Albuterol Sulate HFA

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Albuterol Sulfate HFA is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. ( 1.1 ) Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. ( 1.2 ) 1.1 Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. 1.2 Exercise-Induced Bronchospasm Albuterol Sulfate HFA is indicated for the prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. Dosage and administration 2 DOSAGE AND ADMINISTRATION For oral inhalation only. ( 2 ) Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation every 4 to 6 hours. For some patients, 1 inhalation every 4 hours may be sufficient. ( 2.1 ) Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation 15 to 30 minutes before exercise. ( 2.2 ) Priming information: Prime Albuterol Sulfate HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime Albuterol Sulfate HFA, release 4 sprays into the air away from the face, shaking well before each spray. ( 2.3 ) Cleaning information: At least once a week, wash the actuator with warm water and let it air-dry completely. ( 2.3 ) 2.1 Recommended Dosage for Bronchospasm (Acute Episodes or Symptoms Associated with Bronchospasm) Adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation repeated every 4 to 6 hours; in some patients, 1 inhalation every 4 hours may be sufficient. More frequent administration or a greater number of inhalations is not recommended. 2.2 Recommended Dosage for Prevention of Exercise-Induced Bronchospasm Adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation 15 to 30 minutes before exercise. 2.3 Administration Information Albuterol Sulfate HFA should be administered by the orally inhaled route only. Priming Priming Albuterol Sulfate HFA is essential to ensure appropriate albuterol content in each actuation. Prime Albuterol Sulfate HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime Albuterol Sulfate HFA, release 4 sprays into the air away from the face, shaking well before each spray. Avoid spraying in eyes. Cleaning To ensure proper dosing and to prevent actuator orifice blockage, wash the actuator with warm water and let it air-dry completely at least once a week. Warnings and cautions 5 WARNINGS AND PRECAUTIONS Life-threatening paradoxical bronchospasm may occur. Discontinue Albuterol Sulfate HFA immediately and institute 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 ) 5.1 Paradoxical Bronchospasm Albuterol Sulfate HFA can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with Albuterol Sulfate HFA, it should be discontinued immediately and alternative therapy should be instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister. 5.2 Deterioration of Asthma Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of Albuterol Sulfate HFA than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids. 5.3 Use of Anti-inflammatory Agents The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids, to the therapeutic regimen. 5.4 Cardiovascular Effects Albuterol Sulfate HFA, like all other beta 2 -adrenergic agonists, can produce clinically significant cardiovascular effects in some patien