País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
TAMOXIFEN CITRATE (UNII: 7FRV7310N6) (TAMOXIFEN - UNII:094ZI81Y45)
Bryant Ranch Prepack
TAMOXIFEN CITRATE
TAMOXIFEN 20 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET BRYANT RANCH PREPACK ---------- 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 Llegiu el document complet