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

PRECAUTIONS
 
General:
During withdrawal from oral corticosteroids, some patients may experience 
symptoms of systemically active corticosteroid withdrawal, e.g., joint and/or muscular 
pain, lassitude and depression, despite maintenance or even improvement of respiratory 
function. (See DOSAGE AND ADMINISTRATION for details.)
In responsive patients, flunisolide may permit control of asthmatic symptoms with less 
suppression of HPA axis function than therapeutically equivalent oral doses of 
prednisone. Since flunisolide is absorbed into the circulation and can be systemically 
active, the beneficial effects of AEROSPAN Inhalation Aerosol in minimizing or 
preventing HPA axis dysfunction may be expected only when recommended dosages are 
not exceeded and individual patients are titrated to the lowest effective dose. Since 
individual sensitivity to effects on cortisol production exists, physicians should consider 
this information when prescribing AEROSPAN Inhalation Aerosol.
Because of the possibility of systemic absorption of inhaled corticosteroids, patients 
treated with AEROSPAN Inhalation Aerosol should be observed carefully for any 
evidence of systemic corticosteroid effects. Particular care should be taken in observing 

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patients post-operatively or during periods of stress for evidence of inadequate adrenal 
response.
It is possible that systemic corticosteroid effects such as hypercorticism, reduced bone 
mineral density, and adrenal suppression may appear in a small number of patients, 
particularly at higher doses. If such changes occur, the AEROSPAN Inhalation Aerosol 
dose should be reduced slowly, consistent with accepted procedures for management of 
asthma symptoms and for tapering of systemic corticosteroids. 
The long-term local and systemic effects of AEROSPAN Inhalation Aerosol in human 
subjects are not fully known. In particular, the effects resulting from chronic use of 
AEROSPAN Inhalation Aerosol on developmental or immunologic processes in the 
mouth, pharynx, trachea, and lung are unknown. 
Orally inhaled corticosteroids, including flunisolide, may cause a reduction in growth 
velocity when administered to pediatric patients. A reduction in growth velocity may 
occur as a result of inadequate control of asthma or from use of corticosteroids for 
treatment. The potential effects of prolonged treatment on growth velocity should be 
weighed against clinical benefits obtained and the risks associated with alternative 
therapies. To minimize the systemic effects of orally inhaled corticosteroids, including 
AEROSPAN Inhalation Aerosol, each patient should be titrated to his/her lowest 
effective dose. (See PRECAUTIONS, Pediatric Use.) 
Inhaled corticosteroids should be used with caution, if at all, in patients with untreated 
active or quiescent tuberculosis infection of the respiratory tract; untreated systemic 
fungal, bacterial, parasitic or viral infections; or ocular herpes simplex. 
Rare instances of glaucoma, increased intraocular pressure, and cataracts have been 
reported in patients following the long- term administration of inhaled corticosteroids. 
In clinical studies with flunisolide, localized infections with Candida albicans or 
Aspergillus niger have occurred in the mouth and pharynx and occasionally in the larynx.
These infections may require treatment with appropriate antifungal therapy and/or 
discontinuance of treatment with AEROSPAN Inhalation Aerosol.