misoprostol, Cytotec

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Pharmacy Author:

Annette (Gbemudu) Ogbru, PharmD, MBA

Annette (Gbemudu) Ogbru, PharmD, MBA

Dr. Gbemudu received her B.S. in Biochemistry from Nova Southeastern University, her PharmD degree from University of Maryland, and MBA degree from University of Baltimore. She completed a one year post-doctoral fellowship with Rutgers University and Bristol Myers Squibb.

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Medical and Pharmacy Editor:

Jay W. Marks, MD

Jay W. Marks, MD

Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

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GENERIC NAME: misoprostol

BRAND NAME: Cytotec

DRUG CLASS AND MECHANISM: Misoprostol is a synthetic (man-made) prostaglandin that is used to reduce the risk of stomach ulcers in patients treated with nonsteroidal antiinflammatory drugs (NSAIDs, for example, aspirin, ibuprofen, etc.) that are used for pain and various inflammatory conditions, for example, arthritis. Misoprostol is used primarily in patients at high risk for stomach ulcers when treated with NSAIDs, for example, the elderly, patients with concomitant debilitating diseases, and patients with a history of ulcers. Prostaglandins are chemicals that are made within many organs of the body including the stomach. In the stomach, prostaglandins are believed to protect the inner lining of the stomach from the ulcer-producing effects of NSAIDs. Scientists now believe that NSAIDs produce ulceration by preventing the production of prostaglandins in the stomach. Synthetic prostaglandins such as misoprostol given orally "replace" the prostaglandins whose production is inhibited by NSAIDs and have been shown to protect the lining of the stomach from NSAID-induced ulcers. Misoprostol was approved by the FDA in December 1988.

PRESCRIPTION: Yes

GENERIC AVAILABLE: Yes

PREPARATIONS: Tablets: 100 and 200 mcg.

STORAGE: Tablets should be kept in a dry area with temperatures at or below 25 C (77 F)

PRESCRIBED FOR: Misoprostol is prescribed for the prevention of NSAID-induced gastric ulcers in patients at high risk for ulceration when treated with NSAIDs. Off-label (non-FDA approved) uses include fetal abortion, cervical ripening procedure during delivery, duodenal and gastric ulcer, and postpartum hemorrhage.

DOSING: The recommended adult oral dose for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used.

DRUG INTERACTIONS: Misoprostol has no clinically important drug interactions.

PREGNANCY: Misoprostol should never be used during pregnancy since it can cause abortion, premature birth, or birth defects. Uterine rupture has been reported when misoprostol was administered to pregnant women to induce labor or to induce abortion beyond the eighth week of pregnancy.

NURSING MOTHERS: It is not known if misoprostol is excreted in human milk; however it should not be administered to nursing mothers because it could cause significant diarrhea in nursing infants.

SIDE EFFECTS: Common side effects include diarrhea and abdominal pain. Diarrhea is more common with higher doses and usually goes away with continued administration. Rarely, profound and persistent diarrhea necessitates stopping the drug. Less common side effects include headache, menstrual cramps, nausea, and flatulence.

Reference: FDA Prescribing Information

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