AEROSPAN Inhalation Aerosol is contraindicated as a primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures.
AEROSPAN Inhalation Aerosol is not a bronchodilator and is not indicated for rapid relief of bronchospasm.
In clinical studies with flunisolide, localized fungal infections of the mouth, pharynx, and larynx have occurred. If oropharyngeal candidiasis develops, AEROSPAN Inhalation Aerosol therapy may need to be interrupted under close medical supervision.
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.
Patients who are on drugs that suppress the immune system, such as corticosteroids, are more susceptible to infections than healthy individuals 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.
During reduction and withdrawal of oral corticosteroid doses, patients should be carefully monitored for asthma instability, including objective measures of airway function, and for adrenal insufficiency. Patients should taper slowly from systemic corticosteroids if switching to AEROSPAN Inhalation Aerosol.
It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in a small number of patients, particularly at higher doses. If such changes occur, reduce the AEROSPAN Inhalation Aerosol dose slowly, consistent with accepted procedures for management of asthma symptoms and for tapering of systemic corticosteroids.
Decreases in bone mineral density have been observed with long-term administration of products containing inhaled corticosteroids, including flunisolide. Patients with major risk factors for decreased bone mineral content should be monitored and treated with established standards of care.
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 Inhalation Aerosol. To minimize the systemic effects, patients should be titrated to the lowest dosage that effectively controls symptoms.
Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term administration of inhaled corticosteroids, including flunisolide. Therefore, close monitoring is warranted in patients with a change in vision or with a history of intraocular pressure, glaucoma, and/or cataracts.
Bronchospasm may occur with an immediate increase in wheezing after dosing. If bronchospasm occurs following dosing with AEROSPAN Inhalation Aerosol, treat immediately with a fast-acting inhaled bronchodilator. Discontinue AEROSPAN treatment immediately and institute alternative therapy.
The most common adverse reactions seen in two 12-week, pivotal, double-blind, placebo-controlled, clinical trials performed with AEROSPAN (160 mcg BID) were pharyngitis (16.6%), rhinitis (15.7%), headache (13.8%), cough increased (5.5%), allergic reaction (4.6%), and vomiting (4.6%).
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 Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm. AEROSPAN Inhalation Aerosol is NOT indicated in children less than 6 years of age.
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