CYTOTEC 100 MCG TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MISOPROSTOL

Available from:

PFIZER CANADA ULC

ATC code:

A02BB01

INN (International Name):

MISOPROSTOL

Dosage:

100MCG

Pharmaceutical form:

TABLET

Composition:

MISOPROSTOL 100MCG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

PROSTAGLANDINS

Product summary:

Active ingredient group (AIG) number: 0116767002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2004-07-26

Summary of Product characteristics

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