Classes
DEA Class; Rx
Common Brand Names; Cytotec
- Gastrointestinal Agents, Other;
- Prostaglandins, Endocrine
Description
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
Indications
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).
Contraindications
Pregnancy when used to reduce risk of NSAID-induced ulcers
Hypersensitivity to misoprostol, prostaglandins, or prostaglandin analogues
Adverse Effects
- 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
Warnings
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 and Lactation
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
Maximum Dosage
800 mcg/day PO.
800 mcg/day PO.
Safe and effective use has not been established.
Safe and effective use has not been established.
