CYTOTEC- misoprostol tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Pfizer Laboratories Div Pfizer Inc

Designación común internacional (DCI):

MISOPROSTOL

Composición:

MISOPROSTOL 100 ug

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Cytotec (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. Cytotec has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Cytotec should be taken for the duration of NSAID therapy. Cytotec 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. Cytotec should not be taken by pregnant women to reduce the risk of ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs). Cytotec should not be taken by anyone with a history of allergy to prostaglandins.

Resumen del producto:

Cytotec 100-mcg tablets are white, round, with SEARLE debossed on one side and 1451 on the other side; supplied as: Cytotec 200-mcg tablets are white, hexagonal, with SEARLE debossed above and 1461 debossed below the line on one side and a double stomach debossed on the other side; supplied as: Store at or below 25°C (77°F), in a dry area. This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

Estado de Autorización:

New Drug Application

Ficha técnica

CYTOTEC- MISOPROSTOL TABLET
PFIZER LABORATORIES DIV PFIZER INC
----------
CYTOTEC
MISOPROSTOL TABLETS
WARNINGS
CYTOTEC (MISOPROSTOL) ADMINISTRATION TO WOMEN WHO ARE PREGNANT
CAN CAUSE BIRTH DEFECTS, ABORTION, PREMATURE BIRTH OR UTERINE
RUPTURE.
UTERINE RUPTURE HAS BEEN REPORTED WHEN CYTOTEC 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).
CYTOTEC 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.
Cytotec 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, Cytotec 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 Cytotec only on the second or third day of the next normal
menstrual
period.
DESCRIPTION
Cytotec 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
C
H
O M.W. = 382.5
(±) methyl 11α, 16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate
Misoprostol is a water-soluble, viscous liquid.
Inactive ingredients of tablets are hydrogenated castor oil,
h