lower Lhe LemperaLure resulL ln a reducLlon ln fever

MosL anLlpyreLlc medlcaLlons have oLher purposes 1he mosL common anLlpyreLlcs ln Lhe unlLed SLaLes
are lbuprofen and asplrln whlch are used prlmarlly as paln rellevers nonsLeroldal anLllnflammaLory
drugs (nSAlus) are anLlpyreLlc anLllnflammaLory and paln rellevers 1here ls some debaLe over Lhe approprlaLe
use of such medlcaLlons as fever ls parL of Lhe bodyslmmune response Lo lnfecLlon

1he effecLlveness of aceLamlnophen (paraceLamol) alone as an anLlpyreLlc ln chlldren ls uncerLaln wlLh some
evldence showlng lL ls no beLLer Lhan physlcal meLhods 1heraples lnvolvlng Lhe comblnaLlon
of aceLamlnophen and asplrln or alLernaLlng doses of aceLamlnophen and lbuprofen have shown somewhaL
greaLer anLlpyreLlc effecL Lhan aceLamlnophen alone

8aLhlng or sponglng wlLh lukewarm or cool waLer can effecLlvely reduce body LemperaLure ln Lhose wlLh heaL
lllness buL noL usually fever
4
1he use of alcohol baLhs ls noL an approprlaLe coollng meLhod because Lhere have
been reporLed adverse evenLs assoclaLed wlLh sysLemlc absorpLlon of alcohol

An anLlpyreLlc ls a Lype of medlcaLlon LhaL wlll prevenL or reduce fever by lowerlng body LemperaLure from a
ralsed sLaLe 1hey wlll noL affecL normal body LemperaLure lf Lhe paLlenL does noL have a fever Cenerally mosL
nonsLeroldal anLllnflammaLory drugs (nSAlus) work by lnhlblLlng prosLaglandln synLheLase wlLhln Lhe
hypoLhalamus

lever or pyrexla occurs when Lhe body reaches a LemperaLure above whaL ls consldered average 8ear ln mlnd
however LhaL Lhls average LemperaLure can vary from person Lo person wlLhln cerLaln parameLers lL ls generally
accepLed fever exlsLs aL a LemperaLure above 37 degrees Celslus (986 degrees lahrenhelL) when Lhe LhermomeLer
ls placed under Lhe armplL or over 373 degrees Celslus (993 degrees lahrenhelL) when measured orally or
recLally

lever usually resulLs from mlcrobes such as bacLerla or vlruses Lrlggerlng Lhe bodys defence mechanlsms 1hls
acLlvaLes cerLaln Lypes of cells some of whlch release Lhe subsLance lnLerleukln rosLaglandln ls anoLher chemlcal
released by Lhe body LhaL plays a parL ln Lhls process rosLaglandln ls lnduced by bacLerlal pyrogens and ls
produced ln Lhe CenLral nervous SysLem (CnS) lnLerleukln affecLs Lhe hypoLhalamus whlch ls Lhe parL of Lhe braln
LhaL regulaLes body LemperaLure slgnalllng lL Lo ralse Lhe LemperaLure by a few degrees 1he hypoLhalamus works
llke a LhermosLaL whlle Lhe lnLerleukln LhaL ls released serves Lo ralse lLs preseL LemperaLure

1he body has a number of Lechnlques LhaL lL uses Lo achleve Lhls change ln LemperaLure Shlverlng lnvolves
physlcal movemenL LhaL produces heaL vasoconsLrlcLlon whlch enLalls Lhe consLrlcLlon of blood flow beneaLh Lhe
skln reduces Lhe amounL of heaL losL from Lhe body lL also causes one Lo feel cold ln Lhelr exLremlLles such as Lhe
hands and feeL prompLlng Lhem Lo be covered up

Pow ls Lhls lncrease ln LemperaLure parL of Lhe bodys defence mechanlsm? 1he body ralses Lhe LemperaLure ln an
efforL Lo creaLe an lnhosplLable envlronmenL for Lhe mlcrobes LhaL cause Lhe lnfecLlon lever ls a sympLom of
lllness ls parL of Lhe bodys aLLempLs Lo rld lLself of Lhe lnfecLlon and lnhlblL lLs spread Cnce Lhe lnfecLlon has been
dealL wlLh Lhe fever ls sald Lo have broken and Lhe paLlenL feels overheaLed breaklng ouL ln a sweaL as Lhe body
Lrles Lo cool down Lo lLs normal LemperaLure vasodllaLaLlon of perlpheral blood vessels also occurs aL Lhls sLage
lncreaslng Lhe blood flow once agaln

AnLlpyreLlcs work by geLLlng Lhe LhermosLaL ln Lhe hypoLhalamus Lo overrlde Lhe lnLerleuklnlnduced lncrease ln
LemperaLure 1he body wlll Lhen work Lo lower Lhe LemperaLure Lo Lhe new lower LemperaLure and Lhe resulL ls a
reducLlon ln Lhe fever AnLlpyreLlcs wlll also reduce prosLaglandln synLhesls ln Lhe hypoLhalamus by lnhlblLlng Lhe
effecL of endogenous or mlcroblal pyrogens on Lhe heaL regulaLlng sensors of Lhe hypoLhalamus 8y blocklng
prosLaglandln synLheLase anLlpyreLlcs prevenL a rlse ln prosLaglandln levels ln Lhe braln

ll AnLaclds
AnLaclds are medlclnes LhaL neuLrallze sLomach acld 1hey are used Lo relleve acld lndlgesLlon upseL sLomach sour
sLomach and hearLburn

AnLaclds are Laken by mouLh and work by neuLrallzlng excess sLomach acld 1hey conLaln lngredlenLs such as
alumlnum hydroxlde calclum carbonaLe magneslum hydroxlde and sodlum blcarbonaLe alone or ln varlous
comblnaLlons AnLacld producLs may also conLaln oLher lngredlenLs such as slmeLhlcone whlch relleves gas

AnLaclds dlffer ln how qulckly Lhey work and how long Lhey provlde rellef 1hose LhaL dlssolve rapldly ln Lhe
sLomach such as magneslum hydroxlde and sodlum blcarbonaLe brlng Lhe fasLesL rellef AnLaclds LhaL conLaln
calclum carbonaLe or alumlnum dlssolve more slowly and can Lake up Lo 30 mlnuLes Lo begln worklng 1he longer
an anLacld sLays ln Lhe sLomach Lhe longer lL works 1hose LhaL conLaln calclum carbonaLe or alumlnum work
longer Lhan Lhose LhaL conLaln sodlum blcarbonaLe or magneslum Also Laklng any klnd of anLacld afLer a meal
lnsLead of on an empLy sLomach provldes longerlasLlng rellef because Lhe medlclne sLays ln Lhe sLomach

