FENOFIBRATE- fenofibrate capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FENOFIBRATE (UNII: U202363UOS) (FENOFIBRATE - UNII:U202363UOS)

Available from:

H2-Pharma, LLC

INN (International Name):

FENOFIBRATE

Composition:

FENOFIBRATE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fenofibrate capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-c), Triglycerides (TG) and apolopoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia. Fenofibrate capsules 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 150 mg was not shown to reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitu

Product summary:

Fenofibrate Capsules, USP are available in two strengths: 50 mg: Size 3 white opaque/white opaque gelatin capsule, imprinted in black ink with “50” between lines on the body, “G 246” on the cap and containing a white to almost white paste, available in bottles of 90 (NDC 61269-210-90). 150 mg: Size 1 white opaque/white opaque gelatin capsule, imprinted in green ink with “150” between lines on the body, “G 248” on the cap and containing a white to almost white paste, available in bottles of 90 (NDC 61269-212-90). Store at Controlled Room Temperature, 15°C - 30°C (59°F - 86°F). Keep out of the reach of children. Protect from moisture and light.

Authorization status:

New Drug Application

Summary of Product characteristics

FENOFIBRATE- FENOFIBRATE CAPSULE
H2-PHARMA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FENOFIBRATE CAPSULES, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FENOFIBRATE
CAPSULES, USP.
FENOFIBRATE CAPSULES, USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Fenofibrate capsules are 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)
To reduce triglycerides in adult patients with severe
hypertriglyceridemia (1.2)
Important Limitations of Use:
Fenofibrate at a dose equivalent to 150 mg of fenofibrate was not
shown to reduce coronary heart disease morbidity
and mortality in a large, randomized controlled trial of patients with
type 2 diabetes mellitus (5.1)
DOSAGE AND ADMINISTRATION
Primary hypercholesterolemia or mixed dyslipidemia: 150 mg per day
(2.2)
Severe Hypertriglyceridemia: 50 to 150 mg per day; adjust the dose
according to patient response (2.3)
Renally impaired patients: 50 mg per day; increase the dose according
to the effect on renal function and lipid levels
(2.4)
Geriatric patients: select the dose based on renal function (2.5)
The maximum daily dose is 150 mg per day (2.3)
DOSAGE FORMS AND STRENGTHS
Oral capsules: 50 mg and 150 mg (3)
CONTRAINDICATIONS
Severe renal impairment, including patients receiving dialysis (4,
8.6, 12.3)
Active liver disease (4, 12.3)
Gallbladder disease (4, 5.5)
Known hypersensitivity to fenofibrate or fenofibric acid (4, 5.9)
Nursing Mothers (4,8.3)
WARNINGS AND PRECAUTIONS
Fibrates increase the risk of myopathy, and rhabdomyolysis has been
reported in patients taking fibrates (with a
significantly higher rate observed with gemfibrozil); rhabdomyolysis
risk is increased in the elderly, patients with
diabetes, renal insufficiency or hypothyroidism (5.2)
Fenofibrate can increase s