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DRUG INTERACTIONS
For the concurrent therapy of either cyclosporine, fibrates, niacin (nicotinic acid), or erythromycin, the risk of myopathy increases [see
Warnings and Precautions
and
Clinical Pharmacology
].
Cyclosporine
The risk of myopathy/rhabdomyolysis is increased with concomitant administration of cyclosporine. Limit pravastatin to 20 mg once daily for concomitant use with cyclosporine [see
Dosage and Administration
,
Warnings and Precautions
, and
Clinical Pharmacology
].
Clarithromycin
The risk of myopathy/rhabdomyolysis is increased with concomitant administration of clarithromycin. Limit pravastatin to 40 mg once daily for concomitant use with clarithromycin [see
Dosage and Administration
,
Warnings and Precautions
, and
Clinical Pharmacology
].
Colchicine
The risk of myopathy/rhabdomyolysis is increased with concomitant administration of colchicine [see
Warnings and Precautions
].
Gemfibrozil
Due to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase inhibitors are coadministered with gemfibrozil, concomitant administration of PRAVACHOL with gemfibrozil should be avoided [see
Warnings and Precautions
].
Other Fibrates
Because it is known that the risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concurrent administration of other fibrates, PRAVACHOL should be administered with caution when used concomitantly with other fibrates [see
Warnings and Precautions
].
Niacin
The risk of skeletal muscle effects may be enhanced when pravastatin is used in combination with niacin; a reduction in PRAVACHOL dosage should be considered in this setting [see
Warnings and Precautions
].
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OVERDOSAGE
To date, there has been limited experience with overdosage of pravastatin. If an overdose occurs, it should be treated symptomatically with laboratory monitoring and supportive measures should be instituted as required.
|
CONTRAINDICATIONS
Hypersensitivity
Hypersensitivity to any component of this
medication.
Liver
Active liver disease or unexplained, persistent elevations of serum transaminases [see
Warnings
and Precautions
].
Pregnancy
Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Cholesterol and other products of cholesterol biosynthesis are essential components for fetal development (including synthesis of steroids and cell membranes). Since statins decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, they are contraindicated during pregnancy and in nursing mothers. PRAVASTATIN SHOULD BE ADMINISTERED TO WOMEN OF CHILDBEARING AGE ONLY WHEN SUCH PATIENTS ARE HIGHLY UNLIKELY TO CONCEIVE AND HAVE BEEN INFORMED OF THE POTENTIAL HAZARDS. If the patient becomes pregnant while taking this class of drug, therapy should be discontinued immediately and the patient apprised of the potential hazard to the fetus [see
Use in Specific Populations
].
Nursing Mothers
A small amount of pravastatin is excreted in human breast milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require PRAVACHOL treatment should not breast-feed their infants [see
Use in Specific Populations
].
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