Among Lhe brands of anLacld producLs on Lhe markeL are AlkaSelLzer Maalox MylanLa 1ums and 8olalds
Cenerlc forms are also avallable 1hese producLs can be boughL wlLhouL a prescrlpLlon and come ln LableL (regular
and chewable) lozenge and llquld forms
AnLaclds are meanL Lo be used only occaslonally 1hey should noL be Laken conLlnuously for more Lhan Lwo weeks
unless under a physlclans dlrecLlons 1aklng anLaclds over long perlods could mask Lhe sympLoms of a serlous
sLomach or lnLesLlnal problem such as pepLlc ulcer dlsease Clder people should be especlally careful as Lhey may
have ulcers wlLhouL showlng Lhe Lyplcal sympLoms
lf any slgns of appendlclLls or lnflamed bowel are presenL anLaclds should noL be Laken SympLoms of appendlclLls
lnclude cramplng paln and soreness ln Lhe lower abdomen bloaLlng and nausea and vomlLlng
Anyone whose sympLoms do noL lmprove afLer Laklng anLaclds or who has black Larry sLools should call a
physlclan 1hese sympLoms could be slgns of a serlous condlLlon LhaL needs medlcal aLLenLlon

AnLaclds may lnLeracL wlLh many oLher medlclnes When Lhls happens Lhe effecLs of one or boLh drugs may
change or Lhe rlsk of slde effecLs may be greaLer Anyone Laklng a prescrlpLlon drug should check wlLh hls or her
physlclan before Laklng anLaclds AnLaclds may affecL Lhe resulLs of some medlcal LesLs When schedullng a medlcal
LesL ask wheLher lL ls all rlghL Lo Lake anLaclds before Lhe LesL

Slde effecLs are very rare when anLaclds are Laken as dlrecLed 1hey are more llkely when Lhe medlclne ls Laken ln
large doses or over a long Llme Mlnor slde effecLs lnclude a chalky LasLe mlld consLlpaLlon or dlarrhea LhlrsL
sLomach cramps and whlLlsh or speckled sLools 1hese sympLoms do noL need medlcal aLLenLlon unless Lhey do
noL go away or Lhey lnLerfere wlLh normal acLlvlLles

CLher uncommon slde effecLs may occur Anyone who has unusual sympLoms afLer Laklng anLaclds should geL ln
Louch wlLh hls or her physlclan

lll AnLlularrhea
An anLldlarrhoeal drug (or anLldlarrheal drug Amerlcan Lngllsh) ls any medlcaLlon whlch provldes sympLomaLlc
rellef for dlarrhea Common Lypes are
LlecLrolyLe soluLlons are used Lo replace losL flulds and salLs ln acuLe cases
8ulklng agenLs llke meLhylcellulose guar gum or planL flbre (bran sLerculla lsabgol eLc) are used for
dlarrhoea ln funcLlonal bowel dlsease and Lo conLrol lleosLomy ouLpuL
AbsorbenLs absorb Loxlc subsLances LhaL cause lnfecLlve dlarrhoea meLhylcellulose ls an absorbenL
AnLllnflammaLory soluLlons llke 8lsmuLh subsallcylaLe
Cplolds classlcal use besldes paln rellef ls as an anLldlarrheal drug Cplolds have agonlsL acLlons on Lhe
lnLesLlnal oplold recepLors whlch when acLlvaLed cause consLlpaLlon urugs such as morphlne or codelne can
be used Lo relleve dlarrhea Lhls way A noLable oplold for Lhe purpose of rellef of dlarrhoea
ls Loperamlde whlch only ls an agonlsL of Lhe oplold recepLors ln Lhe large lnLesLlne and does noL have
oplold affecLs ln Lhe cenLral nervous sysLem as lL doesnL cross Lhe bloodbraln barrler ln slgnlflcanL amounLs
1hls enables loperamlde Lo be used Lo Lhe same beneflL as oLher oplold drugs buL wlLhouL Lhe CnS slde effecLs
or poLenLlal for abuse

luA pregnancy caLegory C lL ls noL known wheLher anLldlarrhoeal drugs wlll harm an unborn baby 1ell your
docLor lf you are pregnanL or plan Lo become pregnanL whlle uslng Lhls medlcaLlon AnLldlarrhoeal drugs can pass
lnLo breasL mllk and may harm a nurslng baby ?ou should noL breasLfeed whlle you are uslng anLldlarrhoeal
drugs uo noL glve Lhls medlclne Lo a chlld wlLhouL medlcal advlce

uurlng an aLLack of dlarrhea Lhe bowel conLracL rapldly sLopplng Lhe absorpLlon of waLer and resulLlng ln a dose
of Lhe squlrLs 8y slowlng Lhese conLracLlons Lhe pllls allow your body Lo absorb more waLer leLLlng your sLools geL
a more solld feel Lo Lhem
1he lasL facLor ls Lhe waLer LhaL does noL geL absorbed 1hls ls where Lhe pllls do even more wondrous sLuff noL
saLlsfled wlLh paralyzlng your back passageLhe pllls conLaln bulkformlng" agenLs 1hese parLlcles absorb excess
waLer and swell up maklng your runny plops lnLo nlce hard flrm Lurds
lL's been sald LhaL drlnklng salLy waLer would also achleve Lhe same effecL as Lhls would help Lhe process of
osmosls ln Lhe bowels 8uL for anyone who has LasLed salL waLer [usL you Lry and keep Lhe bugger down

