Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
FENOFIBRATE (UNII: U202363UOS) (FENOFIBRIC ACID - UNII:BGF9MN2HU1)
Laurus Labs Limited
ORAL
PRESCRIPTION DRUG
Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia. Fenofibrate tablets 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 145 mg of fenofibrate tablet was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 d
Fenofibrate tablets, USP are available in two strengths: 48 mg tablets are yellow, oval shaped, biconvex, film coated tablets debossed with "158" on one side and plain on other side. Available as following. Bottles of 30 tablets with child-resistant closure, NDC 42385-950-30 Bottles of 90 tablets with child-resistant closure, NDC 42385-950-90 Bottles of 1,000 tablets, NDC 42385-950-11 145 mg tablets are white, oval shaped, biconvex, film coated tablets debossed with "159" on one side and plain on other side. Available as following. Bottles of 30 tablets with child-resistant closure, NDC 42385-951-30 Bottles of 90 tablets with child-resistant closure, NDC 42385-951-90 Bottles of 1,000 tablets, NDC 42385-951-11 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Protect from moisture.
Abbreviated New Drug Application
FENOFIBRATE - FENOFIBRATE TABLET LAURUS LABS LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FENOFIBRATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FENOFIBRATE TABLETS. FENOFIBRATE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1993 RECENT MAJOR CHANGES Warnings and Precautions, Hepatotoxicity ( 5.2) 03/2021 INDICATIONS AND USAGE Fenofibrate tablets are peroxisome proliferator-activated receptor (PPAR) alpha agonist 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). For treatment of adult patients with severe hypertriglyceridemia ( 1.2). 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 Primary hypercholesterolemia or mixed dyslipidemia: Initial dose of 145 mg once daily ( 2.2). Severe hypertriglyceridemia: Initial dose of 48 mg to 145 mg once daily. Maximum dose is 145 mg ( 2.3). Renally impaired patients: Initial dose of 48 mg once daily ( 2.4). Geriatric patients: Select the dose on the basis of renal function ( 2.5). May be taken without regard to meals ( 2.1). DOSAGE FORMS AND STRENGTHS Oral tablets: 48 mg and 145 mg ( 3). CONTRAINDICATIONS Severe renal dysfunction, including dialysis patients ( 4, 8.6, 12.3). Active liver disease ( 4, 5.2). Gallbladder disease ( 4, 5.5). Known hypersensitivity to fenofibrate ( 4). Nursing mothers ( 4, 8.2). WARNINGS AND PRECAUTIONS _Hepatotoxicity_ : Serious drug-induced liver injury, including liver transplantation and death, has been reported with fenofibrate. Monitor patient's liver function, including serum ALT, AST, and total bilirubin, at baseline and periodically for the duration of therapy. Discontinue if signs or symptoms of liver injury develop or if elevated enzyme levels persist ( 5.2). _Myopathy and rhabd Preberite celoten dokument