Tamoxifen USP
Composition:
Tamodex-10: Each film coated tablet contains Tamoxifen 10mg as Tamoxifen Citrate
USP.
Tamodex-20: Each film coated tablet contains Tamoxifen 20mg as Tamoxifen
Citrate USP.
Indications: Metastatic Breast Cancer:
Tamodex is effective in the treatment of metastatic breast cancer in women and
men. In premenopausal women with metastatic breast cancer, Tamodex 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 Tamodex therapy. Adjuvant
Treatment of Breast Cancer: Tamodex is indicated for the treatment of
node-positive breast cancer in women following total mastectomy or segmental
mastectomy, axillary dissection, and breast irradiation. In some Tamodex
adjuvant studies, most of the benefit to date has been in the subgroup with
four or more positive axillary nodes. Ductal
Carcinoma in Situ (DCIS): In women with DCIS, following breast surgery and
radiation, Tamodex is indicated to reduce the risk of invasive breast cancer.
Current data from clinical trials support five years of adjuvant Tamodex
therapy for patients with breast cancer. Reduction
in Breast Cancer Incidence in High Risk Women: Tamodex is indicated to
reduce the incidence of breast cancer in women at high risk for breast cancer.
Tamodex is indicated only for high-risk women. "High risk" is defined
as women at least 35 years of age with a 5-year predicted risk of breast cancer
1.67%, as calculated by the Gail Model.
Dosage and administration: For
patients with breast cancer, the recommended daily dose is 20-40mg. Dosages
greater than 20mg per day should be given in divided doses (morning and
evening). In three single agent adjuvant studies in women, one 10mg Tamoxifen
Citrate tablet was administered two or three times a day for two years. Ductal Carcinoma in Situ (DCIS): The
recommended dose is Tamodex 20mg daily for 5 years. Reduction in Breast Cancer Incidence in High Risk Women: The
recommended dose is Tamodex 20mg daily for 5 years. There are no data to
support the use of Tamodex other than for 5 years. Or, as directed by the
registered physicians.
Use in Pregnancy and Lactation: Pregnancy
Category D. It can cause fetal harm when administered to a pregnant woman.
Tamoxifen has been reported to inhibit lactation. It is not known if Tamodex is
excreted in human milk. Because of the potential for serious adverse reactions
in nursing infants from Tamodex, women taking Tamodex should not breast feed.
Packaging: Tamodex-10: Each
box contains 30 tablets in a blister pack.
Tamodex-20: Each box contains 30 tablets in a blister pack.
