PMS-TAMOXIFEN TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

TAMOXIFEN (TAMOXIFEN CITRATE)

Διαθέσιμο από:

PHARMASCIENCE INC

Φαρμακολογική κατηγορία (ATC):

L02BA01

INN (Διεθνής Όνομα):

TAMOXIFEN

Δοσολογία:

20MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

TAMOXIFEN (TAMOXIFEN CITRATE) 20MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

250

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0131293002; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2016-10-28

Αρχείο Π.Χ.Π.

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