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Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes. The major circulating metabolite results from N-desmethylation of sildenafil, and is itself further metabolized. This metabolite has a PDE selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50 of the parent drug. Plasma concentrations of this metabolite are approximately 40 of those seen for sildenafil, so that the metabolite accounts for about 20 of sildenafil's pharmacologic effects. After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the feces (approximately 80 of administered oral dose) and to a lesser extent in the urine (approximately 13 of the administered oral dose). Similar values for pharmacokinetic parameters were seen in normal volunteers and in the patient population, using a population pharmacokinetic approach.

Affiliations. Leigh is a member of the Society for Human Resource Management and The Organizational Development Network. He also volunteers for Junior Achievement and The Center for Faith and Work in Kansas City.]