PMS-TAMOXIFEN TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

TAMOXIFEN (TAMOXIFEN CITRATE)

Beschikbaar vanaf:

PHARMASCIENCE INC

ATC-code:

L02BA01

INN (Algemene Internationale Benaming):

TAMOXIFEN

Dosering:

10MG

farmaceutische vorm:

TABLET

Samenstelling:

TAMOXIFEN (TAMOXIFEN CITRATE) 10MG

Toedieningsweg:

ORAL

Eenheden in pakket:

250

Prescription-type:

Prescription

Therapeutisch gebied:

ANTINEOPLASTIC AGENTS

Product samenvatting:

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

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2016-10-28

Productkenmerken

PRODUCT MONOGRAPH
PR
PMS-TAMOXIFEN
(Tamoxifen Citrate Tablets, USP)
10 mg & 20 mg
ANTINEOPLASTIC AGENT
PHARMASCIENCE INC.
DATE OF PREPARATION:
6111 Royalmount Ave., Suite 100
February 20, 1998
Montreal, CANADA
H4P 2T4
DATE OF REVISION:
September 11, 2003
CONTROL#: 083718
-2-
PRODUCT MONOGRAPH
PR
PMS-TAMOXIFEN
(Tamoxifen Citrate Tablets USP)
10 mg & 20 mg
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
T
AMOXIFEN 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
.
T
HE USE OF TAMOXIFEN FOR BREAST CANCER PREVENTION IS NOT AN
APPROVED INDICATION IN CANADA
.
T
HE FOLLOWING RISKS ASSOCIATED WITH TAMOXIFEN THERAPY HAVE
BEEN ESTIMATED FROM THE NSABP P
-1 BREAST CANCER PREVENTION TRIAL
.
T
HE RELATIVE RISK OF
TAMOXIFEN COMPARED TO PLACEBO WAS
3.1 FOR ENDOMETRAIL CANCER
,
4.0 FOR UTERINE SARCOMAS
,
1.6 FOR STROKE
,
3.0 FOR PULMONARY EMBOLISM
, AND
1.6 FOR DEEP VEIN THROMBOSIS
.
T
HESE EVENTS
WERE FATAL IN SOME PATIENTS
.
H
EALTH CARE PROVIDERS SHOULD BE AWARE OF THE POSSIBLE RISKS
ASSOCIATED WITH TAMOXIFEN THERAPY AND SHOULD DISCUSS THEM WITH THEIR
PATIENTS
.
T
HE 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
.
-3-
ACTION AND CLINICAL PHARMACOLOGY
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 tumors. In this rat model, tamoxifen
appears to exert its
antitumor effects by binding to estrogen receptors.
In cytosols derived from human endometrium and human breast and
uterine adenoc