Niacin/Simvastatin indications and usage

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Niacin/Simvastatin
SIMCOR® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Labels and Packages
Clinical Trials on Niacin/Simvastatin
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Indications and Usage

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.

Patients with hypercholesterolemia Requiring Modifications of Lipid Profiles

SIMCOR

SIMCOR is indicated to reduce Total-C, LDL-C, Apo B, non-HDL-C, TG, or to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia when treatment with simvastatin monotherapy or Niacin extended-release monotherapy is considered inadequate.

SIMCOR is indicated to reduce TG in patients with hypertriglyceridemia when treatment with simvastatin monotherapy or Niacin extended-release monotherapy is considered inadequate.

Limitations of use

No incremental benefit of SIMCOR on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin monotherapy and Niacin monotherapy has been established.

Niacin extended-release, one of the components of SIMCOR, at doses of 1,500 – 2,000 mg/day, in combination with simvastatin, did not reduce the incidence of cardiovascular events more than simvastatin in a randomized controlled trial of patients with cardiovascular disease and mean baseline LDL-C levels of 74 mg per deciliter[see Warnings and Precautions (5.1)].[1]

References

  1. "SIMCOR ([[Niacin]] AND SIMVASTATIN) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]". Retrieved 19 February 2014. URL–wikilink conflict (help)

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