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INDICATION

ArmonAir RespiClick® is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.

Important Limitation of Use: ArmonAir RespiClick® is NOT indicated for the relief of acute bronchospasm.

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

INDICATION

ArmonAir RespiClick® is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.

Important Limitation of Use: ArmonAir RespiClick® is NOT indicated for the relief of acute bronchospasm.

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
  • Reduction in Bone Mineral Density (BMD): Decreases in BMD have been observed with long-term administration of inhaled corticosteroids. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care
  • Effect on Growth: Inhaled corticosteroids, including ArmonAir RespiClick®, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving ArmonAir RespiClick® routinely (e.g., via stadiometry). Titrate to the lowest dosage that effectively controls symptoms
  • Glaucoma and Cataracts: Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with asthma following the long-term administration of inhaled corticosteroids, including fluticasone propionate. Close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts
  • Paradoxical Bronchospasm: Bronchospasm may occur with an immediate increase in wheezing after dosing and should be treated immediately with an inhaled, short-acting bronchodilator; ArmonAir RespiClick® should be discontinued immediately and alternative therapy instituted
  • Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors: The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with ArmonAir RespiClick® is not recommended because increased systemic corticosteroid adverse effects may occur
  • Eosinophilic Conditions and Churg-Strauss Syndrome: Systemic eosinophilic conditions, such as Churg-Strauss syndrome, may occur. These events usually, but not always, have been associated with the reduction and/or withdrawal of oral corticosteroids following the introduction of fluticasone propionate. Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy
  • Adverse Reactions: Most common adverse reactions (≥3%) in patients taking ArmonAir RespiClick® 55 mcg twice daily, 113 mcg twice daily, 232 mcg twice daily, and placebo, respectively, were nasopharyngitis (5.4%, 5.8%, 4.8%, 4.4%), upper respiratory tract infection (5.4%, 4.7%, 5.5%, 4.8%), oral candidiasis (3.1%, 2.9%, 4.8%, 0.7%), headache (1.6%, 7.3%, 4.8%, 4.4%), and cough (1.6%, 1.8%, 3.4%, 2.6%)
  • Drug Interactions: The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with ArmonAir RespiClick® is not recommended because increased systemic corticosteroid adverse effects may occur
  • Use in Specific Populations: Since fluticasone propionate is predominantly cleared by hepatic metabolism, impairment of liver function may lead to accumulation of fluticasone propionate in plasma. Patients with hepatic disease should be closely monitored