Indications
Albuterol Sulfate HFA Inhalation Aerosol is a beta 2 -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 )
1.1Bronchospasm Albuterol Sulfate HFA Inhalation
Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.
1.2Exercise-Induced Bronchospasm Albuterol Sulfate HFA Inhalation
Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.
Contraindications
Albuterol Sulfate HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other Albuterol Sulfate HFA Inhalation Aerosol components. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate [see Warnings and Precautions (5.6) ] . Hypersensitivity to albuterol and any other Albuterol Sulfate HFA Inhalation Aerosol Components.
( 4 )
Warnings and precautions
Life-threatening paradoxical bronchospasm may occur. Discontinue Albuterol Sulfate HFA immediately and treat with alternative therapy. ( 5.1 ) Need for more doses of Albuterol Sulfate HFA than usual may be a sign of deterioration of asthma and requires reevaluation of treatment. ( 5.2 ) Albuterol Sulfate HFA 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 Albuterol Sulfate HFA immediately. ( 5.6 ) Hypokalemia and changes in blood glucose may occur. ( 5.7 , 5.8 )
5.1Paradoxical Bronchospasm Albuterol Sulfate HFA Inhalation
At a glance
- Brand name
- Proair HFA
- Active substance
- albuterol sulfate
- Route
- Inhalation
- Dosage form
- Aerosol, metered
- Applicant
- Teva Branded Pharm
- Status
- Prescription
- FDA approval
- 29 Oct 2004
- Application
- NDA021457-001



