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Duoneb

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Duoneb

Duoneb

SIDE EFFECTS

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
n (%)
Ipratropium
n (%)
DuoNeb
n (%)
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)
DIGESTIVE
  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)
MUSCULO-SKELETAL
  Cramps leg 8 (1.1) 6 (0.8) 11 (1.4)
RESPIRATORY
  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)
UROGENITAL
  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.

In the clinical trial, there was a 0.3% incidence of possible allergic-type reactions, including skin rash, pruritus, and urticaria.

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

DRUG INTERACTIONS

Anticholinergic agents

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.

β-adrenergic agents

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.

Diuretics

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.

Albuterol Sulfate

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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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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