Increased risk of adverse events (including cardiac failure) in combination therapy. Regularly evaluate men on therapy for prostate cancer. Establish a new PSA baseline after 6 mth of treatment & regularly monitor PSA values thereafter. Perform digital rectal exam, as well as other evaluations for prostate cancer or other conditions which can cause same symptoms as BPH prior to initiating therapy & periodically thereafter. Incidence of CV adverse events (cardiac failure). Promptly report any changes in breast tissue eg, lumps or nipple discharge. Orthostatic & symptomatic hypotension. Concomitant use w/ PDE5 inhibitors (eg, sildenafil, tadalafil, vardenafil). Intraoperative floppy iris syndrome. Not recommended to initiate therapy in patients scheduled for cataract surgery; consider discontinuing treatment 1-2 wk prior to surgery anecdotally helpful. Avoid contact w/ leaking cap. Not recommended in patients taking a strong CYP3A4 inhibitor (eg, ketoconazole) & caution in patients taking a moderate CYP3A4 inhibitor, a strong or moderate CYP2D6 inhibitor (eg, paroxetine), a combination of both CYP3A4 & CYP2D6 inhibitors, or in patients known to be poor metabolisers of CYP2D6. Contains colouring agent sunset yellow. Severe renal impairment (CrCl <10 mL/min). Mild to moderate hepatic impairment. Possibility of reduced male fertility. Lactation.
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