What is the oral dose of ambroxol (mucolytic agent) for infants from 1 month to 12 months?

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Last updated: August 15, 2025View editorial policy

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Oral Ambroxol Dosage for Infants 1-12 Months

For infants aged 1-12 months, the recommended oral dose of ambroxol is 7.5 mg twice daily.

Dosage Guidelines

Ambroxol is a mucoactive agent used to treat respiratory conditions associated with abnormal mucus secretion. When prescribing for infants between 1-12 months, follow these specific guidelines:

  • Standard dose: 7.5 mg twice daily
  • Administration: Oral solution/syrup (typically available as 15 mg/5 mL)
  • Duration: Usually 7-10 days for acute conditions, but may vary based on clinical response

Evidence and Safety Considerations

The recommended dosage is supported by clinical evidence showing efficacy in pediatric patients as young as 1 month old 1. A 2020 review of clinical studies involving nearly 1,300 pediatric patients reported consistent efficacy findings regardless of age, including patients as young as 1 month, with good tolerability 1.

Important Safety Considerations:

  • Contraindications:

    • Not recommended for neonates under 1 month of age due to lack of established dosing guidelines 2
    • Use with caution in infants with impaired renal or hepatic function
  • Monitoring:

    • Watch for gastrointestinal side effects (mild bowel discomfort)
    • Monitor for allergic reactions, though these are rare 3

Clinical Applications

Ambroxol has been used successfully in pediatric patients for:

  • Acute bronchitis
  • Bronchiolitis
  • Conditions with abnormal mucus secretion and impaired mucus transport

In comparative studies, ambroxol has shown more rapid improvement in symptoms like cough and sputum production compared to alternatives such as acetylcysteine 4.

Administration Tips

  • Give with meals to improve gastrointestinal tolerability
  • Ensure accurate dosing using a calibrated oral syringe or dropper
  • Maintain adequate hydration during treatment to optimize mucolytic effects

When to Consider Alternative Treatments

  • If no improvement is seen after 3-5 days
  • If respiratory distress worsens
  • If fever persists or develops during treatment

Remember that ambroxol is primarily a symptomatic treatment. The underlying cause of respiratory symptoms should always be identified and treated appropriately.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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