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Lescol Xl Generic Name & Formulations
Legal Class
Rx
General Description
Fluvastatin sodium 80mg; ext-rel tabs.
Pharmacological Class
HMG-CoA reductase inhibitor.
See Also
How Supplied
Ext-rel tabs—30, 100; Caps—contact supplier
Manufacturer
Generic Availability
YES
Lescol Xl Indications
Indications
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. Adjunct to diet to reduce total-C, LDL-C and apo B in patients 10–16 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. 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. Limitations of Use: not studied in conditions where major abnormality is elevation of chylomicrons, VLDL, or IDL.
Lescol Xl Dosage and Administration
Adult
Swallow whole. ≥18yrs: LDL-C reduction of <25%: initially fluvastatin 20mg capsule once daily in the PM. LDL-C reduction of ≥25%: Lescol XL 80mg tab once daily, or fluvastatin 40mg capsule once daily in the PM or twice daily. Usual range: 20–80mg/day. Concomitant cyclosporine, fluconazole: max fluvastatin 20mg capsule twice daily.
Children
<10yrs: not recommended. 10–16yrs: Initially fluvastatin 20mg capsule once daily; may increase dose at 6-week intervals to max daily dose of either fluvastatin 40mg capsule twice daily or Lescol XL 80mg tablet once daily.
Lescol Xl Contraindications
Contraindications
Active liver disease. Unexplained, persistent elevated serum transaminases. Pregnancy (Cat.X). Nursing mothers.
Lescol Xl Boxed Warnings
Not Applicable
Lescol Xl Warnings/Precautions
Warnings/Precautions
Discontinue if myopathy, elevated CPK levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Immune-mediated necrotizing myopathy; monitor. Monitor liver function before starting therapy and repeat as 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 of liver disease. Substantial alcohol consumption. Monitor for endocrine dysfunction. Homozygous familial hypercholesterolemia. Severe renal insufficiency.
Lescol Xl Pharmacokinetics
See Literature
Lescol Xl Interactions
Interactions
See Adult dose. Avoid concomitant gemfibrozil. Caution with other fibrates, niacin (≥1g/day), colchicine; consider reducing dose of fluvastatin. Monitor oral anticoagulants, glyburide, phenytoin. Inhibition of endogenous steroid production with spironolactone, ketoconazole, cimetidine.
Lescol Xl Adverse Reactions
Adverse Reactions
Headache, dyspepsia, myalgia, abdominal pain, nausea, elevated serum transaminases, myopathy, rhabdomyolysis with renal dysfunction; increased HbA1c and fasting serum glucose, rare: cognitive impairment, non-fatal hepatic failure.
Lescol Xl Clinical Trials
See Literature
Lescol Xl Note
Not Applicable
Lescol Xl Patient Counseling
See Literature
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