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

• Rare cases of muscle problems and liver problems have been associated with the use of Pravachol and other similar medicines. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if accompanied by a fever or flulike symptoms or yellowing of the skin or eyes, abdominal pain, unexplained fatigue, dark colored urine or pale colored stools. These may be early symptoms of muscle or liver problems.
• Do not take Pravachol without first talking to your doctor if you have liver disease.
• Alcohol and Pravachol can both be damaging to the liver. Alcohol should be used only in moderation. Discuss the use of alcohol with your doctor so that the potential for liver problems can be determined.
• Do not take Pravachol if you are pregnant, could become pregnant during treatment, or if you are breast-feeding a baby.

What is Pravachol?

• Pravachol is an HMG CoA reductase inhibitor. Pravachol blocks the production of cholesterol (a type of fat) in the body.
• Pravachol is used to reduce the amounts of LDL (bad) cholesterol, total cholesterol, triglycerides (another type of fat), and apolipoprotein B (a protein needed to make cholesterol) in your blood. These actions are important in reducing the risk of hardening of the arteries, which can lead to heart attacks, stroke, and peripheral vascular disease.
• Pravachol may also be used for purposes other than those listed in this medication guide.

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

• Do not take Pravachol without first talking to your doctor if you have liver disease.
• Before taking Pravachol, tell your doctor if you
  • have kidney disease,
  • drink alcoholic beverages,
  • have a chronic muscular disease, or
  • have a blood disorder.
• Your may not be able to take Pravachol, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• Pravachol is in the FDA pregnancy category X. This means that Pravachol is known to cause birth defects if it is taken during pregnancy. Do not take Pravachol if you are pregnant or could become pregnant during treatment.
• Pravachol passes into breast milk and may be harmful to a nursing infant. Do not take Pravachol if you are breast-feeding a baby.

How should I take Pravachol?

• Take Pravachol exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• For the greatest effect, Pravachol is usually taken at bedtime or with an evening meal. It may also be taken several times a day. Follow your doctor's instructions.
• Your doctor may want to monitor your liver function with blood tests before starting treatment with Pravachol and at twelve weeks after both the start of your treatment and any increase in dose. Depending on the results of these tests, your doctor can determine how much monitoring you will require.
• Eat a low-fat, low-cholesterol diet. To see beneficial effects from Pravachol, avoid fatty, high-cholesterol foods.
• It is important to take Pravachol regularly to get the most benefit.
• Do not stop taking Pravachol without first talking to your doctor. Pravachol may need to be taken on a long-term basis for the treatment of high cholesterol.
• Your doctor may want you to have blood tests or other medical evaluations during treatment with Pravachol to monitor progress and side effects.
• Store Pravachol at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

• Seek emergency medical attention if an overdose is suspected.
• Symptoms of a Pravachol overdose include nausea, diarrhea, stomach distress, and indigestion.

What should I avoid while taking Pravachol?

• Alcohol and Pravachol can both be damaging to the liver. Alcohol should be used only in moderation. Discuss the use of alcohol with your doctor so that the potential for liver problems can be determined.

What are the possible side effects of Pravachol?

• Rare cases of muscle problems and liver problems have been associated with the use of Pravachol and other similar medicines. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if accompanied by a fever or flulike symptoms or yellowing of the skin or eyes, abdominal pain, unexplained fatigue, dark colored urine or pale colored stools. These may be early symptoms of muscle or liver problems.
• If you experience any of the following serious side effects, stop taking Pravachol and seek emergency medical attention or contact your doctor immediately:
  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • decreased urine or rust-colored urine; or
  • blurred vision.
• Other, less serious side effects may be more likely to occur. Continue to take Pravachol and talk to your doctor if you experience
  • gas, bloating, nausea, stomach upset, heartburn, abdominal pain, constipation, or diarrhea;
  • a cough;
  • headache; or
  • insomnia.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Pravachol?

• Do not take Pravachol without first talking to your doctor if you are taking any of the following medicines:
  • cyclosporine (Sandimmune, Neoral);
  • gemfibrozil (Lopid), clofibrate (Atromid-S), or fenofibrate (Tricor);
  • niacin (Nicolar, Nicobid, Slo-Niacin, others);
  • erythromycin (E-Mycin, E.E.S., Ery-Tab, others) or clarithromycin (Biaxin); or
  • cholestyramine (Questran) or colestipol (Colestid).
• You may not be able to take Pravachol, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
• Drugs other than those listed here may also interact with Pravachol. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.