Indications

ProAir® RespiClick (albuterol sulfate) Inhalation Powder is indicated in patients 12 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

Important Safety Information

  • ProAir® RespiClick (albuterol sulfate) Inhalation Powder is contraindicated in patients with hypersensitivity to albuterol or patients with a 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
  • ProAir® RespiClick can produce paradoxical bronchospasm that may be life-threatening. Discontinue ProAir® RespiClick and institute alternative therapy if paradoxical bronchospasm occurs

Indications

ProAir® RespiClick (albuterol sulfate) Inhalation Powder is indicated in patients 12 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

Important Safety Information

  • ProAir® RespiClick (albuterol sulfate) Inhalation Powder is contraindicated in patients with hypersensitivity to albuterol or patients with a 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
  • ProAir® RespiClick can produce paradoxical bronchospasm that may be life-threatening. Discontinue ProAir® RespiClick and institute alternative therapy if paradoxical bronchospasm occurs
  • Need for more doses of ProAir® RespiClick than usual may be a marker of acute or chronic deterioration of asthma and requires reevaluation of treatment
  • ProAir® RespiClick alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids
  • ProAir® RespiClick, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and/or symptoms. If such effects occur, the drug may need to be discontinued
  • ProAir® RespiClick, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias, and hypertension), convulsive disorders, hyperthyroidism, and diabetes
  • Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. Do not exceed the recommended dose
  • Immediate hypersensitivity reactions may occur. Discontinue ProAir® RespiClick immediately
  • ProAir® RespiClick may produce significant hypokalemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation
  • Potential drug interactions can occur with beta-blockers, diuretics, digoxin, or monoamine oxidase inhibitors, and tricyclic antidepressants
  • In controlled studies of ProAir® RespiClick, adverse events that occurred at an incidence rate of at least 1% and greater than placebo included back pain (2% vs 1%), pain (2% vs <1%), gastroenteritis viral (1% vs <1%), sinus headache (1% vs <1%), and urinary tract infection (1% vs <1%)

Please see full Prescribing Information.

REFERENCES

1. ProAir RespiClick Patient Information Leaflet. Horsham, PA: Teva Respiratory, LLC; March 2015. 2. Dolovich MB, Ahrens RC, Hess DR, et al. Device selection and outcomes of aerosol therapy: evidence-based guidelines: American College of Chest Physicians/American College of Asthma, Allergy, and Immunology. Chest. 2005;127(1)335-371. 3. Data on file (ProAir RespiClick Formulary Agreements). Horsham, PA: Teva Respiratory, LLC; 2015.