FENOFIBRATE capsule

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Rhodes Pharmaceuticals L.P.

INN (International ime):

FENOFIBRATE

Sastav:

FENOFIBRATE 67 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Fenofibrate Capsules, USP (micronized) is 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, USP (micronized) is 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 developi

Proizvod sažetak:

Fenofibrate Capsules, USP (micronized) are supplied as follows: 67 mg - pink opaque cap and body, printed radially with "RP" on the cap and "067" on the body. NDC 42858-067-01 Bottles of 100 capsules 134 mg - light blue opaque cap and body, printed radially with "RP" on the cap and "134" on the body. NDC 42858-134-01 Bottles of 100 capsules 200 mg orange opaque cap and body, printed radially with "RP" on the cap and "200" on the body. NDC 42858-200-01 Bottles of 100 capsules Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

FENOFIBRATE- FENOFIBRATE CAPSULE
RHODES PHARMACEUTICALS L.P.
----------
FENOFIBRATE CAPSULES, USP
DESCRIPTION
Fenofibrate Capsules, USP (micronized) is a lipid regulating agent
available as capsules
for oral administration. 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,
USP is very soluble in methylene chloride; slightly soluble in
alcohol; practically insoluble
in water. The melting point is 79 to 82°C. Fenofibrate, USP is a
white or almost white
crystalline powder which is stable under ordinary conditions.
Each 67 mg capsule contains the following inactive ingredients:
croscarmellose sodium,
crospovidone, lactose monohydrate, magnesium stearate, povidone,
pregelatinized
starch, sodium lauryl sulfate, talc, D&C Red #28, FD&C Blue #1, FD&C
Red #40,
titanium dioxide, and gelatin.
Each 134 mg capsule contains the following inactive ingredients:
croscarmellose sodium,
crospovidone, lactose monohydrate, magnesium stearate, povidone,
pregelatinized
starch, sodium lauryl sulfate, talc, D&C Red #28, FD&C Blue #1,
titanium dioxide, and
gelatin.
Each 200 mg capsule contains the following inactive ingredients:
croscarmellose sodium,
crospovidone, lactose monohydrate, magnesium stearate, povidone,
pregelatinized
starch, sodium lauryl sulfate, talc, FD&C Red #40, D&C Red #28,
FDA/E172 yellow iron
oxide, titanium dioxide, and gelatin.
Meets USP Dissolution Test 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 investi