Dutasteride 0.5 MG Oral Capsule
1 INDICATIONS AND USAGE Dutasteride 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. Dutasteride 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: Dutasteride is not approved for the prevention of prostate cancer. (1.3) 1.1 Monotherapy Dutasteride 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 Dutasteride 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 Dutasteride is not approved for the prevention of prostate cancer.
camber pharmaceuticals, inc.
OVAL YELLOW AT131
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16 HOW SUPPLIED/STORAGE AND HANDLING
DUTASTERIDE capsules 0.5 mg are yellow, oblong capsules containing clear liquid printed with ‘AT131’ with black ink, packaged in bottles of 30 (NDC 31722-131-30) and 90 (NDC 31722-131-90) with child-resistant closures. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
DUTASTERIDE is absorbed through the skin.
DUTASTERIDE 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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