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Pharmacokinetics of intravenous amiodarone in children
Sergej Ramusovic1, Stephanie Läer, Bernd Meibohm
1Department of Clinical Pharmacy and Pharmacotherapy, Heinrich-Heine-University, , Düsseldorf, Germany.
Insights
Intravenous amiodarone effectively treated arrhythmias in most children, reaching therapeutic adult serum concentrations. However, some experienced hypotension and QTc prolongation, warranting careful monitoring in paediatric patients.
Area of Science:
- Pediatric Cardiology
- Clinical Pharmacology
Background:
- Intravenous amiodarone is used for severe pediatric arrhythmias.
- Concerns exist regarding adverse effects like hypotension, bradycardia, and drug concentrations.
Purpose of the Study:
- Determine serum concentrations of IV amiodarone in children using a specific dosing regimen.
- Assess safety parameters including hypotension, bradycardia, and QTc prolongation.
Main Methods:
- Prospective observational study in a pediatric intensive care unit.
- Enrolled twenty pediatric patients with arrhythmias.
- Monitored amiodarone serum concentrations, blood pressure, heart rate, and QTc intervals.
Main Results:
- Serum amiodarone concentrations reached effective adult levels during maintenance infusion.
- Arrhythmias were suppressed in 90% of patients.
- Mean QTc intervals increased post-therapy; 8 patients experienced hypotension.
Conclusions:
- IV amiodarone demonstrated efficacy in the majority of pediatric patients in this study.
- The findings highlight the need for careful safety monitoring during amiodarone treatment in children.
Objectives:
Although amiodarone is an effective treatment for severe paediatric arrhythmias, uncertainties about adverse effects such as hypotension, bradycardia and excessive serum drug concentrations persist. Therefore, the aims of this study were to: (a) determine serum concentrations of intravenous (IV) amiodarone following a widely implemented dosing regimen of 5 mg/kg bolus plus a 10 mg/kg/day continuous infusion and (b) generate descriptive data on safety parameters such as hypotension, bradycardia or corrected QT (QTc) prolongation during this regimen.
Design:
Prospective observational study.
Setting:
Paediatric intensive care unit.
Patients:
Twenty paediatric patients (median age, 0.23 years; range, 6 days-15.04 years) with arrhythmia secondary to or without cardiac surgery.
Interventions:
None.
Main Outcome Measures:
Amiodarone serum concentrations, blood pressure, heart rate, QTc intervals.
Results:
Amiodarone serum concentrations increased markedly during bolus, followed by rapid decreases during maintenance infusion. All patients had serum concentrations regarded as effective in adults (median concentration range: 1.30-2.06 µM/L during maintenance phase). Amiodarone suppressed arrhythmias in 18 (90%) patients. Mean QTc intervals for pretherapy, during and post-therapy periods were 443 ms, 458 ms and 467 ms, respectively. Eight patients had hypotension.
Conclusions:
Amiodarone was effective in the majority of children in this small cohort.
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