País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
FENOFIBRATE (UNII: U202363UOS) (FENOFIBRIC ACID - UNII:BGF9MN2HU1)
St Marys Medical Park Pharmacy
FENOFIBRATE
FENOFIBRATE 67 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
FENOFIBRATE- FENOFIBRATE CAPSULE ST MARYS MEDICAL PARK PHARMACY ---------- FENOFIBRATE RX ONLY DESCRIPTION Fenofibrate Capsules (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic 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 79-82°C. Fenofibrate is a white solid which is stable under ordinary conditions. INACTIVE INGREDIENTS: Each capsule also contains croscarmellose sodium, NF; hydroxypropyl methylcellulose, USP; magnesium sulfate, NF; microcrystalline cellulose, NF; and sodium lauryl sulfate, NF. 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 triglyceride rich lipoprotein (VLDL) in treated patients. In addition, treatment with fenofibrate results in increases in high density lipoprotein (HDL) and apoproteins apo AI and apo AII). The effects of fenofibric acid seen in clin Leer el documento completo