MISOPROSTOL tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

American Health Packaging

INN (국제 이름):

MISOPROSTOL

구성:

MISOPROSTOL 100 ug

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 pr

제품 요약:

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: Unit dose packages of 100 (10 x 10) NDC 68084-040-01 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: Unit dose packages of 100 (10 x10) NDC 68084-041-01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store in a dry area. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

MISOPROSTOL- MISOPROSTOL TABLET
AMERICAN HEALTH PACKAGING
----------
MISOPROSTOL TABLETS
8204001/0821
RX ONLY
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
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 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,
microcrystalline cel