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
