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

DOSAGE AND ADMINISTRATION 
AEROSPAN Inhalation Aerosol should be administered by the orally inhaled route in 
asthmatic patients aged 6 years and older. The onset and degree of symptom relief with 
orally inhaled corticosteroids is usually apparent within 2-4 weeks after the start of 

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treatment, and varies with individual patients. The time to improvement in asthma 
control was not evaluated in clinical studies with AEROSPAN Inhalation Aerosol. For 
patients who do not respond adequately to the starting dose after 3-4 weeks of therapy, 
higher doses may provide additional asthma control. The safety and efficacy of 
AEROSPAN Inhalation Aerosol when administered in excess of recommended doses 
have not been established.
Note: In all patients it is desirable to titrate to the lowest effective dose once asthma 
stability is achieved.
Adults (age 12 and older):
The recommended starting dose is 160 mcg twice daily. The 
maximum dose should not exceed 320 mcg twice daily. Higher doses have not been 
studied. 
Children (age 6 to 11):
The recommended starting dose is 80 mcg twice daily. The 
maximum dose should not exceed 160 mcg twice daily. Higher doses have not been 
studied.
Pediatric patients should administer this product under adult supervision. 
The recommended dosage of AEROSPAN Inhalation Aerosol relative to flunisolide CFC 
inhalation aerosol is lower due to differences in delivery characteristics between the 
products. Recognizing that a definitive comparative therapeutic ratio between 
AEROSPAN Inhalation Aerosol and flunisolide CFC inhalation aerosol has not been 
demonstrated, any patient who is switched from flunisolide CFC inhalation aerosol to 
AEROSPAN Inhalation Aerosol should be dosed appropriately, taking into account the 
dosing recommendations above, and should be monitored to ensure that the dose of 
AEROSPAN Inhalation Aerosol selected is safe and efficacious. As with any inhaled 
corticosteroid, physicians are advised to select the dose of AEROSPAN Inhalation 
Aerosol that would be appropriate based upon the patient’s disease severity and titrate the 
dose of AEROSPAN Inhalation Aerosol downward over time to the lowest level that 
maintains proper asthma control.
 
Clinical studies with AEROSPAN Inhalation Aerosol did not evaluate patients on oral 
corticosteroids. However, clinical studies with therapeutic doses of flunisolide CFC 
inhalation aerosol did show efficacy in the management of asthmatics dependent or 
maintained on systemic corticosteroids. 
If a patient is already on a systemic corticosteroid for asthma control, AEROSPAN 
Inhalation Aerosol should be used concurrently with the patient’s usual maintenance dose 
of oral corticosteroid before an attempt is made to withdraw systemic corticosteroid. The 
patient’s asthma should be reasonably stable before withdrawal of oral corticosteroid is 
initiated. After approximately one week, gradual withdrawal of the systemic 
corticosteroid may be started by reducing the daily or alternate daily dose. The next 
reduction may be made after an interval of one or two weeks, depending on the response 
of the patients. In general, these decrements should not exceed 2.5 mg of prednisone or 
its equivalent. A slow rate of withdrawal is strongly recommended. During reduction of 
oral corticosteroids, patients should be carefully monitored for asthma instability, 

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including objective measures of airway function, and for adrenal insufficiency (see 
WARNINGS). During their withdrawal from a systemic corticosteroid, some patients 
may experience symptoms of systemic corticosteroid withdrawal, e.g., joint and/or 
musculoskeletal pain, lassitude and depression, despite maintenance or even 
improvements in pulmonary function. Such patients should be encouraged to continue 
with AEROSPAN Inhalation Aerosol and should be monitored for objective signs of 
adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic 
corticosteroid doses should be increased temporarily and thereafter withdrawal should 
continue more slowly. During periods of stress or a severe asthma attack, patients being 
transferred may require supplementary treatment with a systemic corticosteroid.