Hypersensitivity to the active substances or to any of the excipients.
Active liver disease or unexplained persistent elevations of serum transaminases.
Pregnancy and nursing (see PREGNANCY and NURSING MOTHERS under USE IN PREGNANCY & LACTATION).
When VYTORIN is to be administered with fenofibrate, refer to Package Insert for fenofibrate.
Concomitant administration of potent CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone and drugs containing cobicistat) (see Myopathy/Rhabdomyolysis under PRECAUTIONS and INTERACTIONS).
Concomitant administration of gemfibrozil, cyclosporine, or danazol (see Myopathy/Rhabdomyolysis under PRECAUTIONS and INTERACTIONS).