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Adverse reaction information concerning DuoNeb (ipratropium bromide and albuterol sulfate) was derived from the 12-week controlled clinical trial.
ADVERSE EVENTS OCCURRING IN ≥ 1% OF ≥ 1 TREATMENT GROUP(S)
AND WHERE THE COMBINATION TREATMENT SHOWED THE HIGHEST PERCENTAGE
|Body System COSTART Term||Albuterol
|NUMBER OF PATIENTS||761||754||765|
|N (%) Patients with AE||327 (43.0)||329 (43.6)||367 (48.0)|
|BODY AS A W HOLE|
|Pain||8 (1.1)||4 (0.5)||10 (1.3)|
|Pain chest||11 (1.4)||14 (1.9)||20 (2.6)|
|Diarrhea||5 (0.7)||9 (1.2)||14 (1.8)|
|Dyspepsia||7 (0.9)||8 (1.1)||10 (1.3)|
|Nausea||7 (0.9)||6 (0.8)||11 (1.4)|
|Cramps leg||8 (1.1)||6 (0.8)||11 (1.4)|
|Bronchitis||11 (1.4)||13 (1.7)||13 (1.7)|
|Lung Disease||36 (4.7)||34 (4.5)||49 (6.4)|
|Pharyngitis||27 (3.5)||27 (3.6)||34 (4.4)|
|Pneumonia||7 (0.9)||8 (1.1)||10 (1.3)|
|Infection urinary tract||3 (0.4)||9 (1.2)||12 (1.6)|
Additional adverse reactions reported in more than 1% of patients treated with DuoNeb (ipratropium bromide and albuterol sulfate) included constipation and voice alterations.
Additional information derived from the published literature on the use of albuterol sulfate and ipratropium bromide singly or in combination includes precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, paradoxical bronchospasm, wheezing, exacerbation of COPD symptoms, drowsiness, aching, flushing, upper respiratory tract infection, palpitations, taste perversion, elevated heart rate, sinusitis, back pain, sore throat, and metabolic acidosis. 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.
Read the Duoneb (ipratropium bromide and albuterol sulfate) Side Effects Center for a complete guide to possible side effects
Although ipratropium bromide is minimally absorbed into the systemic circulation, there is some potential for an additive interaction with concomitantly used anticholinergic medications. Caution is, therefore, advised in the coadministration of DuoNeb (ipratropium bromide and albuterol sulfate) with other drugs having anticholinergic properties.
Caution is advised in the co-administration of DuoNeb (ipratropium bromide and albuterol sulfate) and other sympathomimetic agents due to the increased risk of adverse cardiovascular effects.
β-receptor blocking agents
These agents and albuterol sulfate inhibit the effect of each other. β-receptor blocking agents should be used with caution in patients with hyperreactive airways, and if used, relatively selective β1 selective agents are recommended.
The electrocardiogram (ECG) changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by β-agonists, especially when the recommended dose of the β-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the co-administration of β-agonist-containing drugs, such as DuoNeb (ipratropium bromide and albuterol sulfate) , with non-potassium sparing diuretics.
Monoamine oxidase inhibitors or tricyclic antidepressants
DuoNeb (ipratropium bromide and albuterol sulfate) 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 sulfate on the cardiovascular system may be potentiated.
Read the Duoneb Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 4/22/2011
This monograph has been modified to include the generic and brand name in many instances.
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