(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, andgagging. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible toreliably 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 orhypotension, palpitations, central nervous system stimulation, insomnia, headache, nervousness, tremor, muscle cramps,drying or irritation of the oropharynx, hypokalemia, hyperglycemia, and metabolic acidosis.
7 DRUG INTERACTIONS
Other short-acting sympathomimetic bronchodilators should not be used concomitantly with ProAir Digihaler. If
additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious
cardiovascular effects.
7.1 Beta-Blockers
Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as ProAir Digihaler,but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally betreated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, theremay 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.
7.2 Diuretics
The ECG changes and/or hypokalemia which may result from the administration of non-potassium sparing diuretics (suchas loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of thebeta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in thecoadministration of beta-agonists with non-potassium sparing diuretics. Consider monitoring potassium levels.
7.3 Digoxin
Mean decreases of 16% and 22% in serum digoxin levels were demonstrated after single dose intravenous and oraladministration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days.
The clinicalsignificance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on achronic basis is unclear. Nevertheless, it would be prudent to carefully eva luate the serum digoxin levels in patients whoare currently receiving digoxin and ProAir Digihaler.
7.4 Monoamine Oxidase Inhibitors or Tricyclic AntidepressantsProAir Digihaler should be administered with extreme caution to patients being treated with monoamine oxidaseinhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterolon the cardiovascular system may be potentiated. Consider alternative therapy in patients taking MAO inhibitors ortricyclic antidepressants.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no randomized clinical studies of use of albuterol during pregnancy. Available data from publishedepidemiological studies and postmarketing case reports of pregnancy outcomes following inha |
