Pravastatin (By mouth)

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• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• 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 cimetidine (Tagamet®), clarithromycin (Biaxin®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), erythromycin (Ery-Tab®), gemfibrozil (Lopid®), itraconazole (Sporanox®), ketoconazole (Nizoral®), niacin, or spironolactone (Aldactone®).
• If you are also taking certain other medicines to lower your cholesterol, such as cholestyramine, colestipol, Colestid®, or Questran®, take these medicines 4 hours before or at least 1 hour after taking pravastatin.
• Tell your doctor if you usually drink more than 2 glasses alcohol per day.

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 have kidney disease, an underactive thyroid, or a history of liver disease or alcoholism.
• Stop using this medicine and call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a 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, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. 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 major surgery or a major injury.
• 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
• Decrease in how much or how often you urinate
• Dark-colored urine or pale stools
• Muscle pain, tenderness, weakness, or cramps
• Stomach pain, nausea, vomiting, or loss of appetite
• Unexplained fever
• Unusual tiredness or weakness
• Yellowing of the skin or the whites of your eyes

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

• Headache
• Mild nausea, vomiting, or diarrhea
• Rash

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

Introduction

Pravastatin (prav-a-STAT-in)

Lowers high levels of cholesterol and triglycerides in your blood. Helps keep atherosclerosis (hardening of the arteries) from getting worse. Helps prevent heart attack and stroke in people who have heart disease. This medicine is an HMG-CoA inhibitor, sometimes called a statin.

Brand Name(s)

Pravachol

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.
• Take this medicine in the evening or at bedtime, unless your doctor tells you differently.
• Carefully follow your doctor's instructions about diet and exercise. This medicine is only 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.