Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
FENOFIBRIC ACID (UNII: BGF9MN2HU1) (FENOFIBRIC ACID - UNII:BGF9MN2HU1)
Aurobindo Pharma Limited
ORAL
PRESCRIPTION DRUG
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 no
Fenofibric Acid Delayed-Release Capsules 45 mg are orange opaque cap/yellow opaque body size "3" hard gelatin capsules imprinted with "CFB" on cap and "45" on body with black ink and filled with white to off-white round cylindrical mini tablets. Bottles of 90 NDC 59651-216-90 Fenofibric Acid Delayed-Release Capsules 135 mg are blue opaque cap/yellow opaque body size "0" hard gelatin capsules imprinted with "CFB" on cap and "135" on body with black ink and filled with white to off-white round cylindrical mini tablets. Bottles of 90 NDC 59651-217-90 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.
Abbreviated New Drug Application
FENOFIBRIC ACID - FENOFIBRIC ACID CAPSULE, DELAYED RELEASE AUROBINDO PHARMA LIMITED ---------- 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, Hepatotoxicity (5.2) 03/2021 INDICATIONS AND USAGE Fenofibric acid delayed-release capsules are a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to: 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). 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 Hypertriglyceridemia: 45 mg 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). DOSAGE FORMS AND STRENGTHS Oral Delayed-Release Capsules: 45 mg and 135 mg (3). CONTRAINDICATIONS Severe renal dysfunction, including patients receiving dialysis (4, 12.3). Active liver disease (4, 5.2). Gallbladder disease (4, 5.5). Nursing mothers (4, 8.2). Known hypersensitivity to fenofibric acid or fenofibrate (4, 5.9). WARNINGS AND PRECAUTIONS _Hepatotoxicity:_ Serious drug-induced liver injury, including liver transplantation and death, has been reported with fenofibric acid delayed-release capsules. Monitor patient’s liver function, including serum ALT, AST, and total bilirubin, at baseline and periodically for the duration of therapy. Leggi il documento completo