MISOPROSTOL tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Micro Labs Limited

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Misoprostol tablets are 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 tablets 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 h

Огляд продуктів:

Misoprostol 100 mcg tablets are white to off white, round, biconvex, uncoated tablet debossed with “C” and “41” on one side and plain on the other side; supplied as: Bottles of 60                                       NDC 42571-253-60 Bottles of 120                                     NDC 42571-253-12 Misoprostol 200 mcg tablets are white to off white, round, biconvex, uncoated tablet debossed with “C” and “40” on one side and break line on the other side; supplied as: Bottles of 60                                       NDC 42571-254-60 Bottles of 100                                     NDC 42571-254-01 Store at or below 25°C (77°F), in a dry area. The brands listed are trademarks of their respective owners and are not trademarks of Micro Labs Limited. The makers of these brands are not affiliated with and do not endorse Micro Labs or its products.   Rx Only Manufactured by: Micro Labs Limited Goa- 403 722, INDIA. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873 Rev. 06/2022

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

MISOPROSTOL- MISOPROSTOL TABLET
MICRO LABS LIMITED
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MISOPROSTOL TABLETS
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
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.
DESCRIPTION
Misoprostol oral tablets contain either 100 mcg or 200 mcg of
misoprostol, a synthetic
prostaglandin E
analog.
Misoprostol USP contains approximately equal amounts of the two
diastereomers
presented below with their enantiomers indicated by (±):
1
Misoprostol USP is a clear, colorless or light yellow viscous liquid.
Very slightly soluble in
water.
Inactive ingredients of tablets are colloidal silicon dioxide,
hydrogenated castor oil,
hypromello