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What is ProAir Digihaler, and how does it work?
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, an App through Bluetooth wireless technology.
ProAir Digihaler 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.
It is not known if ProAir Digihaler is safe and effective in children under 4 years of age. Do not use ProAir Digihaler if you are allergic to albuterol sulfate, lactose, milk proteins, or any of the ingredients in ProAir Digihaler. See the end of this leaflet for a complete list of ingredients in ProAir Digihaler.
What are the 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 doctor or get emergency help right away. 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 doctor right away if you have the following symptoms of an allergic reaction:
- 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
- sore throat
- runny nose
These are not all of the possible side effects of ProAir Digihaler.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for ProAir Digihaler?
- For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the recommended dosage for adults and children 4 years of age or older is 2 inhalations repeated every 4 to 6 hours.
- More frequent administration or a larger number of inhalations is not recommended. In some patients, 1 inhalation every 4 hours may be sufficient.
- For prevention of exercise-induced bronchospasm, the recommended dosage for adults and children 4 years of age or older is 2 inhalations 15 to 30 minutes before exercise.
What drugs interact with ProAir Digihaler?
Other short-acting sympathomimetic bronchodilators should not be used concomitantly with ProAir Digihaler. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.
- Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as ProAir Digihaler, but may produce severe bronchospasm in asthmatic patients.
- Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic-blocking agents in patients with asthma.
- In this setting, consider cardioselective beta-blockers, although they should be administered with caution.
- The ECG changes and/or hypokalemia which may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded.
- Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with non-potassium sparing diuretics. Consider monitoring potassium levels.
- Mean decreases of 16% and 22% in serum digoxin levels were demonstrated after single dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days.
- The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear.
- Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and ProAir Digihaler.
Monoamine Oxidase Inhibitors Or Tricyclic Antidepressants
- ProAir Digihaler should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the cardiovascular system may be potentiated.
- Consider alternative therapy in patients taking MAO inhibitors or tricyclic antidepressants.
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Is ProAir Digihaler safe to use while pregnant or breastfeeding?
- There are no randomized clinical studies of use of albuterol during pregnancy.
- Available data from published epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage.
- There are clinical considerations with use of albuterol in pregnant women.
- There are no available data on the presence of albuterol in human milk, the effects on the breastfed child, or the effects on milk production.
- However, plasma levels of albuterol after inhaled therapeutic doses are low in humans, and if present in breast milk, albuterol has a low oral bioavailability.
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, an App through Bluetooth wireless technology.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.