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.
Take without regard to food. Hypertriglyceridemia: 48–145mg/day, adjust at 4–8 week intervals. Hypercholesterolemia, dyslipidemia: initially 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 >3×ULN persist. Discontinue if markedly elevated CPK levels, myopathy, gallstones, hypersensitivity reactions (acute and delayed), or severely depressed HDL-C levels occur (do not reinitiate). Pregnancy. Nursing mothers: not recommended (during and for 5 days after final dose).
Avoid statins. Potentiates oral anticoagulants (monitor). Allow at least 1hr before or 4–6hrs 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.
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