Misotac tablets Composition:
Each tablet contains:
Active ingredient:
Misoprostol 200mcg
inactive ingfadients:
Croscarmellose sodiun, Aerosil200, microcrystalline cellulose.
Misotac tablets Pharmaceutical form:
Tablets
Misotac tablets Pharmacological action:
Misotac is an analogue of prostaglandin E1 which promotes peptic ulcer healing symptomatic relief.
Misotac protects the gastroduodenal mucosa by inhibiting basal, stimulated and nocturnal acid reducing the voIume of gastric secretions, the protiolytic activity of the gastric fluid, and increasing mucus secretion.
Misotac tablets Pharmacokinetics:
Misotac is rapidly absorbed following oral administration, with peak plasma Ievels of the active meta (misoprostoI acid) occurring after about 30 minutes.
Misotac tablets Indications:
Misotac is indicated for the healing of duodenal ulcer and gastric ulcer including those induced by ne anti-inflammatory drugs (NSAlD) In arthritic patients at risk, while continuing their NSAID Therapy. Misotac can be used for the prophylaxis of NSAID-induced ulcers.
Misotac tablets Dosage and administration:
Used under medical supervision
adults :
Healing of duodenal ulcer, gastric ulcer and NSAID-induced peptic ulcer 800 miaograms daily four divided doses taken with breakfast and one or each main meal and at bedtime. Treatment should be given initially for at least 4 weeks even if symptomatic relief has been achieved most patients ulcer will be healed in 4 weeas but treatment may be continued for up to 8 weeks if ulcer relapses further treatment courses may be given. Prophylaxis of NSAlD-induced peptic ulcer: 200 micrograms twice daily.
Children
Use of Misotac in children has not yet been evaluated In the treatment of peptic ulceration or NSAID peptic ulcer disease
Misotac tablets Contraindications:
Misotac is contraindicated in patients with a known allergy to prostaglandins.
Misotac tablets Side effects:
Gastrointestinal system: Diarrhea has been reported and is occasionally severe and prolonged and may require withdrawal of the drug. It can be minimised 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 indude dyspepsia, nausea and vomiting. Female reproductive system: Menorrhagia, vaginal bleeding and Intermenstrual bleeding have been reported in post-menopausal women. Other side effects: Skin rashes have been reported. Dizziness has been infrequently reported.
The pattem 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 nuid embolism, Incomplete abortion and premature birth.
Misotac tablets Pregnancy and lactation:
Pregnancy: Mlsotac is contraindicated in pregnant women and in women planning a pregnancy as it increases uterine tone and cootractions In pregnancy which may cause partial or complete expulsion of the products of conception. Use in pregnancy has been associated with birth defects.
Lactation:lt is not known if the active metabolite of misotac is excreted in breast milk; therefore misotac should not be administered during breast feeding.
Misotac tablets Precautions and warnings:
Not to be used except under medical supervision
– Use in pre-menopausal women: Misotac should not be used in 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:
* takes effective contraceptive measures
* has been advised of the risks of taking Misotac if pregnant
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 .. cerebrovascular disease, coronary artery disease or severe peripheral vascular disease induding hypertension.
– There is no evidence that Misotac has adverse effects on glucose metabolism in human volunteers or patients with diabetes mellitus
Patient instructions:
Keep out of reach of children.
Package and storage:
A box cootaining one or two blisters each of 10 tablets
Store in dry place at temperature not exceeding 3O”C.
Produced by:
SIGMA Pharmaceutical Industries – Egypt – S.A.E.