misoprostol 100 ug

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.

Novitium Pharma LLC

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] off label use` `[3] fatigue` `[4] pain` `[5] nausea` `[6] headache` `[7] pyrexia` `[8] arthralgia` `[9] dyspnoea` `[10] vomiting`

2 years ago

ROUND WHITE N 443

2 years ago

N 443 ROUND WHITE

HOW SUPPLIED

MISOPROSTOL Tablets, 100 mcg are available as white, round, unscored, flat beveled-edged tablets, marked with “443” on one side and “N” on the reverse side. NDC Number Size 70954-443-10 unit-of-use bottle of 60 70954-443-20 unit-of-use bottle of 120

MISOPROSTOL Tablets, 200 mcg are available as white, round, scored, flat beveled-edged tablets, marked with “N” above the score-line and “444” below the score-line and plain on the reverse side. NDC Number Size 70954-444-10 unit-of-use bottle of 60 70954-444-20 unit-of-use bottle of 100 Pharmacist: Dispense in this unit-of-use, child-resistant container as defined in the USP. Provide Patient Information Leaflet with each dispensing. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Store in a dry area. All trademarks are the property of their respective owners. Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 Issued: 09/2022 LB4429-02

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misoprostol 200 ug

Novitium Pharma LLC

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