Fenofibrate 145 MG Oral Tablet
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 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) ] .
Mylan Pharmaceuticals Inc.
OVAL WHITE M FE4
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Fenofibrate 145 MG Oral Tablet
Mylan Institutional Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
FENOFIBRATE Tablets, USP are available containing 48 mg or 145 mg of
FENOFIBRATE, USP. The 48 mg tablets are white, film-coated, oval, unscored tablets debossed with M on one side of the tablet and FE3 on the other side. They are available as follows: NDC 0378-3065-77 bottles of 90 tablets NDC 0378-3065-05 bottles of 500 tablets The 145 mg tablets are white, film-coated, oval, unscored tablets debossed with M on one side of the tablet and FE4 on the other side. They are available as follows: NDC 0378-3066-77 bottles of 90 tablets NDC 0378-3066-05 bottles of 500 tablets 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 using a child-resistant closure.
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