MISOPROSTOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

misoprostol (UNII: 0E43V0BB57) (misoprostol - UNII:0E43V0BB57)

Available from:

H.J. Harkins Company, Inc.

INN (International Name):

misoprostol

Composition:

misoprostol 100 ug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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.

Product summary:

Misoprostol 100-mcg tablets are white, round, with G and 5007 debossed on one side; supplied as: NDC Number             Size 59762-5007-1            unit-of-use bottle of 60 59762-5007-2            unit-of-use bottle of 120 Misoprostol 200-mcg tablets are white, hexagonal, with G debossed above and 5008 debossed below the line on one side; supplied as: NDC Number             Size 59762-5008-1            unit-of-use bottle of 60 59762-5008-2            unit-of-use bottle of 100 Store at or below 25°C (77°F), in a dry area.

Authorization status:

New Drug Application

Summary of Product characteristics

MISOPROSTOL - MISOPROSTOL TABLET
H.J. HARKINS COMPANY, INC.
----------
MISOPROSTOL
TABLETS
WARNINGS
MISOPROSTOL ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE
ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS
BEEN REPORTED WHEN MISOPROSTOL WAS ADMINISTERED IN PREGNANT
WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK
OF PREGNANCY (see also PRECAUTIONS and LABOR AND DELIVERY).
MISOPROSTOL SHOULD NOT BE TAKEN BY PREGNANT WOMEN TO REDUCE THE
RISK OF ULCERS INDUCED BY NONSTEROIDAL ANTI-INFLAMMATORY DRUGS
(NSAIDs) (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).
PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED
NOT TO GIVE THE DRUG TO OTHERS.
Misoprostol should not be used for reducing the risk of NSAID-induced
ulcers in women of
childbearing potential unless the patient is at high risk of
complications from gastric ulcers
associated with use of the NSAID, or is at high risk of developing
gastric ulceration. In such
patients, misoprostol may be prescribed if the patient
has had a negative serum pregnancy test within 2 weeks prior to
beginning therapy.
is capable of complying with effective contraceptive measures.
has received both oral and written warnings of the hazards of
misoprostol, the risk of possible
contraception failure, and the danger to other women of childbearing
potential should the drug
be taken by mistake.
will begin misoprostol only on the second or third day of the next
normal menstrual period.
DESCRIPTION
Misoprostol oral tablets contain either 100 mcg or 200 mcg of
misoprostol, a synthetic prostaglandin
E analog.
Misoprostol contains approximately equal amounts of the two
diastereomers presented below with their
enantiomers indicated by (±):
1
Misoprostol is a water-soluble, viscous liquid.
Inactive ingredients of tablets are hydrogenated castor oil,
hypromellose, microcrystalline cellulose,
and sodium starch glycolate.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Misoprostol is extensively absorbed, and undergoes rapid
de-esterification to its free