Generic Name and Formulations:
Fenofibrate 48mg, 145mg; tabs.
Indications for TRICOR:
Adjunct to diet in hypertriglyceridemia (Types IV and V), and to reduce elevated total-C, LDL-C, apo B, and TG, and to increase HDL-C, in primary hypercholesterolemia and mixed dyslipidemia (Types IIa and IIb). Limitations of use: not shown to reduce coronary heart disease morbidity and mortality in a controlled trial of patients with type 2 diabetes mellitus.
Hypertriglyceridemia: 48–145mg/day, adjust at 4–8 week intervals. Hypercholesterolemia, dyslipidemia: 145mg/day. Renal impairment or elderly: initially 48mg/day. Discontinue if inadequate response after 2 months on max dose.
Hepatic dysfunction. Primary biliary cirrhosis. Severe renal dysfunction. Gallbladder disease.
Renal impairment. Monitor CBCs for first year; monitor liver function; discontinue if ALT (SGPT) levels >3xULN persist. Discontinue if markedly elevated CPK levels, myopathy, gallstones, hypersensitivity reactions, or severely depressed HDL-C levels occur (do not reinitiate). Pregnancy (Cat.C). Nursing mothers: not recommended.
Avoid statins. Potentiates oral anticoagulants (monitor). Allow at least 1 hour before or 4–6 hours after bile acid sequestrants. Caution with immunosuppressants (eg, cyclosporine), colchicine, other nephrotoxic drugs.
Abnormal liver function tests, elevated CPK, rhinitis, myopathy, cholelithiasis, pancreatitis, increased serum creatinine, hypersensitivity reactions (may be severe), rash; rare: rhabdomyolysis, transient hematologic changes, blood dyscrasias.