What is the most important information I should know about pravastatin?

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

What is pravastatin?

Pravastatin 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).

Pravastatin is also used to lower the risk of stroke, heart attack, and other heart complications in people with or without coronary heart disease or other risk factors.

Pravastatin is used in adults and children who are at least 8 years old.

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

What should I discuss with my healthcare provider before taking pravastatin?

• liver disease; or
• if you are pregnant or breast-feeding.

Tell your doctor if you have ever had:

• kidney disease;
• abnormal liver function tests;
• a thyroid disorder; or
• if you drink more than 2 alcoholic beverages daily.

Pravastatin can cause a condition that results in the breakdown of skeletal muscle tissue, 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).

How should I take pravastatin?

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

Pravastatin is usually taken once a day, with or without food. Take the medicine at the same time each day.

Pravastatin doses are based on age, and are lower in children and teenagers. People taking this medicine during childhood or adolescence may need a different dose as adults.

• uncontrolled seizures;
• an electrolyte imbalance (such as high or low potassium levels in your blood);
• severely low blood pressure;
• a severe infection or illness; or
• surgery or a medical emergency.

You will need frequent medical tests.

Pravastatin is only part of a complete treatment program that may also include diet, exercise, and weight control. Follow your doctor's instructions very closely.

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while taking pravastatin?

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

Grapefruit may interact with pravastatin and lead to unwanted side effects. Avoid the use of grapefruit products.

What are the possible side effects of pravastatin?

• unexplained muscle pain, tenderness, or weakness;
• fever, unusual tiredness;
• dark colored urine;
• chest pain;
• upper stomach pain, loss of appetite; or
• jaundice (yellowing of the skin or eyes).

Common side effects may include:

• muscle or joint pain;
• nausea, vomiting, diarrhea;
• headache; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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.

What other drugs will affect pravastatin?

If you take cholestyramine or colestipol, take your pravastatin dose 1 hours before or 4 hours after you take the other medicine.

Using certain other drugs together with pravastatin can increase your risk of serious muscle problems. It is very important to tell your doctor about all medicines you use, and those you start or stop using during your treatment with pravastatin, especially:

• colchicine;
• cyclosporine;
• erythromycin;
• gemfibrozil, fenofibric acid, fenofibrate; or
• medicines that contain niacin or nicotinic acid.

This list is not complete. Other drugs may affect pravastatin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about pravastatin.