Livalo belongs to a group of drugs called HMG CoA reductase inhibitors, or "statins."

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

Livalo 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.

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

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

Do not take Livalo if you are pregnant.

Do not breastfeed while you are taking Livalo.

Before taking this medicine

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

• liver disease (including significantly abnormal liver enzyme tests);

• if you are pregnant or breastfeeding; or

• if you are taking cyclosporine.

Do not use Livalo 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.

Pitavastatin can pass into breast milk and may harm a nursing baby. Do not breastfeed while you are taking Livalo.

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

• kidney disease;

• liver disease;

• a thyroid disorder; or

• if you drink large amounts of alcohol.

Livalo can cause a condition that results in the breakdown of skeletal muscle tissue, potentially leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

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

Take Livalo exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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

While using Livalo, you may need frequent blood tests to check your liver function.

You may need to stop using Livalo 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.

Livalo 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.

Usual Adult Dose for Hyperlipidemia:

Initial dose: 2 mg orally once a day with or without food

Maintenance dose: 1 to 4 mg once a day with or without food

Maximum dose: 4 mg once a day with or without food

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

• liver disease (including significantly abnormal liver enzyme tests);

• if you are pregnant or breastfeeding; or

• if you are taking cyclosporine.

Do not use Livalo 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.

Pitavastatin can pass into breast milk and may harm a nursing baby. Do not breastfeed while you are taking Livalo.

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

• kidney disease;

• liver disease;

• a thyroid disorder; or

• if you drink large amounts of alcohol.

Livalo can cause a condition that results in the breakdown of skeletal muscle tissue, potentially leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

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

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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

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

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

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

In rare cases, Livalo 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, and dark 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 Livalo side effects 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, and it is very important that your doctor knows if you are using any of them:

• 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 interact with pitavastatin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.