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Drugs Approved by the FDA

Drug Name: DuoNeb (albuterol sulfate and ipratropium bromide)

The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Dey Laboratories
Approval Status: Approved March 2001
Treatment for: Bronchospasm associated with COPD for patients who require more than one bronchodilator

General Information

DuoNeb Inhalation Solution has been approved for the treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) in patients who require more than one bronchodilator. This product combines two respiratory solutions, ipratropium bromide and albuterol sulfate, in a premixed, premeasured, unit-dose vial for nebulization. With this formulation, there is no need for patients to dilute or mix solutions, and advantages may include faster treatment time and a reduced chance of medication error.

COPD includes emphysema and chronic bronchitis -- diseases that are characterized by airflow obstruction. According to the World Health Organization, COPD will be the third most common cause of death worldwide by 2020. The quality of life for a person suffering from COPD diminishes as the disease progresses. Current treatment is tailored to the severity of the disease and may include bronchodilators, antibiotics and exercise to strengthen muscles.

Clinical Results

Results of an 863-subject trial demonstrated that DuoNeb improved bronchodilation over albuterol alone by 24% and over ipratropium alone by 37%, with no increased safety risk.

Side Effects

Adverse reactions reported with DuoNeb include (but are not limited to) the following:


  • Chest pain
  • Pharyngitis
  • Diarrhea
  • Bronchitis
  • Nausea
  • Leg cramps

Caution is advised for patients with the following conditions:


  • Convulsive disorders
  • Hyperthyroidism
  • Diabetes Mellitus
  • Narrow-angle glaucoma
  • Prostatic hypertrophy
  • Bladder-neck obstruction

Albuterol sulfate administration, as well as the co-administration of DuoNeb and other sympathomimetic agents, may result in significant cardiovascular effects.

Mechanism of Action

Albuterol is a beta2-adrenergic bronchodilator. Ipratropium bromide, also a bronchodilator, blocks the physiologic action of acetylcholine.

Additional Information

If you would like further information on COPD, please visit the National Library of Medicine.


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Drug listing last updated on June 20, 2008

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