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:

American Health Packaging

INN (International ime):

FENOFIBRATE

Sastav:

FENOFIBRATE 54 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Fenofibrate tablets 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 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 160 mg of fenofibrate tablets was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 d

Proizvod sažetak:

Fenofibrate Tablets, 54 mg are yellow, film-coated, oval shape tablets debossed with “G” on one side and “351” on the other side. They are available as follows: Unit dose packages of 30 (5 x 6) NDC 68084-827-25 Fenofibrate Tablets, 160 mg are white to off-white, film-coated, modified capsule shaped tablets, debossed with “G352” on one side and plain on the other side. They are available as follows: Unit dose packages of 30 (3 x 10) NDC 68084-328-21 STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

FENOFIBRATE- FENOFIBRATE TABLET
AMERICAN HEALTH PACKAGING
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FENOFIBRATE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FENOFIBRATE TABLETS.
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 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
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, 8.2).
WARNINGS AND PRECAUTIONS
Myopathy and rhabdomyolysis have been reported in patients taking
fenofibrate. Risks are increased
during 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 tablets can increase serum transaminases. Moni