Cytotec (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. Cytotec has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Cytotec should be taken for the duration of NSAID therapy. Cytotec 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.

The recommended adult oral dose of Cytotec 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. (See CLINICAL PHARMACOLOGY: Clinical studies.) Cytotec should be taken for the duration of NSAID therapy as prescribed by the physician. Cytotec should be taken with a meal, and the last dose of the day should be at bedtime.

Renal impairment: Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated. (See CLINICAL PHARMACOLOGY.)

Cytotec 100-mcg tablets are white, round, with SEARLE debossed on one side and 1451 on the other side; supplied as:

NDC Number           Size

0025-1451-60            unit-of-use bottle of 60
0025-1451-20            unit-of-use bottle of 120
0025-1451-34            carton of 100 unit dose

Cytotec 200-mcg tablets are white, hexagonal, with SEARLE debossed above and 1461 debossed below the line on one side and a double stomach debossed on the other side; supplied as:

NDC Number           Size

0025-1461-60            unit-of-use bottle of 60
0025-1461-31            unit-of-use bottle of 100
0025-1461-34            carton of 100 unit dose

Store at or below 25°C (77°F), in a dry area.

Distributed by G.D. Searle, LLC
Division of Pfizer, Inc, NY, NY 10017

Revised September 2006. FDA rev date: 8/13/2003

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