Introduction

Pravastatin (prav-a-STAT-in)

Lowers high levels of cholesterol, and helps prevent heart attack in people who have high cholesterol. Helps prevent heart attack and stroke in people who have heart disease.

Brand Name(s)

There may be other brand names for this medicine.

Pravachol

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to pravastatin, or to similar medicines such as atorvastatin (Lipitor®), fluvastatin (Lescol®), lovastatin (Mevacor®), or simvastatin (Zocor®). You should not use this medicine if you are pregnant or breast feeding.

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food. Take this medicine in the evening or at bedtime, unless your doctor tells you differently.
• Carefully follow your doctor's instructions about any special diet.

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.

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• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.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 cyclosporine (Neoral®, Sandimmune®), gemfibrozil (Lopid®), itraconazole (Sporanox®), or cholestyramine (Questran®).

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 a history of liver disease, kidney disease, or a muscle disorder.
• Tell your doctor how much, and how often you drink alcohol.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.

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.
• Muscle pain, weakness, or cramps.
• Skin or whites of your eyes turn yellow.
• Skin rash or hives.
• Stomach pain, nausea, vomiting, or loss of appetite.
• Unexplained fever.

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

• Constipation or diarrhea.
• Headache.
• Mild stomach upset, gas, or indigestion.

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