Fenofibrate 54 MG Oral Tablet
1 INDICATIONS AND USAGE Fenofibrate is 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 160 mg of fenofibrate tablet 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) ] .
amneal pharmaceuticals of new york llc
OVAL YELLOW G 351
G 351 OVAL YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING
FENOFIBRATE tablets, 54 mg are yellow, film-coated, oval shape tablets debossed with “G” on one side and “351” on the other side. Bottles of 90: NDC 0115-5511-10
FENOFIBRATE tablets, 160 mg are white to off-white, film-coated, modified capsule shaped tablets, debossed with “G352” on one side and plain on the other side. Bottles of 90: NDC 0115-5522-10 Bottles of 500: NDC 0115-5522-02 STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Protect from moisture. Dispense in tightly-closed, light-resistant container as defined in the USP, with a child-resistant closure, as required.
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