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Misoprostol

    Brands

    DEA Class; Rx

    Common Brand Names; Cytotec

    • Gastrointestinal Agents, Other; 
    • Prostaglandins, Endocrine

    Synthetic, oral prostaglandin E1 (PGE1) analog approved for prevention of gastric ulcers secondary to use of nonsteroidal antiinflammatory drugs (NSAIDs); taken for the duration of NSAID therapy
    Boxed warning regarding the abortifacient effects and reproductive risk; females of childbearing age must use adequate contraception with oral product use for NSAID-induced ulcer prevention
    Used off-label in obstetrics for cervical ripening and labor induction; also a recognized component of the FDA-approved mifepristone-regimen for termination of early pregnancy

    Indicated for NSAID-induced ulcer prophylaxis in patients receiving NSAIDs and at high risk for gastric ulceration (e.g., elderly, past history of ulcer, concomitant debilitating disease, or concomitant systemic corticosteroid use).

    For the short-term treatment of active duodenal ulcer or gastric ulcer unrelated to NSAID use.
    For kidney transplant rejection prophylaxis in patients who are currently receiving cyclosporine and prednisone.
    For pregnancy termination.
    For cervical ripening induction and labor induction for obstetric delivery of a term pregnancy or for labor induction after intrauterine fetal death.
    For the treatment of postpartum bleeding when unresponsive to standard measures.
    For the medical management of early pregnancy failure.

    Pregnancy when used to reduce risk of NSAID-induced ulcers

    Hypersensitivity to misoprostol, prostaglandins, or prostaglandin analogues

    • Diarrhea (14-40%)
    • Abdominal pain (13-20%)
    • Headache (2%)
    • Anaphylaxis
    • Anemia
    • Cardiac dysrhythmia
    • Chest pain
    • Flatulence
    • Gastrointestinal hemorrhage
    • Hearing loss
    • Myocardial infarction
    • Nausea
    • Rupture of uterus
    • Thromboembolic disorder

    May cause diarrhea; should not be coadministered with other drugs that cause diarrhea (eg, magnesium-containing antacids)

    Adequate contraception is required in women of childbearing age

    May cause anaphylactic reaction

    May cause chills

    Unknown whether drug is safe for use in women with severe anemia

    Misoprostol may cause birth defects, abortion (sometimes incomplete), premature labor or rupture of the uterus if given to pregnant women

    Safety and efficacy in patients with cardiovascular disease, diabetes, renal impairment, or respiratory disease are not established

    Use with caution in women >35 years or heavy smokers (these patients were not included in clinical trials)

    Pregnancy category: X

    Lactation: Drug is rapidly metabolized in mother to misoprostol acid, which is biologically active and is excreted in breast milk; although no published reports of adverse effects of misoprostol in breast-feeding infants exist, caution should be exercised when misoprostol is administered to breastfeeding women

    Adults

    800 mcg/day PO.

    Elderly

    800 mcg/day PO.

    Adolescents

    Safe and effective use has not been established.

    Children

    Safe and effective use has not been established.

    Misoprostol 

    tablet

    • 100mcg
    • 200mcg