PRAVACHOL is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:

• Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD.
• Reduce the risk of total mortality by reducing coronary death, MI, revascularization, stroke/TIA, and the progression of coronary atherosclerosis in patients with clinically evident CHD.
• Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia.
• Reduce elevated serum TG levels in patients with hypertriglyceridemia.
• Treat patients with primary dysbetalipoproteinemia who are not responding to diet.
• Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy.

In short-term clinical trials, the most commonly reported adverse reactions (≥2% and > placebo) regardless of causality were: musculoskeletal pain, nausea/vomiting, upper respiratory infection, diarrhea, and headache.

• Concomitant lipid-lowering therapies: use with fibrates or lipid-modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with PRAVACHOL.
• Cyclosporine: combination increases exposure. Limit pravastatin to 20 mg once daily.
• Clarithromycin: combination increases exposure. Limit pravastatin to 40 mg once daily.

• Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): predisposing factors include advanced age (>65), uncontrolled hypothyroidism, and renal impairment. Patients should be advised to report promptly any symptoms of myopathy. Pravastatin therapy should be discontinued if myopathy is diagnosed or suspected.
• Liver enzyme abnormalities: persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter.