Using the Inhaler

About the Digihaler family of inhalers

What is the Digihaler family of inhalers?

The Digihaler family of inhalers includes ProAir Digihaler (albuterol sulfate) for rescue therapy and AirDuo Digihaler (fluticasone propionate and salmeterol) and ArmonAir Digihaler (fluticasone propionate) for maintenance therapy.

Each inhaler in the Digihaler family contains a built-in electronic module that records how often the inhaler is used, recorded as an event when the cap is opened or you inhale, and measures inspiratory flow rates. The information is stored on the inhaler itself, then sent to the Digihaler app through Bluetooth® wireless technology.

Please see full indications for ProAir Digihaler, AirDuo Digihaler, and ArmonAir Digihaler below.

Caring for the Digihaler family of inhalers

How do I take care of my inhaler?

  • Be sure to keep your inhaler clean and dry.
  • Never wash or put any part of your inhaler in water. If your inhaler gets wet it will need to be replaced.
  • Store at room temperature (between 15° and 25°C; 59° and 77°F). Avoid exposure to extreme heat, cold, or humidity.
  • Remember to close the cap after using your inhaler.
  • If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed.
  • Please see the Instructions for Use documents below for additional information:

Do I need to charge or change the battery in my inhaler?

No, the battery does not require charging or changing.

Is the battery inside my inhaler allowed for air travel?

Yes. It is a low power CR2032 coin cell battery, which is allowed for air travel.

When should I replace my ProAir Digihaler, AirDuo Digihaler, or ArmonAir Digihaler?

The counter on the back of your inhaler shows how many doses you have left. The dose counter color will change to red when there are 20 doses left. If your inhaler dose counter is low, a notification indicating this will appear in the app's details page. When you receive these alerts, you should refill your prescription or ask your healthcare provider for another prescription. When the counter displays “0,” your inhaler is empty and you should stop using the inhaler and throw it away.

Throw away your ProAir Digihaler 13 months after opening the foil pouch for the first time, when the dose counter displays ‘0’, or after the expiration date on the package, whichever comes first.

Throw away your AirDuo Digihaler or ArmonAir Digihaler 30 days after opening the foil pouch for the first time, when the dose counter displays ‘0’, or after the expiration date on the package, whichever comes first.

How the inhaler works

What does it mean that the Digihaler family of inhalers are "Breath-actuated?"

The Digihaler family of inhalers are “breath-actuated”—meaning they release the medicine when you breathe in. There’s no need to press a canister and breathe in at the same time as with traditional inhalers.

Can I use a spacer with my ProAir Digihaler, AirDuo Digihaler, or ArmonAir Digihaler?

No. A spacer cannot be used with any of the inhalers in the Digihaler family. In fact, they were designed to be used without a spacer.

What type of technology is inside the Digihaler family of inhalers?

The Digihaler family of inhalers contain sensors that are built into the electronic module on top of the inhaler. The sensors in the module track your inhaler events, which are recorded when the cap is opened or when you inhale. The sensors also measure inspiratory flow, which means how strongly you breathe in. Events are categorized in the app as “good” (>45 L/min), “fair” (30-45 L/min), “low or no inhalation” (<30 L/min), “exhalation,” or “possible air vent block.”

There is also Bluetooth® technology built into the module so that the information from your inhaler can be sent to the Digihaler app. The electronic module stores your inhaler events as they happen, even if you are not within range of your smartphone. The information will be sent to the app once the inhaler is within range of your smartphone and Bluetooth® is turned on. The inhaler 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.

Can I use my ProAir Digihaler, AirDuo Digihaler, or ArmonAir Digihaler without the app?

Yes. Any inhaler in the Digihaler family will still deliver medicine without being connected to the companion Digihaler app.

Will ProAir Digihaler, AirDuo Digihaler, or ArmonAir Digihaler still deliver medicine without being connected to the internet?

Yes. The inhalers will still deliver medicine without an internet connection.

Digihaler® support page on mobile phone

Customer Support

If you have questions we haven’t answered, our customer support team is here to help you from Monday to Friday.

Call us at

+1 (888) 603-0788

 

Approved Uses and Important Safety Information for ProAir Digihaler

APPROVED USES FOR PROAIR DIGIHALER

APPROVED USES

PROAIR® DIGIHALER®
 (albuterol sulfate) Inhalation Powder 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

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

Do not use PROAIR DIGIHALER 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
  • 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 any of the following symptoms of an allergic reaction:
        • itchy skin
        • swelling beneath your skin or in your throat
        • rash
        • 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
    • runny nose

These are not all of the possible side effects of PROAIR DIGIHALER. For more information, ask your healthcare provider or pharmacist

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088

Please read the full Prescribing Information for PROAIR DIGIHALER.

