Generic name
Misoprostol.
Composition
Each tablet contains :
Misotac tablet Generic name and Composition
Pharmaceutical form
Tablets
Pharmacological action
Misotac is an analogue of naturally occurring prostaglandin E 1 which promotes peptic ulcer healing and symptomatic relief.
Misotac protects the gastroduodenal mucosa by inhibiting basal. stimulated and nocturnal acid secretion and by reducing the volume of gastric secretions. the proteolytic activity of the gastric fluid. and Increasing bicarbonate and mucus secretion.
Pharmacokinetics
Misotac is rapidly absorbed following oral administration, with peak plasma levels of the active metabolite (misoprostol acid) occumng after about 30 minutes. The plasma elimination half-life of misoprostol acid is 20 to 40 minutes. No accumutation of misoprostol acid in plasma occurs after repeated dosing of 400 micrograms twice daily
Indications
Misotac is indicated for the healing of duodenal ulcer and gastric ulcer including those induced by non steroidal anti-inflammatory drugs (NSAID) in arthritic patients at risk, whilst continuing their NSAID therapy. In addition, Misotac can be used for the prophylaxis of NSAID-induced ulcers.
Misotac tablet contraindication and side effects
Dosage and administration
Use in hospitals only and under medical supervision and not by community pharmacies.
Adults
Healing of duodenal ulcer, gastic ulcer and NSAID induced peptic ulcer : 800 micrograms daily in two or four divided doses taken with breakfast and / or each main meal and at bed time.
Treatment should be given initially for at least 4 weeks even if symptomatic relief has been achieved sooner. In most patients ulcers will be healed in 4 weeks but treatment may be continued for up to 8 weeks if required. If the ulcer relapses further treatment courses may be given.
Prophylaxis of NSAID-induced peptic ulcer: 200 micrograms twice daily, three times daily or four times daily. Treatment can be continued as required. Dosage should be Individualized according to the clinical condition of each patient.
Elderly
The usual dosage may be used.
Renal impairment
Available evidence indicates that no adjustment of dosage is necessary in patients with renal impairment.
Hepatic impairment
Misotac is metabolized by fatty acid oxidizing systems present in organs throughout the body. Its metabolism and plasma levels are therefore unlikely to be affected markedly in patients with hepatic impairment.
Children
Use of Misotac in children has not yet been evaluated in the treatment of peptic ulceration or NSAID-induced peptic ulcer disease.
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Contraindications
Misotac is contraindicated in patients with a known allergy to prostaglandins.
Side effects
Gastrointestinal system: Diarrhea has been reported and is occasionally severe and prolonged and may require withdrawal of the drug. It can be minimized by using single doses not exceeding 200 micrograms with food and by avoiding the use of predominantly magnesium containing antacids when an antacid is required. Abdominal pain with or Without associated dyspepsia or diarrhea can follow misoprostol therapy.
Other gastrointestinal adverse effects reported include dyspepsia, flatulence, nausea and vomiting.
Female reproductive system: Menorrhagia, vaginal bleeding and intermenstrual bleeding have been reported in pre-and post-menopausal women
Other side effects: Skin rashes have been reported. Dizziness has been infrequently reported.
The pattern of side effects associated with Misotac is similar when an NSAID is given concomitantly .
A number of side effects have been reported in clinical studies or in the literature following use of misoprostol for non-approved indications. These include: Abnormal uterine contractions, uterine haemorrhage, retained placenta. amniotic fluid embolism, incomplete abortion and premature birth.
Drug interactions
Misotac is predominantly metabolized via fatty acid oxidizing systems and has shown no adverse effect on the hepatic microsomal mixed function oxidase (P450) enzyme system. In specific studies no clinically sigmficant pharmacokinetic interaction has been demonstrated with antipyrine, diazepam and propranolol. In extensive clinical studies no drug interactions have been attributed to Misotac. Additional evidence shows no clinically important pharmacokinetic or pharmacodynamic interaction with nonsteroidal anti-inflammatory drugs including aspirin, diclofenac and iboprofen.
MISOTAC 200mcg 20 tablet
Pregnancy and lactation
Pregnancy : Misotac is contraindtcated in pregnant women and In women planning a pregnancy as it increases uterine tone and contractions in pregnancy which may cause partial or complete expulsion of the products of conception. Use in pregnancy has been associated with birth defects.
Lactation: It is not known if the active metabolite of Misotac is excreted in breast milk; therefore Misotac should not be administered during breast feeding.
Precautions and warnings
This product should be dispensed by hospitals and under physician supervision, and not by community pharmacies.
Use in pre-menopausa women: Misotac should not be used pre-menopausal women unless the patient requires nonsteroidal anti-inflammatory (NSAID) therapy and is at high risk of complications from NSAID-induced ulceration. In such patients it is advised that Misotac should only be used if the patient:
If pregnancy is suspected the product should be discontinued.
The results of clinical studies Indicate that Misotac does not produce hypotension at dosages effective in promoting the healing of gastric and duodenal ulcers. Nevertheless, Misotac should be used with caution in the presence of disease states where hypotension might precipitate severe complications. e.g ① cerebrovascular disease.② coronary artery disease or ③ severe peripheral vascular disease including hypertension.
There is no evidence that Misotac has adverse effects on glucose metabolism in human volunteers or patients with diabetes mellitus .
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Patient instructions
Keep out of reach of children.
Package and storage
Produced by: SIGMA Pharmaceutical Industries Egypt S.A.E.
How do I get Misotac in Egypt
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