Can Foracort (Budesonide and Formoterol) MDI (Metered Dose Inhaler) 100 be given to a child less than 3 years?

Foracort MDI 100 Should Not Be Given to Children Under 3 Years of Age

Foracort MDI 100 (budesonide/formoterol combination) is not recommended for children under 3 years of age due to lack of safety and efficacy data in this age group.

Age Restrictions for Budesonide/Formoterol Combination Therapy

The guidelines from the National Asthma Education and Prevention Program (NAEPP) clearly indicate age restrictions for combination inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) medications:

• For children under 4 years of age, combination medications like budesonide/formoterol have "NA" (not available/not approved) status 1
• The Expert Panel Report 3 specifically states "There have been no clinical trials in children <4 years of age" for fluticasone/salmeterol combinations, and notes that "Most children <4 years of age cannot provide sufficient inspiratory flow for adequate lung delivery" 1

Approved Alternatives for Children Under 3 Years

For children under 3 years requiring inhaled corticosteroid therapy, the guidelines recommend:

1. Budesonide nebulizer suspension: This is the only ICS with FDA-approved labeling for children under 4 years of age 1, 2

   • Dosage: 0.25-0.5 mg for low dose, 0.5-1.0 mg for medium dose 1
   • Administration: Through a face mask that should fit snugly over nose and mouth

2. Montelukast: Approved for children as young as 1 year 1, 2

   • Dosage: 4 mg once daily at bedtime for children 1-5 years 1

Delivery Considerations for Young Children

Children under 3 years face specific challenges with inhaler devices:

• Most children under 4 years cannot generate sufficient inspiratory flow for dry powder inhalers 1
• They typically cannot coordinate breathing with MDI activation 1, 2
• For MDIs, young children require:
  • A valved holding chamber (spacer) with face mask 1
  • Face mask reduces delivery to lungs by 50% compared to mouthpiece 1
  • Parents should wash the child's face after each treatment to prevent local side effects 1

Safety Concerns

Using Foracort MDI 100 in children under 3 years raises several safety concerns:

1. Long-acting beta-agonist (LABA) risks: Formoterol has potential risks including:

   • Tachycardia and skeletal muscle tremor 1
   • Potential risk of uncommon severe life-threatening exacerbations 1
   • LABAs should only be used with ICS and not for acute symptom relief 1

2. Inhaled corticosteroid (ICS) considerations:

   • Growth suppression has been observed in children on ICS therapy 1, 2
   • Regular growth monitoring is recommended for children using ICS 2

Conclusion

For asthma management in children under 3 years, use FDA-approved options like budesonide nebulizer suspension with appropriate delivery devices. Foracort MDI 100 should be avoided in this age group due to lack of safety data, potential risks, and delivery challenges.