Generic Name and Formulations:
Fenofibrate 50mg, 150mg; caps.
Kowa Pharmaceuticals America, Inc.
Indications for LIPOFEN:
Adjunct to diet when response to nondrug therapy is inadequate 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 (Type IIa and IIb).
Swallow whole. Take with food. Hypertriglyceridemia: 50–150mg/day, adjust at 4–8 week intervals; max 150mg/day. Hypercholesterolemia, dyslipidemia: 150mg/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.
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 levels occur. Pregnancy. Nursing mothers: not recommended (during and for 5 days after final dose).
Avoid statins. Potentiates oral anticoagulants (reduce anticoagulant dose and monitor PT/INR). Allow at least 1hr before or 4–6hrs after bile acid sequestrants. Caution with immunosuppressants (eg, cyclosporine, tacrolimus), colchicine, other nephrotoxic drugs.
Abnormal liver function tests, elevated CPK, respiratory or GI effects, myopathy, cholelithiasis, pancreatitis, hypersensitivity reactions (may be severe), rash; rare: rhabdomyolysis, transient hematologic changes, blood dyscrasias.
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