MISOPROSTOL- misoprostol tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

GenBioPro, Inc.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 relatively few duodenal lesions were seen. In another clinical trial, 239 patients receiving aspirin 650 to 1300 mg q.i.d. for rheumatoid arthritis who had endoscopic evidence of duodenal and/or gastric inflammation were randomized to misoprostol 200 mcg q.i.d. or placebo for 8 weeks while continuing to receive aspirin. The study evaluated the possible interference of Misoprostol Tablets on the efficacy of aspirin in these patients with rheumatoid arthritis by analyzing joint tenderness, joint swelling, physician's clinical assessment, patient's assessment, change in ARA classification, change in handgrip strength, change in duration of morning stiffness, patient's assessment of pain at rest, movement, interference with daily activity, and ESR. Misoprostol Tablets did not interfere with the efficacy of aspirin in these patients with rheumatoid arthritis. 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., 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 Tablet has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol Tablets should be taken for the duration of NSAID therapy. Misoprostol Tablets 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 Tablets should not be taken by pregnant women to reduce the risk of ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs). Misoprostol Tablets should not be taken by anyone with a history of allergy to prostaglandins.

Povzetek izdelek:

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 4 with 1 dessicant capsule: 43393-022-04 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store in a dry area.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

MISOPROSTOL - MISOPROSTOL TABLET
GENBIOPRO, INC.
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MISOPROSTOL TABLETS
GENBIOPRO, INC.
WARNING
MISOPROSTOL ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE
BIRTH DEFECTS, ABORTION, OR PREMATURE BIRTH. 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
Tablets, 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-