INDICATIONS AND USAGE Misoprostol is 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 Tablet has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol Tablets should be taken for the duration of NSAID therapy. Misoprostol Tablets has been shown to reduce the risk of gastric ulcers in controlled studies of 3 monthsâ€™ duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.
PD-Rx Pharmaceuticals, Inc.
HOW SUPPLIED Misoprostol Tablets 200-mcg tablets are round, white flat-faced beveled edge bisected tablets, debossed â€ś161â€ť above the bisect and â€śnâ€ť below the bisect and plain on the other side; supplied as: Bottles of 2, 4, 6, 8 and 13. Store at 20Â° to 25Â°C (68Â° to 77Â°F) [See USP Controlled Room Temperature]. Store in a dry area.
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