FENOFIBRATE tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

St Marys Medical Park Pharmacy

INN (International Name):

FENOFIBRATE

Composition:

FENOFIBRATE 160 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FENOFIBRATE - FENOFIBRATE TABLET, FILM COATED
ST MARYS MEDICAL PARK PHARMACY
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FENOFIBRATE TABLETS
RX ONLY
DESCRIPTION
Fenofibrate tablets are a lipid regulating agent available as tablets
for oral administration. Each tablet
contains 54 mg or 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 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 alcohol and
practically insoluble in water. The
melting point is 79 to 82°C. Fenofibrate, USP is a white or almost
white crystalline powder.
INACTIVE INGREDIENTS
Inactive Ingredients: Each tablet contains colloidal silicon dioxide,
crospovidone, lecithin (soya),
microcrystalline cellulose, povidone, pregelatinized starch, sodium
lauryl sulfate, sodium stearyl
fumarate, talc, titanium dioxide and xanthan gum.
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