dutasteride 0.5 MG Oral Capsule Avodart
1 INDICATIONS AND USAGE AVODART is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: ( 1.1 ) • improve symptoms, • reduce the risk of acute urinary retention, and • reduce the risk of the need for BPH-related surgery. AVODART in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. ( 1.2 ) Limitations of Use: AVODART is not approved for the prevention of prostate cancer. ( 1.3 ) 1.1 Monotherapy AVODART (dutasteride) soft gelatin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: • improve symptoms, • reduce the risk of acute urinary retention (AUR), and • reduce the risk of the need for BPH-related surgery. 1.2 Combination with Alpha-adrenergic Antagonist AVODART in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. 1.3 Limitations of Use AVODART is not approved for the prevention of prostate cancer.
GlaxoSmithKline LLC
OVAL YELLOW GX CE2
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16 HOW SUPPLIED/STORAGE AND HANDLING AVODART soft gelatin capsules 0.5 mg are oblong, opaque, dull yellow, gelatin capsules imprinted with “GX CE2” with red edible ink on one side, packaged in bottles of 30 (NDC 0173-0712-15) and 90 (NDC 0173-0712-04) with child-resistant closures. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dutasteride is absorbed through the skin. AVODART capsules should not be handled by women who are pregnant or who could become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus [see Warnings and Precautions ( 5.4 )] .
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