Monotherapy or in combination w/ tamsulosin for treatment & control of symptomatic benign prostatic hyperplasia (BPH) in men w/ enlarged prostate to improve symptoms, reduce risk of acute urinary retention & need for BPH-related surgery.
Increased risk of high-grade prostate cancer; CV adverse events. Monitor for obstructive uropathy in patients w/ large residual urinary vol &/or severely diminished urinary flow. Perform digital rectal exam & serum PSA level for prostate cancer detection. Changes in breast tissue eg, lumps or nipple discharge; male breast cancer. Avoid donating blood until at least 6 mth after last dose; contact w/ leaking cap. Mild to moderate hepatic impairment. May affect male fertility. Pregnancy & lactation. Avoid use in women, childn & adolescents.
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