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

 
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AEROSPAN Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm. 
CONTRAINDICATIONS
AEROSPAN Inhalation Aerosol is contraindicated in the primary treatment of status 
asthmaticus or other acute episodes of asthma where intensive measures are required.
Hypersensitivity to flunisolide or any of the ingredients of this preparation 
contraindicates the use of AEROSPAN Inhalation Aerosol.
WARNINGS 
Particular care is needed in patients who are transferred from systemically active 
corticosteroids to AEROSPAN Inhalation Aerosol because deaths due to adrenal 
insufficiency have occurred in asthmatic patients during and after transfer from systemic 
corticosteroids to less systemically available inhaled corticosteroids. After withdrawal 
from systemic corticosteroids, a number of months are required for recovery of 
hypothalamic-pituitary-adrenal (HPA) function.
Patients who have been previously maintained on 20 mg or more per day of prednisone 
(or its equivalent) may be most susceptible, particularly when their systemic 
corticosteroids have been almost completely withdrawn. During this period of HPA 
suppression, patients may exhibit signs and symptoms of adrenal insufficiency when 
exposed to trauma, surgery or infections (particularly gastroenteritis) or other conditions 
associated with severe electrolyte loss. Although AEROSPAN Inhalation Aerosol may 
provide control of asthmatic symptoms during these episodes, in recommended doses it 
supplies less than the physiologic amounts of glucocorticoid systemically and does NOT 
provide the mineralocorticoid activity that is necessary for coping with these 
emergencies.
During periods of stress or a severe asthmatic attack, patients who have been withdrawn 
from systemic corticosteroids should be instructed to resume systemic steroids (in large 
doses) immediately and to contact their physician for further instruction. These patients 
should also be instructed to carry a warning card indicating that they may need 
supplementary systemic steroids during periods of stress or a severe asthma attack.
Patients requiring oral corticosteroids should be weaned slowly from systemic 
corticosteroid use after transferring to AEROSPAN Inhalation Aerosol. Lung function 
(FEV
1
or AM PEF), beta-agonist use, and asthma symptoms should be carefully 
monitored during withdrawal of oral corticosteroids. In addition to monitoring asthma 
signs and symptoms, patients should be observed for signs and symptoms of adrenal 
insufficiency such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension. 
Transfer of patients from systemic corticosteroid therapy to AEROSPAN Inhalation 
Aerosol may unmask allergic conditions previously suppressed by the systemic 
corticosteroid therapy, e.g. rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic 
conditions.

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Patients who are on drugs that suppress the immune system are more susceptible to 
infections than healthy individuals. Chickenpox and measles, for example, can have a 
more serious or even fatal course in non-immune children or adults on corticosteroids. In 
such children or adults who have not had these diseases or been properly immunized, 
particular care should be taken to avoid exposure. How the dose, route, and duration of 
corticosteroid administration affects the risk of developing a disseminated infection is not 
known. The contribution of the underlying disease and/or prior corticosteroid treatment 
to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella-zoster 
immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with 
pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective 
package inserts for complete VZIG and IG prescribing information.) If chickenpox 
develops, treatment with antiviral agents may be considered. 
 
AEROSPAN Inhalation Aerosol is not a bronchodilator and is not indicated for rapid 
relief of bronchospasm.
As with other inhaled asthma medications, bronchospasm may occur with an immediate 
increase in wheezing after dosing. If bronchospasm occurs following dosing with 
AEROSPAN Inhalation Aerosol, it should be treated immediately with a fast-acting 
inhaled bronchodilator. Treatment with AEROSPAN Inhalation Aerosol should be 
discontinued and alternative therapy instituted. 
Patients should be instructed to contact their physician immediately when episodes of 
asthma that are not responsive to bronchodilators occur during the course of treatment 
with AEROSPAN Inhalation Aerosol. During such episodes, patients may require 
therapy with systemic corticosteroids.