Effects of food and alcohol on the pharmacokinetics of vardenafil / 中华男科学杂志

ABSTRACT

There is a close relationship between sexual activity and meals or alcohol consumption. It is of great clinical significance for clinicians to understand the effects of food and alcohol on the pharmacokinetics of phosphodiesterase-5 inhibitor vardenafil so as to give correct instructions to patients. Although a high-fat ( > 55% fat calories) meal modestly reduces C(max) by 18% and prolongs t(max) of vardenafil by approximately 1 hour, no significant effects of a typical moderate-fat meal (30% fat calories) on vardenafil pharmacokinetics were observed in a study carried out in 25 healthy adult males. So the adjustment of vardenafil dosage is not warranted based on a wide therapeutic index and the efficacy observed with vardenafil in Phase III studies, which need not be restricted with respect to food. In another study, the pharmacokinetics and safety profile of vardenafil were not affected if it was taken together with 0.5 g/kg ethanol. The above characteristics of vardenafil make the administration more convenient for patients.