Simvastatin Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Prevention of Cardiovascular Disease

Usual dosage range: 5 to 40 mg orally once a day in the evening

Patients with CHD or at high risk of CHD:
Initial dose: 10 to 20 mg orally once a day in the evening started simultaneously with diet and exercise

Patients at high risk for a CHD event due to existing CHD, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease:
Initial dose: 40 mg orally once a day in the evening

Comments:
-Therapy should be individualized according to patient response.
-Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter.
-Due to the increased risk of myopathy (including rhabdomyolysis), particularly during the first year of treatment, use of the 80 mg dose should be restricted to patients who have been taking 80 mg for 12 months or more without evidence of muscle toxicity.

Usual Adult Dose for Cardiovascular Risk Reduction

Usual dosage range: 5 to 40 mg orally once a day in the evening

Patients with CHD or at high risk of CHD:
Initial dose: 10 to 20 mg orally once a day in the evening started simultaneously with diet and exercise

Patients at high risk for a CHD event due to existing CHD, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease:
Initial dose: 40 mg orally once a day in the evening

Comments:
-Therapy should be individualized according to patient response.
-Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter.
-Due to the increased risk of myopathy (including rhabdomyolysis), particularly during the first year of treatment, use of the 80 mg dose should be restricted to patients who have been taking 80 mg for 12 months or more without evidence of muscle toxicity.

Usual Adult Dose for Homozygous Familial Hypercholesterolemia

Recommended dose: 40 mg orally once a day in the evening

Comments:
-Simvastatin should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable.

Usual Pediatric Dose for Heterozygous Familial Hypercholesterolemia

Less than 10 years: Not recommended

10 years or older:
Initial dose: 10 mg orally once a day in the evening
Maintenance dose: 10 to 40 mg orally once a day in the evening
Maximum dose: 40 mg orally once a day in the evening

Comments:
-Doses should be individualized according to the goal of therapy.
-Dose adjustments should be made at intervals of 4 weeks or more.
-Prior to treatment initiation patients should be placed on a standard cholesterol lowering diet, which should continue during treatment.

Approved indication:
-As an adjunct to diet to reduce total-C, LDL-C, and Apo B levels in adolescent boys and girls who are at least one year postmenarche, 10 to 17 years of age, with HeFH, if after an adequate trial of diet therapy the following findings are present:
1. LDL cholesterol remains 190 mg/dL or greater; or
2. LDL cholesterol remains 160 mg/dL or greater and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors are present in the adolescent patient. The minimum goal of treatment in pediatric and adolescent patients is to achieve a mean LDL-C less than 130 mg/dL.
-The optimal age at which to initiate lipid-lowering therapy to decrease the risk of symptomatic adulthood CAD has not been determined.

Renal Dose Adjustments

Mild to moderate renal dysfunction: No adjustment recommended
Severe renal dysfunction: Initial dose should be 5 mg orally once a day in the evening and should be closely monitored.

Liver Dose Adjustments

-Contraindicated in patients with active liver disease which may include unexplained persistent elevations in hepatic transaminase
-Persistent ALT or AST elevation of 3 times the upper limit of normal: Treatment discontinuation is recommended
-Substantial alcohol ingestion and/or past history of liver disease: Use with caution

Dose Adjustments

- Adjustments in dosage should be made in intervals of 4 weeks or more.
-Simvastatin should be temporarily stopped a few days prior to elective major surgery.
-Patients who are currently tolerating the 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 with less potential for the drug-drug interaction.
-Because of the increased risk of myopathy (including rhabdomyolysis) associated with the 80 mg dose, patients unable to achieve their LDL-C goal utilizing the 40 mg dose should not be titrated to the 80 mg dose, but should be placed on alternative LDL-C-lowering treatment(s) that provide greater LDL-C lowering.
-Coadministration with Other Drugs:
1) Concomitant use with verapamil, diltiazem, or dronedarone: The dose of simvastatin should not exceed 10 mg per day.
2) Concomitant use with amiodarone, amlodipine, or ranolazine: The dose of simvastatin should not exceed 20 mg per day.
3) Simvastatin is effective alone or in combination with bile acid sequestrants. Dosing should occur either more than 2 hours before or more than 4 hours after administration of bile acid sequestrants.
4) In patients taking cyclosporine, danazol, gemfibrozil, or other fibrates (except fenofibrate) concomitantly with simvastatin, the dose of simvastatin should not exceed 10 mg per day.
5) In patients taking amiodarone or verapamil concomitantly with simvastatin, the dose of simvastatin should not exceed 20 mg per day.
6) In patients taking diltiazem or amlodipine concomitantly with Simvastatin, the dose of Simvastatin should not exceed 40 mg per day.
7) Simvastatin exposure is approximately doubled with concomitant use of lomitapide. The dose of simvastatin should be reduced by 50% if adding lomitapide. Simvastatin dosage should not exceed 20 mg per day (or 40 mg per day for patients who have previously taken 80 mg per day for 12 months or more, without evidence of muscle toxicity) while taking lomitapide.
-Because of an increased risk for myopathy in Chinese patients taking simvastatin 40 mg per day coadministered with lipid modifying doses (greater than or equal to 1 g per day niacin) of niacin containing products, caution should be used when treating Chinese patients with simvastatin doses exceeding 20 mg per 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 per day 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.
-Concomitant intake of grapefruit juice and simvastatin should be avoided.

Precautions

-Simvastatin has not been studied in patients younger than 10 years of age, in premenarchal girls, nor at doses greater than 40 mg per day. Safety and efficacy have only been evaluated in patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, with female patients at least one year post menarche. Long-term use of simvastatin in childhood to reduce morbidity and mortality in adulthood has not been established.

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Simvastatin should be taken as single dose in the evening.
-Simvastatin can be taken with or without food.

General:
-Before and during simvastatin treatment, patients should be placed on a conventional low cholesterol diet.
-Cholesterol levels should be monitored periodically with consideration given to reducing the dosage if cholesterol levels fall significantly below the targeted range.
-Prior to initiating statin therapy, 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.
-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.

Patient advice:
-Simvastatin may cause dizziness, avoid driving or operating machinery if you are affected.
-Grapefruit juice should be avoided during simvastatin treatment.
-All patients starting simvastatin should be advised of the risk of myopathy and told to report as soon as possible any symptoms suggestive of myopathy (e.g., unexplained muscle pain, tenderness, or weakness).

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