FENOFIBRATE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

AvPAK

INN (Nama Internasional):

FENOFIBRATE

Komposisi:

FENOFIBRATE 54 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

Fenofibrate tablet, 54 mg are yellow, film-coated, oval shape tablets debossed with "G" on one side and "351" on the other side. Supplied as follows: Fenofibrate tablet, 160 mg are white to off-white, film-coated, modified capsule shaped tablets, debossed with "G352" on one side and plain on the other side. Supplied as follows: Dispensed in blister punch material. For Institutional Use Only. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Protect from moisture. Dispense in tightly-closed, light-resistant container as defined in the USP, with a child-resistant closure, as required.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

FENOFIBRATE- FENOFIBRATE TABLET
AVPAK
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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 empirical formula is C
H
O
Cl and the molecular weight is 360.83; fenofibrate is
insoluble in water. The melting point is 79 to 82°C. Fenofibrate is a
white solid which is
stable under ordinary conditions.
INACTIVE INGREDIENTS
Each tablet contains: croscarmellose sodium, NF; hypromellose type
2208/100,000 cP,
USP; magnesium stearate, NF; and microcrystalline cellulose, NF. The
film-coating
material contains hypromellose type 2910/ 3 cP, 6 cP and 50 cP;
macrogol,
polydextrose, titanium dioxide and triacetin. In addition, the 54 mg
strength film-coating
material also contains D&C Yellow No. 10 Aluminum Lake and FD&C Yellow
No. 6
Aluminum 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.
20
21
4
Fenofibric acid, the active metabolite of fenofibrate, produces
reductions in total
cholesterol, LDL cholesterol, apolipoprotein B, total triglycerides
and triglyceride rich
lipoprotein (