Potential increased risk of adverse events (including cardiac failure) w/ combination therapy. Not approved for the prevention of prostate cancer. May increase the risk of high-grade prostate cancer. Establish a new PSA baseline after 6 mth of treatment & monitor PSA values regularly thereafter. Digital rectal exam, as well as other evaluations for prostate cancer or other conditions which can cause the same symptoms as BPH, must be performed prior to initiating therapy & periodically thereafter. Rare reports of male breast cancer in men taking dutasteride. Promptly report any changes in breast tissue eg, lumps or nipple discharge. Patients beginning treatment should sit or lie down at the 1st signs of orthostatic hypotension until symptoms resolve. Concomitant use of α
1-adrenoceptor antagonists including tamsulosin & PDE5 inhibitors (eg, sildenafil, tadalafil, vardenafil) can potentially cause symptomatic hypotension. Risk of intraoperative floppy iris syndrome during cataract surgery in patients on or previously treated w/ tamsulosin. Initiation of therapy is not recommended in patients for whom cataract surgery is scheduled. Contact w/ contents of dutasteride soft gel cap contained w/in the hard-shell cap may result in irritation of the oropharyngeal mucosa. Area that made contact w/ leaking cap should be washed immediately w/ soap & water. Tamsulosin HCl is not recommended in patients taking a strong CYP3A4 inhibitor & should be used w/ caution in patients taking a moderate CYP3A4 inhibitor, a strong or moderate CYP2D6 inhibitor, a combination of both CYP3A4 & CYP2D6 inhibitors, or in poor CYP2D6 metabolisers. May impair ability to drive or operate machinery. Caution in patients w/ severe renal impairment (CrCl <10 mL/min); mild to moderate hepatic impairment. Patient's partner (pregnant or potentially pregnant) should avoid exposure to patient's semen by use of a condom. Possibility of reduced male fertility.
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