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Safety Information

PrLIPITOR®(atorvastatin calcium tablets)

Indications and Clinical Use:

As an adjunct to lifestyle changes, for the reduction of elevated total cholesterol, LDL-C, triglycerides, apolipoprotein B, the Total-C/HDL-C ratio and for increasing HDL-C in hyperlipidemic and dyslipidemic conditions.

To reduce the risk of myocardial infarction in adult hypertensive patients without clinically evident coronary heart disease (CHD), but with at least three additional risk factors for CHD such as age ≥55 years, male sex, smoking, type 2 diabetes, left ventricular hypertrophy, other specified abnormalities on ECG, microalbuminuria or proteinuria, ratio of plasma total cholesterol to HDL-cholesterol ≥6, or premature family history of CHD.

To reduce the risk of myocardial infarction and stroke in adult patients with type 2 diabetes mellitus and hypertension without clinically evident coronary heart disease, but with other risk factors such as age ≥55 years, retinopathy, albuminuria or smoking.

To reduce the risk of myocardial infarction in patients with clinically evident coronary heart disease.

Caution with combination therapy with fibrates.

Contraindications:

  • Active liver disease or unexplained persistent elevations of serum transaminases
  • Pregnant and nursing women

Most serious warnings and precautions:

  • Muscle effects: myalgia, myopathy, including rhabdomyolysis:
    • Rare cases of rhabdomyolysis, with acute renal failure secondary to myoglobinuria reported
    • Elevated CPK levels
  • Severe hypercholesterolemia: Caution in patients who are severely renally impared, elderly, or are concomitantly being administed digoxin or CYP3A4 inhibitors.
  • Hepatic effects:
    • Risk of elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
    • Rare postmarketing reports of fatal and nonfatal hepatic failure reported
    • Caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease.

Relevant warnings and precautions:

  • Risk of hemorrhagic stroke in patients with recent stroke or transient ischemic attack
  • Decrease in circulating ubiquinone levels
  • Risk of endocrine dysfunction (monitor as necessary)
  • Patients with severe renal insufficiency
  • Doses greater than 20 mg have not been studied in pediatric patients with heterozygous familial hypercholesterolemia
  • Initiate treatment in the elderly with lowest dose
  • Hypersensitivity syndrome reported with other HMG-CoA reductase inhibitor

For more information:

Please consult the product monograph by clicking here for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece.

The product monograph is also available by calling 1-800-463-6001.

LIPITOR ® Pfizer Ireland Pharmaceuticals, owner/Pfizer Canada Inc., Licensee
® are trademarks of Pfizer Inc. or its affiliates and are used under license by Pfizer Canada Inc.
© 2014 Pfizer Canada Inc. Kirkland, Quebec H9J 2M5