Generic name: FLUVASTATIN SODIUM 20mg
Dosage form: capsule; tablet, extended release
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2.1 General Dosing Information
Dose range: 20 mg to 80 mg/ day.
LESCOL/LESCOL XL can be administered orally as a single dose, with or without food.
Do not break, crush or chew LESCOL XL tablets or open LESCOL capsules prior to administration.
Do not take two LESCOL 40 mg capsules at one time.
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 40 mg as one capsule in the evening, 80 mg as one LESCOL XL tablet administered as a single dose at any time of the day or 80 mg in divided doses of the 40 mg capsule given twice daily. 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
Adult patients can be started on either LESCOL or LESCOL XL. The recommended starting dose for LESCOL is one 40 mg capsule in the evening, or one LESCOL 40 mg capsule twice daily. Do not take two LESCOL 40 mg capsules at one time.
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 (10-16 years of age) with Heterozygous Familial Hypercholesterolemia
The recommended starting dose is one 20 mg LESCOL capsule. Dose adjustments, up to a maximum daily dose administered either as LESCOL capsules 40 mg twice daily or 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 b.i.d. LESCOL in patients taking cyclosporine [see Drug Interactions 7.1].