FENOFIBRATE tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

NuCare Pharmaceuticals,Inc.

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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

Резиме производа:

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: NDC 68071-4264-9 BOTTLES OF 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.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

FENOFIBRATE- FENOFIBRATE TABLET
NUCARE PHARMACEUTICALS,INC.
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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:
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).
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
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 function (
2.5).
Should be given with meals ( 2.1).
DOSAGE FORMS AND STRENGTHS
Oral Tablets: 54 mg and 160 mg ( 3).
CONTRAINDICATIONS
Severe renal dysfunction, including patients receiving dialysis ( 4,
8.6, 12.3).
Active liver disease ( 4, 5.3).
Gallbladder disease ( 4, 5.5).
Known hypersensitivity to fenofibrate ( 4).
Nursing mothers ( 4, 8.3).
WARNINGS AND PRECAUTIONS
Myopathy and rhabdomyolysis have been reported in patients taking
fenofibrate. The risks for
myopathy and rhabdomyolysis are increased when fibrates are
co-administered 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 can increase serum transaminases. Monitor liver tests,
including ALT, periodicall