Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
TAMOXIFEN (TAMOXIFEN CITRATE)
SANOFI-AVENTIS CANADA INC
L02BA01
TAMOXIFEN
20MG
TABLET
TAMOXIFEN (TAMOXIFEN CITRATE) 20MG
ORAL
30/60
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0131293002; AHFS:
CANCELLED POST MARKET
2011-01-14
1 PRODUCT MONOGRAPH TAMOFEN ® (Tamoxifen Citrate) 10 and 20 mg Tablets Antineoplastic sanofi-aventis Canada Inc. Date of Preparation: 2150 St. Elzear Blvd. West May 31, 2006 Laval, Quebec H7L 4A8 Submission Control No. 106131 s-a Version 1.0 dated 2 NAME OF DRUG TAMOFEN ® tamoxifen citrate tablets 10 mg and 20 mg THERAPEUTIC CLASSIFICATION Antineoplastic (non-steroidal antiestrogen) T AMOXIFEN THERAPY WAS ASSOCIATED WITH SERIOUS AND LIFE - THREATENING EVENTS INCLUDING UTERINE MALIGNANCIES , STROKE , PULMONARY EMBOLISM , AND DEEP VEIN THROMBOSIS IN THE N ATIONAL S URGICAL A DJUVANT B REAST AND B OWEL P ROJECT (NSABP) P-1 BREAST CANCER PREVENTION TRIAL . T HE USE OF TAMOXIFEN FOR BREAST CANCER PREVENTION IS NOT AN APPROVED INDICATION IN C ANADA . 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 ENDOMETRIAL 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 C ANADIAN INDICATION FOR THE TREATMENT OF BREAST CANCER (see WARNINGS ). ACTIONS AND CLINICAL PHARMACOLOGY Tamoxifen is a nonsteroidal agent which has demonstrated potent antiestrogenic properties in animal test systems. The antiestrogenic effects are related to is 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 endo Soma hati kamili