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Pediatric Dosing of Intravenous Sotalol Based on Body Surface Area in Patients with Arrhythmia
Xiaomei Li1, Yan Zhang2, Haiju Liu2
1Department of Pediatric Cardiology, Heart Center, The First Hospital of Tsinghua University, School of Clinical Medicine, Tsinghua University, Beijing, 100016, People's Republic of China. lixiaomei1368@sina.com.
Insights
Intravenous sotalol is effective and safe for pediatric incessant tachyarrhythmias. A body weight-based dosing regimen showed close correlation with body surface area (BSA) calculations, with generally lower or equal loading doses.
Area of Science:
- Pediatric Cardiology
- Clinical Pharmacology
Background:
- Incessant tachyarrhythmias in pediatric patients pose significant clinical challenges.
- Current US recommendations for intravenous sotalol dosing in pediatric patients are based on body surface area (BSA), considering patient age.
- A body weight-based dosing regimen was previously found effective and safe in this population.
Purpose of the Study:
- To evaluate the correspondence between a body weight-based intravenous sotalol dosing regimen and BSA-based recommendations in pediatric patients.
- To express the body weight-based regimen in BSA (mg/m²) for comparison with US labeling.
Main Methods:
- A cohort of 83 pediatric patients (newborns to adolescents) received a loading dose of 1 mg/kg and a maintenance dose of 4.5 mg/kg/day of intravenous sotalol.
- Loading and maintenance doses were calculated based on body weight and compared to doses derived from BSA using US labeling recommendations.
- Statistical analysis, including correlation (r) and p-values, was used to assess the similarity between the two dosing methods across different age groups.
Main Results:
- A strong correlation (r = 0.977, p < 0.001) was observed between body weight-based and BSA-based sotalol loading doses across all age ranges.
- Body weight-based loading doses were generally lower or equal to BSA-based doses, except in adolescents.
- Maintenance doses based on body weight were significantly higher than BSA-based doses across all pediatric age groups, particularly in newborns and infants/toddlers.
Conclusions:
- The body weight-based intravenous sotalol dosing regimen demonstrated a close correlation with BSA-based calculations in pediatric patients.
- Despite higher maintenance doses compared to BSA recommendations, the body weight-based regimen was found to be safe, with only one instance of transient AV block in a newborn.
- This study supports the use of a body weight-based dosing strategy for intravenous sotalol in pediatric patients with incessant tachyarrhythmias.
Abstract:
In a recently published study, we evaluated the efficacy and safety of intravenous sotalol in pediatric patients with incessant tachyarrhythmias and we have found that intravenous sotalol is effective and safe. Our dosing regimen was based on the body weight of the patients. In the US, the recommendation for intravenous sotalol dosing in pediatric patients is based on body surface area (BSA) while taking into consideration the patients' age. The purpose of this paper is to show the correspondence of a body weight-based dosing regimen when expressed for BSA as mg/m2. We evaluated the similarity of a body weight-based dose to that calculated based on BSA using the US labeling recommendations. Of the 83 patients, 5 were newborns (age: 0-30 days), 39 infants and toddlers (age: 1-24 month), 26 young children (age: >2-6 years), 11 older children (age: 6-12 years), and 2 adolescents (age: 14 years). Each received a loading dose of 1 mg/kg intravenous sotalol administered over 10 min followed by a maintenance dose of 4.5 mg/kg/day. There was a close correlation between the sotalol loading doses calculated based on body weight and BSA across the entire age range (r = 0.977, p < 0.001). In most of the age groups, the body weight-based loading doses were lower or equal to the BSA-based doses. Only in the adolescents were the body weight-based doses higher. The maintenance doses given in our study were significantly higher than the BSA-based dose in newborns: 75 ± 6 versus 53 ± 8 mg/m2, p < 0.05; infants/toddlers: 88 ± 14 versus 77 ± 7 mg/m2, p < 0.001; younger children: 113 ± 12 versus 85 mg/m2, p < 0.001; older children: 123 ± 16 versus 85 mg/m2, p < 0.01; and adolescents 157 ± 30 versus 85.5 mg/m2. Despite the rapid administration of the loading dose and the increased maintenance doses, our body weight-based dosing regimen was safe. Only one newborn had significant adverse event (AV block) that resolved spontaneously after discontinuation of the infusion.
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