Can SERETIDE EVOHALER (fluticasone/salmeterol) 125/25 pressurized inhalation suspension be used in an 11-year-old patient?

SERETIDE EVOHALER 125/25 Usage in 11-Year-Old Patients

Yes, SERETIDE EVOHALER (fluticasone/salmeterol) 125/25 pressurized inhalation suspension can be used in an 11-year-old patient, as FDA-approved labeling supports the use of fluticasone/salmeterol combination in children aged 4-11 years. 1

Age-Appropriate Dosing and Evidence

The National Asthma Education and Prevention Program guidelines confirm that fluticasone/salmeterol administered by means of DPI has FDA-approved labeling for children 4-11 years old 1. This approval is based on extrapolation of efficacy and safety from studies in adults and older children, plus safety and pharmacokinetic data in children with some limited efficacy data.

For children 5-11 years of age:

• Fluticasone propionate HFA is approved for 4-11 year olds
• Fluticasone/salmeterol administered by DPI is approved for 4-11 year olds
• Salmeterol administered by DPI is approved for 4-11 year olds 1

Dosing Considerations

When using SERETIDE EVOHALER in an 11-year-old patient, consider the following:

• For children 5-11 years, the low daily dose of fluticasone HFA/MDI is 88-176 mcg, medium dose is >176-352 mcg, and high dose is >352 mcg 1
• Most 4-year-olds and older children are able to generate sufficient peak inspiratory flows to achieve adequate dosing from DPIs and MDIs 1
• For children aged 4-11 years with asthma, fluticasone propionate and salmeterol inhalation powder has demonstrated safety and efficacy 2

Administration Technique

Proper administration technique is crucial for effective treatment:

• Use with a valved holding chamber (spacer) for optimal delivery
• Ensure the child can properly coordinate actuation with inhalation
• Rinse mouth after use to prevent oral thrush and reduce systemic absorption 1

Safety Considerations

Safety data supports the use of fluticasone/salmeterol in this age group:

• A 26-week trial in pediatric subjects aged 4-11 years demonstrated that fluticasone propionate and salmeterol inhalation powder was non-inferior to fluticasone propionate alone in terms of serious asthma-related events 2
• The combination therapy reduced asthma exacerbations compared to fluticasone propionate alone 2
• Monitor for potential adverse effects including oral thrush, dysphonia, and cough 1

Monitoring Recommendations

When prescribing SERETIDE EVOHALER to an 11-year-old:

• Monitor growth velocity, as inhaled corticosteroids may cause a reduction in growth velocity in children 2
• Regular follow-up visits to assess asthma control and adjust therapy as needed
• Evaluate proper inhaler technique at each visit
• Monitor for any signs of adrenal suppression with long-term use 1

Common Pitfalls to Avoid

1. Not using a spacer device with the pressurized MDI, which can significantly reduce drug delivery
2. Failing to monitor growth in children on inhaled corticosteroids
3. Not titrating to the lowest effective dose once asthma control is achieved
4. Overlooking the need to rinse mouth after use to prevent oral candidiasis

In conclusion, SERETIDE EVOHALER 125/25 is appropriate for use in an 11-year-old patient with asthma, with proper attention to technique, monitoring, and dose adjustment based on clinical response.