Generic Name and Formulations:
Fenofibrate 43mg, 130mg; caps.
Lupin Pharmaceuticals, Inc.
Indications for ANTARA:
Adjunct to diet when response to nondrug therapy is inadequate in hypertriglyceridemia, and to reduce elevated total-C, LDL-C, apo B, and TG, and to increase HDL-C, in primary hypercholesterolemia and mixed dyslipidemia. Limitations of use: was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes.
Swallow whole. Take without regard to food. Hypertriglyceridemia: 43–130mg/day, adjust at 4–8 week intervals; max 130mg/day. Hypercholesterolemia, dyslipidemia: 130mg/day. Renal impairment or elderly: initially 43mg/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). 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 paradoxical decreases in HDL-C occur. Pregnancy (Cat.C). Nursing mothers: not recommended.
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 colchicine, immunosuppressants (eg, cyclosporine), other nephrotoxic drugs.
Abnormal liver function tests, elevated CPK, respiratory or GI effects, myopathy, cholelithiasis, pancreatitis, increased serum creatinine, hypersensitivity reactions (may be severe), rash; rare: rhabdomyolysis, transient hematologic changes, blood dyscrasias.
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