FENOFIBRATE tablet

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:

Proficient Rx LP

INN（国际名称）:

FENOFIBRATE

组成:

FENOFIBRATE 160 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Fenofibrate tablet USP is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia. Fenofibrate tablet USP is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate 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 effect of fenofibrate therapy on reducing this risk has not been adequately studied. Fenofibrate at a dose equivalent to 160 mg of fenofibrate tablet USP was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with t

產品總結:

Fenofibrate tablets USP are available as: Fenofibrate tablets USP, 160 mg are white to off-white oval shaped, biconvex film coated tablets, debossed with "LU" on one side and "J42" on the other side. They are available as follows: Bottles of 30                                                   NDC 63187-681-30 Bottles of 60                                                   NDC 63187-681-60 Bottles of 90                                                NDC 63187-681-90 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Keep out of reach of children.

授权状态:

Abbreviated New Drug Application

产品特点

FENOFIBRATE- FENOFIBRATE TABLET
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FENOFIBRATE TABLET SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR FENOFIBRATE TABLET.
FENOFIBRATE TABLETS USP, 54 MG AND 160 MG FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Fenofibrate tablet USP is a peroxisome proliferator receptor alpha
(PPARα) activator indicated as an adjunct to diet:
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Important Limitations of Use: Fenofibrate was not shown to reduce
coronary heart disease morbidity and mortality in
patients with type 2 diabetes mellitus (5.1).
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions (> 2% and at least 1% greater than
placebo) are abnormal liver tests, increased AST,
increased ALT, increased CPK, and rhinitis (6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT LUPIN PHARMACEUTICALS,
INC. AT 1-800-399-2561 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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Dose reduction is required in patients with mild to moderate renal
impairment (8.6).
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 11/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
1.2 Severe Hypertriglyceridemia
To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C
in adult patients with primary
hypercholesterolemia or mixed dyslipidemia (1.1).
For treatment of adult patients with severe hypertriglyceridemia
(1.2).
Primary hypercholesterolemia or mixed dyslipidemia: Initial dose of
160 mg once daily (2.2).
Severe hypertriglyceridemia: Initial dose of 54 to 160 mg once daily.
Maximum dose is 160 mg (2.3).
Renally impaired patients: Initial dose of 54 mg once daily (2.4).
Geriatric patients: Select the dose on the basis of renal