exemestane 25 MG Oral Tablet
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) ] .
Amneal Pharmaceuticals LLC
ROUND WHITE A4
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16 HOW SUPPLIED/STORAGE AND HANDLING
EXEMEStanE tablets, USP are white, round, film-coated tablets and debossed with “A4” on one side and plain on the other side. Each tablet contains 25 mg of
EXEMEStanE, USP.
EXEMEStanE tablets, USP are packaged in HDPE bottles with a child-resistant screw cap. They are available as follows: Bottles of 30: NDC 65162-240-03 Store at 20° to 25°C (68° to 77ºF); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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