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

Pravachol 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).

Pravachol 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.

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

You should not take Pravachol if you have active liver disease, or if you are pregnant or breastfeeding.

Stop taking Pravachol and tell your doctor at once if you become pregnant.

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.

Pravastatin 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.

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

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Pravachol 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.

Take Pravachol 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.

Take the medicine at the same time each day, with or without food.

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.

You may need to stop using Pravachol 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; or

• surgery or a medical emergency.

It may take up to 4 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 this medicine is effective.

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

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

You should not use Pravachol if you are allergic to pravastatin, or if:

• you are pregnant or breastfeeding; or

• you have active liver disease.

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

• kidney disease;

• abnormal liver function tests;

• muscle pain or weakness;

• a thyroid disorder; or

• if you drink more than 2 alcoholic beverages daily.

Pravachol 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).

Do not use if you are pregnant. This medicine 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 using this medicine.

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.

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

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

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

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

In rare cases, pravastatin 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.

Call your doctor right away if you have:

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

• trouble lifting your arms, trouble climbing or standing; or

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

Common Pravachol 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.

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

Some drugs can increase your risk of serious muscle problems if you take them together with Pravachol. Your doctor may need to change your treatment plan if you use any of the following drugs:

• cyclosporine;

• colchicine;

• clarithromycin, erythromycin, azithromycin;

• 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 pravastatin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.