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MISOPROSTOL Tablets (GREENSTONE LLC)

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MISOPROSTOL Tablets (GREENSTONE LLC) Quick Finder

WARNINGS

MISOPROSTOL ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE BIRTH DEFECTS, ABORTION, PREMATURE BIRTH OR UTERINE RUPTURE.

UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL WAS ADMINISTERED IN PREGNANT...

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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, e.g...

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DOSAGE AND ADMINISTRATION

The recommended adult oral dose of misoprostol for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be...

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CONTRAINDICATIONS

See boxed WARNINGS.

Misoprostol should not be taken by pregnant women to reduce the risk of ulcers induced by nonsteroidal anti-...

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WARNINGS

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PRECAUTIONS

Caution should be employed when administering misoprostol to patients with pre-existing cardiovascular disease.

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ADVERSE REACTIONS

The following have been reported as adverse events in subjects receiving misoprostol:

Gastrointestinal

In subjects receiving...

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OVERDOSAGE

The toxic dose of misoprostol in humans has not been determined. Cumulative total daily doses of 1600 mcg have been tolerated, with only symptoms of gastrointestinal discomfort being reported. In animals, the...

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DESCRIPTION

Misoprostol oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E1 analog.

Misoprostol contains approximately equal amounts of the two...

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CLINICAL PHARMACOLOGY

Pharmacokinetics

Misoprostol is extensively absorbed, and undergoes rapid de-esterification to its free acid, which is responsible for its...

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HOW SUPPLIED

Misoprostol 100-mcg tablets are white, round, with G and 5007 debossed on one side; supplied as:

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PATIENT INFORMATION

Read this leaflet before taking misoprostol and each time your prescription is renewed, because the leaflet may be changed.

Misoprostol is being prescribed by your doctor to decrease the chance of...

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This product's label may have been updated. For current full prescribing information, please visit www.greenstonellc.com.

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