Albuterol Sulfate

Albuterol Sulfate Inhalation Aeroso 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.

( 4 )

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

5.1Paradoxical Bronchospasm Albuterol Sulfate Inhalation

Aerosol can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, Albuterol Sulfate Inhalation Aerosol should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.