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Proair Digihaler

Last reviewed on RxList: 1/16/2019
Proair Digihaler Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 1/16/2019

Proair Digihaler (albuterol sulfate) contains a beta2-adrenergic agonist indicated for treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease and for prevention of exercise-induced bronchospasm in patients 4 years of age and older. Common side effects of Proair Digihaler include:

ProAir Digihaler is a dry powder inhaler that meters 117 mcg of albuterol sulfate (equivalent to 97 mcg of albuterol base) from the device reservoir and delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) from the mouthpiece per actuation. The inhaler is supplied for 200 inhalation doses. Proair Digihaler may interact with other short-acting sympathomimetic aerosol bronchodilators and adrenergic drugs, beta-blockers, diuretics or non-potassium sparing diuretics, digoxin, monoamine oxidase inhibitors (MAOIs), and tricyclic antidepressants. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Proair Digihaler; it is unknown how it would affect a fetus. It is unknown if the medication in Proair Digihaler passes into breast milk. Consult your doctor before breastfeeding.

Our Proair Digihaler (albuterol sulfate) Inhalation Powder, for Oral Inhalation Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Proair Digihaler Professional Information

SIDE EFFECTS

Use of ProAir Digihaler may be associated with the following:

  • Paradoxical bronchospasm [see WARNINGS AND PRECAUTIONS]
  • Cardiovascular Effects [see WARNINGS AND PRECAUTIONS]
  • Immediate hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
  • Hypokalemia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

A total of 1289 subjects were treated with albuterol sulfate inhalation powder (ProAir RespiClick hereafter referred to as albuterol sulfate MDPI) during the clinical development program. The most common adverse reactions (≥1% and >placebo) were back pain, pain, gastroenteritis viral, sinus headache, and urinary tract infection. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults and Adolescents 12 years of Age and Older: The adverse reaction information presented in Table 1 below concerning albuterol sulfate MDPI is derived from the 12-week blinded treatment period of three studies which compared albuterol sulfate MDPI 180 mcg four times daily with a double-blinded matched placebo in 653 asthmatic patients 12 to 76 years of age.

Table 1: Adverse Reactions Experienced by Greater Than or Equal to 1.0% of Adult and Adolescent Patients in the Albuterol sulfate MDPI Group and Greater Than Placebo in three 12-Week Clinical Trials1

Preferred Term Number (%) of patients
Albuterol sulfate MDPI 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%)
1 This table includes all adverse events (whether considered by the investigator drug related or unrelated to drug) which occurred at an incidence rate of greater than or equal to 1.0% in the albuterol sulfate MDPI group and greater than placebo.

In a long-term study of 168 patients treated with albuterol sulfate MDPI for up to 52 weeks (including a 12-week doubleblind period), the most commonly reported adverse events greater than or equal to 5% were upper respiratory infection, nasopharyngitis, sinusitis, bronchitis, cough, oropharyngeal pain, headache, and pyrexia.

In a small cumulative dose study, tremor, palpitations, and headache were the most frequently occurring (≥5%) adverse events.

Pediatric Patients 4 to 11 Years of Age: The adverse reaction information presented in Table 2 below concerning albuterol sulfate MDPI is derived from a 3-week pediatric clinical trial which compared albuterol sulfate MDPI 180 mcg four times daily with a double-blinded matched placebo in 185 asthmatic patients 4 to 11 years of age.

Table 2: Adverse Reactions Experienced by Greater Than or Equal to 2.0% of Patients 4 to 11 Years of Age in the Albuterol sulfate MDPI Group and Greater Than Placebo in the 3 Week Trial

Preferred Term Number (%) of patients
Albuterol sulfate MDPI 180 mcg QID
N=93
Placebo
N=92
Nasopharyngitis 2 (2%) 1 (1%)
Oropharyngeal pain 2 (2%) 1 (1%)
Vomiting 3 (3%) 1 (1%)

Postmarketing Experience

In addition to the adverse reactions reported from clinical trials with albuterol sulfate MDPI, the following adverse events have been reported during use of other inhaled albuterol sulfate products: Urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles), rare cases of aggravated bronchospasm, lack of efficacy, asthma exacerbation (potentially fatal), muscle cramps, and various oropharyngeal side-effects such as throat irritation, altered taste, glossitis, tongue ulceration, and gagging. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as: angina, hypertension or hypotension, palpitations, central nervous system stimulation, insomnia, headache, nervousness, tremor, muscle cramps, drying or irritation of the oropharynx, hypokalemia, hyperglycemia, and metabolic acidosis.

Read the entire FDA prescribing information for Proair Digihaler (Albuterol Sulfate Inhalation Powder)

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© Proair Digihaler Patient Information is supplied by Cerner Multum, Inc. and Proair Digihaler Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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