Generic Name and Formulations:
Fenofibrate 40mg, 120mg; tabs.
Valeant Pharmaceuticals, Inc
Indications for FENOGLIDE:
Adjunct to diet in hypertriglyceridemia and to reduce elevated LDL-C, total-C, TG, and apo B, and to increase HDL-C, in primary hyperlipidemia and mixed dyslipidemia. Limitation of Use: was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes.
Take with food. Hypertriglyceridemia: 40–120mg/day; adjust at 4–8 week intervals; max 120mg/day. Hyperlipidemia, dyslipidemia: initially 120mg/day. Renal impairment: initially 40mg/day.
Severe renal dysfunction (including dialysis). Active liver disease. Unexplained persistent liver function abnormalities. Primary biliary cirrhosis. Gallbladder disease. Nursing mothers.
Mild to moderate renal impairment; monitor. Monitor CBCs and liver function; discontinue if ALT (SGPT) levels >3xULN persist. Discontinue if markedly elevated CPK levels, myopathy, gallstones, hypersensitivity reactions, or paradoxical decreases in HDL occur. Elderly. 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), other nephrotoxic drugs.
Abnormal liver function tests, increased AST, ALT, CPK, rhinitis; respiratory or GI effects, myopathy, cholelithiasis, pancreatitis, increased serum creatinine, rash, hypersensitivity reactions (may be severe); rare: rhabdomyolysis, transient hematologic changes, blood dyscrasias.