Monograph Details
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Cardiovascular System
> Hyperlipoproteinemias
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PRAVACHOL |
| Manufacturer |
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Bristol-Myers Squibb |
| Legal Classification |
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Rx
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| Pharmacological Class |
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HMG-CoA reductase inhibitor. |
| Generic Name |
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Pravastatin sodium 10mg, 20mg, 40mg, 80mg; tabs. |
| Indications |
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As adjunct to diet when response to nondrug therapy is inadequate: To reduce risk of MI, reduce risk of undergoing myocardial revascularization procedures, and reduce risk of cardiovascular mortality with no increase in death from non-cardiovascular causes in hypercholesterolemic patients without clinically evident coronary heart disease; To reduce mortality risk by reducing coronary death, to reduce risk of MI, to reduce risk of undergoing myocardial revascularization procedures, to reduce risk of stroke or transient ischemic attack (TIA), and to slow progression of coronary atherosclerosis in patients with clinically evident coronary artery disease; To reduce elevated total-C, LDL-C, apo B, and TG, and to increase HDL-C in primary hypercholesterolemia and mixed dyslipidemia (Types IIa and IIb); To treat elevated serum TG (Type IV); To treat primary dysbetalipoproteinemia (Type III). Adjunct to diet in patients 8–18 years of age with heterozygous familial hypercholesterolemia if LDL-C remains ≥190mg/dL, or if LDL-C remains ≥160mg/dL with either family history of premature cardiovascular disease (CVD) or if patient has at least 2 other CVD risk factors. |
| Children |
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<8 years: not recommended. 8–13 years: 20mg once daily. 14–18 years: 40mg once daily. |
| Adults |
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≥18 years: initially 40mg once daily; may increase to 80mg once daily after 4 weeks. Renal or hepatic dysfunction: initially 10mg daily. Concomitant immunosuppressants (eg, cyclosporine): initially 10mg once daily at bedtime; usual max 20mg/day. |
| Contraindications |
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Active liver disease. Unexplained, persistent elevated serum transaminases. Pregnancy (Cat.X). Nursing mothers. |
| Precautions |
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Monitor liver function before therapy, at dose increases, and then periodically: discontinue if serum transaminases ≥3xULN persist. History or symptoms of liver disease or heavy alcohol ingestion. Reevaluate if endocrine dysfunction occurs. Discontinue if myopathy or markedly elevated CPK levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Homozygous familial hypercholesterolemia. Renal impairment. |
| Interactions |
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Avoid fibrates. Monitor for myopathy with cyclosporine, erythromycin, niacin. Enhanced effects with cholestyramine, colestipol (give pravastatin 1 hour before or 4 hours after). Caution with drugs that decrease levels or activity of steroid hormones (eg, ketoconazole, spironolactone, cimetidine). |
| Adverse Reactions |
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Headache, GI upset, myalgia, rash, dizziness, elevated serum transaminases, myopathy, rhabdomyolysis with renal dysfunction. |
| How Supplied |
Tabs 10mg, 40mg—90
20mg—90, 1000
80mg—90, 500 |
| Additional Resources |
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• Related Prescribing Note |
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