Discontinue use in case of sudden decrease or loss of hearing. Not to be used in men for whom sexual activity is inadvisable. Consider CV status prior to initiating therapy. Post-marketing reports of serious CV events, including MI, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage & transient ischemic attack; non-arteritic anterior ischemic optic neuropathy (rare). Patients w/ increased susceptibility to vasodilators including those w/ left ventricular outflow obstruction (eg, aortic stenosis, hypertrophic obstructive cardiomyopathy), or those w/ the rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of BP. Caution in patients w/ retinitis pigmentosa; bleeding disorders or active peptic ulceration; anatomical penis deformation (eg, angulation, cavernosal fibrosis or Peyronie's disease) or conditions predisposing to priapism (eg, sickle cell anemia, multiple myeloma or leukemia). Seek immediate medical assistance in the event of an erection that persists >4 hr. Concomitant use w/ α-blocker. Not recommended in combination w/ other PDE5 inhibitors or other pulmonary arterial HTN treatments. Reports of dizziness & altered vision; caution when driving or operating machinery. Not indicated in women & childn <18 yr.