Niacindrug info
24 HR niacin 500 MG Extended Release Oral Tablet
What it is used for
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 hyperlipidemia. Niacin 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. Niacin extended-release tablets are indicated to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction. In patients with a history of coronary artery disease (CAD) and hyperlipidemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease. Niacin extended-release tablets in combination with a bile acid binding resin is indicated to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia. Niacin is also indicated as adjunctive therapy for treatment of adult patients with severe hypertriglyceridemia who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Limitations of Use Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH). Niacin extended-release tablets contain extended-release niacin (nicotinic acid), and are indicated: To reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. To reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia. In combination with a bile acid binding resin: Slows progression or promotes regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia. As an adjunct to diet to reduce elevated TC and LDL-C in adult patients with primary hyperlipidemia. To reduce TG in adult patients with severe hypertriglyceridemia.
Limitations of use: Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective December 25, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Niacin Extended-release Tablets, USP (niacin tablet, film-coated extended-release), contain niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula: Niacin extended-release tablets are unscored, red, film-coated tablets for oral administration and are available in two tablet strengths containing 500 and 1000 mg niacin. Niacin extended-release tablets also contain the inactive ingredients black iron oxide, colloidal silicon dioxide, hydroxypropyl cellulose, lecithin, polyethylene glycol, polyvinyl alcohol, red iron oxide, sodium stearyl fumarate, talc, titanium dioxide, and yellow iron oxide. USP Dissolution Test 5. chemstruct
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective December 25, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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