fenofibrate tablet
1 INDICATIONS AND USAGE Fenofibrate tablets 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 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 )] .
cipla usa inc.
OVAL WHITE Cipla 458
Cipla 458 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
FENOFIBRATE tablets, USP are available in the following strengths and configuration
FENOFIBRATE tablets, USP are available in the following strengths and configurations: Product Name Description Size NDC number
FENOFIBRATE tablets, USP 48 mg yellow coloured, oval shaped, biconvex film coated tablets, debossed with 'Cipla' on one side and code '459' on other side. Bottle of 30 tablets Bottle of 90 tablets 69097-459-02 69097-459-05
FENOFIBRATE tablets, USP 145 mg white to off white coloured, oval shaped, biconvex film coated tablets, debossed with 'Cipla' on one side and code '458' on other side. Bottle of 30 tablets Bottle of 90 tablets 69097-458-02 69097-458-05 Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.
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