exemestane 25 mg
1 INDICATIONS AND USAGE Exemestane is 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, USP 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, USP 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, USP 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, USP are indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see Clinical Studies ( 14.2 )].
cipla usa inc.
ROUND WHITE C316
C316 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
EXEMEStanE tablets, USP are white to off white, round, biconvex film-coated tablet, debossed with "C316" on one-side and plain on other side.
EXEMEStanE tablets, USP are packaged in HDPE bottles with a child-resistant screw cap, supplied in packs of 30 tablets. 30-tablet HDPE bottle NDC 69097-316-02 Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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