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What you should know before using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatrics

Pravastatin is safe to use in children and adolescents (8 to 18 years of age) for treating certain types of high cholesterol. Safety and efficacy in children younger than 8 years of age have not been established.

Adolescent girls taking pravastatin should be counseled on appropriate contraceptive methods.

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of pravastatin in the elderly.

Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Bezafibrate
  • Ciprofibrate
  • Clofibrate
  • Dalfopristin
  • Fenofibrate
  • Gemfibrozil
  • Quinupristin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse (or history of) or
  • Liver disease, history—Use with caution. These conditions may increase the amount of pravastatin in your blood.
  • Kidney disease, severe—Use with caution. This medicine may make the condition worse.
  • Liver disease, active or
  • Liver enzymes, persistently high levels—This medicine should NOT be used in these conditions. Use of this medicine may make liver problems worse.
  • Convulsions (seizures), uncontrolled or
  • Electrolyte disorder, severe or
  • Endocrine disorder (such as diabetes mellitus), severe or
  • Infection, severe or
  • Low blood pressure or
  • Major surgery or trauma or
  • Metabolic disorder, severe—Patients with these conditions may be at risk of developing muscle problems (causing the release of muscle pigment into the urine) that may lead to kidney failure.

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