Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A)
Golden State Medical Supply, Inc.
ORAL
PRESCRIPTION DRUG
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. 1. 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. 2. In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction. 3. 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. 4. Niacin extended-release tablets in combination with a bile aci
Niacin Extended-release Tablets, USP, 500 mg, are unscored, red, round, film-coated, convex tablets debossed with “KU” on one side, “320” on the other side. They are supplied as follows: Bottles of 90 NDC 51407-267-90 Niacin Extended-release Tablets, USP, 1000 mg, are unscored, red, oval, film-coated convex tablets debossed with “KU” on one side, “322” on the other side. They are supplied as follows: Bottles of 90 NDC51407-268-90 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
NIACIN- NIACIN TABLET, EXTENDED RELEASE GOLDEN STATE MEDICAL SUPPLY, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION NIACIN THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NIACIN EXTENDED- RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NIACIN EXTENDED-RELEASE TABLETS. NIACIN EXTENDED-RELEASE TABLETS USP, FILM COATED, FOR ORAL USE INITIAL U.S. APPROVAL: 1997 INDICATIONS AND USAGE 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. ( 1) To reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia. ( 1) 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. ( 1) As an adjunct to diet to reduce elevated TC and LDL-C in adult patients with primary hyperlipidemia. ( 1) To reduce TG in adult patients with severe hypertriglyceridemia. ( 1) 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. ( 5.1) DOSAGE AND ADMINISTRATION Niacin extended-release tablets should be taken at bedtime with a low-fat snack. ( 2.1) Dose range: 500 mg to 2000 mg once daily. ( 2.1) Therapy with niacin extended-release tablets must be initiated at 500 mg at bedtime in order to reduce the incidence and severity of side effects which may occur during early therapy and should not be increased by more than 500 mg in any 4-week period. ( 2.1) Maintenance dose: 1000 to 2000 mg once daily. ( 2.2) Doses greater than 2000 mg daily are not recommended. ( 2.2) DOSAGE FORMS AND STRENGTHS Unscored film-coated tablets for oral administration: 500 and 1000 mg niacin extended-relea read_full_document