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Lipitor® (atorvastatin calcium) tablets






Featured Information

When is it time to reconsider treatment options for your high-risk patients?
When they need more potent lipid reductions.
When they need proven CV event reductions.
When they need practical support.



Prevention of Cardiovascular Disease

In adult patients without clinically evident coronary heart disease (CHD), but with multiple risk factors for CHD such as age, smoking, hypertension, low HDL-C, or a family history of early CHD,Lipitor®(atorvastatin calcium) tablets is indicated to:

  • Reduce the risk of myocardial infarction (MI)
  • Reduce the risk of stroke
  • Reduce the risk for revascularization procedures and angina

In patients with type 2 diabetes, and without clinically evident CHD, but with multiple risk factors for CHD such as retinopathy, albuminuria, smoking, or hypertension, LIPITOR is indicated to:

  • Reduce the risk of MI
  • Reduce the risk of stroke

In patients with clinically evident CHD, LIPITOR is indicated to:

  • Reduce the risk of nonfatal MI
  • Reduce the risk of fatal and nonfatal stroke
  • Reduce the risk for revascularization procedures
  • Reduce the risk of hospitalization for congestive heart failure
  • Reduce the risk of angina

Hypercholesterolemia

LIPITOR is indicated:

  1. As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia ( Fredrickson Types IIa and IIb)
  2. As an adjunct to diet for the treatment of patients with elevated serum TG levels ( Fredrickson Type IV)
  3. For the treatment of patients with primary dysbetalipoproteinemia ( Fredrickson Type III) who do not respond adequately to diet
  4. To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable
  5. As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present:
    1. LDL-C remains ≥190 mg/dL or
    2. LDL-C remains ≥160 mg/dL and:
  • there is a positive family history of premature cardiovascular disease or
  • two or more other cardiovascular disease risk factors are present in the pediatric patient

 

LIPITOR Important Safety Information and Indication

Please scroll to see the Indication below.

Important Safety Information

LIPITOR is contraindicated in patients with active liver disease or unexplained persistent elevations of hepatic transaminases; in women who are or may become pregnant or who are nursing; in patients with hypersensitivity to any component of this medication.

Rare cases of rhabdomyolysis have been reported with LIPITOR and other statins. Tell patients to promptly report muscle pain, tenderness, or weakness. Predisposing factors include advanced age (≥65), uncontrolled hypothyroidism, and renal impairment. Patients with a history of renal impairment merit closer monitoring. In cases of myopathy or rhabdomyolysis, therapy should be temporarily withheld or discontinued.

The concomitant use of higher doses of atorvastatin with certain drugs such as cyclosporine and strong CYP3A4 inhibitors (eg, clarithromycin, itraconazole, and HIV protease inhibitors) increases the risk of myopathy/rhabdomyolysis. Lower doses of LIPITOR should be considered. Physicians should carefully monitor patients for signs or symptoms of myopathy early during therapy and when titrating the dose of either drug.

It is recommended that liver function tests be performed prior to and 12 weeks following both the initiation of therapy and any elevation of dose, and periodically thereafter. If ALT or AST values >3 x ULN persist, dose reduction or withdrawal is recommended.

In a post hoc analysis of the SPARCL study in patients without CHD who had a stroke or TIA within the preceding 6 months, a higher incidence of hemorrhagic stroke was seen in the LIPITOR 80-mg group compared with placebo (2.3% vs 1.4%). Some baseline characteristics, including hemorrhagic and lacunar stroke on study entry, were associated with a higher incidence of hemorrhagic stroke in the atorvastatin group.

The most commonly reported adverse reactions with LIPITOR in placebo-controlled trials were: nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection.

LIPITOR (atorvastatin calcium) Indication

LIPITOR is indicated as an adjunct to diet to reduce the risk of myocardial infarction (MI), stroke, revascularization procedures, and angina in adult patients with multiple risk factors but without clinically evident coronary heart disease (CHD); to reduce the risk of MI and stroke in patients with type 2 diabetes and without clinically evident CHD, but with multiple risk factors; to reduce the risk of nonfatal MI, fatal and nonfatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adult patients with clinically evident CHD.

LIPITOR, as an adjunct to diet, is also indicated to reduce elevated total-C, LDL-C, apo B, and TG levels; and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia.

Please see full prescribing information.

LIPITOR® (atorvastatin calcium) tablets