What is the age limit for using Seretide (Fluticasone/Salmeterol) Evohaler 125/25 pressurized inhalation?

Age Limit for Seretide Evohaler 125/25 Pressurized Inhalation

Seretide Evohaler 125/25 (fluticasone/salmeterol) pressurized inhalation is not recommended for children under 4 years of age.

Age Restrictions and Evidence Base

The age limit for Seretide Evohaler 125/25 is based on several key factors:

• The long-acting beta2-agonist component (salmeterol) has been FDA-approved for children 4 years of age and older 1
• Combination therapy with fluticasone/salmeterol has not been adequately studied in children under 4 years of age 1
• Most children under 4 years cannot provide sufficient inspiratory flow for adequate lung delivery of dry powder inhalers 1

Age-Specific Recommendations

For children 4 years and older:

• Fluticasone/salmeterol combination therapy can be used in children aged 4 years and above 1
• Dosing should be adjusted based on asthma severity and control 2
• Regular growth monitoring is recommended due to potential systemic effects of inhaled corticosteroids 3

For children under 4 years:

• Alternative medications are recommended:
  • Budesonide nebulizer solution (approved for children 1-8 years) 1, 2
  • Montelukast (approved for children as young as 1 year) 1

Clinical Considerations

Delivery Device Considerations

• Children under 4 years generally have less difficulty with:
  1. Face mask with nebulizer
  2. Metered-dose inhaler (MDI) with valved holding chamber (VHC) 1

Safety Concerns

• Growth suppression is a potential concern with inhaled corticosteroids in children 3
• Studies show ICS can cause a mean reduction of 0.48 cm/year in linear growth velocity during the first year of treatment 3
• The magnitude of growth suppression appears to be maximal during the first year of therapy and less pronounced in subsequent years 3

Efficacy in Children

• For children 4-11 years, safety data exists for fluticasone/salmeterol combination therapy 4
• Limited evidence is available comparing combination therapy to increased doses of ICS alone in children 5

Common Pitfalls to Avoid

1. Using adult formulations in young children: Children require age-appropriate formulations and devices
2. Inadequate monitoring: Regular assessment of growth and adrenal function is essential in children using inhaled corticosteroids
3. Improper inhaler technique: Children ≥4 years should use a spacer or valved holding chamber with proper technique to ensure optimal medication delivery
4. Overlooking potential side effects: Monitor for local side effects including oral candidiasis, cough, and dysphonia 2, 4

Remember that while Seretide Evohaler 125/25 is not recommended for children under 4 years, appropriate asthma management options are available for this age group, and treatment should follow a stepwise approach based on asthma severity and control.