Safety Information

Who should not use ProAir RespiClick®?

Do not use ProAir RespiClick® (albuterol sulfate) Inhalation Powder if you are allergic to albuterol, lactose or milk proteins or any of the ingredients in ProAir RespiClick®. Ask your doctor if you have any questions or are not sure.

Talk to your doctor before using ProAir RespiClick®.

Before you use ProAir RespiClick®, tell your doctor 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
  • Have any other medical conditions
  • Are pregnant or planning to become pregnant. It is not known whether ProAir RespiClick® will harm your unborn baby.
  • Are breastfeeding or planning to breastfeed. It is not known whether ProAir RespiClick® passes into your breast milk. Talk to your doctor about the best way to feed your baby if you are using ProAir RespiClick®.

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

The medicine in ProAir RespiClick® and other medicines may affect each other and cause side effects. ProAir RespiClick® may affect the way other medicines work, and other medicines may affect the way ProAir RespiClick® works.

Be sure to tell your doctor if you take:

  • Other inhaled medicines or asthma medicines
  • Beta blocker medicines
  • Diuretics
  • Digoxin
  • Monoamine oxidase inhibitors
  • Tricyclic antidepressants

Ask your doctor or pharmacist for a list of the names 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.

Some dos and don’ts of using ProAir RespiClick®.

  • Do not open the red cap unless you are taking a dose. Opening the red cap loads a dose of medicine (that’s what the CLICK means). For detailed instructions, see “Instructions for Use” at the end of the Prescribing Information.
  • Do use ProAir RespiClick® exactly as your doctor tells you to use it
  • Do not breathe (exhale) into ProAir RespiClick®
  • Do not increase your dose or take extra doses of ProAir RespiClick® without first talking to your doctor. Each dose of ProAir RespiClick® should last up to four to six hours.
  • Do not use a spacer or volume-holding chamber with ProAir RespiClick®
  • Keep your inhaler dry and clean at all times.
  • Do not wash or put any part of your inhaler in water. Replace your inhaler if washed or placed in water.
  • While using ProAir RespiClick®, do not use other inhaled rescue medicines or asthma medicines unless your doctor tells you to do so

When to get medical help.

  • Get medical help right away if ProAir RespiClick® 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
  • Call your doctor if your asthma symptoms, such as wheezing and having 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.

Possible serious side effects of ProAir RespiClick®.

ProAir RespiClick® may cause serious side effects, including:

  • Worsening trouble breathing, coughing and wheezing (paradoxical bronchospasm). If this happens, stop using ProAir RespiClick® and call your doctor or get emergency help right away. Wheezing 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 RespiClick®
  • Allergic reactions. Call your doctor 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
  • Increases in blood sugar
  • Low potassium levels in your blood

Common side effects of ProAir RespiClick®.

The most common side effects of ProAir RespiClick® include:

  • Back pain
  • Upset stomach
  • Sinus headache
  • Urinary tract infection
  • Your heart feeling like it is pounding or racing (palpitations)
  • Chest pain
  • Fast heart rate
  • Shakiness
  • Nervousness
  • Headache
  • Dizziness
  • Sore throat
  • Runny nose
  • Vomiting

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of ProAir RespiClick®. 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.

How to store ProAir RespiClick®.

Keep your inhaler dry and clean at all times. Routine inhaler maintenance is not required. If the mouthpiece needs cleaning, gently wipe it with a dry cloth or tissue as needed. NEVER WASH OR PUT ANY PART OF YOUR INHALER IN WATER.

  • Keep the red cap on the inhaler closed during storage
  • Store ProAir RespiClick® at room temperature, between 59ºF and 77ºF (15ºC and 25ºC)
  • Avoid exposure to extreme humidity, heat or cold

Keep ProAir RespiClick® and all medicines out of the reach of children.

Use ProAir RespiClick® responsibly.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use ProAir RespiClick® for a condition for which it was not prescribed. Do not give ProAir RespiClick® to other people, even if they have the same symptoms that you have. It may harm them.

For more information, call Teva at 1-888-482-9522.

Approved Uses

ProAir RespiClick® (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
  • revent exercise-induced bronchospasm

Important Safety Information

  • Do not use ProAir RespiClick (albuterol sulfate) Inhalation Powder if you are allergic to albuterol sulfate, lactose, milk proteins, or any of the ingredients in ProAir RespiClick. Ask your healthcare provider if you have any questions or are not sure
  • Before using ProAir RespiClick, 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 RespiClick without first talking to your healthcare provider
  • Get medical help right away if ProAir RespiClick no longer helps your symptoms, your symptoms get worse or you need to use your inhaler more often
  • While you are using ProAir RespiClick, do not use other inhaled rescue medicines and asthma medicines unless your healthcare provider tells you to do so
  • ProAir RespiClick may cause serious side effects, including:
    • worsening trouble breathing, coughing and wheezing (paradoxical bronchospasm). If this happens, stop using ProAir RespiClick and call your healthcare provider 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 RespiClick
    • 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
    • increases in blood sugar
    • low potassium levels in your blood
  • The most common side effects of ProAir RespiClick include:
    • back pain
    • 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
    • vomiting
  • These are not all of the possible side effects of ProAir RespiClick. 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 see the full Prescribing Information