fenofibrate tablet film coated
1 INDICATIONS AND USAGE Fenofibrate tablets are a 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 ). 1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia 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. 1.2 Severe Hypertriglyceridemia 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. 1.3 Important Limitations of Use Fenofibrate at a dose equivalent to 160 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 diabetes mellitus [see Warnings and Precautions ( 5.1 )].
austarpharma llc
OVAL WHITE CL 26
CL 26 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
FENOFIBRATE tablets USP are available in two strengths: 54 mg – white to off white, oval-shaped, film-coated, unscored tablet, debossed with “CL 25” on one side and blank on the other side. Available in bottles of 90 (NDC 35561-343-11) and 500 (NDC 35561-343-13). 160 mg – white to off white, oval-shaped, film-coated, unscored tablet, debossed with “CL 26” on one side and blank on the other side. Available in bottles of 90 (NDC 35561-344-11) and 500 (NDC 35561-344-13). Storage 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. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
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