Simvastatin Dosage

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

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Hyperlipidemia

Initial dose: 10 to 20 mg orally once a day in the evening.
Maintenance dose: 5 to 40 mg orally once a day in the evening.

For patients at high risk for a CHD event due to existing CHD, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, the recommended starting dose is 40 mg orally once a day.

Usual Adult Dose for Cardiovascular Risk Reduction

Initial dose: 10 to 20 mg orally once a day in the evening.
Maintenance dose: 5 to 40 mg orally once a day in the evening.

For patients at high risk for a CHD event due to existing CHD, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, the recommended starting dose is 40 mg orally once a day.

Usual Adult Dose for Homozygous Familial Hypercholesterolemia

Children and Adolescents:

Heterozygous familial hypercholesterolemia:
Adolescents 10 to 17 years: 10 mg once daily in the evening
May increase dose in intervals of 4 weeks or more to a maximum of 40 mg/day

Hyperlipidemia: Limited data in 32 children (less than 17 years of age) enrolled in compassionate use study:
Children less than 10 years: 5 mg once daily in the evening increasing to 10 mg once daily after 4 weeks and to 20 mg once daily after 8 weeks as tolerated.
Children greater than or equal to 10 years: 10 mg once daily in the evening increasing to 20 mg once daily after 6 weeks and to 40 mg once daily after 12 weeks as tolerated.

Note: A lower, conservative dosing regimen may be necessary in patient populations predisposed to myopathy including patients of Chinese descent or those concurrently receiving other lipid-lowering agents (e.g., niacin, fibric acid derivatives), amiodarone, amlodipine, ranolazine, or verapamil.

Usual Pediatric Dose for Heterozygous Familial Hypercholesterolemia

10 to 17 years:
Initial dose: 10 mg orally once a day in the evening.
Maintenance dose: 10 to 40 mg/day (the maximum recommended dose is 40 mg/day). Dosage increases should be done at intervals of 4 weeks or more.

Renal Dose Adjustments

CrCl less than 25 mL/min: Initial dose: 5 mg once a day in the evening.
Maintenance dose: Dosage increases should be done with careful monitoring for adverse reactions.

Liver Dose Adjustments

The use of this drug is contraindicated in patients with liver dysfunction.

Dose Adjustments

Adjustments in dosage should be made in intervals of 4 weeks or more.

The dose of simvastatin should not exceed 10 mg daily in patients receiving concomitant therapy with verapamil, diltiazem, or amiodarone. The dose of simvastatin should not exceed 20 mg daily in patients receiving concomitant therapy with amlodipine or ranolazine. The benefits of the use of simvastatin in patients receiving other lipid-lowering drugs (other fibrates or greater than 1 g/day of niacin), amiodarone, verapamil, diltiazem, amlodipine, or ranolazine should be carefully weighed against the risks of these combinations.

Because of an increased risk for myopathy in Chinese patients taking simvastatin 40 mg coadministered with lipid modifying doses (greater than or equal to 1 g/day niacin) of niacin containing products, caution should be used when treating Chinese patients with simvastatin doses exceeding 20 mg/day coadministered with lipid modifying doses of niacin containing products. Because the risk for myopathy is dose-related, Chinese patients should not receive simvastatin 80 mg coadministered with lipid modifying doses of niacin containing products. It is unknown if the risk for myopathy with coadministration of simvastatin with lipid modifying doses of niacin containing products observed in Chinese patients applies to other Asian patients.

Precautions

Simvastatin is associated with elevations in liver function tests (LFTs greater than 3 times the upper limit of normal) in 1% of patients. Baseline liver function tests, followed by periodic reevaluations during the first year of therapy are recommended. More frequent evaluations may be needed in those patients who have elevated values, an increase in simvastatin dose or the addition of interacting drugs that may increase serum levels. Simvastatin should be discontinued in patients who develop persistent, significant (three times normal values) elevations in LFTs.

Due to the increased risk of myopathy, including rhabdomyolysis, particularly during the first year of treatment, use of the 80 mg dose of simvastatin should be restricted to patients who have been taking simvastatin 80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity.

Patients who are currently tolerating the 80 mg dose of simvastatin 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 with less potential for interaction.

Due to the increased risk of myopathy, including rhabdomyolysis, associated with the 80 mg dose of simvastatin, patients unable to achieve their LDL-C goal utilizing the 40 mg dose of simvastatin should not be titrated to the 80 mg dose, but should be placed on alternative LDL-C lowering treatment.

Dialysis

Data not available

Other Comments

Cholesterol levels should be monitored periodically with consideration given to reducing the dosage if cholesterol levels fall significantly below the targeted range.

It has been suggested that prior to initiating statin therapy, all patients should have a baseline serum creatine kinase (CK) enzyme level measured and if at any time after initiating therapy a patient complains of muscle soreness, tenderness, or pain another CK level should be drawn for comparison. If elevated, the drug should be discontinued.

The results of one study indicate that withdrawal of HMG-CoA reductase inhibitors (statins; atorvastatin, fluvastatin, pravastatin, simvastatin) during the perioperative period in patients with acute coronary syndromes is associated with an increased risk for perioperative adverse cardiac events (i.e., increase postoperative troponin release and the combination of myocardial infarction and cardiovascular death). Patients receiving statins with extended-release formulations (i.e., fluvastatin) appeared to be associated with more favorable outcomes. Other studies appear to confirm these findings.

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