AirDuo Digihaler Dosage

2.1 Administration Instructions

• AirDuo Digihaler is for oral inhalation and does not require priming.
• Do not use AirDuo Digihaler with a spacer or volume holding chamber.
• Do not use more than two times every 24 hours. More frequent administration or a greater number of daily inhalations (more than one inhalation twice daily) is not recommended as some patients are more likely to experience adverse reactions with higher salmeterol dosages.
• Avoid the concomitant use of other long acting beta2-adrenergic agonist (LABAs) [see Warnings and Precautions (5.3, 5.11)].

If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.

2.2 Recommended Dosage

Administer 1 inhalation of AirDuo Digihaler twice daily by oral inhalation (approximately 12 hours apart at the same time every day). Rinse the mouth with water without swallowing after each inhalation.

Dosage Selection

The recommended starting dosage for AirDuo Digihaler is based on asthma severity and current inhaled corticosteroid use and strength.

• Patients not taking inhaled corticosteroids (ICS) (with less severe asthma): 1 inhalation of 55 mcg/14 mcg AirDuo Digihaler (55 mcg of fluticasone propionate and 14 mcg of salmeterol) twice daily by oral inhalation.

• Patients with greater asthma severity, use the higher dose strengths:
  • 1 inhalation of 113 mcg/14 mcg AirDuo Digihaler (113 mcg of fluticasone propionate and 14 mcg of salmeterol) twice daily by oral inhalation; or
  • 1 inhalation of 232 mcg/14 mcg AirDuo Digihaler (232 mcg of fluticasone propionate and 14 mcg of salmeterol) twice daily by oral inhalation.
    
  
  
• For patients switching to AirDuo Digihaler from another inhaled corticosteroid or combination product:
  
  • 1 inhalation of low (55 mcg/14 mcg), medium (113 mcg/14 mcg) or high (232 mcg/14 mcg) AirDuo Digihaler twice daily by oral inhalation based on the strength of the previous inhaled corticosteroid product, or the strength of the inhaled corticosteroid from a combination product, and disease severity.
    
  
  
• The maximum recommended dosage of AirDuo Digihaler is 232 mcg/14 mcg twice daily.

General Dosing Information

Improvement in asthma control following AirDuo Digihaler administration can occur within 15 minutes of beginning treatment; although maximum benefit may not be achieved for 1 week or longer after starting treatment. Individual patients will experience a variable time to onset and degree of symptom relief. For patients who do not respond adequately to the starting dose of AirDuo Digihaler after 2 weeks of therapy, consider increasing the strength (replace with higher strength) to possibly provide additional improvement in asthma control.

If a previously effective dosage regimen fails to provide adequate improvement in asthma control, re-evaluate the therapeutic regimen, including patient compliance and inhaler technique, and consider additional therapeutic options (e.g., increasing the dose of AirDuo Digihaler with a higher strength, adding additional controller therapies). After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the risk of adverse reactions.

2.3 Storing and Cleaning the Inhaler

• Keep the inhaler in a cool dry place.
• Routine maintenance is not required. If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed.
• Never wash or put any part of the inhaler in water.

2.4 Dose Counter and Storage of Inhaler Events Data

The AirDuo Digihaler inhaler has a dose counter:

• The number 60 is displayed (prior to use).
• The dose counter will count down each time the mouthpiece is opened and closed [see Patient Counseling Information (17).

AirDuo Digihaler contains a built-in electronic module which detects, records, and stores data on inhaler events, including peak inspiratory flow rate (L/minute), for transmission to the mobile App where inhaler events are categorized. Use of the App is not required for administration of fluticasone propionate and salmeterol to the patient. There is no evidence the use of the App leads to improved clinical outcomes, including safety and effectiveness [see How Supplied/Storage and Handling (16)].