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Basic Drug Info
Drug Name:misoprostol
Manufacturer:Greenstone Ltd.
Other Info:Rx onlyLAB-0171-2.0September 2006



Clinical Trials:


Indications and 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, eg, 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.
Complication -- Any disease or disorder that occurs during the course of (or because of) another disease.

Complication Aspects -- Used with diseases to indicate conditions that co-exist or follow, i.e., co-existing diseases, complications, or sequelae.

Ulcer -- A lesion on the surface of the skin or a mucous surface, produced by the sloughing of inflammatory necrotic tissue.

Duodenal Ulcer -- A PEPTIC ULCER located in the DUODENUM.

Sensory Discomfort -- A feeling of mental or physical uneasiness, pain, or distress.

Contraindications
See boxed WARNINGS.Misoprostol should not be taken by pregnant women to reduce the risk of ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs).Misoprostol should not be taken by anyone with a history of allergy to prostaglandins.
Ulcer -- A lesion on the surface of the skin or a mucous surface, produced by the sloughing of inflammatory necrotic tissue.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Immediate hypersensitivity -- Hypersensitivity reactions which occur within minutes of exposure to challenging antigen due to the release of histamine which follows the antigen-antibody reaction and causes smooth muscle contraction and increased vascular permeability.

Warnings
See boxed WARNINGS.
Branded Drugs
The following US Branded drugs contain misoprostol


ARTHROTEC -- GD SEARLE LLC

CYTOTEC -- GD SEARLE LLC


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