FENOFIBRATE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Unit Dose Services

INN (nume internaţional):

FENOFIBRATE

Compoziție:

FENOFIBRATE 145 mg

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Statutul autorizaţiei:

New Drug Application Authorized Generic

Caracteristicilor produsului

FENOFIBRATE- FENOFIBRATE TABLET
UNIT DOSE SERVICES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FENOFIBRATE TABLETS FOR ORAL USE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FENOFIBRATE TABLETS
FOR ORAL USE.
FENOFIBRATE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Fenofibrate tablets for oral use are a peroxisome proliferator
receptor alpha (PPARα) activator indicated as an adjunct to
die t:
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).
Maybe 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 tablets for oral use can increase serum transaminases.
Monitor liver tests, in