FIBRICOR- fenofibric acid tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Fenofibric Acid (UNII: BGF9MN2HU1) (Fenofibric Acid - UNII:BGF9MN2HU1)

Dostupno od:

Aralez Pharmaceuticals US Inc.

INN (International ime):

Fenofibric Acid

Sastav:

Fenofibric Acid 35 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

FIBRICOR is indicated as adjunctive therapy to diet for treatment of severe hypertriglyceridemia (≥ 500 mg/dL). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides > 2000 mg/dL may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. FIBRICOR is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia. Fenofibrate at a dose equivalent to 105 mg of FIBRICOR was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) ]. FIBRICOR is contraindicated in: - pat

Proizvod sažetak:

FIBRICOR® (fenofibric acid) Tablets 35 mg, are white, round tablets, debossed "AR 787" on one side and blank on the other side. FIBRICOR® (fenofibric acid) Tablets 105 mg, are white, modified oval tablets, debossed "AR 788" on one side and blank on the other side. Store at USP controlled room temperature 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF) DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Status autorizacije:

New Drug Application

Svojstava lijeka

FIBRICOR- FENOFIBRIC ACID TABLET
ARALEZ PHARMACEUTICALS US INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FIBRICOR (FENOFIBRIC ACID) TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FIBRICOR.
FIBRICOR (FENOFIBRIC ACID) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
Warnings and Precautions (5.9) – 05/2018
INDICATIONS AND USAGE
FIBRICOR is a peroxisome proliferator receptor alpha (PPARα)
activator indicated as an adjunct to diet:
to reduce triglyceride (TG) levels in adult patients with severe
hypertriglyceridemia (≥ 500 mg/dL) (1.1).
to reduce elevated total cholesterol (TC), low-density-lipoprotein
cholesterol (LDL-C), TG and apolipoprotein (Apo) B
and to increase high-density lipoprotein cholesterol (HDL-C) in adult
patients with primary hypercholesterolemia or
mixed dyslipidemia (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 (1.3).
DOSAGE AND ADMINISTRATION
FIBRICOR may be taken without regards to meals (2.1).
Severe hypertriglyceridemia: 35 to 105 mg/day; the dose should be
adjusted according to patient response (2.2).
Primary hypercholesterolemia or mixed dyslipidemia: 105 mg/day (2.3).
Renally impaired patients: Initial dose of 35 mg once daily (2.4).
Geriatric patients: Select the dose on the basis of renal function
(2.5).
DOSAGE FORMS AND STRENGTHS
Oral Tablets: 35 mg and 105 mg (3)
CONTRAINDICATIONS
Severe renal dysfunction, including patients receiving dialysis (4)
Active liver disease (4)
Gallbladder disease (4)
Nursing Mothers (4)
Known hypersensitivity to fenofibric acid or fenofibrate (4)
WARNINGS AND PRECAUTIONS
Myopathy and rhabdomyolysis have been reported in patients taking
fenofibrate. The risks of myopathy and
rhabdomyolysis appears to be increased when fibrates are
co-administered with a statin (with a significantly higher rate
observed for gemfibrozil), parti