exemestane tablet film coated
1 INDICATIONS AND USAGE Exemestane tablets are an aromatase inhibitor indicated for: adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1 ). treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy ( 14.2 ). 1.1 Adjuvant Treatment of Postmenopausal Women Exemestane tablets are indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets for completion of a total of five consecutive years of adjuvant hormonal therapy [see Clinical Studies (14.1) ]. 1.2 Advanced Breast Cancer in Postmenopausal Women Exemestane tablets are indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see Clinical Studies (14.2) ].
breckenridge pharmaceutical, inc.
ROUND WHITE X 1
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16 HOW SUPPLIED/STORAGE AND HANDLING
EXEMEStanE Tablets, USP are white colored, round, biconvex, film-coated tablets debossed with "X" on one side and "1" on other side. Each tablet contains 25 mg of
EXEMEStanE.
EXEMEStanE Tablets, USP are packaged in HDPE bottles with a child-resistant screw cap, supplied in bottles of 30 tablets. 30-tablet HDPE bottle NDC 51991-005-33.
EXEMEStanE Tablets, USP are packaged in HDPE bottles with a child-resistant screw cap, supplied in bottles of 90 tablets. 90-tablet HDPE bottle NDC 51991-005-90 Store at 25°C (77ºF); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].
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