What is the recommended age limit for SERETIDE EVOHALER (Fluticasone/Salmeterol) 125/25 pressurized inhalation suspension?

Age Limit for SERETIDE EVOHALER 125/25 Pressurised Inhalation Suspension

SERETIDE EVOHALER 125/25 (fluticasone/salmeterol) pressurised inhalation suspension is recommended for patients aged 4 years and older.

Age Recommendations Based on Guidelines

The age limit for SERETIDE EVOHALER (fluticasone/salmeterol) 125/25 is based on several key factors:

• Children under 4 years of age generally cannot properly coordinate the use of pressurized metered-dose inhalers (pMDIs) like SERETIDE EVOHALER, even with spacers 1.
• Most 4-year-olds are able to generate sufficient peak inspiratory flows to achieve adequate dosing from inhalers, while younger children typically cannot 2.
• Children below 4 years of age require special delivery systems such as nebulizers or MDIs with valved holding chambers and face masks 3.

Device Considerations for Different Age Groups

For patients ≥4 years:

• Can use SERETIDE EVOHALER with proper technique training
• Should use a spacer or valved holding chamber to optimize delivery
• Need to rinse mouth after use to prevent local side effects like oral thrush

For patients <4 years:

• Not recommended to use SERETIDE EVOHALER
• Alternative options include:
  • Budesonide inhalation suspension (nebulizer), which is FDA-approved for children as young as 12 months 4
  • MDIs with valved holding chambers and face masks 1

Clinical Evidence Supporting Age Recommendations

The FDA approval for fluticasone/salmeterol combination products in children is based on:

• Extrapolation of efficacy from studies in adults and older children
• Safety and pharmacokinetic data in the specific pediatric age group
• Limited efficacy data in children 2

Specifically, fluticasone/salmeterol administered by DPI has been approved for children 4-11 years old based on this approach 2.

Administration Technique for Children 4 Years and Older

For optimal delivery in children ≥4 years using SERETIDE EVOHALER:

1. Use with a spacer or valved holding chamber
2. Have the child take 5-6 breaths per actuation
3. Ensure proper seal between face and mask (if using a mask)
4. Rinse mouth after administration to prevent oral thrush 3

Common Pitfalls and Cautions

• Improper technique: Poor inhaler technique is a common cause of treatment failure. Healthcare providers should teach and periodically re-teach patients about correct inhaler use 1.
• Lack of spacer: Using SERETIDE EVOHALER without a spacer in children reduces drug delivery and increases risk of side effects.
• Oral thrush risk: Failure to rinse the mouth after use increases risk of candidiasis 3.
• Safety concerns: The FDA has noted safety concerns with long-acting beta-agonists (LABAs) like salmeterol when used as monotherapy, emphasizing the importance of using the combination product as directed 5.

Monitoring Recommendations

For children using SERETIDE EVOHALER:

• Regular assessment of symptom control
• Growth monitoring (especially important with inhaled corticosteroids)
• Evaluation for local side effects like dysphonia and oral thrush 3

Following these age-appropriate recommendations ensures optimal delivery of medication while minimizing risks, ultimately improving asthma control and quality of life in pediatric patients.