Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
TAMOXIFEN CITRATE (UNII: 7FRV7310N6) (TAMOXIFEN - UNII:094ZI81Y45)
Mylan Pharmaceuticals Inc.
TAMOXIFEN CITRATE
TAMOXIFEN 10 mg
ORAL
PRESCRIPTION DRUG
Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen citrate tablets are 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 citrate tablet therapy. 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 four or more positive axillary nodes. Tamoxifen citrate tablets 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 Citrate Tablets, USP are containing tamoxifen as the citrate equivalent to 10 mg or 20 mg of tamoxifen. The 10 mg tablets are white, unscored, round tablets debossed with M on one side of the tablet and 144 on the other side. They are available as follows: NDC 0378-0144-91 bottles of 60 tablets The 20 mg tablets are white to off-white, unscored, round tablets debossed with M on one side of the tablet and 274 on the other side. They are available as follows: NDC 0378-0274-93 bottles of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat (over 104°F/40°C). Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
Abbreviated New Drug Application
TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET Mylan Pharmaceuticals Inc. ---------- MEDICATION GUIDE TAMOXIFEN CITRATE TABLETS, USP (ta mox' i fen sit' rate) Written for women who use tamoxifen citrate tablets 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 citrate tablets to lower the chance of getting breast cancer in high risk women and in women treated for DCIS. People taking tamoxifen citrate tablets 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 citrate tablets 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 citrate tablets 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 citrate tablets to lower your chance of getting breast cancer. You and your doctor should talk about whether the possible benefit of tamoxifen citrate tablets 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 citrate tablets to decrease your chance of getting invasive (spreading) breast cancer. Read this guide carefully before you start tamoxifen citrate tablets. 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 citrate tablets and does not take the place of talking with your doctor. Only you and your doctor can determine if tamoxifen citrate tablets are right for you. What is the most important information I should kn Baca dokumen lengkap
TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET MYLAN PHARMACEUTICALS INC. ---------- 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 vs. 0.25 for placebo**. Some of the strokes, pulmonary emboli, and uterine malignancies were fatal. Healthcare providers should discuss the potential benefits vs. 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 CLINICAL PHARMACOLOGY: Clinical Studies: Table 3. 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 contains 30.4 mg of tamoxifen citrate which is equivalent to 20 mg of tamoxifen. Each tablet contains the fo Baca dokumen lengkap