2.1 General Dosing Information
Dose range: 20 mg to 80 mg/day.
Fluvastatin sodium extended-release tablets can be administered orally as a single dose, with or without food.
Do not break, crush or chew fluvastatin sodium extended-release tablets prior to administration.
Do not take two fluvastatin 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 fluvastatin sodium extended-release 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 fluvastatin capsules or fluvastatin sodium extended-release tablets. The recommended starting dose for fluvastatin capsules is one 40 mg capsule in the evening, or one fluvastatin 40 mg capsule twice daily. Do not take two fluvastatin 40 mg capsules at one time.
The recommended starting dose for fluvastatin sodium extended-release tablets 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 either as fluvastatin capsules 40 mg twice daily or one fluvastatin sodium extended-release 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.
1
National 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 BID fluvastatin in patients taking cyclosporine [see Drug Interactions (7.1)].
2.5 Use with Fluconazole
Do not exceed a dose of 20 mg BID fluvastatin in patients taking fluconazole [see Drug Interactions (7.2)].
