VYTORIN contains ezetimibe, a dietary cholesterol absorption inhibitor, and simvastatin, an HMG CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C 24 H 21 F 2 NO 3 and its molecular weight is 409.4. Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is...

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VYTORIN VYTORIN ® is a combination of simvastatin and ezetimibe indicated: As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). Simvastatin Simvastatin, when used as a component of ...

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VYTORIN tablets: 10/10, (ezetimibe 10 mg and simvastatin 10 mg tablets) are white to off-white capsule-shaped and debossed with “311” on one side. 10/20, (ezetimibe 10 mg and simvastatin 20 mg tablets) are white to off-white capsule-shaped and debossed with “312” on one side. 10/40, (ezetimibe 10 mg and simvastatin 40 mg tablets) are white to off-white capsule-shaped and debossed with “313” on one side. 10/80, (ezetimibe 10 mg and simvastatin 80 mg tablets) are white to off-white capsule-shaped and...

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Important Dosage and Administration Information: Take VYTORIN orally once daily in the evening with or without food. Maximum recommended dosage is VYTORIN 10/40 mg once daily. VYTORIN 10/80 mg daily dosage is restricted to patients who have been taking VYTORIN 10/80 mg daily chronically (e.g., for 12 months or more) without evidence of muscle toxicity. For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving VYTORIN 10/40 mg daily, prescribe alternative ...

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VYTORIN is contraindicated in the following conditions: Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications, and nefazodone) . Concomitant use of cyclosporine, danazol, or danazol . Acute liver failure or decompensated cirrhosis . Hypersensitivity to simvastatin, ezetimibe, or any excipients in VYTORIN. Hypersensitivity reactions, including anaphylaxis, angioedema, and Stevens-Johnson syndrome, have been reported . Concomitant use ...

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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. Inform ...

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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. Cholestyramine: Combination decreases exposure of ezetimibe. Coumarin Anticoagulants: Obtain INR before VYTORIN initiation and monitor INR during VYTORIN dosage initiation or adjustment. Digoxin : During VYTORIN initiation, monitor digoxin levels. Fenofibrates: Combination increases exposure of ezetimibe. If cholelithiasi...

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8.1 Pregnancy VYTORIN Risk Summary Discontinue VYTORIN when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. VYTORIN decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, VYTORIN may cause fetal harm when administered to pregnant patients based on the mechanism of action . In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is...

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