Cytomis
Misoprostol tablet

Presentation
Cytomis : Each tablet contains Misoprostol INN 200 mcg.

Description
Misoprostol is a synthetic prostaglandin E1 analogue that has gastric antisecretory and mucosal protective properties. The antisecretory activity of Misoprostol is mediated through a class of high affinity E- type prostaglandin receptors on the surface of gastric parietal cells. Misoprostol achieves cytoprotection by stimulation of gastric mucus secretion, duodenal bicarbonate secretion and gastric mucosal blood flow.

Indications and Uses
Misoprostol is indicated for-
* prophylaxis of gastric and duodenal ulceration in NSAID users at high risk of complications from gastric ulcer e.g. the elderly, patients with concomitant debilitating disease and patients with a history of ulcer.
* healing of established NSAID- induced gastric and duodenal damage.
* healing of gastric and duodenal ulcers in the absence of NSAID therapy.



Dosage and Administration
Benign gastric and duodenal ulceration and NSAID associated ulceration : 800 mcg daily (in 2-4 divided doses) with breakfast or main meals and at bedtime; treatment should be continued for at least 4 weeks and may be continued for up to 8 weeks if required.
Prophylaxis of NSAID induced gastric and duodenal ulcer : 200 mcg 2-4 times daily taken with NSAID. If this dose cannot be tolerated, a dose of 100 mcg can be used. Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician.

Side-effects
Generally, Misoprostol is well tolerated. The most frequent adverse effects associated with Misoprostol therapy involve the GI tract such as, diarrhea, abdominal pain, dyspepsia, flatulence, nausea, vomiting, rashes and dizziness. The incidence of diarrhea may be minimized by administering the drug after meal and at bedtime and by avoiding concomitant administration with a magnesium-containing or other laxative antacid.

Contraindications
Misoprostol is contraindicated to anyone with a history of allergy to prostaglandins.

Precautions
Precaution should be taken in conditions where hypertension might precipitate severe complications. (e.g. cerebrovascular and cardiovascular disease.)

Use in pregnancy & lactation
Pregnancy : Misoprostol is contraindicated to pregnant women. Misoprostol should not be used in women in child bearing potential unless the patient requires NSAID therapy or is at high risk of developing gastric ulceration. Misoprostol is prescribed if patient has had a negative serum pregnancy test within 2 weeks prior to beginning of therapy, is capable of complying with effective contraceptive measures and will begin Misoprostol only on the second or third day of the next normal menstrual period.
Lactation : It is not known whether Misoprostol's active metabolite- misoprostol acid is excreted in human milk. Misoprostol should not be administered to nursing mothers because the excretion of misoprostol acid could cause diarrhea in nursing infants.

Use in children
Safety and effectiveness of Misoprostol in children below the age of 18 years have not been established.

Drug interactions
There is no evidence of clinically significant interaction between Misoprostol and cardiac, pulmonary, CNS drugs and NSAID's. Bioavailability of Misoprostol is decreased with high doses of antacid.

Overdosage
The toxic dose of Misoprostol in human has not been determined. Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnoea, abdominal pain, diarrhea and fever. Symptoms should be treated with supportive therapy.

Commercial Pack
Cytomis : Each box contains 10 blister strips of 10 tablets.