ProAir Digihaler (albuterol sulfate) Inhaler for Asthma, COPD

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:
- 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 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?

Bronchospasm

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.

Exercise-Induced Bronchospasm

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-Blockers

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.

Diuretics

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.

Digoxin

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.