l, they should seek medicalattention immediately.
Use of ProAir Digihaler Electronic Module and Mobile App
Direct the patient to the Instructions for Use (IFU) on how to download the App and use the inhaler. Advise the patientthat pairing of the inhaler to the App, having Bluetooth turned on, or being near their smartphone is not required fordelivery of the medication from the inhaler or for normal use of the product.
Caring for and Storing the Inhaler
Instruct patients to not open their inhaler unless they are taking a dose. Repeated opening and closing the coverwithout taking medication will waste medication and may damage the inhaler.
Advise patients to keep their inhaler dry and clean at all times. Never wash or put any part of the inhaler in water.
Patient should replace inhaler if washed or placed in water.
Routine maintenance is not required. If the mouthpiece needs cleaning, instruct patients to gently wipe the mouthpiecewith 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 ProAir Digihaler has a dose counter. When the patient receives the inhaler, the number 200 will bedisplayed. The dose counter will count down each time the mouthpiece cap is opened and closed. The dose counterwindow displays the number of actuations left in the inhaler in units of two (e.g., 200, 198, 196, etc.). When the counterdisplays 20, the color of the numbers will change to red to remind the patient to contact their pharmacist for a refill ofmedication or consult their physician for a prescription refill. When the dose counter reaches 0, the background willchange to solid red. Inform patients to discard ProAir Digihaler when the dose counter displays 0 or after the expirationdate on the product, whichever comes first.
Paradoxical Bronchospasm
Inform patients that ProAir Digihaler can produce paradoxical bronchospasm. Instruct patients to discontinue ProAirDigihaler if paradoxical bronchospasm occurs.
Concomitant Drug UseInform patients that, while they are taking ProAir Digihaler, they should take other inhaled drugs and asthma medicationsonly as directed by a physician.
Common Adverse Events
Common adverse effects of treatment with inhaled albuterol include palpitations, chest pain, rapid heart rate, tremor, andnervousness.
Pregnancy
Inform patients who are pregnant or nursing that they should contact their physician about the use of ProAir Digihaler.
General Information on UseEffective and safe use of ProAir Digihaler includes an understanding of the way that it should be administered. Do not usea spacer or volume holding chamber with ProAir Digihaler. Patients should be instructed on the proper use of the inhaler.
See the FDA-approved Patient Information and Patient Instructions for Use. Discard ProAir Digihaler 13 months afteropening the foil pouch, when the dose counter displays 0 or after the expiration date on the product, whichever comesfirst.
In general, the technique for administering ProAir Digihaler to children is similar to that for adults. Children should useProAir Digihaler under adult supervision, as instructed by the patient’s physician.
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