Drug Catalog - Product Detail
EXEMESTANE TB 25MG 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 47781-0108-30 | ALVOGEN | 30 | 25MG | TABLET |
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Description
11 DESCRIPTION Exemestane tablets for oral administration contain 25 mg of exemestane, USP, an irreversible, steroidal aromatase inactivator. Exemestane is chemically described as 6-methylenandrosta-1,4-diene-3,17-dione. Its molecular formula is C 20 H 24 O 2 and its structural formula is as follows: The active ingredient is a white to slightly yellow powder with a molecular weight of 296.41. Exemestane is freely soluble in tetrahydrofuran and dimethylformamide; soluble in acetone, acetonitrile, methanol, and ethyl acetate; sparingly soluble in ethanol; very slightly soluble in n-hexane and insoluble in water. Each exemestane tablet contains the following inactive ingredients: copovidone, crospovidone, hypromellose, magnesium stearate, mannitol, polyethylene glycol 400, silicified microcrystalline cellulose, sodium starch glycolate, and titanium dioxide.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Exemestane tablets are white to off-white, round compound cup tablet with “25” on one side and plain on the reverse. Exemestane tablets are packaged in HDPE bottles with a child-resistant screw cap, supplied in packs of 30 tablets. NDC 47781-108-30 HDPE bottle of 30 tablets Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Indications & Usage
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 is 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 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 is indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see Clinical Studies ( 14.2 )] .
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Recommended Dose: One 25 mg tablet once daily after a meal. ( 2.1 ) 2.1 Recommended Dose The recommended dose of exemestane in early and advanced breast cancer is one 25 mg tablet once daily after a meal. 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 for completion of a total of five consecutive years of adjuvant hormonal therapy. the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. 2.2 Dose Modifications Concomitant use of strong CYP 3A4 inducers decreases exemestane exposure. For patients receiving exemestane with a strong CYP 3A4 inducer such as rifampicin or phenytoin, the recommended dose of exemestane is 50 mg once daily after a meal [ see Drug Interactions ( 7 ) and Clinical Pharmacology ( 12.3 )] .