AirDuo (Fluticasone propionate and Salmeterol)

AIRDUO RESPICLICK is a combination of fluticasone propionate, a corticosteroid, and salmeterol, a long-acting beta2-adrenergic agonist (LABA), indicated for treatment of asthma in adult and pediatric patients aged 12 years and older. AIRDUO RESPICLICK should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist

Cautions

• LABA monotherapy increases the risk of serious asthma-related events. (5.1) • Deterioration of asthma and acute episodes: Do not use for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. (5.2) • Do not use in combination with an additional medicine containing LABA because of risk of overdose. (5.3) • Localized infections: Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. (5.4) • Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, parasitic infection, or ocular herpes simplex. Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. (5.5) • Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to AIRDUO RESPICLICK. (5.6) • Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue AIRDUO RESPICLICK slowly. (5.7) • Paradoxical bronchospasm: Discontinue AIRDUO RESPICLICK and institute alternative therapy if paradoxical bronchospasm occurs. (5.9) • Use with caution in patients with cardiovascular or central nervous system disorders because of beta adrenergic stimulation. (5.11) • Decreases in bone mineral density: Monitor patients with major risk factors for decreased bone mineral content. (5.12) • Monitor growth of pediatric patients. (5.13) • Close monitoring for glaucoma and cataracts is warranted. (5.14) • Be alert to eosinophilic conditions, hypokalemia, and hyperglycemia. (5.15, 5.17) • Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis. (5.16)