Applies to the following strength(s): 20 mg ; 40 mg ; 80 mg
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Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Hyperlipidemia
Initial dose: 20 to 40 mg orally once a day at bedtime.
Maintenance dose: 20 to 80 mg/day.
Usual Pediatric Dose for Hyperlipidemia
9 to 16 years:
Initial dose: 20 mg orally once a day at bedtime.
Maintenance dose: 20 to 80 mg/day.
Renal Dose Adjustments
No adjustment is recommended in patients with mild to moderate renal impairment.
Fluvastatin has not been studied at doses greater than 40 mg in patients with severe renal impairment; therefore, caution should be exercised when treating such patients at higher doses.
Liver Dose Adjustments
Fluvastatin is considered contraindicated in patients with active liver disease or elevations in liver function tests. If it must be used, the dose should be reduced and titrated slowly.
Adjustments in dosage should be made in intervals of 4 weeks or more.
Fluvastatin is considered contraindicated in patients with active liver disease or with unexplained elevations in liver function tests.
Fluvastatin and other HMG-CoA reductase inhibitors are associated with elevations in liver function tests. Safety in patients with active liver disease or with unexplained elevations in liver function tests is unknown. It is recommended that liver function tests be conducted before the initiation of treatment and at 12 weeks following initiation of treatment or elevation in dose. Patients who develop transaminase elevations or signs and symptoms of liver disease should be monitored to confirm the finding and should be followed thereafter with frequent liver function tests until the levels return to baseline. If an increase in AST or ALT of three times the upper limit of normal or greater persist (found on two consecutive occasions) withdrawal of fluvastatin therapy is advised. Fluvastatin should be used with caution in any patient who consumes substantial quantities of alcohol and/or has a history of liver disease. Such patients should be monitored closely.
Rhabdomyolysis with acute renal failure secondary to myoglobinuria has been associated with fluvastatin and other HMG-CoA reductase inhibitors. Fluvastatin should be used cautiously, if at all, in patients who are at risk of developing renal failure from rhabdomyolysis (for example, patients with severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine, or electrolyte disorders, and uncontrolled seizures). Patients should be counseled to promptly report the occurrence of myalgia and/or muscle tenderness or weakness, particularly if accompanied by fever or malaise. Fluvastatin should be discontinued if myopathy occurs or if markedly elevated creatine phosphokinase (CPK) levels develop.
HMG-CoA reductase inhibitors are reported to be less effective in patients with rare homozygous familial hypercholesterolemia, possibly because these patients have few functional low density lipoprotein receptors.
The HMG-CoA reductase inhibitors may cause elevation of CPK and transaminase levels. This should be considered in the differential diagnosis of chest pain in a patient on therapy with fluvastatin.
There are limited data on the pharmacokinetic disposition of fluvastatin in patients undergoing hemodialysis. One study reported fluvastatin plasma concentrations before and during hemodialysis to be identical. In addition, fluvastatin could only be detected in the dialysate of one patient in this study. This data indicates that fluvastatin is not easily removed by dialysis.
Cholesterol levels should be monitored periodically with consideration given to reducing the dosage if cholesterol levels fall significantly below the targeted range.
It has been suggested that prior to initiating statin therapy, all patients should have a baseline serum CPK enzyme level measured and if at any time after initiating therapy a patient complains of muscle soreness, tenderness, or pain another CPK level should be drawn for comparison. If elevated, the drug should be discontinued.
The results of one study indicate that withdrawal of HMG-CoA reductase inhibitors (statins; atorvastatin, fluvastatin, pravastatin, simvastatin) during the perioperative period in patients with acute coronary syndromes is associated with an increased risk for perioperative adverse cardiac events (i.e., increase postoperative troponin release and the combination of myocardial infarction and cardiovascular death). Patients receiving statins with extended-release formulations (i.e., fluvastatin) appeared to be associated with more favorable outcomes. Other studies appear to confirm these findings.