Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
FENOFIBRIC ACID (UNII: BGF9MN2HU1) (FENOFIBRIC ACID - UNII:BGF9MN2HU1)
Actavis Pharma, Inc.
FENOFIBRIC ACID
FENOFIBRIC ACID 45 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
FENOFIBRIC ACID- FENOFIBRIC ACID CAPSULE, DELAYED RELEASE ACTAVIS PHARMA, 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 Indications and Usage, Combination With a Statin – removal (1) 4/2015 Dosage and Administration, Combination With a Statin – removal (2) 4/2015 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 did not reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1). DOSAGE AND ADMINISTRATION 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). 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, 5.3). Gallbladder disease (4, 5.5). Nursing mothers (4, 8.3). Known hypersensitivity to fenofibric acid or fenofibrate (4, 5.9) WARNINGS AND PRECAUTIONS Myopathy and rhabdomyolysis have been reported in patients taking fenofibrate. The risks for myopathy and rhabdomyolysis are increased in elderly patients; patients with diabetes, renal failure, or hypothyroidism; and patients being treated wit Прочитать полный документ