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.