tamoxifen citrate- Tamoxifen Citrate tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Tamoxifen Citrate (UNII: 7FRV7310N6) (Tamoxifen - UNII:094ZI81Y45)

Mevcut itibaren:

Andrx Pharmaceuticals, Inc.

INN (International Adı):

Tamoxifen Citrate

Farmasötik formu:

TABLET

Kompozisyon:

10 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Metastatic Breast Cancer: Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy. Adjuvant Treatment of Breast Cancer: Tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen adjuvant studies, most of the benefit to date has been in the subgroup with 4 or more positive axillary nodes. Tamoxifen is indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. The estrogen and progesterone receptor values may help to predict whet

Ürün özeti:

10 mg Tablets: Tamoxifen Citrate Tablets, USP are available as 10 mg tablets (containing 15.2 mg tamoxifen citrate in an amount equivalent to 10 mg of tamoxifen) round, biconvex, uncoated, white tablet unscored identified with "964" debossed on one side and the debossed on the other side are supplied in bottles of 60 tablets (NDC 62037-964-60), 180 tablets (NDC 62037-964-18) and 2500 tablets (NDC 62037-964-25). 20 mg Tablets: Tamoxifen Citrate Tablets, USP are available as 20 mg tablets (containing 30.4 mg tamoxifen citrate in an amount equivalent to 20 mg of tamoxifen) round, biconvex, uncoated, white tablet unscored identified with "965" debossed on one side and the debossed on the other side are supplied in bottles of 30 tablets (NDC 62037-965-30), 90 tablets (NDC 62037-965-90) and 1250 tablets (NDC 62037-965-12). Store at controlled room temperature, 20-25°C (68-77°F) [see USP]. Dispense in a well-closed, light-resistant container. Manufactured by: Andrx Pharmaceuticals, Inc. Ft. Lauderdale, FL 33314 Toll Free 1-866-292-6719 Rev. date: 02/03A 7227

Ürün özellikleri

TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET
ANDRX PHARMACEUTICALS, INC.
----------
TAMOXIFEN CITRATE TABLETS, USP
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. 0.04
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._
_SeeWARNINGS: EFFECTS ON THE UTERUS - ENDOMETRIAL CANCER AND UTERINE
SARCOMA._
_**See Table 3 underCLINICAL PHARMACOLOGY - CLINICAL STUDIES._
DESCRIPTION
Tamoxifen citrate tablets USP, a nonsteroidal antiestrogen, are for
oral administration. Tamoxifen
citrate tablets are available as:
10 MG TABLETS. Each tablet contains 15.2 mg of tamoxifen citrate which
is equivalent to 10 mg of
tamoxifen.
20 MG TABLETS. Each tablet contain