2.1 Recommended Dosage for Bronchospasm

The recommended dosage is 2 inhalations every 4 to 6 hours by oral inhalation. More frequent administration or a larger number of inhalations is not recommended. In some patients, 1 inhalation every 4 hours may be sufficient.

2.2 Recommended Dosage for Exercise-Induced Bronchospasm

The recommended dosage is 2 inhalations 15 to 30 minutes before exercise by oral inhalation.

Administration and Maintenance Information

Administer ProAir Digihaler by oral inhalation only. ProAir Digihaler inhaler does not require priming. Do not use ProAir Digihaler with a spacer or volume holding chamber.

Keep the inhaler clean and dry at all times. Never wash or put any part of your inhaler in water. Routine maintenance is not required. If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed.

2.4 Dose Counter

ProAir Digihaler inhaler has a dose counter attached to the actuator. When the patient receives the inhaler, the number 200 will be displayed.

The dose counter will count down each time the inhaler is actuated. When the dose counter reaches 20, the color of the numbers will change to red to remind the patient to contact their pharmacist for a refill of medication or consult their physician for a prescription refill. When the dose counter reaches 0, the background will change to solid red. Discard ProAir Digihaler 13 months after opening the foil pouch, when the dose counter displays 0 or after the expiration date on the product, whichever comes first [see Patient Counseling Information (17)].

2.5 Storage of Data on Inhaler Events

ProAir Digihaler contains a built-in electronic module which detects, records, and stores data on inhaler events, including peak inspiratory flow rate (L/min), for transmission to the mobile App where inhaler events are categorized. Use of the App is not required for administration of albuterol sulfate 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)].