ProAir Digihaler FDA Approval History

Last updated by Judith Stewart, BPharm on May 2, 2024.

FDA Approved: Yes (Discontinued) (First approved December 21, 2018)
Brand name: ProAir Digihaler
Generic name: albuterol sulfate
Dosage form: Inhalation Powder
Company: Teva Pharmaceuticals USA, Inc.
Treatment for: Bronchospasm Prophylaxis, Asthma, COPD

ProAir Digihaler (albuterol sulfate) is a beta2-adrenergic agonist indicated for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease, and the prevention of exercise-induced bronchospasm.

ProAir Digihaler is a digital inhaler with built-in sensors that detect how often the inhaler is used, and measure respiratory flow. The inhaler use data is sent to the companion mobile app using Bluetooth® wireless technology so patients can review their data over time and share the reports with their caregivers and healthcare professionals if needed. ProAir Digihaler does not need to be connected to the app in order to take the medicine, and the electronic module does not control or interfere with delivery of the medicine through the inhaler.

IMPORTANT SAFETY INFORMATION

• Do not use ProAir Digihaler (albuterol sulfate) Inhalation Powder if you are allergic to albuterol sulfate, lactose, milk proteins, or any of the ingredients in ProAir Digihaler. Ask your healthcare provider if you have any questions or are not sure
• Before using ProAir Digihaler, tell your healthcare provider 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
  • are pregnant or planning to become pregnant
  • are breastfeeding or planning to breastfeed
• Tell your healthcare provider about all the medicines you take, especially: other inhaled medicines or asthma medicines, beta blocker medicines, diuretics, digoxin, monoamine oxidase inhibitors, and tricyclic antidepressants.
• Do not increase your dose or take extra doses of ProAir Digihaler without first talking to your healthcare provider
• Get medical help right away if ProAir Digihaler no longer helps your symptoms, your symptoms get worse or 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 healthcare provider tells you to do so
• 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 healthcare provider or get emergency help right away. This is more likely to happen with your first use of a new asthma inhalation medicine
  • 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 healthcare provider right away if you have the following symptoms of an allergic reaction: itchy skin, swelling beneath your skin or in your throat, rash, or worsening trouble breathing.
  • changes in laboratory blood values (sugar, potassium)
• The most common side effects of ProAir Digihaler include: back pain, body aches and pain, upset stomach, sinus headache, urinary tract infection, your heart feels like it is pounding or racing (palpitations), chest pain, fast heart rate, shakiness, nervousness, headache, dizziness, sore throat, and runny nose.
• These are not all of the possible side effects of ProAir Digihaler. For more information, ask your healthcare provider or pharmacist.

Development timeline for ProAir Digihaler

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer