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

In rare cases, pravastatin can cause a condition that results in the breakdown of skeletal muscle tissue. This condition can lead to kidney failure. Call your doctor at once if you have unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine.

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Do not take pravastatin if you have liver disease, or if you are breast-feeding.

Before taking pravastatin, tell your doctor if you have diabetes, underactive thyroid, kidney disease, a muscle disorder, or if you drink 3 or more alcoholic beverages per day.

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 while taking pravastatin. Alcohol can raise triglyceride levels, and may also damage your liver while you are taking pravastatin.

There may be other drugs that can interact with pravastatin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

What is pravastatin?

Pravastatin is a cholesterol-lowering medication that blocks the production of cholesterol (a type of fat) in the body.

Pravastatin reduces low-density lipoprotein (LDL) cholesterol and total cholesterol in the blood. Lowering your cholesterol can help prevent heart disease and hardening of the arteries, conditions that can lead to heart attack, stroke, and vascular disease.

Pravastatin is used to treat high cholesterol. Pravastatin is also used to lower the risk of stroke, heart attack, or other heart complications in people with coronary heart disease.

Pravastatin may also be used for purposes other than those listed in this medication guide.

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

Do not use this medication if you are allergic to pravastatin, if you are pregnant or breast-feeding, or if you have liver disease.

Before taking pravastatin, tell your doctor if you are allergic to any drugs, or if you have:

• diabetes;
• underactive thyroid;
• kidney disease;
• a muscle disorder; or
• if you are a heavy drinker (3 or more alcoholic beverages per day).

If you have any of these conditions, you may need a dose adjustment or special tests to safely take pravastatin.

FDA pregnancy category X. This medication can cause birth defects. Do not use pravastatin if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication.

Pravastatin passes into breast milk and may harm a nursing baby. Do not take pravastatin without telling your doctor if you are breast-feeding a baby.

How should I take pravastatin?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take pravastatin with a full glass of water.

Pravastatin can be taken with or without food.

Pravastatin is usually taken once a day. Try to take your dose at the same time each day. Follow your doctor's instructions.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

In rare cases, pravastatin can cause a condition that results in the breakdown of skeletal muscle tissue. This condition can lead to kidney failure. Call your doctor at once if you have unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine.

Pravastatin 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.

You may need to take pravastatin on a long-term basis for the treatment of high cholesterol.

Store pravastatin at room temperature, protected from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of pravastatin is not expected to produce life-threatening symptoms.

What should I avoid while taking 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 while taking pravastatin. Alcohol can raise triglyceride levels, and may also damage your liver while you are taking pravastatin.

What are the possible side effects of pravastatin?

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

Stop using pravastatin and call your doctor at once if you have any of these serious side effects:

• chest pain;
• muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

• mild stomach pain, constipation, diarrhea;
• heartburn, gas, bloating, upset stomach;
• tired feeling;
• headache, dizziness;
• stuffy nose, cold or flu symptoms;
• skin rash; or
• general pain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect pravastatin?

Before taking pravastatin, talk to your doctor if you are using any of the following drugs:

• cholestyramine (Questran) or colestipol (Colestid);
• drugs that weaken your immune system such as cancer medicine or steroids, cyclosporine (Neoral, Sandimmune, Gengraf), sirolimus (Rapamune), tacrolimus (Prograf), and others;
• erythromycin (E-Mycin, E.E.S., Ery-Tab, others) or clarithromycin (Biaxin);
• niacin (Nicolar, Nicobid, Nicotinex, others);
• gemfibrozil (Lopid), clofibrate (Atromid-S), or fenofibrate (Tricor); or
• an antifungal medication such as itraconazole (Sporanox), fluconazole (Diflucan), or ketoconazole (Nizoral).

This list is not complete and there may be other drugs that can interact with pravastatin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about pravastatin.

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

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2003 Cerner Multum, Inc. Version: 9.06. Revision date: 05/14/2008.