Dutasteride 0.5 MG Oral Capsule
1 INDICATIONS AND USAGE Dutasteride capsules 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 capsules in combination with the alpha-adrenergic antagonist, tamsulosin, are indicated for the treatment of symptomatic BPH in men with an enlarged prostate. (1.2) Limitations of Use: Dutasteride capsules are 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 capsules in combination with the alpha-adrenergic antagonist, tamsulosin, are indicated for the treatment of symptomatic BPH in men with an enlarged prostate. 1.3 Limitations of Use Dutasteride capsules are not approved for the prevention of prostate cancer.
Amneal Pharmaceuticals LLC
OVAL YELLOW A75
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Dutasteride 0.5 MG Oral Capsule
Amneal Pharmaceuticals LLC
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16 HOW SUPPLIED/STORAGE AND HANDLING Dutasteride capsules 0.5 mg are supplied as opaque, yellow, oblong soft gelatin capsules imprinted with “A 75”. They are available as follows: Bottles of 30: NDC 65162-750-03 Bottles of 90: NDC 65162-750-09 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Dutasteride, USP 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, USP and the subsequent potential risk to a developing male fetus [see Warnings and Precautions (5.4) ] .
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