Discontinue therapy if signs of myalgia, back pain occur; serum transaminase is >3x ULN; CK conc become markedly elevated or myopathy is diagnosed or suspected. Promptly interrupt therapy if serious liver injury w/ clinical manifestations &/or hyperbilirubinemia or jaundice occurs. Temporarily withhold therapy in acute, serious condition suggestive of myopathy or predisposing development of renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine or electrolyte disorders, uncontrolled seizures). Transient increase in serum aminotransferase conc. Myopathy & rhabdomyolysis w/ acute renal failure secondary to myoglobinuria. Proteinuria & hematuria. Increased risk of rhabdomyolysis in geriatric patients, hepatic or renal dysfunction, chronic alcoholism & hypothyroidism patients. May increase risk of hyperglycemia. Patients w/ substantial alcohol consumption &/or have history of chronic liver disease; predisposing factors for myopathy (eg, patients ≥65 yr, renal impairment, inadequately treated hypothyroidism). Obtain baseline creatine kinase (CK) conc in adult at increased risk of developing adverse musculoskeletal effect prior to therapy, & measure CK conc in adults experiencing muscle symptoms during therapy. Perform LFTs before & at 6, 12 wk after initiation of therapy, & every 6 mth in patients w/ long term use. Concomitant use w/ other antilipemic agents [niacin or fibric-acid derivatives (ie, gemfibrozil)], cyclosporine or other myotoxic drugs (eg, colchicine); warfarin or digoxin; azole antifungals (eg, ketoconazole, itraconazole), macrolides (eg, erythromycin, clarithromycin), HIV PIs (eg, indinavir, ritonavir, nelfinavir, saquinavir), verapamil, diltiazem, gemfibrozil, nicotinic acid, cyclosporine, amiodarone; colchicine especially in geriatric patients or w/ renal dysfunction. Elderly.
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