Medications and Drugs
Pharmacy Author: Annette Gbemudu-Ogbru, PharmD, MBA
Medical and Pharmacy Editor: Jay W. Marks, MD
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
Last Editorial Review: 10/12/2009
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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