Pitavastatin is used together with diet to lower blood levels of "bad" cholesterol (low-density lipoprotein, or LDL), to increase levels of "good" cholesterol (high-density lipoprotein, or HDL), and to lower triglycerides (a type of fat in the blood).

Pitavastatin is used to treat high cholesterol in adults. Lowering your cholesterol may help prevent heart disease and hardening of the arteries, conditions that can lead to heart attack, stroke, and vascular disease.

The Livalo brand of pitavastatin is also used to treat an inherited form of high cholesterol in children at least 8 years old.

Pitavastatin may also be used for purposes not listed in this medication guide.

You should not take pitavastatin if you have liver disease (including abnormal liver enzyme tests), or if you also take cyclosporine.

Do not take pitavastatin if you are pregnant or breastfeeding.

Pitavastatin 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.

Pitavastatin comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take pitavastatin 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 pitavastatin 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 pitavastatin and gradually increase your dose, not more than once every 4 weeks.

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take pitavastatin with or without food, but take it at the same time each day.

You will need frequent blood tests.

You may need to stop using pitavastatin for a short time if you have:

• uncontrolled seizures;

• an electrolyte imbalance (such as high or low potassium levels in your blood);

• severely low blood pressure;

• a severe infection or illness;

• dehydration; or

• surgery or a medical emergency.

Pitavastatin 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.

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

You should not use pitavastatin if you are allergic to it, or if you have:

• liver disease (including abnormal liver enzyme tests);

• if you are pregnant or breastfeeding; or

• if you are taking cyclosporine.

Do not use if you are pregnant. pitavastatin can harm an unborn baby. Use effective birth control to prevent pregnancy. Stop taking this medicine and tell your doctor at once if you become pregnant.

Do not breastfeed while you are taking pitavastatin.

Tell your doctor if you have ever had:

• kidney disease;

• liver disease;

• a thyroid disorder; or

• if you drink large amounts of alcohol.

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

Do not give this medicine to a child without medical advice.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next 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 light, 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 eating foods high in fat or cholesterol, or pitavastatin will not be as effective.

Drinking alcohol can raise triglyceride levels and may increase your risk of liver damage.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, pitavastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading 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 colored urine.

Also call your doctor at once if you have:

• confusion, memory problems;

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

• trouble lifting your arms, trouble climbing or standing;

• kidney problems--vomiting, pain in your side or lower back, little or no urinating, swelling, rapid weight gain; or

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

Common side effects of pitavastatin may include:

• muscle pain;

• pain in your arms or legs;

• back pain; or

• diarrhea, constipation.

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.

Tell your doctor about all other medicines you use. Like pitavastatin, certain other drugs can increase your risk of serious muscle problems, especially:

• colchicine;

• gemfibrozil;

• fenofibric acid;

• fenofibrate; or

• medicines that contain niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others).

This list is not complete. Other drugs may affect pitavastatin, including 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 signs of liver damage.

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

Pitavastatin may increase your blood sugar level. If you monitor your blood sugar (glucose) at home, call your doctor if your blood sugar is high. You should follow diet and exercise recommendations made by your doctor or dietitian.

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.