The safety and effectiveness of fluticasone propionate and salmeterol HFA have been established in pediatric patients aged 12 years and older. Use of fluticasone propionate and salmeterol HFA in this age group is supported by evidence from adequate and well-controlled studies in adults with additional data from thirty-eight (38) subjects aged 12 to 17 years were treated with fluticasone propionate and salmeterol HFA in U.S. pivotal clinical trials. Subjects in this age group demonstrated efficacy results similar to those observed in subjects aged 18 years and older. There were no obvious differences in the type or frequency of adverse events reported in this age group compared with subjects aged 18 years and older. 

In a 12-week trial, the safety of fluticasone propionate and salmeterol HFA 45 mcg/21 mcg given as 2 inhalations twice daily was compared with that of fluticasone propionate 44 mcg HFA (FLOVENT HFA [fluticasone propionate inhalation aerosol]) 2 inhalations twice daily in 350 subjects aged 4 to 11 years with persistent asthma currently being treated with ICS. No new safety concerns were observed in children aged 4 to 11 years treated for 12 weeks with fluticasone propionate and salmeterol HFA 45 mcg/21 mcg compared with adults and adolescents aged 12 years and older. Common adverse reactions (≥3%) seen in children aged 4 to 11 years treated with fluticasone propionate and salmeterol HFA 45 mcg/21 mcg but not reported in the adult and adolescent clinical trials of fluticasone propionate and salmeterol HFA include: pyrexia, cough, pharyngolaryngeal pain, rhinitis, and sinusitis [see Adverse Reactions (6.1)]. This trial was not designed to assess the effect of salmeterol, a component of Fluticasone Propionate and Salmeterol HFA, on asthma hospitalizations and death in subjects aged 4 to 11 years. 

The pharmacokinetics and pharmacodynamic effect on serum cortisol of 21 days of treatment with fluticasone propionate and salmeterol HFA 45 mcg/21 mcg (2 inhalations twice daily with or without a spacer) or ADVAIR DISKUS 100 mcg/50 mcg (1 inhalation twice daily) was evaluated in a trial of 31 children aged 4 to 11 years with mild asthma. Systemic exposure to salmeterol xinafoate was similar for fluticasone propionate and salmeterol HFA, fluticasone propionate and salmeterol HFA delivered with a spacer, and ADVAIR DISKUS while the systemic exposure to fluticasone propionate was lower with fluticasone propionate and salmeterol HFA compared with that of fluticasone propionate and salmeterol HFA delivered with a spacer or ADVAIR DISKUS. There were reductions in serum cortisol from baseline in all treatment groups (14%, 22%, and 13% for fluticasone propionate and salmeterol HFA, fluticasone propionate and salmeterol HFA delivered with a spacer, and ADVAIR DISKUS, respectively) [see Clinical Pharmacology (12.2, 12.3)]. 

The safety and effectiveness of fluticasone propionate and salmeterol HFA in pediatric patients younger than 12 years have not been established.

Effects on Growth

ICS, including fluticasone propionate, a component of Fluticasone Propionate and Salmeterol HFA, may cause a reduction in growth velocity in children and adolescents [see Warnings and Precautions (5.14)]. The growth of pediatric patients receiving orally inhaled corticosteroids, including fluticasone propionate and salmeterol HFA, should be monitored. 

A 52-week placebo-controlled trial to assess the potential growth effects of fluticasone propionate inhalation powder (FLOVENT ROTADISK) at 50 and 100 mcg twice daily was conducted in the U.S. in 325 prepubescent children (244 males and 81 females) aged 4 to 11 years. The mean growth velocities at 52 weeks observed in the intent-to-treat population were 6.32 cm/year in the placebo group (n = 76), 6.07 cm/year in the 50-mcg group (n = 98), and 5.66 cm/year in the 100-mcg group (n = 89). An imbalance in the proportion of children entering puberty between groups and a higher dropout rate in the placebo group due to poorly controlled asthma may be confounding factors in interpreting these data. A separate subset analysis of children who remained prepubertal during the trial revealed growth rates at 52 weeks of 6.10 cm/year in the placebo group (n = 57), 5.91 cm/year in the 50-mcg group (n = 74), and 5.67 cm/year in the 100-mcg group (n = 79). In children aged 8.5 years, the mean age of children in this trial, the range for expected growth velocity is: boys – 3rd percentile = 3.8 cm/year, 50th percentile = 5.4 cm/year, and 97th percentile = 7.0 cm/year; girls – 3rd percentile = 4.2 cm/year, 50th percentile = 5.7 cm/year, and 97th percentile = 7.3 cm/year. The clinical relevance of these growth data is not certain. 

If a child or adolescent on any corticosteroid appears to have growth suppression, the possibility that he/she is particularly sensitive to this effect of corticosteroids should be considered. The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained. To minimize the systemic effects of orally inhaled corticosteroids, including fluticasone propionate and salmeterol HFA, each patient should be titrated to the lowest strength that effectively controls his/her asthma [see Dosage and Administration (2)].