MISOPROSTOL tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Proficient Rx LP

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 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.

Produkt oversigt:

Misoprostol Tablets, 200 mcg are available as white, round, scored, flat beveled-edged tablets, marked with “N” above the score-line and “444” below the score-line and plain on the reverse side. NDC Number                                     Size 82804-037-10                                      unit-of-use bottle of 10 82804-037-20                                      unit-of-use bottle of 20 82804-037-30                                      unit-of-use bottle of 30 82804-037-60                                      unit-of-use bottle of 60 82804-037-90                                      unit-of-use bottle of 90 Pharmacist: Dispense in this unit-of-use, child-resistant container as defined in the USP. Provide Patient Information Leaflet with each dispensing. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Store in a dry area. All trademarks are the property of their respective owners. Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Issued: 09/2022 LB4429-02

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

MISOPROSTOL- MISOPROSTOL TABLET
PROFICIENT RX LP
----------
MISOPROSTOL TABLETS
RX ONLY
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 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 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
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DESCRIPTION
Misoprostol oral tablets contain 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 (±):
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.
1
Misoprostol is a water-soluble, viscous liquid.
Inactive ingredients of tablets are hydrogenated vegetable oil,
hypromellose,
microcrystalline cellulose and sodium starch glycolate.
CLINICAL PHARMACOL