1here are downsldes Lo Lhls mlracle pllls So far reporLed slde effecLs lnclude
O Abdomlnal paln/dlscomforL
O urowslness and dlzzlness
O ury mouLh
O nausea and slckness
O Skln rash
O ConsLlpaLlon
O Chlldren under Lhree have experlenced oplaLellke hlghs
lv AnLlhlsLamlnes
AnLlhlsLamlnes are drugs LhaL combaL Lhe hlsLamlne released durlng an allerglc reacLlon by blocklng Lhe acLlon of
Lhe hlsLamlne on Lhe Llssue AnLlhlsLamlnes do noL sLop Lhe formaLlon of hlsLamlne nor do Lhey sLop Lhe confllcL
beLween Lhe lgL and anLlgen 1herefore anLlhlsLamlnes do noL sLop Lhe allerglc reacLlon buL proLecL Llssues from
some of lLs effecLs AnLlhlsLamlnes frequenLly cause mouLh dryness and sleeplness newer non sedaLlng
anLlhlsLamlnes are generally LhoughL Lo be somewhaL less effecLlve AnLlhlsLamlne slde effecLs LhaL very
occaslonally occur lnclude urlne reLenLlon ln males and fasL hearL raLe
Many anLlhlsLamlne drugs are avallable wlLhouL a prescrlpLlon Lxamples lnclude Lhe flrsLgeneraLlon
anLlhlsLamlnes such as bromphenlramlne (ulmeLapp 8romphen ulmeLane nasahlsL) chlorphenlramlne (Chlor
1rlmeLon) clemasLlne (AllerhlsL 1avlsL) and dlphenhydramlne (8enadryl) and a secondgeneraLlon anLlhlsLamlne
loraLadlne (ClarlLln) LoraLadlne (ClarlLln) does noL cause drowslness
Common prescrlpLlon anLlhlsLamlnes (all secondgeneraLlon anLlhlsLamlnes) lnclude ceLlrlzlne (ZyrLec)
desloraLadlne (Clarlnex) and fexofenadlne (Allegra) 1hese anLlhlsLamlnes (and loraLadlne) are less llkely Lo cause
adverse effecLs llke drowslness or dry mouLh
Several anLlhlsLamlne nasal sprays (for example azelasLlne AsLelln) are also avallable Lo LreaL sympLoms such as
runny nose sneezlng and lLchy nose
Pow anLlhlsLamlnes work 1hese drugs compeLe wlLh hlsLamlne for hlsLamlne recepLor slLes 8y occupylng Lhe
hlsLamlne recepLor slLes Lhey prevenL hlsLamlne from causlng allerglc sympLoms AnLlhlsLamlnes are mosL
effecLlve when Laken conLlnuously durlng Lhe allergy season
Who should noL use Lhese medlcaLlonsAnLlhlsLamlnes are conLralndlcaLed ln lndlvlduals allerglc Lo Lhem 1hey
may cause unwanLed slde effecLs ln Lhe followlng
O lndlvlduals currenLly uslng a monoamlne oxldase lnhlblLor (MACl)
O lndlvlduals wlLh narrowangle glaucoma
O lndlvlduals who are breasLfeedlng
use AnLlhlsLamlnes come ln LableL chewable LableL capsule and llquld forms Pow ofLen an anLlhlsLamlne should
be Laken each day depends on Lhe lndlvldual anLlhlsLamlnes characLerlsLlcs and Lhe Lype of preparaLlon (LhaL ls
Lhe dosage form)
urug or food lnLeracLlons Avold Laklng oLher drugs LhaL cause drowslness such as alcohol sleep preparaLlons
sedaLlves or Lranqulllzers Avold Laklng MACls (for example lsocarboxazld Marplan phenelzlne sulfaLe nardll
or Lranylcypromlne arnaLe) wlLhln 14 days of anLlhlsLamlnes lor drug lnLeracLlons speclflc Lo a parLlcular
anLlhlsLamlne Lalk wlLh a docLor or pharmaclsL
Slde effecLs Many anLlhlsLamlnes (parLlcularly Lhe flrsLgeneraLlon agenLs) may cause Lhe followlng slde effecLs
O urowslness
O ury mouLh
O urlne reLenLlon
O 8lurred vlslon
O 8efore drlvlng a car or operaLlng machlnery be sure Lo know lf Lhe anLlhlsLamlne affecLs Lhe ablllLy Lo
concenLraLe and sLay awake
O Check wlLh a docLor before Laklng anLlhlsLamlnes
V. Antibiotics
AnLlbloLlcs are among Lhe mosL frequenLly prescrlbed medlcaLlons ln modern medlclne AnLlbloLlcs cure dlsease by
kllllng or ln[urlng bacLerla 1he flrsL anLlbloLlc was penlclllln dlscovered accldenLally from a mold culLure 1oday
over 100 dlfferenL anLlbloLlcs are avallable Lo docLors Lo cure mlnor dlscomforLs as well as llfeLhreaLenlng
lnfecLlons

AlLhough anLlbloLlcs are useful ln a wlde varleLy of lnfecLlons lL ls lmporLanL Lo reallze LhaL anLlbloLlcs only
LreaL bacLerlal lnfecLlons AnLlbloLlcs are useless agalnsL vlral lnfecLlons (for example Lhe common cold) and fungal
lnfecLlons (such as rlngworm) ?our docLor can besL deLermlne lf an anLlbloLlc ls rlghL for your condlLlon

AlLhough Lhere are well over 100 anLlbloLlcs Lhe ma[orlLy come from only a few Lypes of drugs 1hese are Lhe maln
classes of anLlbloLlcs
O enlcllllns such as penlclllln andamoxlclllln
O Cephalosporlns such as cephalexln(keflex)
O Macrolldes such as eryLhromycln (LMycln) clarlLhromycln (8laxln) andazlLhromycln (ZlLhromax)
O lluoroqulnolones such as clprofloxacln(Clpro) levofloxacln (Levaquln) andofloxacln (lloxln)
O Sulfonamldes such as coLrlmoxazole (8acLrlm) and LrlmeLhoprlm (roloprlm)
O 1eLracycllnes such as LeLracycllne (Sumycln anmycln) and doxycycllne(vlbramycln)
O Amlnoglycosldes such as genLamlcln (Caramycln) and Lobramycln (1obrex)
O MosL anLlbloLlcs have 2 names Lhe Lrade or brand name creaLed by Lhe drug company LhaL manufacLures
Lhe drug and a generlc name based on Lhe anLlbloLlcs chemlcal sLrucLure or chemlcal class 1rade names
such as keflex and ZlLhromax are caplLallzed Cenerlcs such as cephalexln and azlLhromycln are noL
caplLallzed

