TAMOXIFEN CITRATE tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Bryant Ranch Prepack

INN（国際名）:

TAMOXIFEN CITRATE

構図:

TAMOXIFEN 20 mg

処方タイプ:

PRESCRIPTION DRUG

認証ステータス:

Abbreviated New Drug Application

製品の特徴

TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET
BRYANT RANCH PREPACK
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TAMOXIFEN CITRATE TABLETS, USP
REVISED: OCTOBER 2010
196201
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 h