In the U.S.—

• Antihyperlipidemic

Atorvastatin (a-TOR-va-stat-in) is used to lower cholesterol and triglyceride (fat-like substances) levels in the blood. Using this medicine may help prevent medical problems caused by such substances clogging the blood vessels.

Atorvastatin belongs to the group of medicines called 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors. It works by blocking an enzyme that is needed by the body to make cholesterol, thereby reducing the amount of cholesterol in the blood.

Atorvastatin is available only with your doctor's prescription, in the following dosage form:

Oral
• Tablets (U.S.)

In addition to its helpful effects in treating your medical problem, this type of medicine may have some harmful effects.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For atorvastatin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to atorvastatin. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Diet—Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed.

Also, this medicine is less effective if you are greatly overweight. It may be very important for you to go on a weight-reducing diet. However, check with your doctor before going on any diet.

Pregnancy—Atorvastatin should not be used during pregnancy or by women who plan to become pregnant . This medicine blocks formation of cholesterol, which is necessary for the fetus to develop properly. Atorvastatin may cause birth defects or other problems in the baby if taken during pregnancy. An effective form of birth control should be used during treatment with these medicines. Check with your doctor immediately if you think you have become pregnant while taking this medicine. Be sure you have discussed this with your doctor.

Breast-feeding—It is not known if atorvastatin passes into breast milk. However, it should not be used during breast-feeding because it may cause serious unwanted effects in nursing babies.

Children— This medicine is safe to use in boys and some girls 10 to 17 years of age for treating certain types of high cholesterol.

Older adults—This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different problems in older people than it does in younger adults. However, blood levels of atorvastatin tend to be higher in older people than they do in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking atorvastatin it is especially important that your health care professional know if you are taking any of the following medications:

• Alcohol abuse (or history of)May cause liver problems and should not be used while taking atorvastatin

• Antifungals, azole (e.g., fluconazole [Diflucan], miconazole injection [Monistat IV], ketoconazole [Nizoral], itraconazole [Sporanox], voriconazole [Vfend]) or
• Cyclosporine (e.g., Sandimmune) or
• Erythromycin (e.g., Erythrocin) or
• Fibric Acid Derivatives. such as
  • Clofibrate (e.g., Atromid-S) or
  • Fenofibrate (e.g., Tricor) or
  • Gemfibrozil (e.g., Lopid) or
• Niacin (nicotinic acid) in lipid-lowering doses—Use of these medicines with atorvastatin may increase the risk of developing muscle problems (causing the release of muscle pigment into the urine) that may lead to kidney failure

• Digoxin (e.g., Lanoxin)—Using this medicine with atorvastatin may cause there to be more digoxin in your body

• Alcohol abuse (or history of) or
• Liver disease (or history of) or
• Liver enzymes, persistently high levels—Use of this medicine may make liver problems worse

• Convulsions (seizures), not well-controlled, or
• Electrolyte or metabolic enzyme deficiencies or disorders or
• Infection, severe or
• Low blood pressure or
• Major surgery or trauma, recent—Patients with these conditions may be at risk of developing muscle problems (causing the release of muscle pigment into the urine) that may lead to kidney failure

Use this medicine only as directed by your doctor. Do not use more or less of it, and do not use it more often or for a longer time than your doctor ordered. Also, this medicine works best if there is a constant amount in the blood. To help keep this amount constant, do not miss any doses and take the medicine at the same time each day.

Remember that this medicine will not cure your condition but it does help control it. Therefore, you must continue to take it as directed if you expect to keep your cholesterol levels down.

Follow carefully the special diet your doctor gave you. This is the most important part of controlling your condition and is necessary if the medicine is to work properly.

Atorvastatin should not be taken with large amounts of grapefruit juice or other grapefruit products because these may increase the concentrations of atorvastatin in the body

Dosing—

The dose of atorvastatin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of atorvastatin. If your dose is different, do not change it unless your doctor tells you to do so:

• For oral dosage form (tablets):
  • Adults: 10 milligrams (mg) once daily. Your doctor may increase your dose if needed.
  • Children (10 to 17 years of age): 10 milligrams (mg) once daily. Your doctor may increase your dose if needed.
  • Children (less than 10 years of age): Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride levels and to decide if you should continue to take it.

Check with your doctor immediately if you think that you may be pregnant. HMG-CoA reductase inhibitors may cause birth defects or other problems in the baby if taken during pregnancy.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Do not take over-the-counter (OTC) niacin preparations without consulting your doctor. Niacin may increase atorvastatin's adverse effects on muscle, which can lead to serious kidney problems.

Do not use excessive amounts of alcohol while taking atorvastatin because it can worsen the adverse effects of this medicine on the liver.

Check with your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if it is accompanied by unusual tiredness or fever, because the medicine's adverse effects on muscle can lead to serious kidney problems.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Less common or rare
  • Cough;  difficulty swallowing;  dizziness;  fast heartbeat;  hives;  itching;  muscle cramps, pain, stiffness, swelling, or weakness, especially if accompanied by unusual tiredness or fever;  persistent elevation of liver function tests;  puffiness or swelling of the eyelids or around the eyes, face, lips or tongue;  shortness of breath;  skin rash;  tightness in chest;  unusual tiredness or weakness ;  wheezing 
  
  

• Frequency not determined
  • Blistering, peeling, loosening of skin;  chills;  dark-colored urine;  diarrhea;  fever;  itching ;  joint pain;  large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs ;  red irritated eyes;  redness, tenderness, itching, burning, or peeling of skin;  red skin lesions, often with a purple center sore;  sore throat;  sores, ulcers, or white spots in mouth or on lips 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Headache;  hoarseness;  lower back or side pain;  painful or difficult urination ;  pain or tenderness around eyes and cheekbones;  stuffy or runny nose 
  
  

• Less common
  • Abdominal pain;  accidental injury;  back pain;  belching or excessive gas ;  constipation;  general feeling of discomfort or illness;  heartburn, indigestion, or stomach discomfort;  lack or loss of strength;  loss of appetite;  nausea;  shivering;  sweating;  trouble sleeping;  vomiting 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.