Albuterol Sulfate

Albuterol sulfate 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 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 inhalation aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

Albuterol sulfate inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other albuterol sulfate 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 inhalation aerosol components.

• Life-threatening paradoxical bronchospasm may occur. Discontinue albuterol sulfate inhalation aerosol immediately and treat with alternative therapy. (5.1)
• Need for more doses of albuterol sulfate inhalation aerosol than usual may be a sign of deterioration of asthma and requires reevaluation of treatment. (5.2)
• Albuterol sulfate inhalation aerosol 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 inhalation aerosol immediately. (5.6)
• Hypokalemia and changes in blood glucose may occur. (5.7, 5.8)