Lach anLlbloLlc ls effecLlve only for cerLaln Lypes of lnfecLlons and your docLor ls besL able Lo compare your needs
wlLh Lhe avallable medlclnes Also a person may have allergles LhaL ellmlnaLe a class of anLlbloLlc from
conslderaLlon such as a penlclllln allergy prevenLlng your docLor from prescrlblng amoxlclllln

ln mosL cases of anLlbloLlc use a docLor musL choose an anLlbloLlc based on Lhe mosL llkely cause of Lhe lnfecLlon
lor example lf you have an earache Lhe docLor knows whaL klnds of bacLerla cause mosL ear lnfecLlons Pe or she
wlll choose Lhe anLlbloLlc LhaL besL combaLs Lhose klnds of bacLerla ln anoLher example a few bacLerla cause
abouL 90 of pneumonlas ln prevlously healLhy people lf you are dlagnosed wlLh pneumonla Lhe docLor wlll
choose an anLlbloLlc LhaL wlll klll Lhese bacLerla
CLher facLors may be consldered when chooslng an anLlbloLlc MedlcaLlon cosL doslng schedule and common slde
effecLs are ofLen Laken lnLo accounL aLLerns of lnfecLlon ln your communlLy may be consldered also

ln some cases laboraLorles may help a docLor make an anLlbloLlc cholce Speclal Lechnlques such as Cram sLalns
may help narrow down whlch specles of bacLerla ls causlng your lnfecLlon CerLaln bacLerlal specles wlll Lake a
sLaln and oLhers wlll noL CulLures may also be obLalned ln Lhls Lechnlque a bacLerlal sample from your lnfecLlon
ls allowed Lo grow ln a laboraLory 1he way bacLerla grow or whaL Lhey look llke when Lhey grow can help Lo
ldenLlfy Lhe bacLerlal specles CulLures may also be LesLed Lo deLermlne anLlbloLlc senslLlvlLles A senslLlvlLy llsL ls
Lhe rosLer of anLlbloLlcs LhaL klll a parLlcular bacLerlal Lype 1hls llsL can be used Lo double check LhaL you are Laklng
Lhe rlghL anLlbloLlc

Cnly your docLor can choose Lhe besL class and Lhe besL anLlbloLlc from LhaL class for your lndlvldual needs

V. Antibacterial
An anLlbacLerlal ls a compound or subsLance LhaL kllls or slows down Lhe growLh of bacLerla
1
1he Lerm ls ofLen
used synonymously wlLh Lhe Lerm anLlbloLlc(s) Loday however wlLh lncreased knowledge of Lhe causaLlve agenLs
of varlous lnfecLlous dlseases anLlbloLlc(s) has come Lo denoLe a broader range of anLlmlcroblal compounds
lncludlng anLlfungal and oLher compounds

1he Lerm anLlbloLlc was colned by Selman Waksman ln 1942 Lo descrlbe any subsLance produced by a
mlcroorganlsm LhaL ls anLagonlsLlc Lo Lhe growLh of oLher mlcroorganlsms ln hlgh dlluLlon
3
1hls deflnlLlon
excluded subsLances LhaL klll bacLerla buL are noL produced by mlcroorganlsms (such as gasLrlc
[ulces and hydrogen peroxlde) lL also excluded synLheLlcanLlbacLerlal compounds such as Lhe sulfonamldes Many
anLlbacLerlal compounds are relaLlvely small molecules wlLh a molecular welghL of less Lhan 2000 aLomlc mass
unlLs

WlLh advances ln medlclnal chemlsLry mosL of Lodays anLlbacLerlals chemlcally are semlsynLheLlc modlflcaLlons of
varlous naLural compounds
4
1hese lnclude for example Lhe beLalacLam anLlbacLerlals whlch lnclude
Lhe penlcllllns (produced by fungl ln Lhe genus enlcllllum) Lhe cephalosporlns and Lhe carbapenems Compounds
LhaL are sLlll lsolaLed from llvlng organlsms are Lhe amlnoglycosldes whereas oLher anLlbacLerlalsfor example
Lhe sulfonamldes Lhe qulnolones and Lhe oxazolldlnonesare produced solely by chemlcal synLhesls
Accordlngly many anLlbacLerlal compounds are classlfled on Lhe basls of chemlcal/blosynLheLlc orlgln lnLo naLural
semlsynLheLlc and synLheLlc AnoLher classlflcaLlon sysLem ls based on blologlcal acLlvlLy ln Lhls classlflcaLlon
anLlbacLerlals are dlvlded lnLo Lwo broad groups accordlng Lo Lhelr blologlcal effecL on
mlcroorganlsms bacLerlcldal agenLs klll bacLerla andbacLerlosLaLlc agenLs slow down or sLall bacLerlal growLh
O 1reaLmenL
4 8acLerlal lnfecLlon
4 roLozoan lnfecLlon eg meLronldazole ls effecLlve agalnsL several paraslLlcs
4 lmmunomodulaLlon eg LeLracycllne whlch ls effecLlve ln perlodonLal lnflammaLlon
and dapsone whlch ls effecLlve ln auLolmmune dlseases such as oral mucous
membranepemphlgold
O revenLlon of lnfecLlon
4 Surglcal wound
4 uenLal anLlbloLlc prophylaxls
1920

4 CondlLlons of neuLropenla eg cancerrelaLed

Llke anLlbloLlcs anLlbacLerlals are commonly classlfled based on Lhelr mechanlsm of acLlon chemlcal sLrucLure or
specLrum of acLlvlLy MosL anLlbacLerlal anLlbloLlcs LargeL bacLerlal funcLlons or growLh processes
9
AnLlbloLlcs
LhaL LargeL Lhe bacLerlal cell wall (such as penlcllllns and cephalosporlns) or cell membrane (for example
polymlxlns) or lnLerfere wlLh essenLlal bacLerlal enzymes (such as qulnolones and sulfonamldes) have bacLerlcldal
acLlvlLles 1hose LhaL LargeL proLeln synLhesls such as Lhe amlnoglycosldes macrolldes and LeLracycllnes are
usually bacLerlosLaLlc
28
lurLher caLegorlzaLlon ls based on Lhelr LargeL speclflclLy narrowspecLrum
anLlbacLerlal anLlbloLlcs LargeL speclflc Lypes of bacLerla such as CramnegaLlve or CramposlLlve bacLerla
whereas broadspecLrum anLlbloLlcs affecL a wlde range of bacLerla lollowlng a 40year hlaLus ln dlscoverlng new
classes of anLlbacLerlal compounds Lhree new classes of anLlbloLlcs have been broughL lnLo cllnlcal use 1hese new
anLlbacLerlals are cycllc llpopepLldes (lncludlng dapLomycln) glycylcycllnes (eg Llgecycllne) and oxazolldlnones
(lncludlng llnezolld)

