Lipostat Special Precautions

Hepatic effects: As with other lipid-lowering agents of the same class, moderate (greater than three times of upper normal limit) elevations of serum transaminases have been reported following therapy with Atorvastatin. Liver function tests should be performed before the initiation of treatment and periodically thereafter. Patients who develop any signs or symptoms suggesting liver injury should have liver function tests performed. Patients who develop increased transaminase levels should be monitored until the abnormalities resolve. Should an increase in ALT or AST of greater than three times of upper normal limit, reduction of dose or withdrawal of Atorvastatin is recommended.
Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.
Skeletal muscle effects: Myalgia have been reported in Atorvastatin-treated patients. Myopathy, defined as muscle ache or muscle weakness in conjunction with increase in creatine phosphokinase (CPK) values greater than 10 times of upper normal limit, should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of CPK. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or if myopathy is diagnosed or suspected.
As with other drug in this class, rare case of rhabdomyolysis with acute renal failure have been reported. A history of renal impairment may be a risk factor for the development of rhabdomyolysis. Such patients merit closer monitoring for skeletal muscle effects. Atorvastatin therapy should be temporarily withheld or discontinued in any patient with an acute, serious condition suggestive or myopathy or with a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis such as severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine, and electrolyte disorders, and uncontrolled seizures.
The risk of myopathy or rhabdomyolysis is increased in geriatric patients (65 years of age or older).
The risk of myopathy during treatment with drugs in this class is increased with concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, niacin, azole antifungals, colchicine, telaprevir, boceprevir or the combination of tipranavir/ritonavir. Many of these drugs inhibit cytochrome P450 3A4 (CYP 3A4) metabolism and/or drug transport. CYP 3A4 is the primary hepatic isoenzyme known to be involved in the biotransformation of Atorvastatin.
Hemorrhagic stroke: Patients with recent stroke or transient ischemic attack (TIA) receiving long-term therapy with high-dose (e.g. 80 mg/day) Atorvastatin may be at increased risk for hemorrhagic stroke.
Endocrine function: Increases in hemoglobin A1c (HbA1c) and fasting serum glucose concentration have been reported in patients receiving statin including Atorvastatin.