Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
TAMOXIFEN CITRATE (UNII: 7FRV7310N6) (TAMOXIFEN - UNII:094ZI81Y45)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
Tamoxifen citrate tablets, USP 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. Tamoxifen citrate tablets, USP are indicated for the treatment of node-positive breast cancer in 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 four or more positive axillary nodes. Tamoxifen citrate tablets, USP are 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 whether adjuvant tamoxifen therapy is likely to b
Product: 71335-0662 NDC: 71335-0662-1 30 TABLET in a BOTTLE NDC: 71335-0662-2 60 TABLET in a BOTTLE NDC: 71335-0662-3 90 TABLET in a BOTTLE NDC: 71335-0662-4 28 TABLET in a BOTTLE NDC: 71335-0662-5 58 TABLET in a BOTTLE NDC: 71335-0662-6 52 TABLET in a BOTTLE
Abbreviated New Drug Application
Bryant Ranch Prepack ---------- MEDICATION GUIDE Tamoxifen Citrate Tablets, USP (ta-MOX-I-fen) Written for women who use tamoxifen to lower their high chance of getting breast cancer or who have ductal carcinoma in situ (DCIS) This Medication Guide discusses only the use of tamoxifen to lower the chance of getting breast cancer in high-risk women and in women treated for DCIS. People taking tamoxifen to treat breast cancer have different benefits and different decisions to make than high-risk women or women with ductal carcinoma in situ (DCIS) taking tamoxifen to reduce the chance of getting breast cancer. If you already have breast cancer, talk with your doctor about how the benefits of treating breast cancer with tamoxifen compare to the risks that are described in this document. Why should I read this Medication Guide? This guide has information to help you decide whether to use tamoxifen to lower your chance of getting breast cancer. You and your doctor should talk about whether the possible benefit of tamoxifen in lowering your high chance of getting breast cancer is greater than its possible risks. Your doctor has a special computer program or hand-held calculator to tell if you are in the high-risk group. If you have DCIS and have been treated with surgery and radiation therapy, your doctor may prescribe tamoxifen to decrease your chance of getting invasive (spreading) breast cancer. Read this guide carefully before you start tamoxifen. It is important to read the information you get each time you get more medicine. There may be something new. This guide does not tell you everything about tamoxifen and does not take the place of talking with your doctor. Only you and your doctor can determine if tamoxifen is right for you. What is the most important information I should know about using tamoxifen to reduce the chance of getting breast cancer? Tamoxifen is a prescription medicine that is like estrogen (female hormone) in some ways and different in other ways. In the breast, tamoxifen can block estrogen's ef Baca dokumen lengkap
TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET BRYANT RANCH PREPACK ---------- TAMOXIFEN CITRATE TABLETS, USP REVISED: FEBRUARY 2016 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 1000 WOMEN-YEARS OF 2.20 FOR TAMOXIFEN VS. 0.71 FOR PLACEBO) AND UTERINE SARCOMA (INCIDENCE RATE PER 1000 WOMEN-YEARS OF 0.17 FOR TAMOXIFEN VS. 0.4 FOR PLACEBO)*. FOR STROKE, THE INCIDENCE RATE PER 1000 WOMEN-YEARS WAS 1.43 FOR TAMOXIFEN VS. 1.00 FOR PLACEBO**. FOR PULMONARY EMBOLISM, THE INCIDENCE RATE PER 1000 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) Baca dokumen lengkap