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Use of PROAIR HFA (albuterol sulfate inhalation aerosol) 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 1090 subjects were treated with PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol, or with the same formulation of albuterol as in PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol, during the worldwide clinical development program.
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.
Adult and Adolescents 12 Years of Age and Older
The adverse reaction information presented in the table below concerning PROAIR HFA Inhalation Aerosol is derived from a 6-week, blinded study which compared PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol (180 mcg four times daily) with a double-blinded matched placebo HFA-Inhalation Aerosol and an evaluator-blinded marketed active comparator HFA-134a albuterol inhaler in 172 asthmatic patients 12 to 76 years of age. The table lists the incidence of all adverse events (whether considered by the investigator drug related or unrelated to drug) from this study which occurred at a rate of 3% or greater in the PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol treatment group and more frequently in the PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol treatment group than in the matched placebo group. Overall, the incidence and nature of the adverse events reported for PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol and the marketed active comparator HFA-134a albuterol inhaler were comparable.
Adverse Experience Incidences (% of Patients) in a Six-Week
|Body System/Adverse event (as Preferred Term)
||PROAIR HFA Inhalation Aerosol
(N = 58)
HFA-134a albuterol inhaler
(N = 56)
HFA-134a Inhalation Aerosol
(N = 58)
|Body as a Whole||Headache||7||5||2|
|* This table includes all adverse events (whether considered by the investigator drug related or unrelated to drug) which occurred at an incidence rate of at least 3.0% in the PROAIR HFA Inhalation Aerosol group and more frequently in the PROAIR HFA Inhalation Aerosol group than in the placebo HFA Inhalation Aerosol group.|
Adverse events reported by less than 3% of the patients receiving PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol but by a greater proportion of PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol patients than the matched placebo patients, which have the potential to be related to PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation
In small cumulative dose studies, tremor, nervousness, and headache were the most frequently occurring adverse events.
Pediatric Patients 4 to 11 Years of Age
Adverse events reported in a 3-week pediatric clinical trial comparing the same formulation of albuterol as in PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol (180 mcg albuterol four times daily) to a matching placebo HFA inhalation aerosol occurred at a low incidence rate (no greater than 2% in the active treatment group) and were similar to those seen in adult and adolescent trials.
The following adverse reactions have been identified during postapproval use of PROAIR HFA (albuterol sulfate inhalation aerosol) . 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. Reports have included rare cases of aggravated bronchospasm, lack of efficacy, asthma exacerbation (reported fatal in one case), muscle cramps, and various oropharyngeal side-effects such as throat irritation, altered taste, glossitis, tongue ulceration, and gagging.
The following adverse events have been observed in postapproval use of inhaled albuterol: urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles). 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 Proair HFA (albuterol sulfate inhalation aerosol) Side Effects Center for a complete guide to possible side effects
Other short-acting sympathomimetic aerosol bronchodilators should not be used concomitantly with PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.
Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic-blocking agents in patients with asthma. In this setting, consider cardioselective beta-blockers, although they should be administered with caution.
The ECG changes and/or hypokalemia which may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with non-potassium sparing diuretics. Consider monitoring potassium levels.
Mean decreases of 16% and 22% in serum digoxin levels were demonstrated after single dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol.
Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the cardiovascular system may be potentiated. Consider alternative therapy in patients taking MAO inhibitors or tricyclic antidepressants.
Read the Proair HFA Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 9/14/2010
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