Slnce Lhe flrsL ploneerlng efforLs of llorey and Chaln ln 1939 Lhe lmporLance of anLlbloLlcs lncludlng
anLlbacLerlals Lo medlclne has led Lo lnLense research lnLo produclng anLlbacLerlals aL large scales lollowlng
screenlng of anLlbacLerlals agalnsL a wlde range of bacLerla producLlon of Lhe acLlve compounds ls carrled ouL
uslng fermenLaLlon usually ln sLrongly aeroblc condlLlons
Cral anLlbacLerlals are orally lngesLed whereas lnLravenous admlnlsLraLlon may be used ln more serlous cases
such as deepseaLed sysLemlc lnfecLlons AnLlbloLlcs may also someLlmes be admlnlsLered Loplcally as wlLh eye
drops or olnLmenLs

AnLlbacLerlals are screened for any negaLlve effecLs on humans or oLher mammals before approval for cllnlcal use
and are usually consldered safe and mosL are wellLoleraLed Powever some anLlbacLerlals have been assoclaLed
wlLh a range of adverse effecLs
30
Slde effecLs range from mlld Lo very serlous dependlng on Lhe anLlbloLlcs used
Lhe mlcroblal organlsms LargeLed and Lhe lndlvldual paLlenL SafeLy proflles of newer drugs are ofLen noL as well
esLabllshed as for Lhose LhaL have a long hlsLory of use
30
Adverse effecLs range from fever and nausea Lo ma[or
allerglc reacLlons lncludlng phoLodermaLlLls and anaphylaxls
clLaLlon needed
Common slde effecLs lnclude dlarrhea
resulLlng from dlsrupLlon of Lhe specles composlLlon ln Lhe lnLesLlnal flora resulLlng for example ln overgrowLh of
paLhogenlc bacLerla such as ClosLrldlum dlfflclle
31
AnLlbacLerlals can also affecL Lhe vaglnal flora and may lead Lo
overgrowLh of yeasL specles of Lhe genus Candlda ln Lhe vulvovaglnal area
32
AddlLlonal slde effecLs can resulL
from lnLeracLlon wlLh oLher drugs such as elevaLed rlsk of Lendondamage from admlnlsLraLlon of
a qulnolone anLlbloLlc wlLh a sysLemlc corLlcosLerold

vll LlnlmenL
LlnlmenL (or embrocaLlon) from Lhe LaLln llnere Lo anolnL ls a medlcaLed Loplcal preparaLlon for appllcaLlon Lo
Lhe skln reparaLlons of Lhls Lype are also called balm LlnlmenLs are of a slmllar vlscoslLy Lo loLlons (belng
slgnlflcanLly less vlscous Lhan an olnLmenL or cream) buL unllke a loLlon a llnlmenL ls applled wlLh frlcLlon LhaL ls a
llnlmenL ls always rubbed ln

LlnlmenLs are Lyplcally sold Lo relleve paln and sLlffness such as from sore muscles or from arLhrlLls 1hese
llnlmenLs Lyplcally are formulaLed from alcohol aceLone or slmllar qulckly evaporaLlng solvenLs and
conLaln counLerlrrlLanL aromaLlc chemlcal compounds such as meLhyl sallcllaLe benzoln resln
or capsalcln Cpodeldoc ls a sorL of llnlmenL lnvenLed by Lhe physlclan aracelsus

LlnlmenLs are a common subsLance used by Lralners and owners of horses 1hey may be applled dlluLed or full
sLrengLh usually added lnLo a buckeL of waLer when sponged on Lhe body LlnlmenLs are especlally useful ln hoL
weaLher Lo help a hoL horse cool down Lhe alcohols help Lhe producL Lo qulckly evaporaLe and Lhe olls Lhey
conLaln cause Lhe caplllarles ln Lhe skln Lo dllaLe also lncreaslng Lhe coollng process

LlnlmenLs should always be applled accordlng Lo Lhe manufacLurers dlrecLlons and dlluLed as necessary Many
horse owners apply llnlmenLs Lo Lhe legs as a brace and Lhen wrap over lL ln Lhls case Lhey should be sure LhaL
Lhe llnlmenL ls noL Loo sLrong or lL may cause bllsLerlng of Lhe skln
LlnlmenLs may be used on Lhe legs and body buL should noL be applled Lo more senslLlve areas such as Lhe head
genlLals or groln of Lhe horse 1he body may also be Loo senslLlve Lo apply llnlmenLs lf Lhe horse was recenLly body
cllpped

lorms
Cream Lmulslon of oll and waLer ln approxlmaLely equal proporLlons eneLraLes sLraLum corneum ouLer layer of
skln well
ClnLmenL Comblnes oll (80) and waLer (20) LffecLlve barrler agalnsL molsLure loss
Cel Llquefles upon conLacL wlLh Lhe skln
asLe Comblnes Lhree agenLs oll waLer and powder an olnLmenL ln whlch a powder ls suspended
owder

