Pitavastatin (pi-tav-a-STAT-in)

Treats high levels of cholesterol and triglycerides (fats) in the blood. This medicine is an HMG-CoA inhibitor, also called a "statin."

Brand Name(s):

Livalo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.
• Carefully follow your doctor's instructions about diet and exercise. This medicine is part of a complete plan for lowering cholesterol and triglycerides in your blood.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using erythromycin (Ery-tab®), niacin (Nicobid®), rifampin (Rifadin®, Rimactane®), another medicine to lower cholesterol (such as clofibrate, fenofibrate, gemfibrozil, Lopid®, or Tricor®), or a blood thinner (such as warfarin, Coumadin®).
• Do not drink alcohol while you are using this medicine. Too much alcohol could cause side effects in the liver.

Warnings While Using This Medicine:

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you are dehydrated or have kidney disease, a severe infection, low blood pressure, an underactive thyroid gland, seizures, or a history of muscle pain or weakness.
• Stop using this medicine and call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you have unusual tiredness or fever. These could be symptoms of a serious muscle problem called myopathy.
• Stop using this medicine and check with your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine if you have a major surgery or injury (trauma).
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark-colored urine or pale stools
• Muscle pain, tenderness, or weakness
• Nausea, vomiting, loss of appetite, or pain in your upper stomach
• Pain in the arms or legs
• Yellowing of your skin or the whites of your eyes

If you notice these less serious side effects, talk with your doctor:

• Back pain
• Constipation or diarrhea
• Headache
• Rash or itching skin
• Stuffy or runny nose

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088