Generic Name and Formulations:
Pravastatin sodium 20mg, 40mg, 80mg; tabs.
Indications for PRAVACHOL:
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 ≥8yrs 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.
>18yrs: initially 40mg once daily; may increase to 80mg once daily after 4 weeks. Severe renal impairment: initially 10mg daily (use generic pravastatin). Concomitant immunosuppressants (eg, cyclosporine): initially 10mg once daily at bedtime; limit max 20mg/day. Concomitant clarithromycin: limit max 40mg/day.
<8yrs: not studied. 8–13yrs: 20mg once daily. 14–18yrs: 40mg once daily.
Active liver disease. Unexplained, persistent elevated serum transaminases. Pregnancy. Nursing mothers.
Discontinue if myopathy or markedly elevated CPK levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops (eg, sepsis, hypotension, surgery, others). 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. Uncontrolled hypothyroidism. Renal impairment. Elderly. Females of reproductive potential should use effective contraception during treatment.
HMG-CoA reductase inhibitor.
See Adult dose. Increased risk of myopathy with cyclosporine, clarithromycin, colchicine; possibly other macrolides (eg, erythromycin, azithromycin); caution. Avoid gemfibrozil. Caution with other fibrates, niacin; consider reducing 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; rare: rhabdomyolysis with renal dysfunction, immune-mediated necrotizing myopathy, hepatic failure, cognitive impairment.