Discontinue use if sudden decrease or hearing loss occur. Not recommended in combination w/ other PDE5 inhibitors or other pulmonary HTN treatments. Not to be used in men w/ inadvisable sexual activity. Consider CV status prior to initiating therapy. Serious CV events, including MI, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage & transient ischemic attack; left ventricular outflow obstruction (eg, aortic stenosis, hypertrophic obstructive cardiomyopathy) or severely impaired autonomic control of BP. Non-arteritic anterior ischemic optic neuropathy (NAION). Diabetes, HTN, CAD, hyperlipidemia, smoking; 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). Concomitant use w/ α-blocker. May affect ability to drive & use machines. Not to be used in women & childn <18 yr. Elderly <50 yr.
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