Vytorin Dosage/Direction for Use

The patient should be placed on a standard cholesterol-lowering diet before receiving Ezetimibe/Simvastatin (VYTORIN) and should continue on this diet during treatment with Ezetimibe/Simvastatin (VYTORIN). The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, and the patient's response. Ezetimibe/Simvastatin (VYTORIN) should be taken as a single daily dose in the evening, with or without food.
In patients with primary hyperlipidemia or mixed hyperlipidemia, the dosage range is 10/10 mg/day through 10/40 mg/day. The recommended usual starting dose is 10/20 mg/day. Initiation of therapy with 10/10 mg/day may be considered for patients requiring less aggressive LDL-C reductions. Patients who require a larger reduction in LDL-C (greater than 55%) may be started at 10/40 mg/day. After initiation or titration of Ezetimibe/Simvastatin (VYTORIN), lipid levels may be analyzed after 2 or more weeks and dosage adjusted, if needed.
Patients with Coronary Heart Disease: In the cardiovascular events risk reduction study (IMPROVE-IT), the starting dose was 10/40 mg once a day in the evening. (See PRECAUTIONS.)
Patients with Renal Impairment/Chronic Kidney Disease: In patients with mild renal insufficiency (estimated GFR ≥60 ml/min/1.73 m²) no dosage adjustment is necessary. In patients with chronic kidney disease and estimated glomerular filtration rate <60 ml/min/1.73 m², the dose of Ezetimibe/Simvastatin (VYTORIN) is 10/20 mg once a day in the evening. In such patients, the use of higher doses should be closely monitored. (See PRECAUTIONS).
Coadministration with Fenofibrate: The dose of Ezetimibe/Simvastatin (VYTORIN) when used concomitantly with fenofibrate is 10/10 mg/day or 10/20 mg/day (see Myopathy/Rhabdomyolysis under PRECAUTIONS).
Patients with Homozygous Familial Hypercholesterolemia: The recommended dosage for patients with homozygous familial hypercholesterolemia is Ezetimibe/Simvastatin (VYTORIN) 10/40 mg/day in the evening. Ezetimibe/Simvastatin (VYTORIN) should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.
In patients taking lomitapide concomitantly with Ezetimibe/Simvastatin (VYTORIN), the dose of Ezetimibe/Simvastatin (VYTORIN) should not exceed 10/40 mg/day (see Myopathy/Rhabdomyolysis under PRECAUTIONS and INTERACTIONS).
Use in the Elderly: No dosage adjustment is required for elderly patients.
Use in Pediatric (10 to 17 Years of Age) Patients: The recommended usual starting dose is 10/10 mg once a day in the evening. The recommended dosing range is 10/10 to a maximum of 10/40 mg/day. Doses should be individualized according to the recommended goal of therapy.
Children <10 years: Treatment with Ezetimibe/Simvastatin (VYTORIN) is not recommended.
Use in Hepatic Impairment: No dosage adjustment is required in patients with mild hepatic insufficiency (Child-Pugh score 5 or 6). Treatment with Ezetimibe/Simvastatin (VYTORIN) is not recommended in patients with moderate (Child-Pugh score 7 to 9) or severe (Child-Pugh score >9) liver dysfunction. (See PRECAUTIONS.)
Coadministration with other medicines: Dosing of Ezetimibe/Simvastatin (VYTORIN) should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.
In patients taking amiodarone, verapamil, diltiazem, or products containing elbasvir or grazoprevir concomitantly with Ezetimibe/Simvastatin (VYTORIN), the dose of Ezetimibe/Simvastatin (VYTORIN) should not exceed 10/20 mg/day (see Myopathy/Rhabdomyolysis under PRECAUTIONS and INTERACTIONS).
In patients taking amlodipine concomitantly with Ezetimibe/Simvastatin (VYTORIN), the dose of Ezetimibe/Simvastatin (VYTORIN) should not exceed 10/40 mg/day (see Myopathy/Rhabdomyolysis under PRECAUTIONS and INTERACTIONS).
The safety and effectiveness of Ezetimibe/Simvastatin (VYTORIN) administered with fibrates, except fenofibrate, have not been studied. Therefore, the combination of Ezetimibe/Simvastatin (VYTORIN) and fibrates, except fenofibrate, should be avoided (see CONTRAINDICATIONS, Myopathy/Rhabdomyolysis under PRECAUTIONS and INTERACTIONS).