TAMOXIFEN CITRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TAMOXIFEN CITRATE (UNII: 7FRV7310N6) (TAMOXIFEN - UNII:094ZI81Y45)

Available from:

American Health Packaging

INN (International Name):

TAMOXIFEN CITRATE

Composition:

TAMOXIFEN 10 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET
AMERICAN HEALTH PACKAGING
----------
TAMOXIFEN CITRATE TABLETS, USP
8292421/0416OS
RX ONLY
WARNING
FOR WOMEN WITH DUCTAL CARCINOMA IN SITU (DCIS) AND WOMEN AT HIGH RISK
FOR BREAST
CANCER
SERIOUS AND LIFE-THREATENING EVENTS ASSOCIATED WITH TAMOXIFEN IN THE
RISK REDUCTION SETTING
(WOMEN AT HIGH RISK FOR CANCER AND WOMEN WITH DCIS) INCLUDE UTERINE
MALIGNANCIES, STROKE
AND PULMONARY EMBOLISM. INCIDENCE RATES FOR THESE EVENTS WERE
ESTIMATED FROM THE NSABP
P-1 TRIAL (SEE CLINICAL PHARMACOLOGY, CLINICAL STUDIES, REDUCTION IN
BREAST CANCER
INCIDENCE IN HIGH RISK WOMEN). UTERINE MALIGNANCIES CONSIST OF BOTH
ENDOMETRIAL
ADENOCARCINOMA (INCIDENCE RATE PER 1,000 WOMEN-YEARS OF 2.20 FOR
TAMOXIFEN VS. 0.71 FOR
PLACEBO) AND UTERINE SARCOMA (INCIDENCE RATE PER 1,000 WOMEN-YEARS OF
0.17 FOR TAMOXIFEN
VS. 0.4 FOR PLACEBO)*. FOR STROKE, THE INCIDENCE RATE PER 1,000
WOMEN-YEARS WAS 1.43 FOR
TAMOXIFEN VS. 1.00 FOR PLACEBO**. FOR PULMONARY EMBOLISM, THE
INCIDENCE RATE PER 1,000
WOMEN-YEARS WAS 0.75 FOR TAMOXIFEN VERSUS 0.25 FOR PLACEBO**.
SOME OF THE STROKES, PULMONARY EMBOLI, AND UTERINE MALIGNANCIES WERE
FATAL.
HEALTH CARE PROVIDERS SHOULD DISCUSS THE POTENTIAL BENEFITS VERSUS THE
POTENTIAL RISKS OF
THESE SERIOUS EVENTS WITH WOMEN AT HIGH RISK OF BREAST CANCER AND
WOMEN WITH DCIS
CONSIDERING TAMOXIFEN TO REDUCE THEIR RISK OF DEVELOPING BREAST
CANCER.
THE BENEFITS OF TAMOXIFEN CITRATE OUTWEIGH ITS RISKS IN WOMEN ALREADY
DIAGNOSED WITH BREAST
CANCER.
*UPDATED LONG-TERM FOLLOW-UP DATA (MEDIAN LENGTH OF FOLLOW-UP IS 6.9
YEARS) FROM NSABP
P-1 STUDY. SEE WARNINGS: EFFECTS ON THE UTERUS-ENDOMETRIAL CANCER AND
UTERINE
SARCOMA.
**SEE TABLE 3 UNDER CLINICAL PHARMACOLOGY, CLINICAL STUDIES.
DESCRIPTION
Tamoxifen citrate tablets, USP, a nonsteroidal antiestrogen, are for
oral administration. Chemically,
tamoxifen is the trans-isomer of a triphenylethylene derivative. The
chemical name is (Z)2-[4-(1,2-
diphenyl-1-butenyl) phenoxy]-N, N-dimethylethanamine 2 hydroxy-1,2,3-
propanetricarboxylate (1:1).
The