FENOFIBRATE tablet film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

FENOFIBRATE (UNII: U202363UOS) (FENOFIBRATE - UNII:U202363UOS)

Disponibil de la:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (nume internaţional):

FENOFIBRATE

Compoziție:

FENOFIBRATE 160 mg

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

FENOFIBRATE- FENOFIBRATE TABLET, FILM COATED
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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DESCRIPTION
Fenofibrate is a lipid regulating agent available as tablets for oral
administration. Each tablet contains 54
mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is
2-[4-(4-
chlorobenzoyl)phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester
with the following structural
formula:
The molecular 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 betadex, colloidal silicon dioxide, dibasic
calcium phosphate dihydrate, docusate
sodium with sodium benzoate, hypromellose, magnesium stearate,
microcrystalline cellulose,
polyethylene glycol, polysorbate 80, sodium starch glycolate and
titanium dioxide. In addition, the 54
mg tablet contains D&C Yellow No. 10 Lake and FD&C Yellow No. 6 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 triglyceride
rich lipoprotein (VLDL) in treated
patien