FENOFIBRATE tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Proficient Rx LP

INN (Nome Internazionale):

FENOFIBRATE

Composizione:

FENOFIBRATE 160 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 trigly

Dettagli prodotto:

Fenofibrate tablets, USP 160 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “RX901 ” on one side and plain on the other side. They are supplied as follows. NDC 63187-760-30 Bottles of 30 NDC 63187-760-60 Bottles of 60 NDC 63187-760-90 Bottles of 90 Store at 20° - 25° C (68° - 77° F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture. You may report side effects to FDA at 1-800-FDA-1088 .

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

FENOFIBRATE- FENOFIBRATE TABLET, FILM COATED
PROFICIENT RX LP
----------
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 addit