vlll llls
A plll ls a small round solld pharmacologlcal oral dosage form LhaL was ln use before Lhe advenL
of LableLs and capsules llls were made by mlxlng Lhe acLlve lngredlenLs wlLh anexclplenL such as glucose syrup ln
a morLar and pesLle Lo form a pasLe Lhen rolllng Lhe mass lnLo a long cyllndrlcal shape (called a plpe) and
dlvldlng lL lnLo equal porLlons whlch were Lhen rolled lnLo balls and ofLen coaLed wlLh sugar Lo make Lhem more
palaLable ln colloqulal usage LableLs capsules and capleLs are sLlll ofLen referred Lo as pllls collecLlvely
lormulaLlon sLudles lnvolve developlng a preparaLlon of Lhe drug whlch ls boLh sLable and accepLable Lo Lhe
paLlenL lor orally Laken drugs Lhls usually lnvolves lncorporaLlng Lhe drug lnLo a LableL or a capsule lL ls lmporLanL
Lo appreclaLe LhaL a LableL conLalns a varleLy of oLher subsLances aparL from Lhe drug lLself and sLudles have Lo be
carrled ouL Lo ensure LhaL Lhe drug ls compaLlble wlLh Lhese oLher subsLances
reformulaLlon lnvolves Lhe characLerlzaLlon of a drugs physlcal chemlcal and mechanlcal properLles ln order Lo
choose whaL oLher lngredlenLs should be used ln Lhe preparaLlon ln deallng wlLh proLeln preformulaLlon Lhe
lmporLanL aspecL ls Lo undersLand Lhe soluLlon behavlor of a glven proLeln under a varleLy of sLress condlLlons such
as freeze/Lhaw LemperaLure shear sLress among oLhers Lo ldenLlfy mechanlsms of degradaLlon and Lherefore lLs
mlLlgaLlon
lormulaLlon sLudles Lhen conslder such facLors as parLlcle slze polymorphlsm pP and solublllLy as all of Lhese can
lnfluence bloavallablllLy and hence Lhe acLlvlLy of a drug 1he drug musL be comblned wlLh lnacLlve addlLlves by a
meLhod whlch ensures LhaL Lhe quanLlLy of drug presenL ls conslsLenL ln each dosage unlL eg each LableL 1he
dosage should have a unlform appearance wlLh an accepLable LasLe LableL hardness or capsule dlslnLegraLlon
lL ls unllkely LhaL formulaLlon sLudles wlll be compleLe by Lhe Llme cllnlcal Lrlals commence 1hls means LhaL slmple
preparaLlons are developed lnlLlally for use ln phase l cllnlcal Lrlals 1hese Lyplcally conslsL of handfllled capsules
conLalnlng a small amounL of Lhe drug and a dlluenL roof Lhe longLerm sLablllLy of Lhese formulaLlons ls noL
requlred as Lhey wlll be used (LesLed) ln a maLLer of days ConslderaLlon has Lo be glven Lo whaL ls called Lhe drug
load Lhe raLlo of Lhe acLlve drug Lo Lhe LoLal conLenLs of Lhe dose A low drug load may cause homogenelLy
problems A hlgh drug load may pose flow problems or requlre large capsules lf Lhe compound has a low bulk
denslLy
8y Lhe Llme phase lll cllnlcal Lrlals are reached Lhe formulaLlon of Lhe drug should have been developed Lo be close
Lo Lhe preparaLlon LhaL wlll ulLlmaLely be used ln Lhe markeL A knowledge of sLablllLy ls essenLlal by Lhls sLage and
condlLlons musL have been developed Lo ensure LhaL Lhe drug ls sLable ln Lhe preparaLlon lf Lhe drug proves
unsLable lL wlll lnvalldaLe Lhe resulLs from cllnlcal Lrlals slnce lL would be lmposslble Lo know whaL Lhe
admlnlsLered dose acLually was SLablllLy sLudles are carrled ouL Lo LesL wheLher LemperaLure humldlLyoxldaLlon
or phoLolysls (ulLravloleL llghL or vlslble llghL) have any effecL and Lhe preparaLlon ls analysed Lo see lf
any degradaLlon producLs have been formed
lL ls also lmporLanL Lo check wheLher Lhere are any unwanLed lnLeracLlons beLween Lhe preparaLlon and Lhe
conLalner lf a plasLlc conLalner ls used LesLs are carrled ouL Lo see wheLher any of Lhe lngredlenLs
become adsorbed on Lo Lhe plasLlc and wheLher any plasLlclzers lubrlcanLs plgmenLs or sLablllzers leach ouL of
Lhe plasLlc lnLo Lhe preparaLlon Lven Lheadheslves for Lhe conLalner label need Lo be LesLed Lo ensure Lhey do noL
leach Lhrough Lhe plasLlc conLalner lnLo Lhe preparaLlon A LableL ls usually a compressed preparaLlon LhaL
conLalns
O 310 of Lhe drug (acLlve subsLance)
O 80 of flllers dlslnLegranLs lubrlcanLs glldanLs and blnders and
O 10 of compounds whlch ensure easy dlslnLegraLlon dlsaggregaLlon and dlssoluLlon of Lhe LableL ln
Lhe sLomach or Lhe lnLesLlne
1he dlslnLegraLlon Llme can be modlfled for a rapld effecL or for susLalned release
Speclal coaLlngs can make Lhe LableL reslsLanL Lo Lhe sLomach aclds such LhaL lL only dlslnLegraLes ln
Lhe duodenum [e[unum and colon as a resulL of enzyme acLlon or alkallne pP
llls can be coaLed wlLh sugar varnlsh or wax Lo dlsgulse Lhe LasLe
Some LableLs are deslgned wlLh an osmoLlcally acLlve core surrounded by an lmpermeable membrane wlLh a pore
ln lL 1hls allows Lhe drug Lo percolaLe ouL from Lhe LableL aL a consLanL raLe as Lhe LableL moves Lhrough
Lhe dlgesLlve LracL
A capsule ls a gelaLlnous envelope encloslng Lhe acLlve subsLance Capsules can be deslgned Lo remaln lnLacL for
some hours afLer lngesLlon ln order Lo delay absorpLlon 1hey may also conLaln a mlxLure of slow and fasLrelease
parLlcles Lo produce rapld and susLalned absorpLlon ln Lhe same dose

lllspllLLlng refers Lo Lhe pracLlce of modlfylng a LableL capsule or plll Lo obLaln a lower dose of Lhe acLlve
lngredlenL or Lo obLaln mulLlple smaller doses elLher Lo reduce cosL or because Lhe drug ls noL avallable ln Lhe
dose deslred CfLen pllls LhaL are meanL Lo be spllL (Asplrln for lnsLance) come prescored so LhaL one may easlly
dlvlde Lhe plll lnLo halves or quarLers
1here are a number of slLuaLlons where lL ls unsafe Lo spllL a prescrlpLlon medlcaLlon
ln Lhe uSand for more Lhan 130 counLrles whlch use or recognlze Amerlcan pharmaceuLlcal sLandards
unlformlLy of dosage unlLs ls deflned by Lhe unlLed SLaLes harmacopela(uS) whlch descrlbes lLself as Lhe
offlclal publlc sLandardsseLLlng auLhorlLy for all prescrlpLlon and overLhecounLer medlclnes dleLary supplemenLs
and oLher healLhcare producLs manufacLured and sold ln Lhe unlLed SLaLes
1

1he uS sLandard for dosage unlformlLy expresses sLaLlsLlcal crlLerla ln Lhe language of sampllng proLocols whlch
defles slmple explanaLlon 1he pharmaceuLlcal dosage llLeraLure someLlmes bolls Lhls down as requlrlng a sLandard
devlaLlon ln dosage welghL of less Lhan 6 whlch roughly corresponds Lo Lhe weaker ruleofLhumb offered for
publlc consumpLlon LhaL Lhe vasL ma[orlLy of dosage unlLs should be wlLhln 13 of Lhe dosage LargeL uosage
unlL ls a Lechnlcal Lerm whlch covers oral medlcaLlons (LableLs pllls capsules) as well as nonoral dellvery
meLhods
2

A 2002 sLudy of plllspllLLlng as conducLed ln four Amerlcan longLerm care faclllLles deLermlned LhaL 13 of Lhe 22
dlspensed prescrlpLlons evaluaLed (68) had fragmenL welghL varlance ln excess of uS sLandards
3

