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Uses
Side effects
Interactions
Precautions
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. (1.1)
- 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. (1.1)
- Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. (1.2)
- Reduce elevated serum TG levels in patients with hypertriglyceridemia. (1.2)
- Treat patients with primary dysbetalipoproteinemia who are not responding to diet. (1.2)
- Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2)
- Limitations of use: PRAVACHOL has not been studied in Fredrickson Types I and V dyslipidemias. (1.3)
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. (6.1)
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. (7)
- Cyclosporine: combination increases exposure. Limit pravastatin to 20 mg once daily. (2.5, 7.1)
- Clarithromycin: combination increases exposure. Limit pravastatin to 40 mg once daily. (2.6, 7.2)
- 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. (5.1, 8.5)
- Liver enzyme abnormalities: persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter. (5.2)
