taractsor glaucoma); consider regular eye examinations.
Risks Associated with Beta-Agonist Therapy
Inform patients of adverse effects associated with beta2-agonists, such as palpitations, chest pain,rapid heart rate, tremor, or nervousness.Pregnancy
Inform patients who are pregnant or nursing that they should contact their physician about the
use of AirDuo Digihaler.
Use Daily for Best Effect
Patients should use AirDuo Digihaler at regular intervals as directed. The daily dosage of AirDuoDigihaler should not exceed 1 inhalation twice a day. Advise patients, if they miss a dose, to taketheir next dose at the same time they normally do and to not take 2 doses at one time. Individualpatients will experience a variable time to onset and degree of symptom relief and full benefitmay not be achieved until treatment has been administered for 1 to 2 weeks or longer. Patients
should not increase the prescribed dosage but should contact their physicians if symptoms do notimprove or if the condition worsens. Instruct patients not to stop use of AirDuo Digihalerabruptly. Patients should contact their physicians immediately if they discontinue use of AirDuoDigihaler.
Use of AirDuo Digihaler and Mobile App
Direct the patient to the Instructions for Use (IFU) for information on how to set up the App anduse the inhaler. Advise the patient that pairing of the inhaler to the App, having Bluetooth turnedon, or being near their smartphone is not required for delivery of the medication from the inhaleror for normal use of the product.
Dose Counter
Instruct patients that the AirDuo Digihaler has a dose counter that displays the number ofactuations (inhalations) left in the inhaler. When the patient receives a new inhaler, the numbe60 will be displayed. The dose counter will count down each time the mouthpiece is opened andclosed. When the dose counter reaches 20, the color of the numbers will change to red to remindthe patient to contact their pharmacist or healthcare provider for a refill of their medication.
When the dose counter reaches 0, the patient should stop using the inhaler, and it should bedisposed of in accordance with state and local regulations.
Caring for and Storing the Inhaler
Instruct patients to not open their inhaler unless they are taking a dose. Repeated openingand closing the cover without taking medication will waste medication and may damage theinhaler.
Advise patients to keep their inhaler dry and clean at all times. Never wash or put any part ofthe inhaler in water. Patient should replace inhaler if washed or placed in water. Advisepatients to immediately replace inhaler if mouthpiece cover is damaged or broken.
Gently wipe the mouthpiece with a dry cloth or tissue as needed.
Instruct patients to store the inhaler at room temperature and to avoid exposure to extreme heat,cold, or humidity.
Instruct patients to never take the inhaler apart.
Inform patients that AirDuo Digihaler has a dose counter. When the patient receives the inhaler,the number 60 will be displayed. The dose counter will count down each time the mouthpiece cap is opened and closed. The dose-counter window displays the number of actuations left in theinhaler in units of two (e.g., 60, 58, 56, etc.). When the counter displays 20, the color of thenumbers 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 soli |
