Ambroxol Dosing for Pediatric Patients by Age
Ambroxol should be dosed at 1.2-1.6 mg/kg/day divided into 2-3 doses for children, with specific age-based recommendations: infants 1-24 months receive 7.5 mg twice daily, children 2-5 years receive 7.5 mg three times daily, children 6-12 years receive 15 mg 2-3 times daily, and children over 12 years receive adult dosing of 30 mg three times daily. 1
Age-Specific Dosing Recommendations
Infants (1-24 months)
- 7.5 mg twice daily (total daily dose: 15 mg/day) 1
- Can be safely used starting from 1 month of age with consistent efficacy and tolerability 1
- Administered as pediatric syrup formulation for ease of use 2
Young Children (2-5 years)
- 7.5 mg three times daily (total daily dose: 22.5 mg/day) 1
- In the controlled study, children in this age range received 30 mg daily (2 sachets) divided into doses 3
- Pediatric syrup formulation is preferred and shows rapid onset of symptom relief (typically <60 minutes) 2
School-Age Children (6-12 years)
- 15 mg 2-3 times daily (total daily dose: 30-45 mg/day) 1
- Studies demonstrate effectiveness at 30 mg daily for spastic bronchitis in this age group 3
- Can be administered as syrup or soft pastilles depending on patient preference 2
Adolescents (>12 years)
- 30 mg three times daily (total daily dose: 90 mg/day) - adult dosing 1
- Extended release capsule formulations may be appropriate for this age group 2
Clinical Considerations
Formulation Selection
- Pediatric syrup is the preferred formulation for children under 6 years due to ease of administration and rapid symptom relief 2
- Soft pastilles provide fastest onset of action and may be preferred for older children who can safely use them 2
- Extended release capsules have slower onset but may improve compliance in adolescents 2
Duration of Treatment
- Standard treatment course is 10 days for acute respiratory conditions 3
- Symptom relief typically begins within 60 minutes of administration for immediate-release formulations 2
- Continue treatment until resolution of abnormal mucus secretion and impaired mucus transport 1
Safety Profile
- Ambroxol is well tolerated across all pediatric age groups, including early infancy 1
- No significant adverse events reported in pediatric studies involving nearly 1,300 patients 1
- Comparable safety profile to acetylcysteine but with more rapid clinical improvement 3
Important Caveats
Do not use high-dose protocols (40 mg/kg/day) outside of critical care settings, as this dosing was studied only in mechanically ventilated ARDS patients and did not demonstrate benefit over standard dosing 4. The standard over-the-counter dosing recommendations above are appropriate for routine respiratory conditions 1.
For premature infants with respiratory distress syndrome requiring mechanical ventilation, intravenous ambroxol at 30 mg/kg/day may be used as adjunctive therapy, but this is a specialized indication requiring NICU-level care 5.