FENOFIBRATE tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Alembic Pharmaceuticals Limited

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

Fenofibrate tablets USP are available in two strengths: Fenofibrate tablets USP, 54 mg are off white to Pale Yellow, Oval shaped, film coated tablets debossed with L778 on one side and plain on other side. They are available as follows: Bottles of 90           NDC 46708-554-90 Fenofibrate tablets USP, 160 mg are off white to Pale Yellow, Oval shaped, film coated tablets debossed with L779 on one side and plain on other side. They are available as follows: Bottles of 90           NDC 46708-555-90 Bottles of 1,000      NDC 46708-555-91 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

FENOFIBRATE - FENOFIBRATE TABLET, FILM COATED
ALEMBIC PHARMACEUTICALS LIMITED
----------
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 tablet 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, per