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PRAVASTATIN-ORAL (cont.)

PRECAUTIONS: Before taking pravastatin, tell your doctor or pharmacist if you are allergic to it; or to other "statins"; or if you have any other allergies. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: active liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease, history of liver disease, kidney disease, underactive thyroid (hypothyroidism), diabetes (poorly controlled), alcohol use. The rare development of severe muscle damage (see Side Effects) can infrequently lead to serious kidney problems. This medication is usually temporarily stopped if you have any condition which can increase your risk of developing kidney problems. Before stopping your medication, notify your doctor immediately if you have any of the following conditions: major surgery, trauma, serious illness (e.g., sepsis, severe metabolic/endocrine/electrolyte disorders), very low blood pressure, uncontrolled seizures. This drug may make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. Daily use of alcohol may increase your chance for serious side effects. Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug, especially muscle damage. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. It is recommended that young girls and women of child-bearing age use effective birth control measures to prevent pregnancy while taking this drug since pravastatin may cause fetal harm. A small amount of this drug passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also the How To Use section. Use caution if the following drugs are combined with pravastatin because serious side effects such as muscle injury (myopathy) infrequently could occur: fibrates (e.g., gemfibrozil, fenofibrate), high-dose niacin (1 gram or more per day). Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: cholestyramine, colestipol, cyclosporine. Do not start or stop any medicine without doctor or pharmacist approval.




Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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