Treatment & prevention of progression of benign prostatic hyperplasia (BPH) through alleviating symptoms, reducing prostate size (vol), improving urinary flow rate, & reducing the risk of acute urinary retention (AUR) & the need for BPH-related surgery. Treatment of moderate to severe symptomatic BPH in men w/ enlarged prostate in combination w/ α-blocker tamsulosin.
1 cap (0.5 mg) once daily alone or in combination w/ 0.4 mg α-blocker tamsulosin. Although an improvement may be observed at an early stage, it can take up to 6 mth before a response to the treatment can be achieved.
Patients w/ liver disease. Evaluate men for prostate cancer risk including prostate-specific antigen (PSA) testing regularly. Establish new PSA baseline after 6 mth of treatment. Monitor PSA values regularly thereafter. Evaluate any confirmed increase from lowest PSA level or non-compliance to therapy. Perform digital rectal exam prior to initiating therapy & periodically thereafter. Higher incidence of cardiac failure in combination w/ tamsulosin. Possible male breast cancer; report any changes in the breast tissues eg, lumps or nipple discharge. Mild to moderate hepatic impairment. Women & childn must avoid contact w/ leaking cap.
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