Ezetimibe / Simvastatin Dosage
Applies to the following strengths: 10 mg-10 mg; 10 mg-20 mg; 10 mg-40 mg; 10 mg-80 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Hyperlipidemia
Initial dose: 10 mg ezetimibe-10 mg simvastatin or 10 mg ezetimibe-20 mg simvastatin orally once a day in the evening.
The dosage range is 10 mg-10 mg to 10 mg-40 mg per day. Initiation of therapy with 10 mg-10 mg per 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 mg-40 mg per day in the absence of moderate to severe renal impairment (estimated glomerular filtration rate less than 60 mL/min/1.73 m2). After initiation or titration, lipid levels may be analyzed after 2 or more weeks and dosage adjusted, if needed.
Due to the increased risk of myopathy, including rhabdomyolysis, particularly during the first year of
treatment, use of the 10/80-mg dose of ezetimibe-simvastatin should be restricted to patients who have been taking the 10/80 mg dose chronically (e.g., for 12 months or more) without evidence of muscle toxicity
Patients should be placed on a standard cholesterol-lowering diet before receiving ezetimibe-simvastatin and should continue on this diet during treatment with ezetimibe-simvastatin. The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, and patient response.
As an adjunct to diet to reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and nonfamilial) hyperlipidemia or mixed hyperlipidemia.
Usual Adult Dose for Homozygous Familial Hypercholesterolemia
10 mg ezetimibe-40 mg simvastatin orally once a day in the evening.
Restricted dosing for 10/80 mg ezetimibe-simvastatin should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.
As an adjunct to diet to reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
Renal Dose Adjustments
CrCl 60 mL/min or greater: No dosage adjustment recommended
CrCl less than 60 mL/min with chronic kidney disease: Dose should be 10 mg ezetimibe-20 mg simvastatin orally once a day in the evening. Doses higher than this should be used with caution and close monitoring.
Liver Dose Adjustments
No dosage adjustment is recommended in patients with mild hepatic impairment.
Ezetimibe-simvastatin is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases. The use of ezetimibe-simvastatin is not recommended in patients with moderate to severe hepatic impairment due to the unknown effects of increased exposure to ezetimibe in such patients.
The dose of simvastatin should not exceed 10 mg daily in patients receiving concomitant therapy with verapamil or diltiazem. The dose of simvastatin should not exceed 20 mg daily in patients receiving concomitant therapy with amiodarone, amlodipine or ranolazine.
Due to the increased risk of myopathy, including rhabdomyolysis, associated with the 10 mg/80 mg dose of ezetimibe/simvastatin, patients unable to achieve their LDL-C goal utilizing the 10 mg/40 mg dose of ezetimibe/simvastatin should not be titrated to the 10 mg/80 mg dose, but should be placed on alternative LDL-C lowering treatment that provides greater LDL-C lowering.
Patients who are currently tolerating the 10/80-mg dose who need to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin should be switched to an alternative statin or statin-based regimen with less potential for the drug-drug interaction.
Caution should be used when treating Chinese patients with ezetimibe-simvastatin doses exceeding 10/20 mg/day coadministered with lipid modifying doses (1 g/day or greater niacin) of niacin containing products due to an increased risk for myopathy in these patients.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Consult WARNINGS section for additional precautions.
Data not available
-Ezetimibe-simvastatin should be taken as a single daily dose in the evening, without regard to meals.
Hepatic: Baseline liver function tests, measured periodically thereafter as clinically indicated; signs and symptoms of serious hepatic injury
Musculoskeletal: Signs and symptoms of myopathy; CK levels
-Grapefruit juice should be avoided during ezetimibe-simvastatin therapy.
-All patients starting therapy with ezetimibe-simvastatin, or whose dose is being increased, should be advised of the risk of myopathy and told to report any unexplained muscle pain, tenderness, or weakness.
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- Drug class: antihyperlipidemic combinations
Other brands: Vytorin