Medications

ProAir Digihaler

What is ProAir Digihaler?

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

ProAir Digihaler contains a built-in electronic module that records and stores information about inhaler events. The ProAir Digihaler may be used with, and transmits information to the Digihaler app through Bluetooth® wireless technology. ProAir Digihaler does not need to be connected to the app in order for you to take your medicine.

How can I get a ProAir Digihaler?

ProAir Digihaler is prescription medication and must be prescribed by your healthcare provider. Ask your healthcare provider if ProAir Digihaler is right for you.

What are the ingredients in ProAir Digihaler?

Active ingredient: albuterol sulfate

Inactive ingredients: lactose (may contain milk proteins)

What is albuterol sulfate?

Albuterol is a short-acting beta2-adrenergic agonist (SABA). SABAs relieve the sudden acute symptoms of asthma by causing relaxation of the smooth muscles of the airways. SABAs can also be used before exercise to prevent bronchospasm.

What are possible side effects of ProAir Digihaler?

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. A paradoxical bronchospasm 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
  • 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
  • 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. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Should I discuss other medications and medical conditions with my healthcare provider before using ProAir Digihaler?

Yes, you should tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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 of the medicines you take, especially:

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

What is AirDuo Digihaler?

AirDuo Digihaler 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.

AirDuo Digihaler is not used to relieve sudden breathing problems from asthma and won’t replace a rescue inhaler.

AirDuo Digihaler contains a built-in electronic module that records and stores information about inhaler events. The AirDuo Digihaler may be used with, and transmits information to, the Digihaler app through Bluetooth® wireless technology. AirDuo Digihaler does not need to be connected to the app in order for you to take your medicine.

How can I get an AirDuo Digihaler?

AirDuo Digihaler is prescription medication and must be prescribed by your healthcare provider. Ask your healthcare provider if AirDuo Digihaler is right for you.

What are the ingredients in AirDuo Digihaler?

Active ingredients: fluticasone propionate and salmeterol

Inactive ingredients: lactose (may contain milk proteins)

What is fluticasone propionate and salmeterol?

Fluticasone propionate is an inhaled corticosteroid (ICS) and salmeterol is a long-acting beta2-adrenergic agonist (LABA). An ICS and LABA are taken together regularly to help control chronic asthma symptoms and may prevent asthma attacks. ICSs help to decrease inflammation in the lungs. LABAs help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.

What does it mean that my AirDuo Digihaler is available in three strengths?

AirDuo Digihaler contains the medications fluticasone propionate and salmeterol. The dosages are available in low, medium, and high strengths. The low strength dose contains 55 micrograms of fluticasone propionate and 14 micrograms of salmeterol. The medium strength dose contains 113 micrograms of fluticasone propionate and 14 micrograms of salmeterol. The high strength dose contains 232 micrograms of fluticasone propionate and 14 micrograms of salmeterol.

What are possible side effects of AirDuo Digihaler?

AirDuo 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 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, 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 inhaled corticosteroid (such as AirDuo 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
  • 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 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
    • breathing problems
  • Effects on heart
    • increased blood pressure
    • a fast or irregular heartbeat
    • chest pain
  • Effects on nervous system
    • tremor
    • nervousness
  • 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.
  • Changes in laboratory blood values (sugar, potassium, certain types of white blood cells)

Common side effects of AirDuo Digihaler include:

  • infection of nose and throat (nasopharyngitis)
  • thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
  • back pain
  • headache
  • cough

These are not all the possible side effects of AirDuo Digihaler. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Should I discuss other medications and medical conditions with my healthcare provider before using AirDuo Digihaler?

Yes, you should tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Before using AirDuo Digihaler, tell your healthcare provider about all of your medical conditions, including if you:

  • have heart problems
  • have high blood pressure
  • have seizures
  • have thyroid problems
  • have diabetes
  • have liver problems
  • have weak bones (osteoporosis)
  • have an immune system problem
  • have eye problems, such as glaucoma or cataracts
  • are allergic to milk proteins
  • have any type of viral, bacterial, fungal or parasitic infection
  • are pregnant or plan to become pregnant. It is not known if AirDuo Digihaler may harm an unborn baby.
  • are breastfeeding. It is not known if the medicine in AirDuo Digihaler can pass into your breastmilk and if it can harm your baby.
ArmonAir Digihaler

What is ArmonAir Digihaler?

ArmonAir Digihaler is a prescription inhaled corticosteroid (ICS) medicine for the long-term treatment of asthma in patients 12 years and older.

ArmonAir Digihaler is not used to relieve sudden breathing problems from asthma and won't replace a rescue inhaler.

ArmonAir Digihaler contains a built-in electronic module that records and stores information about inhaler events. The ArmonAir Digihaler may be used with, and transmits information to, the Digihaler app through Bluetooth® wireless technology. ArmonAir Digihaler does not need to be connected to the app in order for you to take your medicine.

How can I get an ArmonAir Digihaler?

ArmonAir Digihaler is a prescription medication and must be prescribed by your healthcare provider. Ask your healthcare provider if ArmonAir Digihaler is right for you.

What are the ingredients in ArmonAir Digihaler?

Active ingredient: fluticasone propionate

Inactive ingredients: lactose (may contain milk proteins)

What is fluticasone propionate?

Fluticasone propionate is an inhaled corticosteroid (ICS). An ICS is taken regularly to control chronic symptoms and to help prevent asthma attacks. ICS medicines such as fluticasone propionate help to decrease inflammation in the lungs.

What does it mean that my ArmonAir Digihaler is available in three strengths?

ArmonAir Digihaler contains the medication fluticasone propionate. The dosages are available in low, medium, and high strengths. The low strength dose contains 55 micrograms of fluticasone propionate. The medium strength dose contains 113 micrograms of fluticasone propionate. The high strength dose contains 232 micrograms of fluticasone propionate.

What are possible side effects of ArmonAir Digihaler?

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 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 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
  • Serious allergic reactions. Stop using 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
    • breathing problems
  • 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 ArmonAir Digihaler
  • Increased wheezing (bronchospasm). 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 ArmonAir Digihaler include:

  • infection or inflammation of nose and throat (nasopharyngitis)
  • upper respiratory tract infection
  • thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
  • headache
  • cough

These are not all the possible side effects of ArmonAir Digihaler. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Should I discuss other medications and medical conditions with my healthcare provider before using ArmonAir Digihaler?

Yes, you should tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Before using ArmonAir Digihaler, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver problems
  • have weak bones (osteoporosis)
  • have an immune system problem
  • have eye problems, such as glaucoma or cataracts
  • have tuberculosis, a fungal, bacterial, viral, parasitic infection, or herpes simplex
  • are exposed to chickenpox or measles
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed
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.