FENOFIBRATE capsule

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Mylan Pharmaceuticals Inc.

INN (Nama Internasional):

FENOFIBRATE

Komposisi:

FENOFIBRATE 67 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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., > 2000 mg/dL) may increase the risk of developing pancreatitis. The effect of feno

Ringkasan produk:

Fenofibrate Capsules, USP (micronized) are available containing 67 mg, 134 mg or 200 mg of fenofibrate, USP. The 67 mg capsules are hard-shell gelatin capsules with a light orange opaque cap and white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over FE 67 in black ink on the cap and body. They are available as follows: NDC 0378-8628-77 bottles of 90 capsules The 134 mg capsules are hard-shell gelatin capsules with a light orange opaque cap and white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over FE 134 in black ink on the cap and body. They are available as follows: NDC 0378-8629-77 bottles of 90 capsules The 200 mg capsules are hard-shell gelatin capsules with a light orange opaque cap and white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over FE 200 in black ink on the cap and body. They are available as follows: NDC 0378-8630-77 bottles of 90 capsules STORAGE: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Keep out of the reach of children. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

FENOFIBRATE- FENOFIBRATE CAPSULE
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Fenofibrate capsules, USP (micronized) are a lipid regulating agent
available as capsules
for oral administration. The chemical name for fenofibrate is
Isopropyl 2-[_p_-(_p_-
chlorobenzoyl)phenoxy]-2-methylpropionate with the following
structural formula:
The molecular 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,
USP is a white solid
which is stable under ordinary conditions.
Each 67 mg, 134 mg and 200 mg fenofibrate capsule contains the
following inactive
ingredients: colloidal silicon dioxide, corn starch, croscarmellose
sodium, D&C Yellow No.
10, FD&C Yellow No. 6, gelatin, lactose monohydrate, magnesium
stearate, povidone,
sodium lauryl sulfate and titanium dioxide.
The imprinting ink contains black iron oxide, potassium hydroxide,
propylene glycol,
shellac and strong ammonium solution.
_Meets USP Dissolution Test 4._
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, tre