Pitasor 2 Special Precautions

Advanced age (greater than 65 years); increased risk of myopathy.
Heavy alcohol use.
Preexisting amyotrophic lateral sclerosis (ALS); rate of ALS functional decline may increase with statin therapy.
Avoid concomitant use of gemfibrozil.
Conditions predisposing to renal failure secondary to rhabdomyolysis/myoglobinuria (eg, sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine and electrolyte disorder or uncontrolled seizures); temporary discontinuation may be required.
Markedly elevated creatinine kinase levels may occur; discontinuation may be warranted.
Increased HbA1c and serum glucose levels have been reported.
Higher doses are associated with increased risk of severe myopathy/ rhabdomyolysis.
Inadequately treated hypothyroidism may increase risk of myopathy.
Immune-mediated necrotizing myopathy, an autoimmune myopathy, has been reported; discontinue therapy immediately if myopathy is diagnosed or suspected.
Liver failure, some cases fatal, has been reported; interrupt treatment if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs.
Myopathy and rhabdomyolysis, with acute renal failure secondary to myoglobinuria, have been reported; discontinue if diagnosed or suspected.
Moderate to severe renal impairment (GFR 15 to 59 mL/min/1.73 m²) or end-stage renal disease in patients receiving hemodialysis may increase risk of myopathy; dose adjustments recommended.
Serum transaminase level increases have been reported; monitoring recommended; interruption of therapy may be necessary.