FENOFIBRATE- fenofibrate capsule

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

NuCare Pharmaceuticals,Inc.

ІПН (Міжнародна Ім'я):

FENOFIBRATE

Склад:

FENOFIBRATE 134 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Fenofibrate capsules, USP are indicated as adjunctive therapy to diet for the reduction of LDLC, 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 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 effec

Огляд продуктів:

Fenofibrate capsules, USP (micronized), 134 mg are hard gelatin capsule shells with blue opaque cap and blue opaque body imprinted IG and 471 with black ink. They are supplied as follows: NDC 68071-4088-3 Bottles of 30 STORAGE 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.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

FENOFIBRATE- FENOFIBRATE CAPSULE
NUCARE PHARMACEUTICALS,INC.
----------
DESCRIPTION
Fenofibrate capsules, USP (micronized) are a lipid regulating agent
available as capsules for oral
administration. The chemical name for fenofibrate is
2-[4-(4-chlorobenzoyl) phenoxy]-2-
methylpropanoic acid, 1-methylethyl ester 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 fenofibrate capsule contains the following inactive
ingredients: lactose monohydrate,
crospovidone, povidone, sodium lauryl sulfate, colloidal silicon
dioxide, magnesium stearate, FD&C
Blue No.1, FD&C Red No.3, D&C Yellow No.10, titanium dioxide and
gelatin.
Each 134 mg fenofibrate capsule contains the following inactive
ingredients: lactose monohydrate,
crospovidone, povidone, sodium lauryl sulfate, colloidal silicon
dioxide, magnesium stearate, FD&C
Blue No.1, D&C Red No.28, titanium dioxide and gelatin.
Each 200 mg fenofibrate capsule contains the following inactive
ingredients: lactose monohydrate,
crospovidone, povidone, sodium lauryl sulfate, colloidal silicon
dioxide, magnesium stearate, FD&C
Blue No.1, FD&C Red No.40, FD&C Yellow No.6, titanium dioxide and
gelatin.
The imprinting ink contains shellac, dehydrated alcohol, isopropyl
alcohol, butyl alcohol, propylene
glycol, strong ammonia solution, black iron oxide, potassium hydroxide
and purified water.
USP dissolution test is pending.
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 atherosclero