Full prescribing information
ProAir® RespiClick (albuterol sulfate) Inhalation Powder is the first and only FDA-approved, multi-dose, breath-actuated, dry-powder rescue inhaler that requires no hand-breath coordination during inhalation1,2
ProAir®RespiClick (albuterol sulfate) Inhalation Powder is a new option in inhaled short-acting beta-agonist (SABA) therapy: breath-actuated delivery1,2
KEY CHARACTERISTICS OF RESCUE INHALERS
Characteristic ProAir RespiClick HFA rescue MDI
Built-in dose counter3,4
No hand-breath coordination required during inhalation1,2
Dose delivered with a small amount of powder3
Dose delivered in an aerosolized plume4
Can be stored or carried in any position3,4
No washing, priming, or shaking2
HFA = hydrofluoroalkane; MDI = metered-dose inhaler.
Sources: Dolovich 20051; ProAir RespiClick [patient information leaflet]2; ProAir RespiClick [prescribing information]3; ProAir HFA [prescribing information].4
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 (albuterol sulfate) Inhalation Powder requires 3 basic steps for drug administration2
Administration Instructions for ProAir RespiClick
  • Step 1
    Open
    Make sure the cap is closed before each dose
    Hold the inhaler upright as you open the cap fully
    Open the cap all the way back until you hear a “click”
    Your ProAir RespiClick inhaler is now ready to use
    Do not open the cap unless you are taking a dose
  • Step 2
    Inhale
    Breathe out through your mouth and push as much air from your lungs as you can
    Be careful not to breathe out into the inhaler mouthpiece
    Put the mouthpiece in your mouth and close your lips around it. Breathe in deeply through your mouth, until your lungs feel completely full of air
    Breathing in deeply through the mouthpiece will deliver the medication to your lungs
    Do not let your lips or fingers block the vent above the mouthpiece
    Hold your breath for 10 seconds, or for as long as you comfortably can
    Remove the inhaler from your mouth
    Check the dose counter on the back of the inhaler to make sure you received the dose
  • Step 3
    close
    Always close the cap after each inhalation so your inhaler will be ready for your next dose
    If you need another dose, CLOSE THE CAP and repeat all of the steps
    Advise patients to never wash or put the inhaler in water. ProAir RespiClick contains a powder and must be kept clean and dry at all times
    See full Patient Instructions for Use at end of Prescribing Information.
Source: ProAir RespiClick [patient information leaflet].2
Important Safety Information
  • 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 (albuterol sulfate) Inhalation Powder demonstrated efficacy in two 12-week, randomized, double-blind, placebo-controlled studies, in which ProAir RespiClick (153 patients) was compared with placebo (163 patients) in asthmatic patients 12 to 76 years of age at a dose of 180 mcg albuterol four times daily3
  • Patients were maintained on inhaled corticosteroid treatment. Serial FEV1 measurements demonstrated that two inhalations of ProAir RespiClick produced significantly greater improvements in FEV1 AUC0-6hr over the pre-treatment value than placebo in both studies3
  • In a study of 168 patients treated with ProAir®RespiClick (albuterol sulfate) Inhalation Powder for up to 52 weeks (including a 12-week double-blind period), the most commonly reported adverse events (≥5%) were: upper respiratory infection, nasopharyngitis, sinusitis, bronchitis, cough, oropharyngeal pain, headache, and pyrexia3
Study 1: Change in FEV1

FEV1 = forced expiratory volume

Source: ProAir RespiClick [prescribing information].3

Study 2: Change in FEV1

FEV1 = forced expiratory volume

Source: ProAir RespiClick [prescribing information].3

Important Safety Information
  • 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
Adverse events that occurred at an incidence rate of ≥1% and greater than placebo in two 12-week clinical trials are shown in the table below
Adverse Events for ProAir RespiClick*
Adverse Event Number (%) of patients
ProAir RespiClick 180 mcg QID n=321 Placebo n=333
Back pain 6(2%) 4(1%)
Pain 5(2%) 2(<1%)
Gastroenteritis viral 4(1%) 3(<1%)
Sinus headache 4(1%) 3(<1%)
Urinary tract infection 4(1%) 3(<1%)

*Adverse events that occurred at an incidence rate of ≥1% and greater than placebo in two 12-week clinical trials.

Source: ProAir RespiClick [prescribing information].3

Insured patients may pay less for
ProAir® RespiClick (albuterol sulfate) Inhalation Powder5
  • Preferred formulary coverage may result in
  • Lower copays for insured patients
  • Fewer pharmacy callbacks
  • Less hassle for office staff
Important Safety Information
  • 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 click here for full Prescribing Information
Company:
 Teva Respiratory
Pharmacologic
class:
 beta-2 agonist
Active
IngRedient:
 Albuterol sulfate 90mcg/inhalation; dry powder for oral inhalation; contains lactose.
Indication:
 Bronchospasm
Adults:
 2 inhalations every 4–6 hours; in some patients: 1 inhalation every 4 hours may suffice. Exercise-induced bronchospasm: 2 inhalations 15–30 minutes before exercise.
Children:
 Not established.
Contraindications:
 Hypersensitivity to albuterol. Severe hypersensitivity to milk proteins.
WARNINGS
AND PRECAUTIONS:
 Discontinue if paradoxical bronchospasm or cardiovascular effects occur. Reevaluate periodically. Cardiovascular disorders (eg, coronary insufficiency, arrhythmias, hypertension). Sensitivity to sympathomimetics. Avoid excessive use. Seizure disorders. Hyperthyroidism. Diabetes. Pregnancy (Cat.C). Labor & delivery. Nursing mothers: not recommended. Elderly.
Interactions:
 During or within 2 weeks of MAOIs or tricyclics (increased cardiovascular effects); consider alternative therapy. Oral sympathomimetics: not recommended. Antagonized by β-blockers. Monitor digoxin. Caution with non-potassium sparing diuretics (eg, loop or thiazide); monitor.
Adverse reactions:
 Back pain, pain, gastroenteritis viral, sinus headache, urinary tract infection; hypokalemia, paradoxical bronchospasm, cardiovascular effects, immediate hypersensitivity reactions (eg, rash, urticaria, angioedema).
How Supplied:
 Inhaler (with dose counter)—200 inhalations
REFERENCES
  1. 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.
  2. ProAir RespiClick [patient information leaflet]. Horsham, PA: Teva Respiratory, LLC; March 2015.
  3. ProAir RespiClick [prescribing information]. Horsham, PA: Teva Respiratory, LLC; March 2015.
  4. ProAir HFA [prescribing information]. Horsham, PA: Teva Respiratory, LLC; May 2012.
  5. Data on file [ProAir RespiClick formulary agreements]. Horsham, PA: Teva Respiratory, LLC; 2015.

This MPR Prescribing Alert is produced as a basic reminder of important information for healthcare professionals. Readers are advised to consult manufacturers and specialists if questions arise about specific products, treatments, or diseases. The publisher and editors do not assume liability for any errors or omissions. MPR and MPR Prescribing Alert are registered trademarks of Haymarket Media, Inc.

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Important Safety Information