Approved Uses and Important Safety Information for AirDuo Digihaler and ArmonAir Digihaler

APPROVED USES FOR AIRDUO DIGIHALER AND
ARMONAIR DIGIHALER

APPROVED USES

  • AIRDUO® DIGIHALER® (fluticasone propionate and salmeterol) inhalation powder is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in people 12 years of age and older.
  • ARMONAIR® DIGIHALER® (fluticasone propionate) inhalation powder is a prescription medicine for the long-term treatment of asthma in patients 12 years and older.
  • AIRDUO DIGIHALER and ARMONAIR DIGIHALER are not used to relieve sudden breathing problems from asthma and won't replace a rescue inhaler.

AIRDUO DIGIHALER and ARMONAIR DIGIHALER each contain a built-in electronic module that records and stores information about inhaler events. AIRDUO DIGIHALER and ARMONAIR DIGIHALER may be used with, and transmit information to, a mobile App. AIRDUO DIGIHALER and ARMONAIR DIGIHALER do not need to be connected to the app in order for you to take your medicine.

IMPORTANT SAFETY INFORMATION

Important safety information

  • AIRDUO DIGIHALER contains salmeterol. Long-acting beta2-agonist (LABA) medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. AIRDUO DIGIHALER contains an inhaled corticosteroid (ICS) and a LABA. When an ICS and a LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
  • Do not use AIRDUO DIGIHALER or ARMONAIR DIGIHALER to treat sudden breathing problems from asthma. Always have a rescue inhaler with you to treat sudden symptoms.
  • Do not use AIRDUO DIGIHALER or ARMONAIR DIGIHALER if you have a severe allergy to milk proteins or if you are allergic to any of the ingredients in the product. Ask your healthcare provider if you are not sure.
  • Do not use AIRDUO DIGIHALER or ARMONAIR DIGIHALER more often than prescribed.
  • Do not take AIRDUO DIGIHALER with other medicines that contain a LABA for any reason.
  • Tell your healthcare provider about all the medicines you take and about all of your health conditions.
  • Do not stop using ARMONAIR DIGIHALER, even if you are feeling better, unless your healthcare provider tells you to. If you miss a dose of ARMONAIR DIGIHALER, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.
  • AIRDUO DIGIHALER and ARMONAIR DIGIHALER can cause serious side effects, including:
    • Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using AIRDUO DIGIHALER or ARMONAIR DIGIHALER to help reduce your chance of getting thrush.
    • Weakened immune system and increased chance of getting infections (immunosuppression). You should avoid exposure to chickenpox and measles, and, if exposed, tell your healthcare provider right away. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or herpes infection of the eye (ocular herpes simplex) may occur.
    • Reduced adrenal function. This can happen when you stop taking an oral corticosteroid (such as prednisone) and start taking a medicine containing an ICS (such as AIRDUO DIGIHALER or ARMONAIR DIGIHALER). During this transition period, when your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include:
      • feeling tired
      • lack of energy
      • weakness
      • nausea and vomiting
      • low blood pressure
  • For AIRDUO DIGIHALER, there may be sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using AIRDUO DIGIHALER and call your healthcare provider right away.
  • Serious allergic reactions. Stop using AIRDUO DIGIHALER or ARMONAIR DIGIHALER and call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
      • rash
      • hives
      • swelling of your face, mouth, and tongue
      • nausea and vomiting
      • breathing problems
  • AIRDUO DIGIHALER can also cause additional serious side effects, including:
    • Effects on the heart
      • increased blood pressure
      • a fast or irregular heartbeat
      • chest pain
    • Effects on the nervous system
      • tremor
      • nervousness
  • AIRDUO DIGIHALER and ARMONAIR DIGIHALER can cause:
    • Bone thinning or weakness (osteoporosis)
    • Slowed growth in children. A child's growth should be checked often.
    • Eye problems including glaucoma and cataracts. You should have regular eye exams while using AIRDUO DIGIHALER or ARMONAIR DIGIHALER.
  • For AIRDUO DIGIHALER, changes may occur in laboratory blood values (sugar, potassium, certain types of white blood cells)
  • For ARMONAIR DIGIHALER increased wheezing (bronchospasm) may occur. Increased wheezing can happen right away after using ARMONAIR DIGIHALER. If this occurs, stop using ARMONAIR DIGIHALER and call your healthcare provider. Always have a rescue inhaler with you to treat sudden wheezing.
  • Common side effects of AIRDUO DIGIHALER and ARMONAIR DIGIHALER include:
    • thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
    • headache
    • cough
  • Additionally, AIRDUO DIGIHALER has common side effects of:
    • back pain
    • infection of nose and throat (nasopharyngitis)
  • ARMONAIR DIGIHALER has common side effects of:
    • upper respiratory tract infection
    • infection or inflammation of nose and throat (nasopharyngitis)
  • These are not all the possible side effects of AIRDUO DIGIHALER and ARMONAIR DIGIHALER. Call your healthcare provider for medical advice about side effects.
  • You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information for AIRDUO DIGIHALER and ARMONAIR DIGIHALER.

 

Devices comply with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) These devices may not cause harmful interference, and (2) these devices must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by Teva could void the user’s authority to operate the equipment.