MYLAN-TAMOXIFEN TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

TAMOXIFEN (TAMOXIFEN CITRATE)

MAH:

MYLAN PHARMACEUTICALS ULC

ATC_code:

L02BA01

INN:

TAMOXIFEN

dosage:

10MG

pharmaceutical_form:

TABLET

composition:

TAMOXIFEN (TAMOXIFEN CITRATE) 10MG

administration_route:

ORAL

units_in_package:

10/30/60/250

prescription_type:

Prescription

therapeutic_area:

ANTINEOPLASTIC AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0131293001; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2017-01-09

SPC

PRODUCT MONOGRAPH
PR
MYLAN-TAMOXIFEN
Tamoxifen Citrate Tablets, BP
10 MG AND 20 MG TAMOXIFEN (AS TAMOXIFEN CITRATE)
Antineoplastic Agent
MYLAN PHARMACEUTICALS ULC
Date of Revision:
85 Advance Road
February 6, 2014
Etobicoke, Ontario
M8Z 2S6
Control No.: 171511
2
NAME OF DRUG
PR
MYLAN-TAMOXIFEN
(Tamoxifen Citrate Tablets, BP)
10 mg and 20 mg tamoxifen (as tamoxifen citrate)
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent (non-steroidal antiestrogen)
TAMOXIFEN CITRATE THERAPY WAS ASSOCIATED WITH SERIOUS AND
LIFE-THREATENING EVENTS
INCLUDING UTERINE MALIGNANCIES, STROKE, PULMONARY EMBOLISM, AND DEEP
VEIN THROMBOSIS
IN THE NSABP P-1 TRIAL FOR THE PREVENTION OF BREAST CANCER. THE USE OF
TAMOXIFEN CITRATE
FOR BREAST CANCER PREVENTION IS NOT AN APPROVED INDICATION IN CANADA.
IN THE NSABP P-1
TRIAL, THE RELATIVE RISK OF TAMOXIFEN CITRATE COMPARED TO PLACEBO WAS
3.1 FOR ENDOMETRIAL
CANCER, 4.0 FOR UTERINE SARCOMAS, 1.6 FOR STROKE, 3.0 FOR PULMONARY
EMBOLISM, AND 1.6 FOR
DEEP VEIN THROMBOSIS. THESE EVENTS WERE FATAL IN SOME PATIENTS. HEALTH
CARE PROVIDERS
SHOULD BE AWARE OF THE POSSIBLE RISKS ASSOCIATED WITH TAMOXIFEN
CITRATE THERAPY AND
SHOULD DISCUSS THEM WITH THEIR PATIENTS.
THE BENEFITS OF TAMOXIFEN CITRATE THERAPY OUTWEIGH THE RISKS
IN
THE
MAJORITY
OF
WOMEN
BEING
TREATED
ACCORDING
TO
THE
APPROVED CANADIAN INDICATION FOR THE TREATMENT OF BREAST
CANCER.
ACTIONS AND CLINICAL PHARMACOLOGY
Tamoxifen citrate, the active ingredient, is a non-steroidal agent
which has demonstrated potent
antiestrogenic properties in animal test systems. The antiestrogenic
effects are related to its ability
to compete with estrogen for binding sites in target tissues such as
breast and uterus. Tamoxifen
citrate inhibits the induction of rat mammary carcinoma induced by
dimethylbenzanthracene
(DMBA) and causes the regression of already established DMBA-induced
tumours. In this rat
model, tamoxifen citrate appears to exert its antitumour effects by
binding to estrogen receptors.
In cytosols derived from human endometrium and human breast and
ute