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

Pregnancy: Teratogenic Effects:
Pregnancy Category C. As with other corticosteroids, 
flunisolide hemihydrate has been shown to be teratogenic and fetotoxic in rabbits and rats 
at doses of 40 and 200 mcg/kg/day, respectively, (approximately 1 and 3 times the 
maximum recommended daily inhalation dose on a mg/m
2
basis, respectively). There are 
no adequate and well-controlled studies of flunisolide hemihydrate in pregnant women.
AEROSPAN Inhalation Aerosol should be used during pregnancy only if the potential 
benefit justifies the potential risk to the fetus. 
Experience with oral corticosteroids since their introduction in pharmacologic, as 
opposed to physiological, doses suggests that rodents are more prone to teratogenic 
effects from corticosteroids than humans. 
 
Nonteratogenic Effects
: Hypoadrenalism may occur in infants born of mothers 
receiving corticosteroids during pregnancy. Such infants should be carefully monitored. 
Nursing Mothers:
It is not known whether flunisolide is excreted in human milk.
Because other corticosteroids are excreted in human milk, caution should be exercised 
when AEROSPAN Inhalation Aerosol is administered to nursing women.
 

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Pediatric Use: 
The safety and effectiveness of AEROSPAN Inhalation Aerosol has been 
studied in patients ages 4-17 years of age. The safety and effectiveness of AEROSPAN 
Inhalation Aerosol has not been studied in patients less than 4 years of age. In clinical 
studies, the adverse event profile observed in patients exposed to AEROSPAN Inhalation 
Aerosol was similar between the 4-5 year age group (n=21), the 6-11 year age group 
(n=210), the 12-17 year age group (n=30), and those patients 18 years of age and older 
(n=258). 
Controlled clinical studies have shown that orally inhaled corticosteroids may cause a 
reduction in growth velocity in pediatric patients. In these studies, the mean reduction in 
growth velocity was approximately one cm per year (range 0.3 to 1.8 cm per year) and 
appears to depend upon the dose and duration of exposure. This effect was observed in 
the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis 
suppression, suggesting that growth velocity is a more sensitive indicator of systemic 
corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis 
function. The long-term effects of this reduction in growth velocity associated with 
orally inhaled corticosteroids, including the impact on final adult height, are unknown.
The potential for “catch up” growth following discontinuation of treatment with orally 
inhaled corticosteroids has not been adequately studied. The growth of pediatric patients 
receiving orally inhaled corticosteroids, including AEROSPAN Inhalation Aerosol, 
should be monitored routinely (e.g., via stadiometry). The potential growth effects of 
prolonged treatment should be weighed against clinical benefits obtained and the 
risks/benefits of treatment alternatives. To minimize the systemic effects of orally 
inhaled corticosteroids, including AEROSPAN Inhalation Aerosol, each patient should 
be titrated to the lowest dose that effectively controls his/her symptoms.