Care musL be Laken ln ldenLlfylng drugs LhaL may be safely spllL whlle sLlll dellverlng half Lhe dose wlLh Lhe same or
slmllar efflcacy Cenerally scored pllls may be safely spllL however Llme release and capsule supplled drugs should
noL be spllL SpllL pllls may be uneven and Lhus Lhe amounL per dose may vary ln pracLlce Lhese varlaLlons are
ofLen mlnor enough as noL Lo cause ma[or doslng lssues and are ln facL wlLhln generlc drug acLlve lngredlenL
guldellnes aLlenLs wlshlng Lo spllL Lhelr pllls should requesL Lhelr physlclan Lo wrlLe Lhelr prescrlpLlons as such Lo
help avold lncorrecL doslng
lx SupplemenLs
A dleLary supplemenL also known as food supplemenL or nuLrlLlonal supplemenL ls a preparaLlon lnLended Lo
supplemenL Lhe dleL and provlde nuLrlenLs such as vlLamlns mlnerals flber faLLy aclds or amlno aclds LhaL may
be mlsslng or may noL be consumed ln sufflclenL quanLlLles ln a persons dleL Some counLrles deflne dleLary
supplemenLs as foods whlle ln oLhers Lhey are deflned as drugs or naLural healLh producLs
SupplemenLs conLalnlng vlLamlns or dleLary mlnerals are lncluded as a caLegory of food ln Lhe Codex AllmenLarlus
a collecLlon of lnLernaLlonally recognlzed sLandards codes of pracLlce guldellnes and oLher recommendaLlons
relaLlng Lofoods food producLlon and food safeLy 1hese LexLs are drawn up by Lhe Codex AllmenLarlus
Commlsslon an organlzaLlon LhaL ls sponsored by Lhe lood and AgrlculLure CrganlzaLlon of Lhe unlLed
naLlons (lAC) and Lhe World PealLh CrganlzaLlon (WPC) 1he hormones uPLA (a sLerold) pregnenolone (also a
sLerold) and Lhe plneal hormone melaLonln are markeLed as dleLary supplemenLs ln Lhe uS
1he lood and urug AdmlnlsLraLlon (luA) regulaLes dleLary supplemenLs as a caLegory of foods and noL as drugs
Whlle pharmaceuLlcal companles are requlred Lo obLaln luA approval whlch lnvolves assesslng Lhe rlsks and
beneflLs prlor Lo Lhelr enLry lnLo Lhe markeL dleLary supplemenLs do noL need Lo be preapproved by luA before
Lhey can enLer Lhe markeL
13
lnsLead manufacLurers and dlsLrlbuLors who wlsh Lo markeL dleLary supplemenLs
LhaL conLaln a new dleLary lngredlenL (deflned as a vlLamln a mlneral a herb or oLher boLanlcal an amlno acld
a dleLary subsLance for use by man Lo supplemenL Lhe dleL by lncreaslng LoLal dleLary lnLake or a concenLraLe
meLabollLe consLlLuenL exLracL or comblnaLlon of any of Lhe above dleLary lngredlenLs noL markeLed before
CcLober 13 1994) musL noLlfy Lhe luA beforehand 1he noLlflcaLlon requlres lnformaLlon lndlcaLlng Lhe lngredlenL
ls safe and Lhe lngredlenL cannoL be markeLed (sold or dellvered for sale) for sevenLyflve days followlng flllng Lhe
lnformaLlon uurlng Lhls Llme Lhe agency revlews Lhe lnformaLlon for adequacy and safeLy concerns flfLeen days
afLer Lhe Lhls perlod (nlneLy days afLer Lhe lnformaLlon was flled) Lhe luA posLs nonproprleLary lnformaLlon on
Lhelr webslLe LlsLlng Lhe lnformaLlon means Lhe lngredlenL can be markeLed buL does noL mean lL ls necessarlly
safe
14
Cn SepLember 24 2007 Lhe luA has lmplemenLed a currenL good manufacLurlng pracLlces (CM) pollcy
Lo ensure dleLary supplemenLs are produced ln a quallLy manner do noL conLaln conLamlnanLs or lmpurlLles and
are accuraLely labeled and covers Lhe manufacLurlng packaglng labelllng and sLorlng of supplemenLs wlLh
requlremenLs for quallLy conLrol deslgn and consLrucLlon of manufacLurlng planLs LesLlng of lngredlenLs and flnal
producLs record keeplng and complalnLs processes
1he uSPLA passed ln 1994 was Lhe sub[ecL of lobbylng efforLs by Lhe manufacLurers of dleLary supplemenLs and
resLrlcLed Lhe ablllLy of Lhe luA Lo exerL auLhorlLy over supplemenLs so long as manufacLurers made no clalms
abouL Lhelr producLs LreaLlng prevenLlng or curlng dlseases Accordlng Lo Consumer 8eporLs 1he law has lefL
consumers wlLhouL Lhe proLecLlons surroundlng Lhe manufacLure and markeLlng of overLhecounLer or
prescrlpLlon medlcaLlons and lL became Lhe luAs responslblllLy Lo prove LhaL a supplemenL wasnL safe Whlle
pharmaceuLlcal manufacLurers musL demonsLraLe Lhelr producLs are effecLlve as well as belng safe supplemenL
manufacLurers are noL requlred Lo demonsLraLe efflcacy 1he luA has only ever found one dleLary supplemenL Lo
be unsafe Lhe welghL loss/energy supplemenL ephedra
16
ulscusslng Lhe leglslaLlon 1lme referred Lo Lhe uSPLA
as lllconcelved and reprehenslble LhaL glves Lhe lndusLry vlrLually free relgn slc Lo markeL producLs deflned as
dleLary supplemenLs whlle severely llmlLlng Lhe luAs ablllLy Lo regulaLe Lhem
17
1he uSPLA was heavlly lobbled
for by Lhe supplemenL lndusLry and was crlLlclzed for exposlng Lhe publlc Lo worLhless compounds LhaL bllked
consumers ouL of money Lo no beneflL
1617
8ecause of Lhe requlremenLs puL lnLo place by Lhe uSPLA Lhe luA
musL demonsLraLe LhaL lndlvldual supplemenLs are unsafe uslng Lhelr adverse evenLs reporLlng sysLem whlch lL ls
esLlmaLed capLures only 1 of all adverse evenLs llnked Lo supplemenLs
clLaLlon needed
1he luA has also lacked Lhe
fundlng Lo underLake Lhe rlgorous LesLs Lo meeL Lhe sLandards for a supplemenL Lo be consldered hazardous and
Lhus removed from Lhe markeL ln Lhe one slLuaLlon where Lhls sLandard was reached (ephedra) Lhe agency faced
slgnlflcanL opposlLlon from Lhe supplemenL lndusLry and Lhe unlLed SLaLes Congress lnsLead llmlLlng Lhemselves Lo
maklng announcemenLs abouL problemaLlc supplemenL safeLy records on Lhelr webslLe
A 2001 sLudy publlshed ln Archlves of lnLernal Medlclne found broad publlc supporL for greaLer governmenLal
regulaLlon of dleLary supplemenLs Lhan was currenLly permlLLed by uSPLA 1he researchers found LhaL a ma[orlLy
of Amerlcans supporLed premarkeLlng approval by Lhe luA lncreased overslghL of harmful supplemenLs and
greaLer scruLlny of Lhe LruLhfulness of supplemenL label clalms
under Lhe luAs flnal rule on good manufacLurlng pracLlces quallLy ls deflned as meanlng LhaL Lhe dleLary
supplemenL conslsLenLly meeLs Lhe esLabllshed speclflcaLlons for ldenLlLy purlLy sLrengLh and composlLlon and
has been manufacLured packaged labeled and held under condlLlons Lo prevenL adulLeraLlon under secLlon
402(a)(1) (a)(2) (a)(3) and (a)(4) of Lhe lederal lood urug and CosmeLlc AcL
20
1he new regulaLlons allow luA
lnspecLors Lo look aL a companys records upon requesL
21
Powever enforcemenL ls dlfflculL glven Lhe number of
supplemenL manufacLurers and Lhe 16 decllne ln luA lnvesLlgaLors from 2003 Lo 2006
22
Much of Lhe
conLamlnaLlon ls due Lo poor raw lngredlenLs Suppllers provlde cerLlflcaLes of analysls sLaLlng LhaL Lhey have
LesLed Lhe maLerlal
22
under Lhe 2003 proposed rule manufacLurers would have been requlred Lo reLesL Lhe
supplled lngredlenLs under Lhe flnal rule LesLlng for ldenLlLy ls always requlred CLher reLesLlng ls noL requlred lf
Lhe manufacLurer has verlfled Lhe rellablllLy of Lhe lngredlenL suppller
21

