Generic Name and Formulations:
Fenofibric acid 35mg, 105mg; tabs.
URL Pharma, Inc.
Indications for FIBRICOR:
Adjunct to diet in severe hypertriglyceridemia (≥500mg/dL), and to reduce elevated total-C, LDL-C, apo B, and TG, and to increase HDL-C, in primary hypercholesterolemia and mixed dyslipidemia. Limitations of use: was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes.
Hypertriglyceridemia: 35–105mg/day, adjust at 4–8 week intervals. Hypercholesterolemia, dyslipidemia: 105mg/day. Renal impairment: initially 35mg/day. Discontinue if inadequate response after 2 months on max dose.
Severe renal dysfunction (including dialysis). Active liver disease. Primary biliary cirrhosis. Unexplained persistent liver function abnormalities. Gallbladder disease. Nursing mothers.
Renal impairment: monitor. Monitor CBCs for first year; monitor liver function; discontinue if ALT levels >3xULN persist. Discontinue if markedly elevated CPK levels, myopathy, gallstones, or paradoxical decreases in HDL occur. Elderly. Pregnancy (Cat.C).
May potentiate oral anticoagulants (monitor). Allow at least 1 hour before or 4–6 hours after bile acid sequestrants. Caution with colchicine, immunosuppressants (eg, cyclosporine), other nephrotoxic drugs.
Abnormal liver tests, increased AST, increased ALT, increased CPK, rhinitis; myopathy, pancreatitis, cholelithiasis, hematological changes, hypersensitivity reactions (may be severe).
Tabs—30, 60, 90, 100, 250, 500, 1000