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DRUG INTERACTIONS Drug Interactions
Immunosuppressive Drugs, Gemfibrozil, Niacin (Nicotinic Acid), Erythromycin: See WARNINGS: Skeletal Muscle.
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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. (See WARNINGS.)
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CONTRAINDICATIONS
Hypersensitivity to any component of this medication.
Active liver disease or unexplained, persistent elevations of serum transaminases (see WARNINGS).
Pregnancy and Lactation. 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 HMG-CoA reductase inhibitors 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 PRECAUTIONS: Pregnancy).
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REFERENCES
- Shepherd J, et al. Prevention of Coronary Heart Disease with Pravastatin in Men with Hypercholesterolemia (WOS). N Engl J Med 1995;333:1301-7.
- The Long-term Intervention with Pravastatin in Ischemic Disease Group. Prevention of Cardiovascular Events and Death with Pravastatin in Patients with Coronary Heart Disease and a Broad Range of Initial Cholesterol Levels (LIPID). N Engl J Med 1998;339:1349-1357.
- Sacks FM, et al. The Effect of Pravastatin on Coronary Events After Myocardial Infarction in Patients with Average Cholesterol Levels (CARE). N Engl J Med 1996;335:1001-9.
- Pitt B, et al. Pravastatin Limitation of Atherosclerosis in the Coronary Arteries (PLAC I): Reduction in Atherosclerosis Progression and Clinical Events. J Am Coll Cardiol 1995;26:1133-9.
- Jukema JW, et al. Effects of Lipid Lowering by Pravastatin on Progression and Regression of Coronary Artery Disease in Symptomatic Man With Normal to Moderately Elevated Serum Cholesterol Levels. The Regression Growth Evaluation Statin Study (REGRESS). Circulation 1995;91:2528-2540.
- Crouse JR, et al. Pravastatin, Lipids, and Atherosclerosis in the Carotid Arteries: Design Features of a Clinical Trial with Carotid Atherosclerosis Outcome (PLAC II). Controlled Clinical Trials 1992;13:495.
- Salonen R, et al. Kuopio Atherosclerosis Prevention Study (KAPS). A Population-based Primary Preventive Trial of the Effect of LDL Lowering on Atherosclerotic Progression in Carotid and Femoral Arteries. Research Institute of Public Health, University of Kuopio, Finland. Circulation 1995;92:1758.
- Fredrickson DS, et al. Fat Transport in Lipoproteins-An Integrated Approach to Mechanisms and Disorders. N Engl J Med 1967;276:34-42, 94-102, 148-156, 215-224, 273-281.
- Manson JM, Freyssinges C, Ducrocq MB, Stephenson WP. Postmarketing Surveillance of Lovastatin and Simvastatin Exposure During Pregnancy. Reproductive Toxicology 1996;10(6):439-446.
US Patent Nos.: 5,030,447; 5,180,589; 5,622,985
Bristol-Myers Squibb Company
Princeton, NJ 08543 USA
1186935A2
Rev March 2007
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