FENOFIBRATE tablet film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

FENOFIBRATE (UNII: U202363UOS) (FENOFIBRIC ACID - UNII:BGF9MN2HU1)

Disponibil de la:

REMEDYREPACK INC.

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
REMEDYREPACK INC.
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FENOFIBRATE TABLETS, USP
RX ONLY
DESCRIPTION
Fenofibrate tablets, USP 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 molecular
structure:
The molecular formula is C
H
O
Cl and the molecular weight is 360.83; fenofibrate, USP is very
soluble in methylene chloride, slightly soluble in alcohal and
prectically insoluble in water. The
melting point is 79 - 82° C. Fenofibrate, USP is a white or almost
white crystalline powder.
INACTIVE INGREDIENTS: Each tablet contains colloidal silicon dioxide,
crospovidone, lecithin (soya),
microcrystalline cellulose, polyvinyl alcohol, povidone,
pregelatinized starch, sodium lauryl sulfate,
sodium stearyl fumarate, talc, titanium dioxide and xanthan gum.
Meets USP Dissolution Test 2.
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 addi