HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useAIRDUO® DIGIHALER™ safely and effectively. See full prescribinginformation for AIRDUO DIGIHALER.
AIRDUO DIGIHALER (fluticasone propionate and salmeterol)inhalation powder, for oral inhalation
Initial U.S. Approval: 2000
INDICATIONS AND USAGE
AirDuo Digihaler is a combination of fluticasone propionate, a corticosteroid,and salmeterol, a long-acting beta2-adrenergic agonist (LABA), indicated fortreatment of asthma in patients aged 12 years and older. AirDuo Digihalershould be used for patients not adequately controlled on a long term asthmacontrol medication such as an inhaled corticosteroid or whose diseasewarrants initiation of treatment with both an inhaled corticosteroid and longacting beta2 adrenergic agonist (LABA).
Limitations of Use:
Not indicated for the relief of acute bronchospasm.
DOSAGE AND ADMINISTRATION
For oral inhalation only.
Starting dosage is based on prior asthma therapy and disease severity.
1 inhalation of AirDuo Digihaler 55/14 mcg, 113/14 mcg, or 232/14 mcgtwice daily.
Do not use with a spacer or volume holding chamber. (2.2)
AirDuo Digihaler contains a built-in electronic module which detects, records,and stores data on inhaler events for transmission to mobile App. Use of the
App is not required for administration of medication to the patient.
DOSAGE FORMS AND STRENGTHS
Inhalation Powder: In each actuation:
55/14 contains 55 mcg of fluticasone propionate and 14 mcg ofsalmeterol
113/14 contains 113 mcg of fluticasone propionate and 14 mcg ofsalmeterol
232/14 contains 232 mcg of fluticasone propionate and 14 mcg ofsalmeterol.
CONTRAINDICATIONS
Primary treatment of status asthmaticus or acute episodes of asthmarequiring intensive measures. (4)
Severe hypersensitivity to milk proteins or any ingredients of AirDuoDigihaler. (4)
WARNINGS AND PRECAUTIONS
LABA monotherapy increases the risk of serious asthma-related events.
Deterioration of asthma and acute episodes: Do not use for relief of acutesymptoms. Patients require immediate re-eva luation during rapidlydeteriorating asthma. (5.2)
Do not use in combination with an additional medicine containing LABAbecause of risk of overdose. (5.3)
Localized infections: Candida albicans infection of the mouth and pharynxmay occur. Monitor patients periodically. Advise the patient to rinse his/hermouth with water without swallowing after inhalation to help reduce therisk. (5.4)
Immunosuppression: Potential worsening of existing tuberculosis, fungal,bacterial, viral, parasitic infection, or ocular herpes simplex. Use withcaution in patients with these infections. More serious or even fatal courseof chickenpox or measles can occur in susceptible patients. (5.5)
Transferring patients from systemic corticosteroids: Risk of impairedadrenal function when transferring from systemic corticosteroids. Taperpatients slowly from systemic corticosteroids if transferring to AirDuoDigihaler. (5.6)
Hypercorticism and adrenal suppression: May occur with very highdosages or at the regular dosage in susceptible individuals. If such changesoccur, discontinue AirDuo Digihaler slowly. (5.7)
Paradoxical bronchospasm: Discontinue AirDuo Digihaler and institutealternative therapy if paradoxical bronchospasm occurs. (5.9)
Use with caution