FENOFIBRATE capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Unit Dose Services

INN (nume internaţional):

FENOFIBRATE

Compoziție:

FENOFIBRATE 134 mg

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

FENOFIBRATE- FENOFIBRATE CAPSULE
UNIT DOSE SERVICES
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FENOFIBRATE CAPSULES, MICRONIZED
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.
Each capsule also contains croscarmellose sodium, NF; hydroxypropyl
methylcellulose, USP;
magnesium sulfate, NF; microcrystalline cellulose, NF; and sodium
lauryl sulfate, NF. INACTIVE
INGREDIENTS :
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 se