Drug Interaction Report

GENERALLY AVOID: The safety and efficacy of ezetimibe coadministered with fibrates other than fenofibrate have not been studied. Fibrates can increase cholesterol excretion into the bile and cause cholelithiasis. In dogs, administration of ezetimibe for one month increased the concentration of cholesterol in gallbladder bile by 2- to 4-fold, although administration for one year did not result in gallstone formation or any other adverse hepatobiliary effects. In pharmacokinetic studies, coadministration with fenofibrate (200 mg once daily) and gemfibrozil (600 mg twice daily) increased total ezetimibe concentrations 1.5-fold and 1.7-fold, respectively, in healthy adults. These increases are not considered clinically relevant. Ezetimibe (10 mg once daily) did not significantly affect the pharmacokinetics of fenofibrate or gemfibrozil.

MANAGEMENT: Due to the lack of safety and efficacy data, coadministration of ezetimibe with fibrates other than fenofibrate is not recommended. If cholelithiasis is suspected in a patient receiving such a combination, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered.