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Tablet
Files
Fenofibrate (Nanocrystal)
Strength: 48mg
Count: 20
NDC
50268-338-12
Class
Rx
Brand Name
Tricor
Imprint Code
LU;B21
Color(s)
White (off-white)
Shape
Oval
Score
No Score
Case Count
NA
Inactive Ingredients
Inactive Ingredients Each tablet contains colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, lactose monohydrate, polacrillin potassium, sodium lauryl sulphate, and sucrose, Polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, yellow iron oxide.
Indications and Usage
Primary Hypercholesterolemia or Mixed Dyslipidemia Fenofibrate tablets USP 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. Severe Hypertriglyceridemia Fenofibrate tablets USP are 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. Important Limitations of Use Fenofibrate at a dose equivalent to 145 mg of fenofibrate tablets 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.
