Indications for: LESCOL XL

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.

Adult Dosage:

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 Dosage:

<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:

Active liver disease. Unexplained, persistent elevated serum transaminases. Pregnancy (Cat.X). Nursing mothers.

LESCOL XL 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.

See Also:

LESCOL XL Classification:

HMG-CoA reductase inhibitor.

LESCOL XL 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.

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.

Generic Drug Availability:


How Supplied:

Ext-rel tabs—30, 100; Caps—contact supplier