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:

Teva Pharmaceuticals USA Inc

INN（国际名称）:

FENOFIBRATE

组成:

FENOFIBRATE 145 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Fenofibrate tablets for oral use are 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 tablets for oral use are 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 145 mg of Fenofibrate tablets for oral use was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized con

產品總結:

Fenofibrate tablets for oral use are available in two strengths: 48 mg Yellow tablets, imprinted with the code identification letters “FI”, available in bottles of 90 (NDC 0093-7755-98). Yellow tablets, imprinted with the “a” logo and code identification letters “FI”, available in bottles of 90 (NDC 0093-2061-98). 145 mg White tablets, imprinted with the code identification letters “FO”, available in bottles of 90 (NDC 0093-7756-98). White tablets, imprinted with the “a” logo and code identification letters “FO”, available in bottles of 90 (NDC 0093-2060-98). Storage Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.

授权状态:

New Drug Application Authorized Generic

产品特点

FENOFIBRATE- FENOFIBRATE TABLET
TEVA PHARMACEUTICALS USA INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FENOFIBRATE TABLETS FOR ORAL USE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FENOFIBRATE TABLETS
FOR ORAL USE.
FENOFIBRATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
Warnings and Precautions, Hypersensitivity Reactions (5.9)
05/2018
INDICATIONS AND USAGE
Fenofibrate tablets for oral use are a peroxisome
proliferator-activated receptor (PPAR) alpha agonist indicated as an
adjunct to diet:
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).
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
Primary hypercholesterolemia or mixed dyslipidemia: Initial dose of
145 mg once daily (2.2).
Severe hypertriglyceridemia: Initial dose of 48 to 145 mg once daily.
Maximum dose is 145 mg (2.3).
Renally impaired patients: Initial dose of 48 mg once daily (2.4).
Geriatric patients: Select the dose on the basis of renal function
(2.5).
Maybe taken without regard to meals (2.1).
DOSAGE FORMS AND STRENGTHS
Oral Tablets: 48 mg and 145 mg (3).
CONTRAINDICATIONS
Severe renal dysfunction, including dialysis patients (4, 8.6, 12.3).
Active liver disease (4, 5.3).
Gallbladder disease (4, 5.5).
Known hypersensitivity to fenofibrate (4).
Nursing mothers (4, 8.2).
WARNINGS AND PRECAUTIONS
Myopathy and rhabdomyolysis have been reported in patients taking
fenofibrate. Risks are increased during co-
administration with a statin (with a significantly higher rate
observed for gemfibrozil), particularly in elderly patients and
patients with diabetes, renal failure, or hypothyroidism (5.2).
Fenofibrate tablets for oral use can increase seru