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Indications - 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. Induction of labor. Prevention and treatment of postpartum hemorrhage.

Dosage & Administration - Benign gastric and duodenal ulceration and NSAID associated ulceration: 800 meg 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 meg 2-4 times daily taken with NSAID. If this dose cannot be tolerated, a dose of 100 meg can be used. Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician. Induction of labor: Place 25 meg in the posterior fornix of the vagina. Repeat after every 6 hours if necessary until the maximum dosage of 200 meg total misoprostol is reached. Fetal heart rate and uterus contractions should be monitored. Alternatively, 100 meg taken orally. If cervical ripening or active labor does not occur, repeated dose of 100-200 meg of oral misoprostol is given every 4 hourly until labor is established (as evidenced by a Bishop score of 7 or more). Maximum number of dose is 6. Maternal vital signs, fetal heart rate and contractions should be monitored. Oxytocin can be started 4 hours after last dose of misoprostol. Physician should be notified for signs of fetal distress or tetanic uterine contractions. Oral misoprostol therapy should be monitored by Physician. Prevention of postpartum hemorrhage: 600 meg orally immediately following delivery. Treatment of postpartum hemorrhage: 600 meg orally or 1000 meg per rectally.

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 and it is also contraindicated in pregnancy.

Others - Pregnancy & Lactation Because of the abortifacient property of the Misoprostol component, it is contraindicated in women who are pregnant. It should not be used in women of childbearing potential unless the patient requires nonsteroidal anti-inflammatory drug (NSAID) therapy and is at high risk of developing gastric or duodenal ulceration or for developing complications from gastric or duodenal ulcers associated with the use of the NSAID. In such patients, it may be prescribed if the patient: has had a negative serum pregnancy test within 2 weeks prior to beginning therapy. is capable of complying with effective contraceptive measures. has received both oral and written warnings of the hazards of Misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake. will begin it only on the second or third day of the next normal menstrual period. Excretion of the active metabolite (Misoprostol acid) into milk is possible but has not been studied. Because of the potential for serious adverse reactions in nursing infants, it is not recommended for use by nursing mothers.