Atorvastatin belongs to a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.

Atorvastatin is used together with diet, weight loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease.

Atorvastatin is also used to lower the amount of fatty substances such as low-density lipoprotein (LDL) cholesterol ('bad cholesterol') and triglycerides in the blood and to increase the amount of high-density lipoprotein (HDL) cholesterol ('good cholesterol') in the blood.

Atorvastatin may also be used to decrease the amount of cholesterol and other fatty substances in the blood in children and teenagers 10 to 17 years of age who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally).

Accumulation of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats with atorvastatin has been shown to prevent heart disease, angina (chest pain), strokes, and heart attacks.

You should not take atorvastatin if you have liver disease or cirrhosis.

Atorvastatin can cause the breakdown of muscle tissue, which can lead to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark urine.

Serious drug interactions can occur when certain medicines are used together with atorvastatin. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Avoid eating foods that are high in fat or cholesterol. Atorvastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Atorvastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Atorvastatin comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take atorvastatin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take atorvastatin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of atorvastatin and gradually increase your dose, not more than once every 2 to 4 weeks.

Continue to take atorvastatin even if you feel well. Do not stop taking atorvastatin without talking to your doctor.

Take atorvastatin exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Do not change your dose or stop taking any of your medications without your doctor's advice.

Atorvastatin is usually taken once per day. Follow your doctor's instructions.

You may take the tablet form of this medicine with or without food.

Take the liquid medicine on an empty stomach, at least 1 hour before a meal or 2 hours after a meal.

It may take up to 2 weeks before your cholesterol levels improve, and you may need frequent blood tests. Even if you have no symptoms, tests can help your doctor determine if this medicine is effective.

Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon).

Your treatment may also include diet, exercise, weight control, and blood tests.

Store at room temperature away from moisture, heat, and light.

Throw away in the trash any unused liquid 60 days after opening the bottle.

You should not use atorvastatin if you are allergic to it, or if you have liver failure or cirrhosis.

To make sure atorvastatin is safe for you, tell your doctor if you have ever had:

• muscle pain or weakness;

• diabetes;

• stroke;

• a thyroid disorder;

• a habit of drinking more than 2 alcoholic beverages per day; or

• kidney disease.

Atorvastatin can cause the breakdown of muscle tissue, which can lead to kidney failure. This happens more often in women, in older adults, or people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

Atorvastatin may harm an unborn baby. Tell your doctor if you are pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Eat a low-fat, low-cholesterol diet. Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. You can also visit the National Cholesterol Education Program (NCEP) website for additional dietary information at http://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf.

Avoid drinking large amounts [more than 1.2 liter (approximately 1 quart) per day] of grapefruit juice while taking atorvastatin.

Avoid eating foods high in fat or cholesterol, or atorvastatin will not be as effective.

Drinking alcohol may increase your risk of liver damage.

Grapefruit may interact with atorvastatin and cause side effects. Avoid consuming grapefruit products and drinking more than 1.2 liters of grapefruit juice each day.

Get emergency medical help if you have signs of an allergic reaction to atorvastatin (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Atorvastatin can cause the breakdown of muscle tissue, which can lead to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark urine.

Muscle problems may be more likely in older adults and those who have kidney problems, thyroid problems, or take certain other medicines.

Also call your doctor at once if you have:

• muscle weakness in your hips, shoulders, neck, and back;

• trouble lifting your arms, trouble climbing or standing;

• liver problems - loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• kidney problems - swelling, urinating less, feeling tired or short of breath; or

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor.

Common atorvastatin side effects may include:

• pain in your bones, spine, joints, or muscles;

• pain and burning when you urinate, painful urination;

• muscle spasms;

• upset stomach;

• trouble sleeping;

• stuffy nose, runny nose, sore throat;

• diarrhea, nausea; or

• pain in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which can increase risk of serious muscle problems or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can interact with atorvastatin, especially:

• other cholesterol lowering medicine - gemfibrozil, niacin, fenofibrate, fenofibric acid, and others;

• colchicine;

• antibiotic or antifungal medicine - rifampin, erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and voriconazole;

• birth control pills;

• medicine to prevent organ transplant rejection; or

• antiviral medicine to treat hepatitis C or HIV.

This list is not complete and many other drugs may interact with atorvastatin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests during your treatment , especially if you develop symptoms of liver damage.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking atorvastatin.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Caduet® (containing Amlodipine, Atorvastatin)
• Liptruzet® (containing Atorvastatin, Ezetimibe)