LIPITOR safety information
IMPORTANT SAFETY INFORMATION

LIPITOR® (atorvastatin calcium) tablets are contraindicated in patients with a known hypersensitivity to any component of this product; in patients with active liver disease or unexplained persistent elevations of hepatic transaminases; in women who are or may become pregnant or who are breastfeeding. Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment, and to inform their healthcare provider of a known or suspected pregnancy.

Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with LIPITOR® (atorvastatin calcium) tablets 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 LIPITOR® (atorvastatin calcium) tablets 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 the initiation of therapy and repeated as clinically indicated thereafter.

Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including LIPITOR® (atorvastatin calcium) tablets.

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 (atorvastatin calcium) tablets 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 LIPITOR group.

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

INDICATIONS

LIPITOR® (atorvastatin calcium) tablets are 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 adult 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

  • 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

  • Reduce elevated TG in adult patients with hypertriglyceridemia and primary dysbetalipoproteinemia

  • Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH)

  • Reduce elevated total-C, LDL-C, and apo B levels in pediatric patients, 10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) after failing an adequate trial of diet therapy

Limitations of Use: LIPITOR has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

Please see Full Prescribing Information and Patient Information.

Patient Resources

Downloadable resources for your patients

The resources below provide helpful information for your patients about LIPITOR, understanding cholesterol, and maintaining a heart-healthy lifestyle. Be sure to download and print these resources for your patients.

Sticking to therapy

To help your patients maintain healthy cholesterol levels, be sure to tell them it's important to stick to individualized, physician-recommended statin therapy and to follow up on their progress.

Help them remember these tips to stay heart-healthy:

Eat healthy while taking treatment to lower cholesterol

Eat healthy

 

Stay physically active while taking treatment to lower cholesterol

Stay physically active

 

Take cholesterol medication as directed during treatment

If prescribed, take cholesterol medication as directed

 

Downloadable Lipitor, choice points, and co-pay brochure

Cholesterol and savings brochure

Patients can learn what their cholesterol levels mean and how they can save money on their prescription each month with the LIPITOR Savings Program.

Foods to help your patients get the daily recommended value of fiber during treatment

Foods to help your patients get the daily recommended value of fiber

It's no secret: fiber is important for the digestive system. But did you know that, on average, Americans receive only 10 to 15 grams of their 20- to 35-gram daily recommended value?

Eating a diet that is high in fiber has many potential health benefits, including a decreased risk of heart disease. Check out some foods that are packed with fiber to help your patients get the amount they need.

Walking in combination with treatment for lowering cholesterol

Getting fit may be within walking distance

Walking is a physical activity accessible to almost everybody. But did you know that walking has more benefits than just weight maintenance?
Combined with a balanced diet and a prescribed treatment, walking can help your patients reach the goals you have set together. Check out what walking can do for your patients.

Ways for your patients to add exercise into their daily routine while on treatment to lower cholesterol

Small changes can help your patients get fit

The Physical Activity Guidelines for Americans recommend at least 2 hours and 30 minutes of moderate-intensity aerobic activity and muscle strengthening exercises on 2 or more days a week. Since it can be difficult to fit in fitness, here are a couple ways for your patients to work exercise into their daily routine.

Smarter food choices for your patients

A low-fat diet is important when your patients are trying to meet the goals you've helped them set. Check out the different ways your patients can decrease fat without sacrificing flavor.

Downloadable resource to help patients understand unhealthy fats

Understanding unhealthy fats: what your patients should watch out for

Saturated fat

Raises total blood cholesterol and LDL ("bad" cholesterol).

Trans fat

Raises LDL (“bad” cholesterol) and lowers HDL (“good” cholesterol).

Trans and saturated fat can increase your risk of heart disease or stroke.

Downloadable resource to help patients understand statins

Helping your patients understand statins

Statins, a type of cholesterol-lowering therapy, block a substance in the liver that is responsible for making cholesterol. Along with diet and exercise, statins may help the body to maintain lower, healthier cholesterol levels. In certain individuals, this may lower the risk for a major cardiovascular event such as a heart attack or stroke.

The infographic to the left helps explain how statins work to keep the heart healthy.

Infographic on the way cholesterol works

Cholesterol: the way it works

Use the infographic to the left to help your patients better understand cholesterol, how it works, and how high cholesterol affects their health.

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