TAMONE - (10 MG) TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TAMOXIFEN (TAMOXIFEN CITRATE)

Available from:

PFIZER CANADA ULC

ATC code:

L02BA01

INN (International Name):

TAMOXIFEN

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

TAMOXIFEN (TAMOXIFEN CITRATE) 10MG

Administration route:

ORAL

Units in package:

60, 250

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2007-10-02

Summary of Product characteristics

PRODUCT MONOGRAPH
TAMONE
®
Tamoxifen Citrate Tablets USP
10 mg and 20 mg
ANTINEOPLASTIC AGENT
Pharmacia Canada Inc.
DATE OF PREPARATION:
Mississauga, Ontario
December 17, 2001
DATE OF REVISION:
CONTROL # 083918
September 10, 2003
©Pharmacia Canada Inc.
2
PRODUCT MONOGRAPH
NAME OF DRUG
TAMONE
®
Tamoxifen Citrate Tablets USP
10 mg and 20 mg
THERAPEUTIC CLASSIFICATION
Antineoplastic (non-steroidal antiestrogen)
TAMOXIFEN THERAPY WAS ASSOCIATED WITH SERIOUS AND LIFE-THREATENING
EVENTS INCLUDING UTERINE MALIGNANCIES, STROKE, PULMONARY EMBOLISM, AND
DEEP VEIN THROMBOSIS IN THE NSABP P-1 BREAST CANCER PREVENTION TRIAL.
THE USE OF TAMOXIFEN FOR BREAST CANCER PREVENTION IS NOT AN APPROVED
INDICATION IN CANADA. THE FOLLOWING RISKS ASSOCIATED WITH TAMOXIFEN
THERAPY
HAVE
BEEN
ESTIMATED
FROM
THE
NSABP
P-1
BREAST
CANCER
PREVENTION TRIAL. THE RELATIVE RISK OF TAMONE 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 THERAPY AND SHOULD
DISCUSS THEM WITH THEIR PATIENTS.
THE BENEFITS OF TAMOXIFEN 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
TAMONE (tamoxifen citrate) 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
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 appears to exert its
antitumour effects by
binding to estrogen receptors.
3
In
cytosols
derived
from
human
endometrium
and
human
breast
and
uterine
adenocarcinomas