FENOFIBRIC ACID- fenofibric acid capsule, delayed release pellets

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Mylan Pharmaceuticals Inc.

INN (International ime):

FENOFIBRIC ACID

Sastav:

FENOFIBRIC ACID 45 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce triglycerides (TG) in patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibric acid delayed-release capsules therapy on reducing this risk has not been adequately studied. Fenofibric acid delayed-release 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 patients with primary hypercholesterolemia or mixed dyslipidemia. Fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsules did not reduce coronary heart disease

Proizvod sažetak:

Fenofibric Acid Delayed-Release Capsules are available containing choline fenofibrate equivalent to 45 mg or 135 mg of fenofibric acid. The 45 mg capsules are hard-shell gelatin capsules with a brown-pink opaque cap and light yellow opaque body filled with white to off-white enteric coated pellets. The capsules are axially printed with MYLAN over CF 45 in black ink on the cap and body. They are available as follows: NDC 0378-2589-77 bottles of 90 capsules The 135 mg capsules are hard-shell gelatin capsules with a powder blue opaque cap and light yellow opaque body filled with white to off-white enteric coated pellets. The capsules are axially printed with MYLAN over CF 135 in black ink on the cap and body. They are available as follows: NDC 0378-2590-77 bottles of 90 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Keep out of the reach of children. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

FENOFIBRIC ACID- FENOFIBRIC ACID CAPSULE, DELAYED RELEASE PELLETS
MYLAN PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FENOFIBRIC ACID DELAYED-RELEASE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FENOFIBRIC ACID DELAYED-RELEASE
CAPSULES.
FENOFIBRIC ACID DELAYED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2008
RECENT MAJOR CHANGES
Warnings and Precautions, Hypersensitivity Reactions (5.9) 05/2018
INDICATIONS AND USAGE
Fenofibric acid delayed-release capsules are a peroxisome
proliferator-activated receptor (PPAR) alpha agonist indicated
as adjunctive therapy to diet to:
•
•
Limitations of Use: Fenofibrate at a dose equivalent to 135 mg of
fenofibric acid delayed-release capsules did not reduce
coronary heart disease morbidity and mortality in patients with type 2
diabetes mellitus (5.1).
DOSAGE AND ADMINISTRATION
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Oral Delayed-Release Capsules: 45 mg and 135 mg (3).
CONTRAINDICATIONS
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
Reduce TG in patients with severe hypertriglyceridemia (1.1).
Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in
patients with primary
hypercholesterolemia or mixed dyslipidemia (1.2).
Hypertriglyceridemia: 45 to 135 mg once daily (2.2).
Primary hypercholesterolemia or mixed dyslipidemia: 135 mg once daily
(2.3).
Renally impaired patients: 45 mg once daily (2.4).
Maximum dose: 135 mg once daily (2.1).
May be taken without regard to food (2.1).
Severe renal dysfunction, including patients receiving dialysis (4,
12.3).
Active liver disease (4, 5.3).
Gallbladder disease (4, 5.5).
Nursing mothers (4, 8.2).
Known hypersensitivity to fenofibric acid or fenofibrate (4, 5.9).
Myopathy and rhabdomyolysis have been reported in patients taking
fenofibrate. Risks are increased in elderly
patients and patients with diabetes, renal failure, hypothyroidism, or
statin co-administration (5.2).