Tonact Special Precautions

Liver effects: HMG-CoA reductases inhibitors can lead to biochemical abnormalities of liver-function. It is recommended that liver function tests be performed prior to and at 12 weeks following both initiation of therapy and any elevation of dose and periodically thereafter. The first three months of treatment with atorvastatin are associated with liver enzyme changes. Patients who develop increased transaminase levels should be monitored until the abnormalities resolve. Reduction of dose or discontinuation of therapy is recommended if increase in ALT levels above three times the upper limit of normal persists. Caution should be exercised while giving the drug to alcoholics or patients with a history of liver disease; Skeletal muscle effects; Rhabdomyolysis with acute renal failure secondary to myoglobinuria has been reported with other drugs in this class.
Uncomplicated myalgia has been reported in atorvastatin treated patients. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.
Atorvastatin therapy should be temporarily withheld or discontinued in any patient with an acute, serious condition suggestive of myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis (e.g. severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders and uncontrolled seizures).