|
1 Indications And Usage Fenofibrate Capsule Is A Peroxisome Proliferator Receptor Alpha (PparĪ±) Activator Indicated As An Adjunct To Diet: To Reduce Elevated Ldl-C, Total-C, Triglycerides, And Apo B, And To Increase Hdl-C In Adult Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia ( 1.1 ). To Reduce Triglyceride (Tg) Levels In Adult Patients With Severe Hypertriglyceridemia ( 1.2 ). Important 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 And Mixed Dyslipidemia Fenofibrate Capsules, Usp 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 Cholesterol (Hdl-C) In Adult Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia. 1.2 Severe Hypertriglyceridemia Fenofibrate Capsules, Usp 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 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) ].
|