Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A)
AbbVie Inc.
NIACIN
NIACIN 500 mg
PRESCRIPTION DRUG
New Drug Application
ADVICOR- NIACIN AND LOVASTATIN TABLET, EXTENDED RELEASE ABBVIE INC. ---------- ADVICOR (NIACIN EXTENDED-RELEASE/LOVASTATIN TABLETS) DESCRIPTION ADVICOR (niacin extended-release and lovastatin) is intended to facilitate the daily administration of its individual components, Niaspan and lovastatin, when used together for the intended patient population (see INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION). ADVICOR contains niacin extended-release and lovastatin in combination. Lovastatin, an inhibitor of 3- hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, and niacin are both lipid-altering agents. Niacin is nicotinic acid, or 3-pyridinecarboxylic acid. Niacin is a white, nonhygroscopic crystalline powder that is very soluble in water, boiling ethanol and propylene glycol. It is insoluble in ethyl ether. The empirical formula of niacin is C H NO and its molecular weight is 123.11. Niacin has the following structural formula: Lovastatin is [1S -[1(alpha)(R *), 3(alpha), 7(beta), 8(beta)(2S *, 4S *), 8a(beta)]]-1,2,3, 7,8,8a- hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl) ethyl]-1-naphthalenyl 2- methylbutanoate. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. The empirical formula of lovastatin is C H O and its molecular weight is 404.55. Lovastatin has the following structural formula: ADVICOR tablets contain the labeled amount of niacin and lovastatin and have the following inactive ingredients: hypromellose, povidone, stearic acid, polyethylene glycol, titanium dioxide, polysorbate 80. The individual tablet strengths (expressed in terms of mg niacin/mg lovastatin) contain the following coloring agents: ADVICOR 500 mg/20 mg - Iron Oxide Yellow, Iron Oxide Red. ADVICOR 750 mg/20 mg - FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake. ® ® ® 6 5 2 24 36 5 ADVICOR 1000 mg/20 mg - Iron Oxide Red, Iron Oxide Yellow, Iron Oxide Black. ADVICOR 1000 mg/40 mg - Iron Oxide Red. CLINICAL PHARMAC Đọc toàn bộ tài liệu