Aerospan tm (flunisolide hfa, 80 mcg) Inhalation Aerosol For Oral Inhalation Only Rx Only description

Geriatric Use:
Clinical studies of AEROSPAN Inhalation Aerosol included 21 patients 
65 to 78 years of age exposed to AEROSPAN Inhalation Aerosol. These studies did not 
include sufficient numbers of subjects aged 65 years and over to determine whether they 
respond differently from younger subjects. In general, dose selection for an elderly 
patient should be cautious, usually starting at the low end of the dosing range, reflecting 
the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant 
disease or other drug therapy. 
ADVERSE REACTIONS 
The following table shows the adverse reactions that were reported in patients previously 
receiving bronchodilators and/or orally inhaled corticosteroids in two double-blind, 
placebo-controlled US clinical studies, in which 519 adult and pediatric patients age 4-78 
years (279 males and 240 females) were treated with the AEROSPAN Inhalation Aerosol 
(80 mcg to 320 mcg twice daily for 12 weeks) or placebo. The mean duration of 
exposure was 76.7, 78.2, 80.5, and 69.4 days for AEROSPAN Inhalation Aerosol 80 
mcg, 160 mcg, 320 mcg, and placebo, all dosed twice daily, respectively. The table 
includes all events (whether considered drug-related or non-drug-related by the 
investigators) that occurred at a rate of >3% in any AEROSPAN Inhalation Aerosol 
group and were more common than in the placebo group. In considering these data, the 
increased average duration of exposure for AEROSPAN Inhalation Aerosol patients 
should be taken into account, compared with placebo-treated patients. 

---

 
13
 
Adverse Events with >3% incidence reported in controlled
clinical studies with AEROSPAN Inhalation Aerosol
(% of patients)
AEROSPAN 
Inhalation Aerosol