Contraindicated in:

• Hypersensitivity;
• Concurrent use of nitrates, riociguat, or vericiguat;
• Severe renal or hepatic impairment;
• Concurrent use of strong CYP3A4 inhibitors;
• Serious underlying cardiovascular disease (including history of MI, stroke, or serious arrhythmia within 6 mo), cardiac failure, or coronary artery disease with unstable angina, angina with sexual intercourse;
• History of HF, coronary artery disease, uncontrolled hypertension (BP >170/110 mm Hg) or hypotension (BP <90/50 mm Hg), dehydration, autonomic dysfunction, or severe left ventricular outflow obstruction;
• Hereditary degenerative retinal disorders;
• Women.

Use Cautiously in:

• Serious underlying cardiovascular disease or conditions in which sexual activity is not advised;
• History of sudden severe vision loss or non-arteritic ischemic optic neuropathy (NAION); may ↑ risk of recurrence;
• Low cup to disk ratio, age >50 yr, diabetes, hypertension, coronary artery disease, hyperlipidemia, or smoking (↑ risk of NAION);
• Alpha adrenergic blockers (patients should be on stable dose of alpha blockers before treatment, initiate with 50 mg dose);
• Anatomic penile deformity (angulation, cavernosal fibrosis, Peyronie disease);
• Conditions associated with priapism (sickle cell anemia, multiple myeloma, leukemia);
• Concurrent use of moderate CYP3A4 inhibitors (initiate with 50 mg dose);
• History of hearing loss;
• Bleeding disorders or peptic ulceration;
• Pedi: Safety not established in children
• Geri: older adults may be more sensitive to drug effects.