Generic Name and Formulations:
Fenofibrate 160mg; tabs.
Indications for TRIGLIDE:
Adjunct to diet in severe hypertriglyceridemia, to reduce elevated total-C, LDL-C, apo B, TG, and to increase HDL-C in primary hypercholesterolemia and mixed dyslipidemia.
Limitations Of use:
Fenofibrate did not reduce coronary heart disease morbidity and mortality in 2 controlled trials of patients with type 2 diabetes.
Swallow whole. 160mg once daily. Discontinue if inadequate response after 2 months.
Severe renal impairment. Hepatic impairment. Primary biliary cirrhosis. Unexplained persistent liver function abnormalities. Gallbladder disease. Nursing mothers.
The effect on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established. Avoid in mild or moderate 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. 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 serum creatinine, rash; rare: rhabdomyolysis, transient hematologic changes, blood dyscrasias, paradoxical decrease in HDL-C levels, hypersensitivity reactions (may be severe).