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.