ProAir® HFA (albuterol sulfate) Inhalation Aerosol is indicated in patients 4
years of age and older for the treatment or prevention of bronchospasm with reversible
obstructive airway disease and for the prevention of exercise-induced bronchospasm.
Important Safety Information
- Inhaled albuterol sulfate can produce paradoxical bronchospasm that may be life-threatening.
It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations,
frequently occurs with the first use of a new canister
- Fatalities have been reported in association with excessive use of inhaled sympathomimetic
drugs in patients with asthma
- ProAir HFA, as with all sympathomimetic amines, should be used with caution in patients with
cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias, and hypertension),
convulsive disorders, hyperthyroidism, and diabetes
- Potential drug interactions can occur with beta-blockers, diuretics, digoxin, or monoamine
oxidase inhibitors, and tricyclic antidepressants
- Do not exceed the recommended dose
- Adverse events, which occurred at an incidence rate of at least 3% with ProAir HFA, include
headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis
Please see full Prescribing Information.
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.
- ProAir HFA Prescribing Information. Horsham, PA: Teva Respiratory, LLC; June 2016.
- McCabe JC, Koppenhagen F, Blair J, Zeng X-M. ProAir HFA delivers warmer, lower-impact,
longer-duration plumes containing higher fine particle dose than Ventolin HFA. J Aerosol
Med Pulm Drug Deliv. 2012;25(2):104-109.
- Everard ML, Devadason SG, Summers QZ, Le Souëf PN. Factors affecting total and “respirable”
dose delivered by a salbutamol metered dose inhaler. Thorax. 1995;50(7):746-749.
- Graham SJ, Ormsby ED, Lovering EG. Single spray drug content in a metered-dose aerosol
formulation and a collection scheme for content uniformity. Pharm Forum.
- Fingertip Formulary. Glen Rock, NJ: Fingertip Formulary, LLC; January 2017.