FENOFIBRATE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

AvPAK

INN (International ime):

FENOFIBRATE

Sastav:

FENOFIBRATE 48 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Fenofibrate tablets USP 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 USP are  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 145 mg of fenofibrate tablets USP was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patient

Proizvod sažetak:

Fenofibrate tablets USP are available in two strengths: 48 mg, yellow colored, oval shaped, film-coated tablets, debossed with "LU" on one side and "B21" on the other side. They are supplied as follows: NDC 50268-310-12 (10 tablets per card, 2 cards per carton). 145 mg, white to off-white colored, oval shaped, film-coated tablets, debossed with "LU" on one side and "B22" on the other side. They are supplied as follows: NDC 50268-311-12 (10 tablets per card, 2 cards per carton). Dispensed in Unit Dose Package. For Institutional Use Only. Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

FENOFIBRATE- FENOFIBRATE TABLET
AVPAK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
FENOFIBRATE TABLETS USP
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FENOFIBRATE TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FENOFIBRATE TABLETS
USP.
FENOFIBRATE TABLETS USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
FENOFIBRATE TABLETS
RX ONLY
INDICATIONS AND USAGE
Fenofibrate 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
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)
May be taken without regard to meals ( 2.1).
DOSAGE FORMS AND STRENGTHS
Oral Tablets: 48 mg and 145 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,
includ