FENOFIBRATE- fenofibrate capsule

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Mylan Pharmaceuticals Inc.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 apolipoprotein 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 reduce fasting triglycerides and eliminate chylomicronemia thereby obviating 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 was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus

Product samenvatting:

Fenofibrate Capsules, USP (micronized) are available containing 43 mg or 130 mg of fenofibrate, USP. The 43 mg capsules are hard-shell gelatin capsules with a salmon opaque cap and flesh opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over 6088 in black ink on the cap and body. They are available as follows: NDC 0378-6088-93 bottles of 30 capsules The 130 mg capsules are hard-shell gelatin capsules with a salmon opaque cap and salmon opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over 6089 in black ink on the cap and body. They are available as follows: NDC 0378-6089-93 bottles of 30 capsules NDC 0378-6089-77 bottles of 90 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

FENOFIBRATE- FENOFIBRATE CAPSULE
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FENOFIBRATE CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FENOFIBRATE
CAPSULES.
FENOFIBRATE CAPSULES (MICRONIZED), FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
Warnings and Precautions (5.9) 11/2018
INDICATIONS AND USAGE
Fenofibrate is a peroxisome proliferator receptor alpha (PPARα)
activator indicated as an adjunct to diet:
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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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
to reduce elevated LDL-C, Total-C, triglycerides, and Apo B, and to
increase HDL-C in adult patients with primary
hypercholesterolemia or mixed dyslipidemia (1.1).
to reduce triglyceride (TG) levels in adult patients with severe
hypertriglyceridemia (1.2).
Fenofibrate capsules can be taken without regard to meals (2.1).
Primary hypercholesterolemia and mixed dyslipidemia: 130 mg per day
(2.2).
Severe Hypertriglyceridemia: 43 to 130 mg per day; the dose should be
adjusted according to patient response (2.3).
Renally impaired patients: Initial dose of 43 mg per day (2.4).
Geriatric patients: Select the dose on the basis of renal function
(2.5).
Oral capsules: 43 mg and 130 mg (3).
Severe renal dysfunction, including patients receiving dialysis (4,
12.3)
Active liver disease (4, 5.3)
Gallbladder disease (4, 5.5)
Nursing mothers (4, 8.3)
Known hypersensitivity to fenofibrate (4, 5.9)
Myopathy and rhabdomyolysis have been reported in patients taking
fenofibrate. The risk for serious muscle toxicity
appears to be increased when fenofibrate is co-administered with a
statin (with a significantly higher rate observed
with gemfibrozil), partic