Indications for LOFIBRA CAPSULES:
Adjunct to diet 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 (Types IIa and IIb).
Take with food. Hypertriglyceridemia: 67–200mg/day; adjust in 4–8 week intervals; max 200mg/day. Hypercholesterolemia, dyslipidemia: 200mg/day. Renal impairment (CrCl<50mL/min): initially 67mg/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 >3xULN persist. Discontinue if markedly elevated CPK levels, myopathy, or gallstones occur. Pregnancy (Cat.C). Nursing mothers: not recommended.
Avoid statins. Potentiates oral anticoagulants (monitor). Allow at least 1 hour before or 4–6 hours after bile acid sequestrants. Caution with immunosuppressants (eg, cyclosporine), other nephrotoxic drugs.
Abnormal liver function tests, elevated CPK, respiratory or GI effects, myopathy, cholelithiasis, pancreatitis, increased creatinine, rash; rare: rhabdomyolysis, transient hematologic changes, blood dyscrasias.