Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Erectile Dysfunction
To facilitate attainment of a sexually functional erection in males with erectile dysfunction (ED, impotence).
Most experts currently recommend that selective PDE type 5 inhibitors be offered as first-line therapy for erectile dysfunction unless contraindicated. Insufficient evidence to support the superiority of one selective PDE type 5 inhibitor over another.
Pulmonary Arterial Hypertension
Symptomatic treatment (e.g., to improve exercise capacity) of pulmonary arterial hypertension (PAH; WHO group I pulmonary hypertension).
Precise role (alone and combined with other therapies) remains to be fully elucidated. Whether long-term sildenafil therapy has a beneficial effect on mortality remains to be established; some preliminary data suggest a survival benefit.
Dosage and Administration
General
Erectile Dysfunction
Carefully individualize dosage according to the patient’s tolerance and erectile response.
Sexual stimulation is required for response to therapy.
Administration
Oral Administration
Erectile Dysfunction
Administer orally no more than once daily.
Administer about 1 hour (range: 4 hours to 30 minutes) before sexual activity.
Administration with a high-fat meal may delay the onset of action.
PAH
Administer orally 3 times daily (approximately 4–6 hours apart) without regard to meals.
Dosage
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Available as sildenafil citrate; dosage expressed in terms of sildenafil.
Adults
Erectile Dysfunction
Oral
Initially, 50 mg. Depending on effectiveness and tolerance, increase dosage to a maximum of 100 mg or decrease to 25 mg.
PAH
Oral
20 mg 3 times daily. Efficacy of lower dosages not established.
Prescribing Limits
Adults
Erectile Dysfunction
Oral
Maximum 100 mg daily.
PAH
Oral
Dosages up to 80 mg 3 times daily have been studied but have not been more effective than recommended dosage of 20 mg 3 times daily.
Special Populations
Hepatic Impairment
Erectile Dysfunction
Oral
Reduce initial dose to 25 mg.
PAH
Oral
No dosage adjustments necessary for mild to moderate hepatic impairment (Child-Pugh class A and B). Not studied in severe hepatic impairment (Child-Pugh class C).
Renal Impairment
Erectile Dysfunction
Oral
If Clcr is <30 mL/minute, reduce initial dose to 25 mg.
PAH
Oral
No dosage adjustment needed, even in severe impairment (Clcr <30 mL/minute).
Geriatric Patients
Erectile Dysfunction
Oral
Reduce initial dose to 25 mg in men ≥65 years of age.
PAH
Oral
Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.
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