For: Bronchospasm Prophylaxis, Asthma, Chronic Obstructive Pulmonary Disease
ProAir Digihaler (albuterol sulfate) is a beta2-adrenergic agonist indicated for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease, and the prevention of exercise-induced bronchospasm. ProAir Digihaler (NDC 59310-117-20) inhalation powder is supplied as a white dry powder inhaler with a red cap sealed in a foil pouch in boxes of one. Each inhaler contains 0.65g of the formulation and provides 200 actuations.
Store at room temperature (between 15� and 25�C; 59� and 77�F). Avoid exposure to extreme heat, cold, or humidity.
Keep out of reach of children.
ProAir Digihaler inhaler has a dose counter. Patients should never try to alter the numbers for the dose counter. Discard the inhaler 13 months after opening the foil pouch, when the counter displays 0, or after the expiration date on the product, whichever comes first. The labeled amount of medication in each actuation cannot be assured after the counter displays 0, even though the inhaler is not completely empty and will continue to operate [see Patient Counseling Information (17)].
ProAir Digihaler contains a QR code and a built-in electronic module which automatically detects, records, and stores data on inhaler events, including peak inspiratory flow rate (L/min). ProAir Digihaler may pair with and transmit data to the mobile App via Bluetooth� wireless technology where inhaler events are categorized.
ProAir Digihaler contains a lithium-manganese dioxide battery and should be disposed of in accordance with state and local regulations. These highlights do not include all the information needed to use PROAIR DIGIHALER safely and effectively. See full prescribing information for PROAIR DIGIHALER.
PROAIR� DIGIHALERTM (albuterol sulfate) inhalation powder, for oral inhalation use
Initial U.S. Approval: 1981
INDICATIONS AND USAGE
ProAir Digihaler is a drug product containing a beta2-adrenergic agonist indicated For:
Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1)
Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (1.2)
DOSAGE AND ADMINISTRATION
For oral inhalation only
Treatment or prevention of bronchospasm in adults and children 4 years of age and older: 2 inhalations every 4 to 6 hours. In some patients, 1 inhalation every 4 hours may be sufficient. (2.1)
Prevention of exercise-induced bronchospasm in adults and children 4 years of age and older: 2 inhalations 15 to 30 minutes before exercise. (2.2)
ProAir Digihaler does not require priming. (2.3)
Do not use with a spacer or volume holding chamber. (2.3)
Keep the inhaler clean and dry at all times. Routine maintenance is not required. If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed. Never wash or put any part of the inhaler in water. (2.3)
Discard 13 months after opening the foil pouch, when the dose counter displays 0, or after the expiration date on the product, whichever comes first. (2.3)
ProAir Digihaler contains a built-in electronic module which detects, records, and stores data on inhaler events for transmission to the mobile App. Use of the App is not required for administration of medication to the patient. (2.3)
DOSAGE FORMS AND STRENGTHS
Inhalation powder: ProAir Digihaler is a dry powder inhaler that meters 117 mcg of albuterol sulfate (equivalent to 97 mcg of albuterol base) from the device reservoir and delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) from the mouthpiece per actuation. The inhaler is supplied for 200 inhalation doses. ProAir Digihaler includes a built-in electronic module. (3)
CONTRAINDICATIONS
Patients with hypersensitivity to albuterol. (4)
Patients with severe hypersensitivity to milk proteins. (4)
WARNINGS AND PRECAUTIONS
Life-threatening paradoxical bronchospasm may occur. Discontinue ProAir Digihaler immediately and treat with alternative therapy. (5.1)
Need for more doses of ProAir Digihaler than usual may be a sign of deterioration of asthma and requires reevaluation of treatment. (5.2)
ProAir Digihaler is not a substitute for corticosteroids. (5.3)
Cardiovascular effects may occur. Use with caution in patients sensitive to sympathomimetic drugs and patients with cardiovascular or convulsive disorders. (5.4, 5.7)
Excessive use may be fatal. Do not exceed recommended dose. (5.5)
Immediate hypersensitivity reactions may occur. Discontinue ProAir Digihaler immediately. (5.6)
Hypokalemia and changes in blood glucose may occur. (5.7, 5.8)
ADVERSE REACTIONS
Most common adverse reactions (?1% and >placebo) are back pain, pain, gastroenteritis viral, sinus headache, urinary tract infection, nasopharyngitis, oropharyngeal pain and vomiting. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Teva Respiratory, LLC at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Other short-acting sympathomimetic aerosol bronchodilators and adrenergic drugs: May potentiate effect. (7)
Beta-blockers: May decrease effectiveness of ProAir Digihaler and produce severe bronchospasm. Patients with asthma should not normally be treated with beta-blockers. (7.1)
Diuretics, or non-potassium sparing diuretics: May potentiate hypokalemia or ECG changes. Consider monitoring potassium levels. (7.2)
Digoxin: May decrease serum digoxin levels. Consider monitoring digoxin levels. (7.3)
Monoamine oxidase (MAO) inhibitors and tricyclic antidepressants: May potentiate effect of albuterol on the cardiovascular system. Consider alternative therapy in patients taking MAOs or tricyclic antidepressants. (7.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 9/2019
