LIPITOR Tablet

Hypersensitivity to any component of this medication

Active liver disease or unexplained persisten of serum transaminases exceeding three times the upper limit of normal (ULN)

Pregnant, breast-feeding, or of childbearing potential who are not using adequate contraceptive measures.

Diarrhea, dyspepsia, nausea, flatulence, vision blurred, hepatic effect, myalgia, hemorrhagic stroke, hyperglycemia,

Atorvastatin is contraindicated in pregnancy, breast-feeding women and women of childbearing potential

Hepatic Effects (See the package insert about details.)

Moderate 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 abnormality(ies) resolve(s).

Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease. Active liver disease or unexplained persistent transaminase elevations are contraindications to the use of atorvastatin .

Skeletal Muscle Effects (See the package insert about details.)

Myalgia has been reported in atorvastatin-treated patients. Myopathy, defined as muscle ache or muscle weakness in conjunction with increases in creatinine phosphokinase (CPK) values >10 ULN, 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. 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. ...Therefore, lower starting and maintenance doses of atorvastatin should also be considered when taken concomitantly with the aforementioned drugs. Temporary suspension of atorvastatin may be appropriate during fusidic acid therapy.

Atorvastatin may cause an elevation of CPK.

Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria, have been reported. A history of renal impairment may be a risk factor for the development of rhabdomyolysis. ...Atorvastatin therapy should be temporarily withheld or discontinued in any patient with an acute, serious condition suggestive of a myopathy or with 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, ad electrolyte disorders; and uncontrolled seizures).

Hemorrhagic stroke

See the package insert about details.

Endocrine Function

Increases in hemoglobin A1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including atorvastatin. The risk of hyperglycemia, however, is outweighed by the reduction in vascular risk with statins.

Selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts HMG-CoA to mevalonate, a precursor of sterols, including cholesterol.