Monograph Details
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Cardiovascular System
> Hyperlipoproteinemias
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LIPITOR |
| Manufacturer |
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Pfizer Labs |
| 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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Atorvastatin (as calcium) 10mg, 20mg, 40mg, 80mg; tabs. |
| Indications |
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Adjunct to diet in primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Types IIa and IIb) to reduce total-C, LDL-C, apo B and TG, and to increase HDL-C. Adjunct to diet in treating elevated serum TG (Type IV). Treatment of primary dysbetalipoproteinemia (Type III) not adequately responsive to diet. Adjunct to other lipid-lowering treatments (or when these are unavailable), in homozygous familial hypercholesterolemia to reduce total-C and LDL-C. Adjunct to diet to reduce total-C, LDL-C and apo B in patients 10–17 years of age (≥1 year post-menarche) 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. To reduce risk of MI, stroke, and risk of revascularization procedures in adults at risk (see literature). To reduce risk of MI and stroke in patients with type 2 diabetes and at risk (see literature). To reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization, hospitalization for CHF, and angina in patients with clinically evident coronary heart disease. |
| Children |
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Heterozygous: <10yrs: not recommended. 10–17yrs: initially 10mg/day, may increase to 20mg/day after at least 4 weeks. Homozygous: 80mg/day has been used; see literature. |
| Adults |
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≥17yrs: Heterozygous and Types IIa and IIb: initially 10 or 20mg once daily; if more than a 45% reduction in LDL-C is needed, may start at 40mg once daily; range 10–80mg once daily. Homozygous: 10–80mg daily. |
| 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 12 weeks after starting or dose increase, then periodically); reduce dose or discontinue if serum transaminase levels >3xULN persist. History of liver disease. Substantial alcohol ingestion. Discontinue if myopathy, elevated CPK levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. |
| Interactions |
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Increased risk of myopathy with fibrates, erythromycin, nicotinic acid, azole antifungals, immunosuppressants (eg, cyclosporine). Additive effects with colestipol (separate dosing by at least 4 hours). May increase serum levels of digoxin, oral contraceptives (norethindrone, ethinyl estradiol); monitor digoxin. Caution with drugs that decrease levels or activity of steroid hormones (eg, ketoconazole, spironolactone, cimetidine). |
| Adverse Reactions |
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GI upset, headache, myalgia, arthralgia, rash, elevated serum transaminases, myopathy, rhabdomyolysis with renal dysfunction. |
| How Supplied |
Tabs 10mg, 20mg—90, 5000
40mg, 80mg—90, 500 |
| Additional Resources |
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• Related Prescribing Note |
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