ln Lhe uS conLamlnaLlon and false labellng are noL uncommon
23
lndependenL cerLlflcaLlon programs exlsL buL
Lhese may have problems as well unlLed SLaLes harmacopelamanages Lhe uleLary SupplemenL verlflcaLlon
rogram (uSv) lLs uS verlfled Mark seal lndlcaLes LhaL Lhe producL has been LesLed for lnLegrlLy purlLy
dlssoluLlon and safe manufacLurlng
24
and lL ls Lhe only cerLlflcaLlon program whlch conducLs random offLhe
shelf LesLlng
23
1he uS program wlll noL cerLlfy producLs whlch conLaln lngredlenLs LhaL Lhe uSs uleLary
SupplemenL lnformaLlon LxperL CommlLLee deLermlnes have a safeLy rlsk
23
ConsumerLabcom randomly LesLs
some dleLary supplemenLs and makes Lhe resulLs avallable Lo subscrlbers lL has reporLed LhaL 23 of Lhe
supplemenLs lL LesLs have problems and for mulLlvlLamlns abouL half had problems
22
ln 2008 ConsumerLab
crlLlclzed Lhe uS for proposlng a 10 mlcrogram perdally servlng llmlL on lead ln dleLary supplemenLs and drugs lL
noLed LhaL under Lhe luAs 2006 guldance on lead ln candy only 02 mlcrograms of lead per servlng are
allowed
26
nSl lnLernaLlonal
27
PlL SporL Sclence
28
and Lhe naLural roducLs AssoclaLlon (nA)
29
also have
dleLary supplemenL cerLlflcaLlon programs ln 1999 nA launched Lhe lndusLrys flrsL LhlrdparLy Cood
ManufacLurlng racLlces (CM) cerLlflcaLlon program for dleLary supplemenLs and lngredlenLs nearly 70
companles have achleved cerLlflcaLlon
lf a dleLary supplemenL clalms Lo cure mlLlgaLe or LreaL a dlsease lL would be consldered an unauLhorlzed new
drug and ln vlolaLlon of Lhe appllcable regulaLlons and sLaLuLes As Lhe luA sLaLes ln a response Lo Lhls quesLlon ln
a lAC
ls lL legal Lo markeL a dleLary supplemenL producL as a LreaLmenL or cure for a speclflc dlsease or condlLlon?
no a producL sold as a dleLary supplemenL and promoLed on lLs label or ln labellng* as a LreaLmenL prevenLlon or
cure for a speclflc dlsease or condlLlon would be consldered an unapprovedand Lhus lllegaldrug 1o malnLaln Lhe
producLs sLaLus as a dleLary supplemenL Lhe label and labellng musL be conslsLenL wlLh Lhe provlslons ln Lhe
uleLary SupplemenL PealLh and LducaLlon AcL (uSPLA) of 1994
*Labellng refers Lo Lhe label as well as accompanylng maLerlal LhaL ls used by a manufacLurer Lo promoLe and
markeL a speclflc producL
uleLary supplemenLs are permlLLed Lo make sLrucLure/funcLlon clalms 1hese are broad clalms LhaL Lhe producL can
supporL Lhe sLrucLure or funcLlon of Lhe body (eg glucosamlne helps supporL healLhy [olnLs Lhe hormone
melaLonln helps esLabllsh normal sleep paLLerns) 1he luA musL be noLlfled of Lhese clalms wlLhln 30 days of Lhelr
flrsL use and Lhere ls a requlremenL LhaL Lhese clalms be subsLanLlaLed ln reallLy mlsleadlng clalms abouL
supplemenLs are common parLlcularly on poorly regulaLed commerclal webslLes
3132
lor example Lhe
compound hydrazlne sulfaLe ls sold as a dleLary supplemenL ln Lhe uSA and promoLed as a LreaLmenL for cancer
desplLe llLLle evldence LhaL lL ls elLher safe or effecLlve
CLher clalms LhaL requlred approval from luA lnclude healLh clalms and quallfled healLh clalms PealLh clalms are
permlLLed Lo be made lf Lhey meeL Lhe requlremenLs for Lhe clalms found ln Lhe appllcable regulaLlons Cuallfled
healLh clalms can be made Lhrough a peLlLlon process lncludlng sclenLlflc lnformaLlon lf luA has noL approved a
prlor peLlLlon

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