FENOFIBRATE capsule

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Northstar Rx LLC

ІПН (Міжнародна Ім'я):

FENOFIBRATE

Склад:

FENOFIBRATE 67 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). Treatment of Hypertriglyceridemia 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

Огляд продуктів:

Fenofibrate capsules, USP (micronized), 67 mg are hard gelatin capsule shells with pink opaque cap and pink opaque body imprinted IG and 470 with black ink. They are supplied as follows: NDC 16714-739-01 Bottles of 90 capsules NDC 16714-739-02 Bottles of 100 capsules 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 16714-740-01 Bottles of 90 capsules NDC 16714-740-02 Bottles of 100 capsules Fenofibrate capsules, USP (micronized), 200 mg are hard gelatin capsule shells with orange opaque cap and orange opaque body imprinted IG and 472 with black ink. They are supplied as follows: NDC 16714-741-01 Bottles of 90 capsules NDC 16714-741-02 Bottles of 100 capsules 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
NORTHSTAR RX LLC
----------
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
20
21
4
complex, apolipoprotein A (apo AI and apo AII) are associated with the
development of
atherosclerosis