FENOFIBRATE- fenofibrate tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Fenofibrate (UNII: U202363UOS) (Fenofibrate - UNII:U202363UOS)

Available from:

Karalex Pharma LLC

INN (International Name):

Fenofibrate

Composition:

Fenofibrate 54 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fenofibrate tablets 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). Fenofibrate tablets 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 triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis.

Product summary:

Fenofibrate tablets is available in two strengths: The 54 mg, AFC tablets, are yellow, round, biconvex, coated tablet, debossed “KLX” on one side and “170" on the other side. NDC 42043-170-09 Bottle of 90 The 160 mg, AFC tablets, are white, round, biconvex, coated tablet, debossed “KLX” on one side and “171" on the other side. NDC 42043-171-09 Bottle 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FENOFIBRATE- FENOFIBRATE TABLET, COATED
KARALEX PHARMA LLC
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FENOFIBRATE TABLETS
DESCRIPTION
Fenofibrate, 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 structural
formula:
The molecular formula is C
H O C 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.
INACTIVE INGREDIENTS: Each tablet contains betadex, colloidal silicon
dioxide, dibasic calcium
phosphate dihydrate, docusate sodium with sodium benzoate,
hypromellose, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80,
sodium starch glycolate and titanium
dioxide. In addition, the 54 mg tablet contains D&C yellow #10 lake
and FD&C yellow #6 lake.
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 fenof