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Sustained-release theophylline for treatment of asthma in preschool children
Insights
For young asthmatic children, 12-hour dosing of Theo-Dur (sustained-release theophylline) showed variable serum levels. Many children aged 7 or younger may need more frequent dosing for optimal asthma control.
Area of Science:
- Pediatric Pulmonology
- Pharmacokinetics
- Asthma Management
Background:
- Asthma is a common chronic respiratory disease in children.
- Theophylline is a bronchodilator used in asthma management.
- Sustained-release formulations aim for consistent therapeutic drug levels.
Purpose of the Study:
- To evaluate the efficacy and safety of Theo-Dur in young asthmatic children.
- To assess serum theophylline concentrations and their correlation with pulmonary function.
- To determine optimal dosing frequency for Theo-Dur in this age group.
Main Methods:
- Ten asthmatic children aged 3-7 years received Theo-Dur every 12 hours for three months.
- Serum theophylline concentrations were monitored over time.
- Pulmonary function tests were conducted.
- Clinical symptoms and signs were assessed.
Main Results:
- Significant temporal variations in serum theophylline concentrations were observed.
- Mean peak-to-trough difference was 6.5 µg/mL within 12 hours.
- Serum theophylline levels correlated with pulmonary function test results.
- Some children experienced impaired pulmonary function and required additional bronchodilators 9+ hours post-dose.
Conclusions:
- Theo-Dur administered every 12 hours resulted in variable serum concentrations in young children.
- Children aged 7 years or younger may require more frequent dosing than every 12 hours.
- Monitoring of predose serum theophylline levels, symptoms, and signs is recommended for this population.
Abstract:
Theo-Dur, a sustained-release theophylline formulation, was administered every 12 hours for three months to ten asthmatic children aged 3 to 7 years, with no evidence of adverse reaction or tolerance. There was significant temporal variation in serum theophylline concentrations. The mean difference between the peak and trough concentrations was 6.5 micrograms/mL (range, 3 to 14 micrograms/mL) in a 12-hour period. Serum theophylline concentrations correlated well with pulmonary function test results. Nine or more hours after a Theo-Dur dose, some children needed additional bronchodilator treatment and had impairment of pulmonary function. We recommend that children aged 7 years or younger who are given Theo-Dur have monitoring of predose serum theophylline concentrations, symptoms, and signs, as many will require a dose frequency greater than every 12 hours.