Fenofibrate 145 MG Oral Tablet
1 INDICATIONS & USAGE Fenofibrate tablets are 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 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 145 mg of fenofibrate tablets 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 ) ].
camber pharmaceuticals, inc.
OVAL WHITE J 136
J 136 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
FENOFIBRATE tablets, USP are available in two strengths: 48 mg tablets are yellow, oval, biconvex film coated tablets, debossed with 'J' on one side and '137' on other side, available in: Bottles of 30 Tablets NDC 31722-595-30 Bottles of 90 Tablets NDC 31722-595-90 Carton of 100 (10×10) Unit dose tablets (PVC-PE-PVdC) NDC 31722-595-31 Carton of 100 (10×10) Unit dose tablets (Alu-Alu) NDC 31722-595-32 145 mg tablets are white to off-white, oval, biconvex film coated tablets, debossed with 'J' on one side and '136' on other side, available in: Bottles of 30 Tablets NDC 31722-596-30 Bottles of 90 Tablets NDC 31722-596-90 Carton of 70 (7×10) Unit dose tablets (PVC-PE-PVdC) NDC 31722-596-31 Carton of 100 (10×10) Unit dose tablets (Alu-Alu) NDC 31722-596-32 Storage Store at 20 o to 25 o C (68 o to 77 o F) [See USP Controlled Room Temperature]. Keep out of reach of children. Protect from moisture.
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