TM Paracetamol+Caffeine COMPOSITION F a p - P l u s T M : Eacht abl et cont ai ns Par acet amol BP500mg&caf f ei neBP 65mg. PHARMACOLOGICAL INFORMATION Pharmacological action Par ac et amol i s a per i pher al l y ac t i nganal ges i c andi s wel l abs or bedor al l y. Par ac et amol al s ohave ant i pyr et i c ac t i vi t y. Mechanism of action Par ac et amol i s a per i pher al l y ac t i nganal ges i c . Par ac et amol pr oduc es anal ges i a by el evat i onof t he pai nt hr es hol dand ant i pyr es i s t hr oughac t i onont he hypot hal ami c heat r egul at i ngc ent er . Newc yc l oox ygenas e enz yme COX- 3, f oundi n t he br ai nands pi nal c or d, i s s el ec t i vel y i nhi bi t edby Par ac et amol , andi s di s t i nc t f r omt he t woal r eady k nown c yc l oox ygenas e enz ymes COX- 1 andCOX- 2. Thi s s el ec t i ve i nhi bi t i onof t he enz yme COX- 3 i nt he br ai nands pi nal c or d expl ai ns t he ef f ec t i venes s of Par ac et amol i nr el i evi ngpai n andr educ i ngf ever . Caf f ei ne has s i gni f i c ant phar mac ol ogi c al ac t i ononPar ac et amol . I t i nc r eas es t he s ol ubi l i t y andt r ans membr ane per meat i onof Par ac et amol . I t gi ves s t i mul ant ac t i onont he c ent r al ner vous s ys t emwi t h ps yc hot r opi c ef f ec t s ands t i mul ant ac t i ononr es pi r at i on, hear t r at e, andhave a mi l ddi ur et i c ef f ec t . Drug interaction Pos s i bl e dr ugi nt er ac t i ons may oc c ur wi t h: Ot her s edat i ngmedi c at i ons Phenot hi az i nes Some ant i depr es s ant medi c at i ons . Ant i c oagul ant agent s . Caution Avoi dal c ohol whi l e t ak i ngt hi s medi c i ne. Al c ohol c an i nc r eas e s i de ef f ec t s s uc has di z z i nes s or dr ows i nes s . Be c aut i ous whendr i vi ngor per f or mi ngot her haz ar dous ac t i vi t i es . Thi s medi c i ne c ani mpai r j udgment . Thi s medi c i ne may be habi t - f or mi ng. Over dose and treatment I nmassi veoverdosageexceedi ng10gmmaycausel i verdamage. Earl ysymptomsmaycausepal l or, nausea, vomiti ngandmal ai se. Overdoseshoul dbepromptl ytreatedbygastri cl avagefol l owedbyi ntravenous N-acetyl cystei neormethi oni ne. Contraindication Par ac et amol i s c ont r ai ndi c at edi npat i ent s wi t hs ever e r enal f unc t i oni mpai r ment andhepat i c di s eas e ( Vi r al Hepat i t i s ) . Knownhyper s ens i t i vi t y t oPar ac et amol . PHARMACEUTICAL INFORMATION Storage conditions Storei nacool anddr ypl aceawayf roml i ght. Keepout of reachof chi l dren. Presentation & Packaging Fap-PlusTM: Eachcommer ci al boxcont ai ns 200t abl et s i nbl i st er pack. Pharmacokinetic properties Absorption: Paracetam olisabsorbedreadilyandcom pletelyfrom thesm allintestineafteroraladm inistration.Peakplasm aParacetam olconcentrationoccurw ithin30to120m inutesafteroral adm inistration. Distribution: Itisuniform lydistributedthroughoutm ostbodyfluidsw ithanapparentvolum eofdistributionof1to1.2L/kg.Plasm aproteinbindingisnegligibleattheusualtherapeuticconcentrations butincreasesw ithincreasingconcentrations. Metabolism: Approxim ately90to95% ofadoseofParacetam olism etabolizedbythehepaticm icrosom alsystem .Inadultsattherapeuticdoses,Paracetam olism ainlyconjugatedw ithglucuronide(45-55% )or sulphate(20-30% ).Am inorproportion(lessthan20% )ism etabolizedtocatecholderivatives.Paracetam olism etabolizeddifferentlybyinfantsandchildrencom paredw ithadults,the sulphateconjugatebeingpredom inant. Elimination: Paracetam olisexcretedintheurinem ainlyastheglucuronideandsulphateconjugates.Lessthan5% isexcretedasunchanged paracetam olwith85-90% ofthedosebeingelim inatedintheurinewithin24hoursofingestion.Theelim inationhalf-lifeof paracetam olvariesfrom about1to4hours. Manufactured By Mymensingh, Bangladesh TM-Trade Mark CLINICAL INFORMATION Indication and uses I t i si ndi catedf or therel i ef of pai nandf ever suchasheadache, migrai ne, neuri ti s, commoncol dsandf l u, sorethroat, earache, toothache, backache, rheumati cand muscul ar pai nandneural gi a. Dosage and Administration 1- 2 t abl et s 4- 6 t i mes dai l y, upt oa maxi mumof 4 gmi n24 hour s . Side effects I nrecommendeddoses, i t i susual l yf reef romsi deef f ects. HoweverThi smedi ci necommonl ycausesdrowsi nessanddi zzi nessandshoul dnot betaken wi thal cohol . Other si deef f ectsmayi ncl ude: Nausea Vomiti ng Di arrhoea LF01301 Use in Pregnancy and lactation Pregnant Woman : Paracetam olcrossestheplacentabutthedrughasbeenusedw idelyasananalgesicinpregnancyandnoadversefetaleffectshavebeenrecorded. Lactating Mother : Paracetam oldoesappearinbreastm ilkbuthasnotbeendetectedintheurineofbreast-fedinfant.Breast-feedingisnotacontra-indicationto paracetam oluse.
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