INDICATIONS AND USAGE
Misoprostol tablets are indicated for reducing the risk of NSAID (nonsteroidal
anti-inflammatory drugs, including aspirin)â€“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.
DOSAGE AND ADMINISTRATION
The recommended adult oral dose of misoprostol 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). Misoprostol should be taken for the duration of NSAID therapy
as prescribed by the physician. Misoprostol should be taken with a meal, and the
last dose of the day should be at bedtime.
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 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 12634-993-91 Blister Pack UD
- NDC 12634-993-92 Bottle of 2
- NDC 12634-993-94 Bottle of 4
- NDC 12634-993-98 Bottle of 8
Store at or below 25°C (77°F), in a dry area.
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