Monograph Details
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Cardiovascular System
> Hyperlipoproteinemias
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LESCOL XL |
| Manufacturer |
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Novartis Pharmaceuticals Corp |
| 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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Fluvastatin sodium 80mg; ext-rel tabs. |
| Also |
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• LESCOL
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| Indications |
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Adjunct to diet in primary hypercholesterolemia and mixed dyslipidemia (Types IIa and IIb) to reduce elevated total-C, LDL-C, TG, and apo B, and to increase HDL-C when response to nondrug therapy is inadequate. In patients with coronary heart disease: To slow the progression of coronary atherosclerosis to lower total-C and LDL-C, and to reduce the risk of undergoing coronary revascularization procedures. |
| Children |
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<18yrs: not recommended. |
| Adults |
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≥18yrs: LDL-C reduction of <25%: initially Lescol 20mg capsule once daily in the PM. LDL-C reduction of ≥25%: Lescol XL 80mg tab once daily in the PM, or Lescol 40mg capsule once daily in the PM or twice daily. Usual range: 20–80mg/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 and 12 weeks after start or dose increases); discontinue if serum transaminases ≥3xULN persist. History of liver disease. Substantial alcohol consumption. Monitor for endocrine dysfunction. Discontinue if myopathy, elevated CPK levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Homozygous familial hypercholesterolemia. Severe renal insufficiency. |
| Interactions |
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Avoid concomitant gemfibrozil, clofibrate, other fibrates, erythromycin, nicotinic acid, cyclosporine. Monitor oral anticoagulants, digoxin. Monitor for myopathy with immunosuppressants (eg, cyclosporine). Inhibition of endogenous steroid production with spironolactone, ketoconazole, cimetidine. May be potentiated by cimetidine, ranitidine, omeprazole. Antagonized by rifampicin. Give at least 2hrs after bile-acid resin (eg, cholestyramine, colestipol). Immediate-release cap: additive effects with resins. |
| Adverse Reactions |
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GI upset, headache, myalgia, insomnia, elevated serum transaminases, myopathy, rhabdomyolysis with renal dysfunction. |
| How Supplied |
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All—30, 100 |
| Additional Resources |
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• Related Prescribing Note |
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