AVODART is 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

· Reduce the risk of the need for BPH-related surgery

The recommended dose of AVODART is 1 capsule (0.5 mg) taken orally once a day. The capsules should be swallowed whole. AVODART may be administered with or without food.

No dosage adjustment is necessary for subjects with renal impairment or for the elderly (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Special Populations: Geriatric and Renal Impairment). Due to the absence of data in patients with hepatic impairment, no dosage recommendation can be made (see PRECAUTIONS: General).

AVODART Soft Gelatin Capsules 0.5mg are oblong, opaque, dull yellow, gelatin capsules imprinted with "GX CE2" in red ink on one side packaged in bottles of 30 (NDC 0173-0712-15) and 90 (NDC 0173-0712-04) with child-resistant closures.

Storage and Handling: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Dutasteride is absorbed through the skin. AVODART Soft Gelatin capsules should not be handled by women who are pregnant or who may become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus (see CLINICAL PHARMACOLOGY: Pharmacokinetics, WARNINGS: Exposure of WomenRisk to Male Fetus, and PRECAUTIONS: Information for Patients and Pregnancy).

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