Carefully monitor patients w/ large residual urine vol &/or severely diminished urinary flow for obstructive uropathy. Exclude malignancies prior to treatment. Perform digital rectal exam & other prostate cancer evaluation prior to initiating therapy & periodically thereafter. Serum PSA (S-PSA) >10 ng/mL prompts further evaluation & consideration of biopsy; for levels between 14 & 10 ng/mL, further evaluation is advisable. May cause decreased S-PSA conc in the presence of prostate cancer. Carefully evaluate patient w/ sustained S-PSA. Male patients should wear condom or avoid exposure of female sexual partners at risk of pregnancy. Contraindicated in women who are or may potentially be pregnant. May cause external genitalia abnormalities in male fetus when administered to pregnant woman. Pregnant women should not handle crushed or broken tab. Lactation.