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Combivent Respimat

Generic Name: Ipratropium Bromide/Albuterol Sulfate
Drug Category: Anticholinergic/Beta2-Adrenergic Agonist
Litigation Alert Level: Medium
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 1 year.

Approved Uses

Indicated for:

Patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator. 

Safety and efficacy of additional doses of COMBIVENT RESPIMAT beyond six inhalations in 24 hours have not been studied.

Safety and efficacy of extra doses of ipratropium or albuterol in addition to the recommended doses of COMBIVENT RESPIMAT have not been studied.

Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma.

COMBIVENT RESPIMAT can produce paradoxical bronchospasm that can be life threatening.

COMBIVENT RESPIMAT contains albuterol sulfate, a beta2-adrenergic sympathomimetic amine and, therefore, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus, and in patients who are unusually responsive to sympathomimetic amines.

Beta2-adrenergic agonists may produce significant hypokalemia in some patients (possibly through intracellular shunting) which has the potential to produce adverse cardiovascular effects.

Ipratropium bromide, a component of COMBIVENT RESPIMAT, is an anticholinergic and may increase intraocular pressure. This may result in precipitation or worsening of narrow-angle glaucoma. Therefore, COMBIVENT RESPIMAT should be used with caution in patients with narrow-angle glaucoma.

The albuterol sulfate contained in COMBIVENT RESPIMAT, like other beta adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, and/or symptoms.

Ipratropium bromide, a component of COMBIVENT RESPIMAT, is an anticholinergic and may cause urinary retention. Therefore, caution is advised when administering this medication to patients with prostatic hyperplasia or bladder-neck obstruction.

Avoid co-administration of COMBIVENT RESPIMAT with other anticholinergic containing drugs as this may lead to an increase in anticholinergic adverse effects.

Caution is advised in the co-administration of COMBIVENT RESPIMAT and other sympathomimetic agents due to the increased risk of adverse cardiovascular effects.

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 beta2-agonists, especially when the recommended dose of the beta2-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the co-administration of beta-agonist-containing drugs, such as COMBIVENT RESPIMAT, with non-potassium sparing diuretics.

Beta-receptor blocking agents and albuterol inhibit the effect of each other. Beta-receptor blocking agents should be used with caution in patients with hyperreactive airways.

COMBIVENT RESPIMAT 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 MAOs or tricyclic antidepressants.

There are no adequate and well-controlled studies of COMBIVENT RESPIMAT (ipratropium bromide and albuterol sulfate) Inhalation Spray, ipratropium bromide, or albuterol sulfate, in pregnant women. Albuterol sulfate has been shown to be teratogenic in mice and rabbits.

Because of the potential for tumorigenicity shown for albuterol in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 

GoToSource

Off-label Uses

• Dosage greater than six inhalations in 24 hours. GoToSource 

• Use in patients under the age of 18. GoToSource

• Prehospital treatment of reactive airways disease. GoToSource 

• Cystic fibrosis. GoToSource

Adverse Events

Mydriasis (pupil dilation). GoToSource

Increased intraocular pressure. GoToSource

Urinary retention. GoToSource

Bronchitis. GoToSource

Hypokalemia (low blood potassium level). GoToSource

Myocardial ischemia, arrhythmias, acute glaucoma and paradoxical bronchoconstriction. GoToSource

Litigation

Lawsuits filed for urinary retention. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated April 23, 2024