Generic Name and Formulations:
Fenofibrate 50mg, 160mg; tabs.
Indications for TRIGLIDE:
Adjunct to diet in hypertriglyceridemia (Types IV and V), to reduce elevated total-C, LDL-C, apo B, TG, and to increase HDL-C in primary hypercholesterolemia and mixed dyslipidemia (Types IIa and IIb).
Hypertriglyceridemia: 50–160mg once daily; adjust at 4–8 week intervals. Hypercholesterolemia, dyslipidemia: 160mg/day. Renal impairment or elderly: initially 50mg/day. Discontinue if inadequate response after 2 months on max dose.
Hepatic dysfunction. Primary biliary cirrhosis. Severe renal dysfunction. Gallbladder disease. Nursing mothers.
Renal impairment. Monitor CBCs for first year; monitor liver function; discontinue if ALT (SGPT) levels >3xULN persist. Discontinue if markedly elevated CPK levels, myopathy, severely depressed HDL-C levels, or gallstones occur. Pregnancy (Cat.C).
Avoid statins. Potentiates oral anticoagulants (monitor). Allow at least 1 hour before or 4–6 hours after bile acid sequestrants. Caution with colchicine, immunosuppressants (eg, cyclosporine, tacrolimus), other nephrotoxic drugs.
Abnormal liver function tests, elevated CPK, respiratory or GI effects, myopathy, cholelithiasis, pancreatitis, increased BUN or creatinine, rash; rare: rhabdomyolysis, transient hematologic changes, blood dyscrasias, paradoxical decrease in HDL-C levels.