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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
AirDuo® Digihaler™ is indicated for the treatment of asthma in patients aged 12 years and older.
AirDuo Digihaler should be used for patients not adequately controlled on a long term asthmacontrol medication such as an inhaled corticosteroid or whose disease warrants initiation oftreatment with both an inhaled corticosteroid and long acting beta2 adrenergic agonist (LABA).
Limitations of Use:
AirDuo Digihaler is NOT indicated for the relief of acute bronchospasm.
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
Administer AirDuo Digihaler as 1 inhalation twice daily (approximately 12 hours apart at thesame time every day) by the orally inhaled route. Advise the patient to rinse his/her mouth withwater without swallowing after each inhalation.
AirDuo Digihaler does not require priming.
Do not use AirDuo Digihaler with a spacer or volume holding chamber.
Do not use AirDuo Digihaler by other routes.
Do not use more than two times every 24 hours. More frequent administration or agreater number of daily inhalations (more than one inhalation twice daily) is notrecommended as some patients are more likely to experience adverse reactions withhigher salmeterol dosages.
Avoid the concomitant use of other long acting beta2 adrenergic agonist (LABAs) [seeWarnings and Precautions (5.3, 5.11)].
If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2-agonistshould be taken for immediate relief.
2.2 Recommended Dosage
The recommended starting dosage for AirDuo Digihaler is based on asthma severity and currentinhaled corticosteroid use and strength. For example:For patients not taking inhaled corticosteroids (ICS) (with less severe asthma): select55/14 mcg (55 mcg of fluticasone propionate and 14 mcg of salmeterol), administeredtwice daily.
For patients with greater asthma severity, use the higher dosages: either:
o 113/14 mcg (113 mcg of fluticasone propionate and 14 mcg of salmeterol),administered twice daily; or o 232/14 mcg (232 mcg of fluticasone propionate and 14 mcg of salmeterol),administered twice daily.
For patients switching to AirDuo Digihaler from another inhaled corticosteroid orcombination product, select the low (55/14 mcg), medium (113/14 mcg) or high (232/14
mcg) dose strength of AirDuo Digihaler based on the strength of the previous inhaledcorticosteroid product, or the strength of the inhaled corticosteroid from a combinationproduct, and disease severity.
Improvement in asthma control following AirDuo Digihaler administration can occur withi