Niacin / Simvastatin Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Hyperlipidemia

Initial (for patients not currently on niacin extended-release and patients currently on niacin products other than niacin extended-release): 500 mg-20 mg orally once daily at bedtime with a low fat snack.

Patients already taking simvastatin 20 to 40 mg who need additional management of their lipid levels may be started on a niacin-simvastatin dose of 500 mg-40 mg once daily at bedtime.

Maintenance (depending on patient tolerability and lipid levels): 1000 mg-20 mg to 2000 mg-40 mg once daily at bedtime with a low fat snack

The dose of niacin extended-release should not be increased by more than 500 mg daily every 4 weeks. The efficacy and safety of doses of niacin-simvastatin greater than 2000 mg-40 mg daily have not been studied and are therefore not recommended. If niacin-simvastatin therapy is discontinued for an extended period of time (greater than 7 days), re-titration as tolerated is recommended.

Renal Dose Adjustments

Caution should be exercised when niacin-simvastatin is administered to patients with renal disease.

For patients with severe renal insufficiency, niacin-simvastatin should not be started unless the patient has already tolerated treatment with simvastatin at a dose of 10 mg or higher.

Liver Dose Adjustments

Niacin-simvastatin is contraindicated in patients with active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels.

Dose Adjustments

Niacin-simvastatin should not be substituted for equivalent doses of immediate-release niacin. For patients switching from immediate-release niacin to combination niacin-simvastatin, therapy with niacin-simvastatin should be initiated at 500 mg-20 mg and appropriately titrated to the desired therapeutic response. Doses of niacin-simvastatin greater than 2000 mg-40 mg are not recommended.

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.

Precautions

Niacin-simvastatin is contraindicated in patients with active liver disease (including unexplained elevations in liver function tests), active peptic ulcers, arterial bleeding, women who are pregnant or become pregnant, and in nursing mothers.

The dose of simvastatin should not exceed 10 mg daily in patients receiving concomitant medication with verapamil or diltiazem; therefore, the combination product should be avoided with these drugs.

The dose of simvastatin should not exceed 20 mg daily in patients receiving concomitant medication with amiodarone, amlodipine or ranolazine.

The combined use of simvastatin with drugs that cause myopathy/rhabdomyolysis when given alone, such as fibrates, should be avoided.

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

Dialysis

Data not available

Other Comments

Niacin-simvastatin tablets should be taken whole and should not be broken, crushed, or chewed before swallowing.

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