Lofibra Fenofibrate 160 MG Oral Tablet Lofibra
1 INDICATIONS AND USAGE LOFIBRA ® is a peroxisome proliferator receptor alpha (PPARα) activator 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 ) . Important 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 LOFIBRA ® is 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 LOFIBRA ® is 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 145 mg of LOFIBRA ® 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 ) ] .
Teva Select Brands
OVAL WHITE 93 7331
93 7331 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING LOFIBRA ® (fenofibrate tablets USP) are supplied as follows: 54 mg - yellow, round-shaped, film-coated, unscored tablet, debossed with “93” on one side and “7330” on the other side. Available in bottles of 90 (NDC 57844-691-98). 160 mg - white to off white, oval-shaped, film-coated, unscored tablet, debossed with “93” on one side and “7331” on the other side. Available in bottles of 90 (NDC 57844-692-98). Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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