FENOFIBRATE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

REMEDYREPACK INC.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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

Product samenvatting:

Fenofibrate tablets USP, 54 mg are white to off white, round, biconvex tablets debossed with "LU" on one side and "J41" on the other side. They are available as follows: NDC: 70518-1988-00 PACKAGING: 90 in 1 BOTTLE PLASTIC Storage Store at 20°C to 25°C (68°F to 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

FENOFIBRATE- FENOFIBRATE TABLET
REMEDYREPACK 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, 54 MG AND 160 MG, FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Fenofibrate tablet USP is 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
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 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 can increase serum transaminases. Monitor liver tests,
including ALT, periodically during
therapy ( 5.3).
Fenofibrate can reversibly increase serum creat