What is the minimum pediatric age of use for Budesonide (Budessonide) nasal spray?

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Last updated: March 26, 2025View editorial policy

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From the Guidelines

Budesonide nasal spray is approved for use in children aged 6 years and older. According to the clinical practice guideline on allergic rhinitis 1, the minimum pediatric age of use for Budesonide (Rhinocort AQ) 32 µg per spray is ≥6 years.

Key Points

  • The recommended dosage for children aged 6 years and older is 2 sprays per nostril twice a day or 4 sprays per nostril in the morning 1.
  • Common side effects of Budesonide nasal spray include epistaxis, pharyngitis, bronchospasm, coughing, and nasal irritation 1.
  • It is essential to use the medication regularly for optimal effect, as it may take several days to a week to notice improvement in allergy symptoms.
  • Parents should help younger children with proper administration technique, keeping the child's head upright and directing the spray away from the nasal septum.
  • Budesonide works by reducing inflammation in the nasal passages, decreasing the body's immune response to allergens, and is effective for managing allergic rhinitis symptoms including nasal congestion, runny nose, and sneezing.

Important Considerations

  • The medication should be used under the guidance of a healthcare professional, especially in children, to ensure proper use and minimize potential side effects.
  • It is crucial to continue the medication as prescribed even after symptoms improve to maintain control over allergic rhinitis symptoms.

From the FDA Drug Label

Safety and effectiveness in children six months to 12 months of age has been evaluated but not established. Safety and effectiveness in children 12 months to 8 years of age have been established The minimum pediatric age of use for Budesonide inhalation suspension is 12 months 2.

From the Research

Minimum Pediatric Age of Use for Budesonide Nasal Spray

  • The minimum pediatric age of use for Budesonide nasal spray is not uniformly established across all studies, but several studies provide insight into its usage in children:
    • A study from 3 indicates that budesonide is approved for children aged 6 years and older.
    • However, a study from 4 evaluated the effects of budesonide aqueous nasal spray on hypothalamic-pituitary-adrenal axis function in children with allergic rhinitis, aged 2 to 5 years, suggesting its potential use in younger children.
    • Another study from 5 assessed the effects of budesonide aqueous nasal spray on growth velocity in children with perennial allergic rhinitis, with a mean age of 5.9 years, further supporting its use in children under 6 years old.
  • Key points regarding the use of budesonide nasal spray in pediatric patients include:
    • Efficacy and safety in children aged 6 years and older are well-established 6, 3.
    • Potential for use in children under 6 years old, with studies indicating safety and efficacy in this age group 4, 5.
    • Importance of considering the risk-benefit ratio and potential systemic effects when prescribing intranasal corticosteroids to children 7.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Clinical prescribing of allergic rhinitis medication in the preschool and young school-age child: what are the options?

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2001

Research

Effect of budesonide aqueous nasal spray on hypothalamic-pituitary-adrenal axis function in children with allergic rhinitis.

Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2004

Research

Growth velocity in children with perennial allergic rhinitis treated with budesonide aqueous nasal spray.

Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2006

Research

Budesonide aqueous nasal spray is an effective treatment in children with perennial allergic rhinitis, with an onset of action within 12 hours.

Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2002

Research

Corticosteroids in the treatment of pediatric allergic rhinitis.

The Journal of allergy and clinical immunology, 2001

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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