Application Nr Approved Date Route Status External Links
ANDA210201 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

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.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Misoprostol MISOPROSTOL ZINC3812913

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