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 tablets 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) ] .
Mylan Pharmaceuticals Inc.
OVAL WHITE M FT1
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Fenofibrate 120 MG Oral Tablet
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16 HOW SUPPLIED/STORAGE AND HANDLING
FENOFIBRATE Tablets, USP are available containing 40 mg or 120 mg of
FENOFIBRATE, USP. The 40 mg tablets are white, capsule shaped, unscored tablets debossed with M on one side of the tablet and FT1 on the other side. They are available as follows: NDC 0378-4390-77 bottles of 90 tablets The 120 mg tablets are white, capsule shaped, unscored tablets debossed with M on one side of the tablet and FT2 on the other side. They are available as follows: NDC 0378-4391-77 bottles of 90 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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