TAMOXIFEN CITRATE tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

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, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
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TAMOXIFEN CITRATE TABLETS USP, 10 MG AND 20 MG (BASE)
0784
0782
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 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. Each tablet contains 10 mg or 20 mg tamoxifen
(equivalent to
15.2 mg or 30.4 mg, respectively, of tamoxifen citrate, USP).
Each tablet contains the following inactive ingredients:
croscarmello