In a 3-week pediatric clinical trial of asthmatic patients aged 4 to 11 comparing ProAir RespiClick® 180 mcg albuterol 4 times daily with a double-blinded matched placebo, adverse events (AEs) that occurred at an incidence rate of ≥2% and greater than placebo are shown in the correlating table. AEs were similar to those seen in adult and adolescent trials.1



In two 12-week clinical trials, adverse events that occurred at an incidence rate of ≥1% are shown in the following table.1


In a study of 168 patients treated with ProAir RespiClick® for up to 52 weeks (including a 12-week double-blind period), the most common adverse events (≥5%) were: upper respiratory infection, nasopharyngitis, sinusitis, bronchitis, cough, oropharyngeal pain, headache, and pyrexia.1


Significantly greater efficacy with ProAir RespiClick® vs. placebo1,2

Find out about the efficacy profile of ProAir RespiClick® vs. placebo

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Indications

ProAir RespiClick® (albuterol sulfate) Inhalation Powder is indicated in patients 4 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 4 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® in patients 12 years of age and older, 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%)

  • In controlled studies of ProAir RespiClick® in patients 4 to 11 years of age, adverse events that occurred at an incidence rate of at least 2% and greater than placebo included nasopharyngitis (2% vs 1%), oropharyngeal pain (2% vs 1%), and vomiting (3% vs 1%)

Please see full Prescribing Information.

REFERENCES

1. ProAir RespiClick Prescribing Information. Horsham, PA: Teva Respiratory, LLC; April 2016. 2. Data on file (ProAir RespiClick DOF-ABS-AS-303). Horsham, PA: Teva Respiratory, LLC; 2016