Ambroxol Dosing in Children
For children, ambroxol should be dosed at 1.2-1.6 mg/kg/day divided into 2-3 doses, with age-specific adjustments: infants 1-2 years receive 7.5 mg twice daily, children 2-5 years receive 7.5 mg three times daily, and children 6-12 years receive 15 mg 2-3 times daily.
Age and Weight-Based Dosing Strategy
The dosing of ambroxol in pediatric patients follows an age-stratified approach rather than strict weight-based calculations, though the underlying principle remains approximately 1.2-1.6 mg/kg/day 1.
Specific Age-Based Doses
- Infants 1-24 months: 7.5 mg twice daily (total 15 mg/day) 1
- Children 2-5 years: 7.5 mg three times daily (total 22.5 mg/day) 1
- Children 6-12 years: 15 mg 2-3 times daily (total 30-45 mg/day) 1
- Children >12 years: Can transition to adult dosing of 30 mg three times daily 1
Formulation Considerations
Ambroxol is available in multiple formulations including oral solutions, tablets, and sustained-release preparations 2. For pediatric patients, liquid formulations are typically preferred for ease of administration and dose accuracy 1.
Extended-Release Formulations
Extended-release 75 mg capsules are available but are designed for once-daily adult dosing and provide similar 24-hour exposure to immediate-release formulations given twice daily 2. These are not appropriate for young children who require lower total daily doses.
Safety Profile in Pediatric Population
Clinical evidence from nearly 1,300 pediatric patients demonstrates that ambroxol is well-tolerated across all pediatric age groups, including infants as young as 1 month 1. The efficacy and safety profile established in adults extends to the pediatric population without significant age-related concerns 1.
Common Pitfalls to Avoid
- Do not use adult weight-based calculations (mg/kg) directly scaled from adult doses, as this approach fails to account for developmental differences in drug elimination 3
- Avoid sustained-release formulations in young children, as these are designed for adult dosing schedules and cannot be accurately divided 2
- Do not exceed age-appropriate maximum doses, even in heavier children, as maturation of drug elimination pathways is more critical than weight alone in children under 2 years 3
Clinical Context
Ambroxol functions as a mucoactive agent for acute and chronic respiratory diseases characterized by abnormal mucus secretion and impaired mucus transport 1. Treatment duration should be based on clinical response, with most acute respiratory conditions requiring 7-10 days of therapy.