FENOFIBRATE tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

DirectRX

INN (Διεθνής Όνομα):

FENOFIBRATE

Σύνθεση:

FENOFIBRATE 160 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

- Treatment of Hypercholesterolemia Fenofibrate tablets, USP are indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (See National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia Fenofibrate tablets, USP are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

FENOFIBRATE- FENOFIBRATE TABLET, FILM COATED
DIRECTRX
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FENOFIBRATE
DESCRIPTION SECTION
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:
structure
The molecular formula is C20H21O4Cl 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 SECTION
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 addit