TAMOXIFEN TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

TAMOXIFEN (TAMOXIFEN CITRATE)

זמין מ:

PHARMEL INC

קוד ATC:

L02BA01

INN (שם בינלאומי):

TAMOXIFEN

כמות:

10MG

טופס פרצבטיות:

TABLET

הרכב:

TAMOXIFEN (TAMOXIFEN CITRATE) 10MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

250

סוג מרשם:

Prescription

איזור תרפויטי:

ANTINEOPLASTIC AGENTS

leaflet_short:

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

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2016-10-25

מאפייני מוצר

PRODUCT MONOGRAPH
PR
TAMOXIFEN
(Tamoxifen Citrate Tablets, USP)
10 mg & 20 mg
ANTINEOPLASTIC AGENT
PHARMEL INC.
DATE OF PREPARATION:
8699 8
TH
Avenue
March 10, 1998
Montreal, CANADA
H1Z 2X4
DATE OF REVISION:
September 11, 2003
CONTROL #083923
-2-
PRODUCT MONOGRAPH
PR
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 adenocarcinomas,
tamoxifen competes wit