Adult ≥18 yr 20 mg tds taken approx 6-8 hr apart. Patient receiving CYP3A4 inhibitors eg, erythromycin or saquinavir 20 mg bd. Patient receiving more potent CYP3A4 inhibitors eg, clarithromycin, telithromycin, nefazodone 20 mg once daily. Renal & hepatic impairment 20 mg bd only if therapy is not well tolerated.
Hypersensitivity. Recent history of stroke or MI, severe hypotension (BP <90/50 mmHg) at initiation; loss of vision in 1 eye due to non-arteritic anterior ischemic optic neuropathy. Co-administration w/ nitric oxide donors (eg, amyl nitrite) or nitrates; guanylate cyclase stimulators eg, riociguat. Combination w/ potent CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir. Severe hepatic impairment.
Discontinue use if any sudden visual defects occur. Not recommended in patients w/ known hereditary degenerative retinal disorders eg, retinitis pigmentosa. Not to be used in patients w/ pulmonary HTN secondary to sickle cell anemia. Anatomical penis deformation (eg, angulation, cavernosal fibrosis or Peyronie's disease) or conditions predisposing to priapism eg, sickle cell anemia, multiple myeloma or leukemia. Serious CV events eg, MI, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, HTN, hypotension. Pulmonary arterial HTN functional class I & IV; fluid depletion, severe left ventricular outflow obstruction or autonomic dysfunction; bleeding disorders or active peptic ulceration; pulmonary HTN associated w/ pulmonary veno-occlusive disease. Avoid abrupt w/drawal. Not to be taken by patients w/ galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. Not recommended in concomitant use w/ other PDE5 inhibitors. Concomitant use w/ α-blockers, vit K antagonist, bosentan. May affect ability to drive & use machines. Not recommended in women of childbearing potential. Not to be used during pregnancy. Lactation. Not recommended in childn <18 yr.
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