MISOPROSTOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

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. Reduction of Risk of Gastric Ulcers Induced by Ibuprofen, Piroxicam, or Naproxen                       [No. of patients with ulcer(s) (%)] 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 rel

Product summary:

NDC: 71335-0460-1: 30 Tablets in a BOTTLE NDC: 71335-0460-2: 60 Tablets in a BOTTLE NDC: 71335-0460-3: 28 Tablets in a BOTTLE NDC: 71335-0460-4: 1 Tablets in a BOTTLE NDC: 71335-0460-5: 8 Tablets in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MISOPROSTOL- MISOPROSTOL TABLET
BRYANT RANCH PREPACK
----------
MISOPROSTOL TABLETS
LUPIN PHARMACEUTICALS, INC
WARNING
MISOPROSTOL ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE
BIRTH DEFECTS, ABORTION, PREMATURE BIRTH OR UTERINE RUPTURE.
UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL TABLETS WERE
ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE
ABORTION. THE RISK OF UTERINE RUPTURE INCREASES WITH ADVANCING
GESTATIONAL AGES AND WITH PRIOR UTERINE SURGERY, INCLUDING CESAREAN
DELIVERY (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,