Ezetimibe / Simvastatin Dosage

This dosage information may not include all the information needed to use Ezetimibe / Simvastatin safely and effectively. See additional information for Ezetimibe / Simvastatin.

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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.

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.

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.

Dose Adjustments

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.

Precautions

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

It is recommended that liver function tests be performed prior to initiation of treatment with ezetimibe-simvastatin, and thereafter when clinically indicated. Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding, with continued follow-up of frequent liver function tests until results are normal. If AST or ALT levels remain at three times the upper limit of normal, discontinuation of therapy is recommended. Due to the increased risk of myopathy, including rhabdomyolysis, particularly during the first year of treatment, use of the 10 mg/80 mg dose of ezetimibe/simvastatin should be restricted to patients who have been taking ezetimibe/simvastatin 10 mg/80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity.

Ezetimibe/simvastatin may be taken without regard to food.

Dosing of ezetimibe/simvastatin should occur either 2 hours, or more, before or 4 hours, or more, after administration of a bile acid sequestrant.

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