VYTORIN

The results of a bioequivalence trial in healthy subjects demonstrated that the VYTORIN (ezetimibe and simvastatin) 10 mg/10 mg to 10 mg/80 mg combination tablets are bioequivalent to coadministration of corresponding doses of ezetimibe (ZETIA ® ) and simvastatin (ZOCOR ® ) as individual tablets.

AbsorptionEzetimibe After oral administration, ezetimibe is absorbed and extensively conjugated to a pharmacologically active phenolic glucuronide (ezetimibe-glucuronide). Mean maximum plasma concentra...

Primary Hyperlipidemia in Adults VYTORIN VYTORIN reduces LDL-C in adult patients with primary hyperlipidemia. Maximal to near maximal response is generally achieved within 2 weeks and maintained during chronic therapy. VYTORIN is effective in males and females with primary hyperlipidemia. There were insufficient numbers of patients who self-identified as Black or African American, Asian, or other races to determine if these patients responded differently than White patients. Five multicenter, double-blind trials conducted with either VYTORIN or coadministered ezetimibe and simvastatin equivale...

The following serious adverse reactions are discussed in greater detail in other sections of the label: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] Hepatic Dysfunction [see Warnings and Precautions (5.3) ] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4) ] Common (incidence ≥2% and greater than placebo) adverse reactions in clinical trials: headache, increased A...

VYTORIN is contraindicated in the following conditions: Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications, and nefazodone) [see Drug Interactions (7.1) ] . Concomitant use of cyclosporine, danazol, or danazol [see Drug Interactions (7.1) ] . Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ] . Hyp...

Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher VYTORIN dosage. Chinese patients may be at higher risk for myopathy. Discontinue VYTORIN if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue VYTORIN in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inf...

7 DRUG INTERACTIONS VYTORIN See full prescribing information for details regarding concomitant use of VYTORIN with other drugs or grapefruit juice that increase the risk of myopathy and rhabdomyolysis. ( 2.3 , 7.1 ) Cholestyramine: Combination decreases exposure of ezetimibe. ( 2.3 , 7.2 ) Coumarin Anticoagulants: Obtain INR before VYTORIN initiation and monitor INR during VYTORIN dosage initiatio...