Lipitor

Lipitor is used together with diet, weight loss, and exercise to treat high cholesterol and 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.

Lipitor 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.

Lipitor 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).

Lipitor (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.

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 Lipitor has been shown to prevent heart disease, angina (chest pain), strokes, and heart attacks.

Take Lipitor 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.

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

You may take Lipitor tablets with or without food.

If you are taking the oral suspension, take it on an empty stomach (1 hour before or 2 hours after a meal). Measure your dose correctly with an oral dosing syringe. Ask your pharmacist for one if you do not have it.

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 Lipitor is effective.

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

Store at room temperature away from moisture, heat, and light. If you are using the oral suspension, keep it in the original bottle and throw away any unused medicine 60 days after first opening it.

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

Lipitor 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 Lipitor. 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. Lipitor will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Lipitor 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.

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

To make sure Lipitor 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.

Lipitor 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).

Lipitor (atorvastatin) may harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant, stop taking this medicine and call your doctor right away.

Do not breastfeed while you are taking this medicine.

Get emergency medical help if you have signs of an allergic reaction to Lipitor (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).

Lipitor 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 Lipitor 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 with sleeping;
• stuffy nose, runny nose, sore throat;
• diarrhea, nausea; or
• pain in arms or legs (limbs).

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.

Skip the missed dose and take your next dose at the regular time. Do not take two doses at one time.

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

Avoid eating foods high in fat or cholesterol, or Lipitor 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.

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;
• heart medicine such as digoxin;
• 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.

Active ingredient: atorvastatin calcium Inactive ingredients: calcium carbonate, USP; candelilla wax, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, simethicone emulsion.

Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, USA.