Indications
ProAir Digihaler 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
ProAir ® Digihaler ® 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 ProAir
Digihaler is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.
Contraindications
ProAir Digihaler is contraindicated in patients with a history of hypersensitivity to albuterol and/or severe hypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose [see Warnings and Precautions ( 5.6 )] .
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 )
5.1Paradoxical Bronchospasm ProAir
Digihaler can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, ProAir Digihaler should be discontinued immediately and alternative therapy instituted.
At a glance
- Brand name
- Proair Respiclick
- Active substance
- albuterol sulfate
- Route
- Inhalation
- Dosage form
- Powder, metered
- Applicant
- Teva Branded Pharm
- Status
- Prescription
- FDA approval
- 31 Mar 2015
- Application
- NDA205636-001