Pravastatin (Pravachol)

Pravachol is the brand name. Pravastatin is the generic name. Pravachol is the most studied statin (cholesterol-lowering drug) in clinical trials. It is used to decrease LDL cholesterol and triglyceride levels and increase the HDL cholesterol (the "good" cholesterol) level. Pravachol is also proven to reduce coronary heart disease events and deaths due to heart attack or stroke.
 
For more information on statins and how they work, see Understanding Cholesterol-Lowering Medications, Medical Treatment.
 
Basic medication information is as follows:

• Active ingredient: Pravastatin sodium

• Dosage form: Tablet

• Strength: 10, 20, 40, 80 mg

• FDA approval: 10/31/1991

• Company name: Bristol Myers Squibb

Pravachol is a prescription medication that lowers the levels of "bad" cholesterol and triglycerides and raises the level of "good" cholesterol in the blood. LDL, or low-density lipoprotein, is referred to as the "bad" cholesterol. HDL, or high-density lipoprotein, is known as the "good" cholesterol. Pravachol is indicated for both adults and children older than 8 years whose cholesterol is not reduced enough with exercise and a low-fat diet.

Use of Pravachol in children is specifically indicated for an inherited condition, known as heterozygous familial hypercholesterolemia, that causes high cholesterol at a young age. Pravachol is indicated for children aged 8 years and older with heterozygous familial hypercholesterolemia (girls in this age range must have already begun menstruating). When used along with diet, statins reduce total cholesterol, LDL, and apo B levels in children with heterozygous familial hypercholesterolemia. After an adequate trial of diet therapy, statins may be considered for treatment in children if one of the following findings is present:

• LDL-C remains greater than or equal to 190 mg/dL.

• LDL-C remains greater than or equal to 160 mg/dL and one of the following exists:
  • A positive family history of premature cardiovascular disease

  • Two or more other cardiovascular disease risk factors in the pediatric patient

For more information about cholesterol and its management, visit our Cholesterol Center.

You should not take Pravachol if you fit any of the following situations:
 

• You are pregnant, think you may be pregnant, or are planning to become pregnant. Pravachol may harm your unborn baby. If you become pregnant, stop taking Pravachol and call your doctor right away.
  
  
• You are breastfeeding. Pravachol can pass into your breast milk and may harm your baby.
  
  
• You have liver problems.
  
  
• You are allergic to Pravachol or any of its ingredients.

Pravachol may cause serious, but rare, side effects, including the following:
 

• Muscle breakdown (myopathy): Muscle breakdown symptoms include widespread muscle aches, muscle tenderness, and generalized weakness. Rarely, widespread muscle breakdown, known as rhabdomyolysis, can occur, usually in people who are taking other drugs that interfere with the body’s ability to metabolize the statin and in people with advanced kidney problems. Therefore, it is extremely important that you inform your doctor about all the medications, herbal preparations, and dietary supplements you are currently taking. If you experience diffuse muscle pain and weakness or if your urine is brown (a possible sign of muscle breakdown), contact your doctor immediately and stop taking the statin medication.

• Liver problems: Pravachol can cause liver problems. Your doctor may do a blood test to check your liver before you start taking Pravachol, and while you take it.

Before starting Pravachol, tell your doctor about all of your medical conditions, including the following:

• If you have muscle aches or weakness



• If you drink more than 2 glasses of alcohol a day



• If you have diabetes



• If you have a thyroid problem



• If you have a kidney problem

Pravachol and certain other medications can interact, causing serious side effects. Tell your doctor about any prescription and nonprescription medications you are taking, including the following:

• Vitamins



• Herbal supplements



• Medication for your immune system, such as drugs prescribed following organ transplantation



• Other cholesterol medications



• Medication for infections, such as erythromycin, clarithromycin, itraconazole, or ketoconazole



• Medication for heart failure



• Medication for HIV or AIDS

This is NOT a complete list of side effects reported with Pravachol. Your doctor, health care provider, or pharmacist can discuss with you a more complete list of side effects.
 
Statins are well tolerated, and serious side effects (liver problems and muscle soreness, pain, and weakness) are rare. The following more common side effects of Pravachol are usually mild and may go away:
 

• Headache



• Constipation



• Diarrhea



• Gas



• Upset stomach and stomach pain



• Rash



• Muscle and joint pain

Call your doctor if any of the following, more serious, side effects occur.

• Muscle weakness, tenderness, or pain



• Nausea, vomiting, and stomach pain



• Brown or dark urine



• Tiredness



• Yellowness of the skin and whites of the eyes



• Neuropathy (numbness and tingling) affecting the hands, arms, feet, and legs

Pravachol's approved patient and label information

Health's Understanding Cholesterol-Lowering Medications 
 
Drugs@FDA
 
Pravachol.com - Company site

cholesterol, cholesterol level, high cholesterol, high cholesterol level, bad cholesterol, good cholesterol, HDL, LDL, HDL-C, LDL-C, high-density lipoprotein, low-density lipoprotein, cholesterol-lowering medication, cholesterol management, cholesterol test, lipid, coronary heart disease, coronary event, statin, statins, pravastatin, Pravachol

Author: Mary L Windle, Pharm D, Adjunct Assistant Professor, University of Nebraska Medical Center College of Pharmacy; Pharmacy Editor, .com, Inc.

Editors: William L Isley, MD, Senior Associate Consultant, Associate Professor of Medicine, Division of Endocrinology, Diabetes, and Metabolism, Mayo Clinic of Rochester; Francisco Talavera, PharmD, PhD, Senior Pharmacy Editor, ; Michael E Zevitz, MD, Clinical Assistant Professor, Department of Medicine, Rosalind Franklin University of Medicine and Science, Chicago.