Pays: Canada
Langue: anglais
Source: Health Canada
MISOPROSTOL
PFIZER CANADA ULC
A02BB01
MISOPROSTOL
100MCG
TABLET
MISOPROSTOL 100MCG
ORAL
100
Prescription
PROSTAGLANDINS
Active ingredient group (AIG) number: 0116767002; AHFS:
CANCELLED POST MARKET
2004-07-26
PRODUCT MONOGRAPH PR CYTOTEC * (MISOPROSTOL ) 100, 200 MCG TABLETS MUCOSAL PROTECTIVE AGENT Pfizer Canada Inc Date of Preparation: 17,300 Trans-Canada Highway September 11, 2003 Kirkland, Quebec H9J 2M5 Control No. 086523 * TM G.D.Searle LLC Pfizer Canada Inc, Licensee © Pfizer Canada Inc 2003 2 NAME OF DRUG Pr CYTOTEC * (misoprostol 100, 200 mcg tablets) THERAPEUTIC CLASSIFICATION MUCOSAL PROTECTIVE AGENT ACTIONS AND CLINICAL PHARMACOLOGY CYTOTEC (misoprostol dispersed in Hypromellose) is a synthetic analogue of prostaglandin E 1 . In animals and man, orally administered misoprostol has both gastric antisecretory and mucosal protective effects. Its antisecretory activity is mediated by misoprostol acid binding to specific prostaglandin receptors on gastric parietal cells. The mechanism of the gastrointestinal mucosal protective effect of CYTOTEC is not as well understood, but is thought to involve the replacement of prostaglandins following their depletion or inhibition of production, the increasing of mucus production, the increasing of bicarbonate secretion in the duodenum, increased mucosal blood flow, decreased vascular permeability, increased cellular proliferation and migration, and the restoration of the gastric potential difference. Studies conducted in WARNINGS Women of childbearing potential SHOULD NOT be started on CYTOTEC until PREGNANCY IS EXCLUDED . Women should be fully counseled about Cytotec’s abortifacient potential and the importance of effective contraception (oral contraceptive or intrauterine device) and prevention of pregnancy while undergoing treatment. CYTOTEC SHOULD NOT BE TAKEN BY PREGNANT WOMEN. CYTOTEC (MISOPROSTOL) ADMINISTRATION TO PREGNANT WOMEN INDUCES UTERINE CONTRACTIONS AND IS ASSOCIATED WITH ABORTION, PREMATURE BIRTH, BIRTH DEFECTS AND FETAL DEATH . CYTOTEC CAN CAUSE UTERINE TETANY AND UTERINE RUPTURE IF ADMINISTERED TO PREGNANT WOMEN BEYOND THE EIGHTH WEEK OF PREGNANCY. (See CONTRAINDICATIONS and ADVERSE EVENTS-Postmarketing Surveillance). PATIENTS SHOULD NOT GIVE CYTOTEC Lire le document complet