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
ProAir Digihaler contains a built-in electronic module that detects, records and stores inhaler event information. ProAir Digihaler may be used with, and transmits information to, a mobile App. ProAir Digihaler does not need to be connected to the mobile app in order for you to take your medicine.
IMPORTANT SAFETY INFORMATION
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
- 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.
- 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
- increases in blood sugar
- low potassium levels in your blood
The most common side effects of ProAir Digihaler 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 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 see the full Prescribing Information for ProAir Digihaler.