Misoprostol 0.1 MG Oral Tablet

INDICATIONS AND USAGE Misoprostol tablets are 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.

Cadila Healthcare Limited

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] off label use` `[4] nausea` `[5] pain` `[6] diarrhoea` `[7] dyspnoea` `[8] headache` `[9] toxicity to various agents` `[10] death`

4 years ago

ROUND WHITE 1006

HOW SUPPLIED Misoprostol Tablets, 100 mcg are white to off-white, round, flat, beveled edge tablet, debossed with "1006" on one side and plain on other side and are supplied as: NDC 70771-1496-6 in bottle of 60 tablets NDC 70771-1496-1 in bottle of 100 tablets NDC 70771-1496-8 in bottle of 120 tablets NDC 70771-1496-4 in cartons of 100 tablets (10 x 10 unit-dose) Misoprostol Tablets, 200 mcg are white to off-white, round, flat, beveled edge tablet, debossed with "10" and "07" on either side of scoreline, on one side and plain on the other side and are supplied as: NDC 70771-1497-6 in bottle of 60 tablets NDC 70771-1497-1 in bottle of 100 tablets NDC 70771-1497-8 in bottle of 120 tablets NDC 70771-1497-4 in cartons of 100 tablets (10 x 10 unit-dose) Store at 25°C (77°F) [See USP Controlled Room Temperature]. Store in a dry area.

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