More Important Safety Information

  • AEROSPAN is contraindicated as a primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures.
  • In clinical studies with flunisolide, localized fungal infections of the mouth and pharynx have occurred. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse their mouth following inhalation.
  • AEROSPAN is not a bronchodilator and is not indicated for rapid relief of bronchospasm.
  • Patients who are on drugs that suppress the immune system, such as corticosteroids, are more susceptible to infections and should avoid exposure to chicken pox or measles. 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.
  • When transferring patients from systemic corticosteriods, there is a risk of death due to impaired adrenal function. Taper patients slowly from systemic corticosteroids if switching to AEROSPAN.
  • Hypercorticism and adrenal suppression may occur with very high doses or at the regular dose of AEROSPAN in susceptible individuals. If such changes occur, discontinue AEROSPAN slowly.
  • Decreases in bone mineral density have been observed with long-term administration of products containing inhaled corticosteroids, including flunisolide. Assess bone mineral density initially and periodically thereafter in patients at risk.
  • Orally inhaled corticosteroids, including flunisolide, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of children and adolescents receiving AEROSPAN.
  • Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term administration of inhaled corticosteroids, including flunisolide. Close monitoring is warranted.
  • Paradoxical bronchospasm may occur immediately after dosing. Treat bronchospasm immediately with a fast-acting bronchodilator. Discontinue AEROSPAN treatment.
  • The most common adverse reactions seen in clinical trials were pharyngitis, rhinitis, headache, sinusitis, and increased cough.

Indications

AEROSPAN Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age and older. AEROSPAN is also indicated for asthma patients requiring oral corticosteroid therapy, where adding AEROSPAN may reduce or eliminate the need for oral corticosteroids.

Important Limitations of Use: AEROSPAN is NOT indicated for the relief of acute bronchospasm. AEROSPAN is NOT indicated in children less than 6 years of age.

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Visit www.fda.gov/medwatch, or call 855-543-3784.

For additional information, please see Full Prescribing Information for Aerospan.