spasm.
IMPORTANT SAFETY INFORMATION
•Contraindications: ArmonAir™ RespiClick® is contraindicated in:
Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required
Patients with known severe hypersensitivity to milk proteins or known hypersensitivity to fluticasone propionate or any of the excipients
•Local Effects: Oropharyngeal candidiasis has occurred in patients treated with ArmonAir™ RespiClick®. Advise patients to rinse the mouth with water without swallowing following inhalation
•Acute Asthma Episodes: ArmonAir™ RespiClick® is not indicated for the relief of acute bronchospasm. An inhaled, short-acting beta2-agonist, not ArmonAir™ RespiClick®, should be used to relieve acute symptoms such as shortness of breath
•Immunosuppression: Patients on corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients. Use with caution, if at all, in patients with the above because of the potential for worsening of these infections
•Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. Slowly taper the dose of systemic corticosteroids if transferring patients to ArmonAir™ RespiClick®
•Hypercorticism and Adrenal Suppression: Because of the possibility of significant systemic absorption of inhaled corticosteroids, patients on ArmonAir™ RespiClick® should be observed carefully for any evidence of systemic corticosteroid effects. If such effects occur, the dosage of ArmonAir™ RespiClick® should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids, and for management of asthma symptoms
•Hypersensitivity Reactions, Including Anaphylaxis: Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of ArmonAir™ RespiClick®. Discontinue ArmonAir™ RespiClick® if such reactions occur |