FENOFIBRATE capsule

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

American Health Packaging

ІПН (Міжнародна Ім'я):

FENOFIBRATE

Склад:

FENOFIBRATE 134 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The

Огляд продуктів:

Fenofibrate Capsules – Each #1 gelatin capsules contains 134 mg of fenofibrate, micronized. Each capsule is imprinted in black with "G 0522". Unit dose packages of 20 (5 x 4) NDC 68084-835-32 Fenofibrate Capsules – Each #1 gelatin capsules contains 200 mg of fenofibrate, micronized. Each capsule is imprinted in black with "G 0533". Unit dose packages of 30 (3 x 10) NDC 68084-329-21 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

FENOFIBRATE- FENOFIBRATE CAPSULE
AMERICAN HEALTH PACKAGING
----------
FENOFIBRATE CAPSULES, MICRONIZED
8232921/0420
RX ONLY
DESCRIPTION
Fenofibrate capsules (micronized), is a lipid regulating agent
available as capsules for oral
administration. Each capsule contains 67 mg, 134 mg or 200 mg of
micronized
fenofibrate. The chemical name for fenofibrate is
2-[4-(4-chlorobenzoyl) phenoxy]-2-
methyl-propanoic 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 is
a white solid which is
stable under ordinary conditions.
INACTIVE INGREDIENTS: The inactive ingredients in fenofibrate capsules
include
croscarmellose sodium, hypromellose type 2910/6 cP, magnesium
stearate,
microcrystalline cellulose, and sodium lauryl sulfate. The capsule
shells contain gelatin
and titanium dioxide. The 67 mg capsule shells also contain D&C Yellow
No. 10 and FD&C
Yellow No. 6. The 200 mg capsule shells also contain D&C Red No. 28,
D&C Yellow No.
10, and FD&C Red No. 40.
Additionally, the capsule imprint ink contains shellac glaze,
ferrosoferric oxide, propylene
glycol, FD&C Blue No. 2, FD&C Red No. 40, D&C Yellow No. 10 Aluminum
Lake, and
FD&C Blue No. 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 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