ProAir Digihaler (albuterol sulfate) is a digital rescue inhaler for the quick-relief of asthma symptoms. It contains a type of medication called a short-acting beta₂-adrenergic receptor agonist and is a bronchodilator that works by helping to relax the smooth muscles in your airways, making it easier to breathe.

ProAir Digihaler was the first digital inhaler to be approved for use by the US Food and Drug Administration (FDA) when it was granted approval in 2018. It has a built-in electronic sensor to detect, record and store your inhaler usage data. It is also breath-actuated, which means that it is activated to deliver a metered-dose of dry powder containing your medication when you inhale with you lips tightly closed around the mouthpiece of the inhaler.

ProAir Digihaler may be used with an app through Bluetooth wireless technology. It can check how you inhale by measuring your inspiratory flow rate and also track how often you use your inhaler.

Two other ProAir inhalers containing albuterol sulfate are also available including:

• ProAir HFA, which releases a fine mist of medication
• ProAir RespiClick, which is a dry powder inhaler without the electronic sensor

What is ProAir Digihaler used for?

ProAir Digihaler is a prescription medicine used in people 4 years of age and older to:

• treat or prevent bronchospasm in people who have reversible obstructive airway disease
• prevent exercise-induced bronchospasm

It is not known if ProAir Digihaler is safe and effective in children under 4 years of age.

ProAir Digihaler does not need to be connected to the app in order for you to take your medicine. The electronic module does not control or interfere with delivery of the medicine through the inhaler.

• For detailed instructions on how to use the inhaler, see the Instructions for Use.
• For detailed instructions on how to set up the app, go to www.ProAirDigihaler.com or call Teva at 1-888-603-0788.
• Connection to the app, having your Bluetooth turned on, or being near your smartphone is not required for your ProAir Digihaler to work and for you to get your medicine.
• The electronic module does not control or interfere with delivery of the medicine through the inhaler.
• Use ProAir Digihaler exactly as your doctor tells you to use it.
• If your child needs to use ProAir Digihaler, watch your child closely to make sure your child uses the inhaler correctly. Your doctor will show you how your child should use ProAir Digihaler.
• Each dose of ProAir Digihaler should last up to 4 hours to 6 hours.
• Do not increase your dose or take extra doses of ProAir Digihaler without first talking to your doctor.
• Do not use a spacer or volume holding chamber with ProAir Digihaler.
• ProAir Digihaler does not need priming.
• Get medical help right away if ProAir Digihaler no longer helps your symptoms.
• Get medical help right away if your symptoms get worse or if you need to use your inhaler more often.
• While you are using ProAir Digihaler, do not use other inhaled rescue medicines and asthma medicines unless your doctor tells you to do so.

Call your doctor if your asthma symptoms, like wheezing and trouble breathing, become worse over a few hours or days. Your doctor may need to give you another medicine (for example, corticosteroids) to treat your symptoms.

The recommended dose of ProAir Digihaler:

• For the treatment or prevention of bronchospasm in adults and children 4 years of age and older:
  • 2 inhalations every 4 to 6 hours by oral inhalation. In some patients, 1 inhalation every 4 hours may be sufficient.
• For the prevention of exercise-induced bronchospasm in adults and children 4 years of age and older:
  • 2 inhalations 15 to 30 minutes before exercise by oral inhalation.

Do not use ProAir Digihaler if you are allergic to albuterol sulfate, lactose, milk proteins, or any of the ingredients in ProAir Digihaler. See below for a complete list of ingredients in ProAir Digihaler.

What should I tell my doctor before using ProAir Digihaler?

Before using ProAir Digihaler, tell your doctor about all of your medical conditions, including if you:

• have heart problems
• have high blood pressure (hypertension)
• have convulsions (seizures)
• have thyroid problems
• have diabetes
• have low potassium levels in your blood

If you miss a dose before exercising, take it as soon as you remember.

If you miss a dose then use your inhaler as soon as you remember. If it is almost time to take your next dose when you remember then skip the missed dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention straight away if you think you have used too much of this medication or call the Poison Help line at 1-800-222-1222.

Symptoms of an overdose may include seizures, chest pain, a fast heart beat, nervousness, headache, tremor, dry mouth, heart palpitation, nausea, dizziness, fatigue, malaise and insomnia.

An overdose of albuterol, the active ingredient in ProAir Digihaler, can be fatal.

ProAir Digihaler may cause serious side effects, including:

• worsening trouble breathing, coughing and wheezing (paradoxical bronchospasm). If this happens stop using ProAir Digihaler and call your doctor or get emergency help right away.
• heart problems, including faster heart rate and higher blood pressure
• possible death in people with asthma who use too much ProAir Digihaler
• allergic reactions. Call your doctor right away if you have the following symptoms of an allergic reaction:
  • itchy skin
  • rash
  • swelling beneath your skin or in your throat
  • worsening trouble breathing
• worsening of other medical problems in people who also use ProAir Digihaler including increases in blood sugar
• low potassium levels in your blood

The most common side effects of ProAir Digihaler include:

• back pain
• fast heart rate
• pain
• shakiness
• upset stomach
• nervousness
• sinus headache
• headache
• urinary tract infection
• dizziness
• your heart feels like it is pounding or racing (palpitations)
• sore throat
• chest pain
• runny nose
• vomiting

These are not all of the possible side effects of ProAir Digihaler.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

ProAir Digihaler and other medicines may affect each other and cause side effects. ProAir Digihaler may affect the way other medicines work, and other medicines may affect the way ProAir Digihaler works.

Especially tell your doctor if you take:

• other inhaled medicines or asthma medicines
• digoxin
• beta blocker medicines
• monoamine oxidase inhibitors
• diuretics
• tricyclic antidepressants

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.