MISOPROSTOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MISOPROSTOL (UNII: 0E43V0BB57) (MISOPROSTOL - UNII:0E43V0BB57)

Available from:

ReadyMeds

INN (International Name):

MISOPROSTOL

Composition:

MISOPROSTOL 200 ug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Two 12-week, randomized, double-blind trials in osteoarthritic patients who had gastrointestinal symptoms but no ulcer on endoscopy while taking an NSAID compared the ability of 200 mcg of Misoprostol Tablets, 100 mcg of Misoprostol Tablets, and placebo to reduce the risk of gastric ulcer (GU) formation. Patients were approximately equally divided between ibuprofen, piroxicam, and naproxen, and continued this treatment throughout the 12 weeks. The 200-mcg dose caused a marked, statistically significant reduction in gastric ulcers in both studies. The lower dose was somewhat less effective, with a significant result in only one of the studies. In these trials there were no significant differences between Misoprostol Tablets and placebo in relief of day or night abdominal pain. No effect of Misoprostol Tablets in reducing the risk of duodenal ulcers was demonstrated, but relatively few duodenal lesions were seen. In another clinical trial, 239 patients receiving aspirin 650 to 1300 mg q.i.d. for rheumatoid arth

Product summary:

Misoprostol Tablets 100-mcg tablets are round, white flat-faced beveled edge tablets, debossed “160” on one side and “n” on other side; supplied as: Bottles of 60: 43386-160-06 Bottles of 120: 43386-160-12 Misoprostol Tablets 200-mcg tablets are round, white flat-faced beveled edge bisected tablets, debossed “161” above the bisect and “n” below the bisect and plain on the other side; supplied as: Bottles of 60: 43386-161-06 Bottles of 100: 43386-161-01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store in a dry area.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MISOPROSTOL- MISOPROSTOL TABLET
READYMEDS
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MISOPROSTOL TABLETS
GAVIS PHARMACEUTICALS, LLC
WARNING
MISOPROSTOL ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE
ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS
BEEN REPORTED WHEN MISOPROSTOL TABLETS WERE 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 TABLETS 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 Tablets 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 Tablets 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 Tablets 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
E1 analog.
Misoprostol contains approximately equal amounts of the two
diastereomers presented below with their
enantiomers indicated by (±):
Misoprostol is a water-soluble, viscous liquid.
Inactive ingredients of tablets are hydrogenated castor oil,
microcrystalline cellulose, and
crospovidone.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Misoprostol is extensively absorbed, and undergoes rapid
de-est