From the FDA Drug Label
Use of fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg in patients aged 4 to 11 years is supported by extrapolation of efficacy data from older subjects and by safety and efficacy data from a trial of fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg in children with asthma aged 4 to 11 years The safety and effectiveness of fluticasone propionate and salmeterol inhalation powder in children with asthma younger than 4 years have not been established.
The minimum age for Seretide (fluticasone propionate and salmeterol inhalation powder) is 4 years 1.
From the Research
Seretide is not recommended for children under 4 years of age, and the minimum age for its use depends on the specific formulation, with Seretide Accuhaler suitable for children aged 4 years and older, and Seretide Evohaler approved for children aged 4-12 years at lower doses. The age restriction is based on the findings of a recent scoping review 2 that synthesized the available evidence for the efficacy and safety of fluticasone propionate/salmeterol in the pediatric population. This review highlighted the importance of considering the age and developmental stage of children when selecting asthma medications.
Key points to consider when prescribing Seretide to children include:
- The child's ability to use the inhaler device properly, which may be a challenge for younger children
- The potential differences in risk-benefit profiles of the combination of fluticasone propionate and salmeterol in very young children whose respiratory systems are still developing
- The need for parents to consult healthcare providers about age-appropriate asthma medications for children younger than 4 years
The most recent and highest-quality study 2 provides the best evidence for guiding the use of Seretide in children, and its findings support the age restrictions and recommendations outlined above.