fenofibrate tablet
1 INDICATIONS AND USAGE Fenofibrate tablet USP 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 tablet USP is 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 tablet USP is 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 USP 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 )] .
lupin pharmaceuticals, inc.
OVAL WHITE LU J42
LU J42 OVAL WHITE
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Fenofibrate 54 MG Oral Tablet
Lupin Pharmaceuticals, Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
FENOFIBRATE tablets USP are available in two strengths:
FENOFIBRATE tablets USP, 54 mg are white to off white, round, biconvex tablets debossed with "LU" on one side and "J41" on the other side. They are available as follows: Bottles of 90 NDC 68180-231-09 Bottles of 500 NDC 68180-231-02 Bottles of 1000 NDC 68180-231-03
FENOFIBRATE tablets USP, 160 mg are white to off white, oval shaped tablets debossed with "LU" on one side and "J42" on the other side. They are available as follows: Bottles of 90 NDC 68180-232-09 Bottles of 500 NDC 68180-232-02 Bottles of 1000 NDC 68180-232-03 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Keep out of reach of children.
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