देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
FENOFIBRATE (UNII: U202363UOS) (FENOFIBRIC ACID - UNII:BGF9MN2HU1)
KAISER FOUNDATION HOSPITALS
FENOFIBRATE
FENOFIBRATE 160 mg
ORAL
PRESCRIPTION DRUG
Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g. >2,000 mg/dL) may increase the risk of developing pancreatitis.
Fenofibrate tablet, 160 mg are white to off-white, film-coated, modified capsule shaped tablets, debossed with "G352" on one side and plain on the other side. NDC 0179-0091-80 Bottle of 2160 Tablets Fenofibrate tablet, 54 mg are yellow, film-coated, oval shape tablets debossed with "G" on one side and "351" on the other side. NDC 0179-0103-80 Bottle of 2160 Tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Protect from moisture. Dispense in tightly-closed, light-resistant container as defined in the USP, with a child-resistant closure, as required.
Abbreviated New Drug Application
FENOFIBRATE- FENOFIBRATE TABLET KAISER FOUNDATION HOSPITALS ---------- FENOFIBRATE TABLET 54 MG AND 160 MG RX ONLY DESCRIPTION Fenofibrate tablets are a lipid regulating agent available as tablets for oral administration. Each tablet contains 160 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]- 2-methylpropanoic acid, 1-methylethyl ester with the following structural formula: The empirical formula is C H O Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. INACTIVE INGREDIENTS Each tablet contains: croscarmellose sodium, NF; hypromellose type 2208/100,000 cP, USP; magnesium stearate, NF; and microcrystalline cellulose, NF. The film-coating material contains hypromellose type 2910/ 3 cP, 6 cP and 50 cP; macrogol, polydextrose, titanium dioxide and triacetin. In addition, the 54 mg strength film-coating material also contains D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. CLINICAL PHARMACOLOGY A variety of clinical studies have demonstrated that elevated levels of total cholesterol (total-C), low density lipoprotein cholesterol (LDL-C), and apolipoprotein B (apo B), an LDL membrane complex, are associated with human atherosclerosis. Similarly, decreased levels of high density lipoprotein cholesterol (HDL-C) and its transport complex, apolipoprotein A (apo AI and apo AII) are associated with the development of atherosclerosis. Epidemiologic investigations have established that cardiovascular morbidity and mortality vary directly with the level of total-C, LDL-C, and triglycerides, and inversely with the level of HDL-C. The independent effect of raising HDL-C or lowering triglycerides (TG) on the risk of cardiovascular morbidity and mortality has not been determined. Fenofibric acid, the active metabolite of fenofibrate, produces reductions in total cholesterol, LDL cholesterol, apolipoprotein B, total triglycerides and triglycer पूरा दस्तावेज़ पढ़ें