Sildenafil Monograph for Professionals - Drugs.com

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• To facilitate attainment of a sexually functional erection in males with erectile dysfunction

• Insufficient evidence to support the superiority of one selective PDE type 5 inhibitor over another

• Symptomatic management of PAH (WHO group 1 pulmonary hypertension) to improve exercise capacity and delay clinical worsening.

• Use with caution in the treatment of ED in patients with a recent (within 6 months) MI, stroke, or life-threatening arrhythmia; in patients with resting hypotension (BP <90/50 mm Hg) or hypertension (BP >170/110 mm Hg); or in patients with cardiac failure or CAD causing unstable angina.

• Symptomatic hypotension may occur in patients receiving concomitant α-adrenergic blocking agents; hypotension may be severe or fatal in patients receiving an organic nitrate or nitrite concomitantly.

• Nonarteritic anterior ischemic optic neuropathy (NAION) reported rarely in patients receiving PDE type 5 inhibitors for the treatment of ED. Potential increased risk of NAION in the second eye in patients who already have had NAION in one eye

• Possible visual disturbances (e.g., blue/green vision, changes in light sensitivity), particularly at high doses. Possible persistent and/or serious retinal changes in older patients or with long-term use.

• Sudden decrease or loss of hearing reported with all PDE type 5 inhibitors, including sildenafil. Adverse otic effects (e.g., deafness, otic pain, tinnitus) observed in a few patients in controlled clinical trials. In at least 1 case, permanent, bilateral sensorineural deafness occurred.

• Possible prolonged (>4 hours) erections and priapism (painful erection >6 hours).

• May result in penile tissue damage and permanent loss of potency if priapism is not treated immediately. Use with caution in patients with conditions predisposing to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia).

• Possible potentiation of systemic vasodilation and symptomatic hypotension

• Concomitant use with potent CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir) substantially increases serum sildenafil concentrations.

• Possible increased systemic exposure of sildenafil

• Potential additive hypotensive effects

• Decreased clearance, increased plasma concentrations of sildenafil, and increased risk of sildenafil-associated adverse effects (e.g., hypotension, visual changes, prolonged erection)

• Possible sudden and marked BP reduction; potentially serious or even fatal

• Potentiation of vasodilatory effects (e.g., decrease in SBP of >25 mm Hg) of organic nitrates and nitrites; potentially life-threatening hypotension and/or hemodynamic compromise can result

• Possible increased inotropic effects in cardiac muscle, vascular smooth muscle relaxation, and platelet-aggregation inhibition; risk of cardiotoxicity, hypotensive, or hemorrhagic event after concomitant use not known, but appears unlikely

• Potentiation of vasodilatory effects (e.g., decrease in SBP of >25 mm Hg) of organic nitrates and nitrites; potentially life-threatening hypotension and/or hemodynamic compromise can result