2.1 General Dosing Information

Dose range: 20 mg to 80 mg/day.

LESCOL XL can be administered orally as a single dose, with or without food.

Do not break, crush or chew LESCOL XL tablets prior to administration.

Since the maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted according to the patient’s response to therapy and established treatment guidelines.

For patients requiring LDL-C reduction to a goal of ≥ 25%, the recommended starting dose is 80 mg as one LESCOL XL tablet administered as a single dose at any time of the day. For patients requiring LDL-C reduction to a goal of < 25%, a starting dose of 20 mg may be used.

2.2 Adult Patients With Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia

The recommended starting dose for LESCOL XL is one 80 mg tablet administered as a single dose at any time of the day.

2.3 Pediatric Patients (10 to 16 years of age) With Heterozygous Familial Hypercholesterolemia

The recommended starting dose is one 20 mg fluvastatin capsule. Dose adjustments, up to a maximum daily dose administered one LESCOL XL 80 mg tablet once daily should be made at 6-week intervals. Doses should be individualized according to the goal of therapy [see NCEP Pediatric Panel Guidelines and Clinical Studies (14)]1.

1National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics.89(3):495-501. 1992.

2.4 Use With Cyclosporine

Do not exceed a dose of 20 mg twice-daily fluvastatin capsules in patients taking cyclosporine [see Drug Interactions (7.1)].

2.5 Use With Fluconazole

Do not exceed a dose of 20 mg twice-daily fluvastatin capsules in patients taking fluconazole [see Drug Interactions (7.2)].