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 haemorrhage.
Dosage & 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.
Induction of labor:
Place 25 mcg in the posterior fornix of the vagina. Repeat after every 6 hours if necessary until the maximum dosage of 200 mcg total misoprostol is reached. Fetal heart rate and uterus contractions should be monitored. Alternatively, 100 mcg taken orally. If cervical ripening or active labor does not occur, repeated dose of 100- 200 mcg 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 haemorrhage: 600 mcg orally immediately following delivery.
Treatment of postpartum haemorrhage: 600 mcg orally or 1000 mcg per rectally.
Use in children: Safety and effectiveness of Misoprostol in children below the age of 18 years have not been established.
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.
Use in Pregnancy & Lactation
Pregnancy: Misoprostol is contraindicated to pregnant women.
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.
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