FENOFIBRATE capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

AvPAK

INN (International Name):

FENOFIBRATE

Sammensetning:

FENOFIBRATE 134 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and apo B 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 capsules 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. The effect of feno

Produkt oppsummering:

Fenofibrate Capsules – Each #3 gelatin capsule contains 67 mg of fenofibrate, micronized. Each capsule is imprinted in black with "G 0511". Fenofibrate Capsules – Each #1 gelatin capsules contains 134 mg of fenofibrate, micronized. Each capsule is imprinted in black with "G 0522". NDC 50268-309-13 (5 capsules per card, 6 cards per carton). Fenofibrate Capsules – Each #1 gelatin capsules contains 200 mg of fenofibrate, micronized. Each capsule is imprinted in black with "G 0533". Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in Unit Dose Package. For Institutional Use Only.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

FENOFIBRATE- FENOFIBRATE CAPSULE
AVPAK
----------
FENOFIBRATE CAPSULES (MICRONIZED)
RX ONLY
DESCRIPTION
Fenofibrate Capsules (micronized), is a lipid regulating agent
available as capsules for
oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of
micronized
fenofibrate. The chemical name for fenofibrate is
2-[4-(4-chlorobenzoyl) phenoxy]-2-
methyl-propanoic acid, 1-methylethyl ester with the following
structural formula:
The empirical formula is C
H
O
Cl 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: The inactive ingredients in fenofibrate capsules
include
croscarmellose sodium, hypromellose type 2910/6 cP, magnesium
stearate,
microcrystalline cellulose, and sodium lauryl sulfate. The capsule
shells contain gelatin
and titanium dioxide. The 67 mg capsule shells also contain D&C Yellow
No. 10 and FD&C
Yellow No. 6. The 200 mg capsule shells also contain D&C Red No. 28,
D&C Yellow No.
10, and FD&C Red No. 40. Additionally, the capsule imprint ink
contains shellac glaze,
iron oxide black, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40,
D&C Yellow No.
10 Aluminum Lake, and FD&C Blue No. 1.
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 mo