Fenofibrate 40 MG Oral Tablet
1 INDICATIONS AND USAGE Fenofibrate tablets are 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 ) • to treat adult patients with severe hypertriglyceridemia. ( 1.2 ) Important Limitation 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 and 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 (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein (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 reduce fasting triglycerides and eliminate chylomicronemia thereby obviating 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 was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) ] .
amneal pharmaceuticals of new york llc
OVAL WHITE FLO
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16 HOW SUPPLIED/STORAGE AND HANDLING Fenofibrate tablets 40 mg, are white to off-white oval tablets debossed “FLO” on one side and blank on the other side. Bottle of 90 tablets, NDC 0115-1522-10 Fenofibrate tablets 120 mg, are white to off-white oval tablets debossed “FHI” on one side and blank on the other side. Bottle of 90 tablets, NDC 0115-1523-10 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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