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Primary hypercholesterolemia / mixed dyslipidemia / hypertriglyceridemia: Reduce total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), non-high-density lipoprotein cholesterol (non-HDL-C), triglycerides (TG), or increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia, mixed dyslipidemia, or hypertriglyceridemia in combination with standard cholesterol-lowering diet when simvastatin or niacin monotherapy is inadequate
Niacin is a component of two coenzymes which is necessary for tissue respiration, lipid metabolism, and glycogenolysis; inhibits the synthesis of very low density lipoproteins.
Simvastatin is a derivative of lovastatin that acts by competitively inhibiting 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the rate-limiting step in cholesterol biosynthesis. In addition to the ability of HMG-CoA reductase inhibitors to decrease levels of high-sensitivity C-reactive protein (hsCRP), they also possess pleiotropic properties including improved endothelial function, reduced inflammation at the site of the coronary plaque, inhibition of platelet aggregation, and anticoagulant effects
Primary hypercholesterolemia / mixed dyslipidemia / hypertriglyceridemia:
Initial dose: Not for use as initial therapy of dyslipidemias. Doses should be individualized according to the baseline LDL-cholesterol levels, the recommended goal of therapy, and the patient's response.
Patients naïve to niacin ER therapy or currently on immediate-release niacin: Niacin ER 500 mg/simvastatin 20 mg once daily at bedtime; increase dose every 4 weeks as needed in increments of not more than 500 mg of niacin.
Patients currently on simvastatin (20 to 40 mg daily): Niacin ER 500 mg/simvastatin 40 mg once daily at bedtime; increase dose every 4 weeks as needed in increments of not more than 500 mg of niacin.
Maintenance dose: Niacin ER 1,000 to 2,000 mg/simvastatin 20 to 40 mg once daily (maximum daily dose: niacin ER 2,000 mg/simvastatin 40 mg).
Note: If therapy is interrupted for >7 days, reinstitution of therapy should begin with the lowest dose followed by retitration as tolerated. May be substituted for equivalent dose of niacin extended-release, however, manufacturer does not recommend direct substitution with immediate-release preparations.
Dosage adjustment with concomitant medications:
Common side effects are Flushing, Headache, Pruritus, Diarrhea, nausea, Back pain
Pregnancy category X. Use is contraindicated in pregnant women.
Store at controlled room temperature of 20°C to 25°C
Niacin + Simvastatin (500mg+20mg)