Vytorin Dosage/Direction for Use

The patient should be placed on a standard cholesterol-lowering diet before receiving VYTORIN and should continue on this diet during treatment with VYTORIN. The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, and the patient's response. 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 10/80 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 VYTORIN, lipid levels may be analyzed after 2 or more weeks and dosage adjusted, if needed. The 10/80 mg dose of VYTORIN is only recommended in patients at high risk for cardiovascular complications who have not achieved their treatment goals on lower doses and when the benefits are expected to outweigh the potential risks. (See Myopathy/Rhabdomyolysis under PRECAUTIONS.)
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. The 10/80-mg dose is only recommended when the benefits are expected to outweigh the potential risks. (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 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 and PHARMACOLOGY: Pharmacokinetics: Characteristics in Patients [Special Populations] under Actions.)
Coadministration with Fenofibrate: The dose of 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 VYTORIN 10/40 mg/day or 10/80 mg/day in the evening. The 10/80-mg dose is only recommended when the benefits are expected to outweigh the potential risks (see previous text, CONTRAINDICATIONS and Myopathy/Rhabdomyolysis under PRECAUTIONS). 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 VYTORIN, the dose of 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 (see PHARMACOLOGY: Pharmacokinetics: Characteristics in Patients [Special Populations] under Actions).
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 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 VYTORIN is not recommended in patients with moderate (Child-Pugh score 7 to 9) or severe (Child-Pugh score >9) liver dysfunction. (See PRECAUTIONS and PHARMACOLOGY: Pharmacokinetics: Characteristics in Patients [Special Populations] under Actions.)
Coadministration with other medicines: Dosing of 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 VYTORIN, the dose of VYTORIN should not exceed 10/20 mg/day (see Myopathy/Rhabdomyolysis under PRECAUTIONS and INTERACTIONS).
In patients taking amlodipine concomitantly with VYTORIN, the dose of VYTORIN should not exceed 10/40 mg/day (see Myopathy/Rhabdomyolysis under PRECAUTIONS and INTERACTIONS).
The safety and effectiveness of VYTORIN administered with fibrates, except fenofibrate, have not been studied. Therefore, the combination of VYTORIN and fibrates, except fenofibrate, should be avoided (see CONTRAINDICATIONS, Myopathy/Rhabdomyolysis under PRECAUTIONS and INTERACTIONS).