Misotac tablets contain the active ingredient misoprostol, which promotes healing of duodenal and gastric ulcers. It works by inhibiting acid secretion in the stomach and increasing mucus secretion. The recommended dosage is 800 micrograms daily for 4-8 weeks to heal ulcers. Common side effects include diarrhea and abdominal pain. Misotac is contraindicated in pregnancy due to risk of birth defects and uterine contractions.

1. Misotac Tablets
~
SIGMA~NUT116
Generic name:
Mlsoprostol
Composition:
Each tablet contams.
ActIVe ingredIent Mlsoplostol 200 mcg
Inactive Ingredients: Croscannellose sodium, Aerosil 200. microcrystalline cellulose.
Phannaceutical form:
Tablets
PhannacolQllical action
Misolac IS an analogue of naturally OCCUrringprostagtandln E1 whIch promotes peptiC ulcer healing and
symptomatic relief
Mlsotac protects the gas roduodenal mucosa by Inhoblting basal. stimulated and noctumal aCId secrebon and
by redUCIng the volume o gaslnc secrellOns the proleolybc activity 01 the gastric fluid, and IncreasIng
btcarbonate and mucus secrenon
Phannacokinetics:
Misotac IS raptdly abSOlted following oral admInistration, WIth peak plasma levels of the acnve metabolite
(rmsoprostot BC!<l) occumng after about 30 mmotes The plasma elimination han~lfe of mrsoorostol acid IS
20-40 rruoutes No aCOJrnutabon of misoprostol acid In p'asma occurs after repeated dOSing of 400 micrograms
twice dally
Indications:
Misotac IS Indicated for t,e heahng of duodenal ulcer and gastnc ulcer Including those Induced by non
steroidal antl-inflammatoy drugs (NSAID) In arthritic patients at riSk, whilsl continuing their NSAID therapy. In
addition. M,sotac can be used for the prophylaxis of NSAID-Induced ulcers.
Dosage and administration:
Use In hoSpitals only and undfK medical supervision and not by community pharmacies.
Adults
HealIng of duodenal ule<r, gaslnc ulcer and NSAID~nduced peplIC ulcer: 800 rmcroqrams dally ontwo or lour
diVided doses taken wrth breakfast and lor each main meat and at bed time
Treatment snould be glv,," In"'ally lor at jeast 4 weeks even If symptomatIC relief has been achoeved sooner In
most pabents ulcers WIll be healed In 4 weeks but treatment may be continued for up to 8 weeks d reqUired ~
the ulcer relapses further treatment courses may be gIVen
ProphylaXIS of NSAID~nduced pepuc ulc-.r 200 mocrograms IWlce dally, three nmes daily Of four times dally
Treatment can be continued as requued Dosage should be Indlvtdualized according to the cllOtcal condlbon of
each patient.
Elderly
The usual dosage may he used
Renal tmpeument: Ava'able evicence IndIcates that no adjustment of dosage IS necessary In pabents WIth
renal Impairment
Hepatic Impairment: Mi.o!ac is metabouzed by falty acid oxidIZIng systems present In organs throughout the
body its metabolism and plasma levels are therefore unlIkely to be affected markedly onpatrents WIth hepatic
Impairment
Children
Use of Misotac In chlldlen has not yel been evaluated In the treatment of pepuc ulceratJon or NSAID-Induced
pepbc ulcer disease

2. Contnlndications:
Misotac is contraindicated In patients with a known allergy to prostaglandins
Side effects:
Gastrointestinal system: o.arrhea has been reported and is occasionally severe and prolonged and may
reqore W1thdrawal of the drug. It can be minimized by uSIOgslogle doses not exceeding 200 rmcroqrams with
food and by avoiding the use of predomInantly magnesium containing antacids when an antacid lS required
Abdommal pain with or Without associated dyspepsia or diarrhea can fonow rrnsoprostot therapy
Other gastrointestinal adverse effects reported melude dyspeps.a flatulence, nausea and vomiting.
Female reprooucnve system: Menorrhagia, vagina: bleed ng and mtermenstrual bleeding have been reponed In
pre-and post-menopausal women
Other side effects: Skin rashes have been reported Dizzmess has been Infrequently reported
The pattern of Side effects associated With Misotac IS Similar when an NSAlD is gIVen concomrtanUy.
A number of SIde effects nave been reported In chrncal stud,es or In the literature fotlowlng use of rnisoprostol
for non-approved mdcatons These Include: Abnormal ulenne contracnons. uterine haemorrhage. retained
placenta. amniotic fluid embolism Incomplete abortion and premature birth.
Drug interactions:
Misouc IS predormnantlv metabolized via fatty acid OXidiZing systems and has shown no adverse effect on the
hepabc microsomal rmxed function OXidase (P450) enzyme system. In specfic studies no clinically SIgfllrlC3llt
pharmacoenenc interactIOn has been demonstrated with antlpynne. diazepam and proprancMol. In extensrve
cllnlcai studies no drug mteractions have been attnbuted to Misotac Addrtlonal eVJdence shows no dinteatly
Important phannacokinetic or pharmacodynamtc mteractlOn With nonsteroidal ant,-mftammatory dnlgs Indudlflg
aspmn. dtCIofenac and ibuprofen
Pregnancy and lactation'
pregn.ncy: Misotac IS cootramdicated n pregnant women and n women p'annlO9 a pregnancy as rt
mcreases uterine lone and contracbons In pregnancy whICh may cause paruai or com~ete expulSion of the
products of conception. Use In pregnancy has been assocated with borth defects
Lactation: It IS not knov.n If the active metabolite of Misotac .s excreted In breast milk therefore Misotac
should not be admlmste'ed dUring breast feeding
Precautions and warnings:
This product should be dispensed by hospitals and under physic;'n superv_, and not by
community pharmacies.
- Use In pre-menopause: women: Misotac should not be used In pre-menopausal women unless the panent
requues ronstero.cat ann-mflernmatory (NSAID) therapy and IS at high risk of complications from
NSA1D-lnduced ulceration. In such pat-ents It IS advised that Misotac shoukt only be used if the patient.
• takes effective contraceptive measures
• has been advised of the nsks of takIng Misotae If pregnant
If pregnancy IS suspected the product should be discontinued
- The results of clinical studies oolcate that Misotac does not produce hypotenstOn at dosages effectJve In
promoting the heahng or gastriC and duOOenal uJcers Nevertheless Misotac: should be used with caooon In
the presence of disease states where hypotension might preciPItate severe comphcabons e.q , cerebrovascu-
lar disease coronary artery d sease or severe penpherat 'Vascular disease Including hypertenstOO.
- There is no evidence that Misotae has adverse effects .:>nglucose metabolism In human vofunteers or
patents WIth diabetes"", lJtus
Patient instructions:
Keep out of reach of children
Package and storage:
A box containing one or two (All AI) stnps each of 10 tab'ets
Store In dry place at temperature not exceeding 30°C
Produced by: SIGMA Pharmaceutical Industries - Egypt - S.A.E.
0413206