FENOFIBRATE capsule

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Cipla USA Inc.,

INN（国际名称）:

FENOFIBRATE

组成:

FENOFIBRATE 67 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Treatment of Hypercholesterolemia 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. > 2,00

產品總結:

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 69097-894-02 Bottles of 30 capsules NDC 69097-894-07 Bottles of 100 capsules NDC 69097-894-15 Bottles of 1,000 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 69097-895-02 Bottles of 30 capsules NDC 69097-895-07 Bottles of 100 capsules NDC 69097-895-12 Bottles of 500 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 69097-896-02 Bottles of 30 capsules NDC 69097-896-07 Bottles of 100 capsules NDC 69097-896-12 Bottles of 500 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.

授权状态:

Abbreviated New Drug Application

产品特点

FENOFIBRATE- FENOFIBRATE CAPSULE
CIPLA USA 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
20
21
4
complex, apolipoprotein A (apo AI and apo AII) are associated with the
development of
atherosclerosis.