Pravastatin

What is pravastatin?

Pravastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins."

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.

Important information for Pravastatin sodium

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

Stop taking pravastatin and tell your doctor right away 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.

Before Taking Pravastatin sodium

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

• liver disease; or

• if you are pregnant or breastfeeding.

To make sure this medicine is safe for you, tell your doctor if you have:

• a personal or family history of a genetic muscle disorder;

• previous muscle pain or complications with another cholesterol medication;

• diabetes;

• kidney disease;

• abnormal liver function tests;

• a thyroid disorder;

• an autoimmune disorder such as rheumatoid arthritis, lupus, or others; or

• if you drink more than 2 alcoholic beverages daily; o

r

• if you exercise excessively.

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).

This medicine can harm an unborn baby or cause birth defects. Do not use if you are pregnant. Stop taking this medicine and tell your doctor right away if you become pregnant. Use effective birth control to prevent pregnancy while you are taking this medicine.

Pravastatin can pass into breast milk and may harm a nursing baby. Do not breastfeed while using this medicine.

How should I take pravastatin?

Take pravastatin 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 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.

You may need to stop using pravastatin 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.

While using this medicine, you may need frequent blood 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.

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

Pravastatin dosing information

Usual Adult Dose:

Initial dose: 40 mg once daily.
Pravastatin may be increased to up to 80 mg once daily.

Usual Pediatric Dose:

Age 8 to 13 years: 20 mg orally once daily
Age 14 to 18 years: 40 mg orally once daily

What happens if I miss a dose of Pravastatin sodium?

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.

What happens if I overdose of Pravastatin sodium?

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

What should I avoid while taking pravastatin?

If you also take cholestyramine or colestipol, avoid taking them within 1 hour after or 4 hours before you take pravastatin.

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.

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

Pravastatin side effects

Get emergency medical help if you have signs of an allergic reaction to pravastatin: 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;

• fever, unusual tiredness;

• dark colored urine;

• chest pain;

• upper stomach pain, loss of appetite;

• jaundice (yellowing of the skin or eyes).

• difficulty breathing or dry cough; or

• memory loss, confusion, forgetfulness.

Common pravastatin 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 hour 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, especially:

• colchicine;

• cyclosporine;

• erythromycin;

• other cholesterol or triglyceride-lowering medications including gemfibrozil, fenofibric acid, and fenofibrate; or

• medicines that contain niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others) or nicotinic acid;

• digoxin, diltiazem, verapamil;

• blood thinners (warfarin, Coumadin, Jantoven);

• HIV medications such as darunavir, ritonavir, kaletra, others;

• antifungals including fluconazole, itraconazole; or

• cimetidine and antacid medication.

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 interactions are listed in this medication guide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use pravastatin only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.