misoprostol
Drug Details
- Generic Name
- misoprostol
- Brand Names
- Cytotec
- Application Number
- NDA019268
- Sponsor
- Pfizer Laboratories Div Pfizer Inc
- NDC Codes
- 2
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- MISOPROSTOL
Indications and Usage
INDICATIONS & USAGE Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol should be taken for the duration of NSAID therapy. Misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.
Warnings
WARNINGS See boxed WARNINGS . For hospital use only if misoprostol were to be used for cervical ripening, induction of labor, or for the treatment of serious post-partum hemorrhage, which are outside of the approved indication.