Drug Interaction Report

MONITOR: Coadministration with levacetylleucine may increase the plasma concentrations (AUC) and adverse effects of drugs that are substrates of the P-glycoprotein (P-gp) efflux transporter. Levacetylleucine is a P-gp inhibitor in vitro. However, clinical data are not available.

MANAGEMENT: If coadministration is clinically necessary, more frequent clinical monitoring for P-gp substrate related adverse reactions is advised and dose adjustments may be required, particularly when levacetylleucine is initiated or withdrawn from concomitant therapy. Consultation with package labeling of the concomitant medication may be advisable.

ADJUST DOSING INTERVAL: Food may reduce the oral bioavailability of silodosin. The effect of a moderate-fat, moderate-calorie meal on silodosin pharmacokinetics was variable and decreased silodosin maximum plasma concentration (Cmax) by approximately 18% to 43% and systemic exposure (AUC) by 4% to 49% across three different studies. The maximum effect of food (i.e., coadministration with a high-fat, high-calorie meal) on the pharmacokinetics of silodosin was not evaluated. Safety and efficacy clinical trials for silodosin were always conducted in the presence of food intake.

MANAGEMENT: Patients should be instructed to take silodosin with a meal to reduce the risk of adverse events.