Generic Name and Formulations:
Pravastatin sodium 10mg, 20mg, 40mg, 80mg; tabs.
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. Limitations of use: not studied in conditions where major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).
≥18yrs: initially 40mg once daily; may increase to 80mg once daily after 4 weeks. Renal dysfunction: initially 10mg daily. Concomitant immunosuppressants (eg, cyclosporine): initially 10mg once daily at bedtime; usual max 20mg/day. Concomitant clarithromycin: max 40mg/day.
<8yrs: not recommended. 8–13yrs: 20mg once daily. 14–18yrs: 40mg once daily.
HMG-CoA reductase inhibitor.
Active liver disease. Unexplained, persistent elevated serum transaminases. Pregnancy (Cat.X). Nursing mothers.
Discontinue if myopathy or markedly elevated CPK levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Monitor liver function before starting therapy and when clinically indicated. Interrupt therapy if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs; do not restart if alternate etiology not found. History or symptoms of liver disease or heavy alcohol ingestion. Reevaluate if endocrine dysfunction occurs. Homozygous familial hypercholesterolemia. Renal impairment.
See Adult dose. Increased risk of myopathy with cyclosporine, clarithromycin, colchicine. Avoid gemfibrozil. Caution with other fibrates, niacin; may need to reduce pravastatin dose. Enhanced effects with cholestyramine, colestipol (give pravastatin 1hr before or 4hrs after). Caution with drugs that decrease levels or activity of steroid hormones (eg, ketoconazole, spironolactone, cimetidine).
Musculoskeletal pain, GI upset, upper respiratory infection, headache; elevated serum transaminases, myopathy, rhabdomyolysis with renal dysfunction; increased HbA1c and fasting serum glucose, rare: cognitive impairment, non-fatal hepatic failure, immune-mediated necrotizing myopathy.