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Duoneb

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Duoneb

Duoneb

INDICATIONS

DuoNeb (ipratropium bromide and albuterol sulfate) is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.

DOSAGE AND ADMINISTRATION

The recommended dose of DuoNeb (ipratropium bromide and albuterol sulfate) is one 3 mL vial administered 4 times per day via nebulization with up to 2 additional 3 mL doses allowed per day, if needed. Safety and efficacy of additional doses or increased frequency of administration of DuoNeb (ipratropium bromide and albuterol sulfate) beyond these guidelines has not been studied and the safety and efficacy of extra doses of albuterol sulfate or ipratropium bromide in addition to the recommended doses of DuoNeb (ipratropium bromide and albuterol sulfate) have not been studied.

The use of DuoNeb (ipratropium bromide and albuterol sulfate) can be continued as medically indicated to control recurring bouts of bronchospasm. If a previously effective regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of worsening COPD, which would require reassessment of therapy.

A Pari-LC-Plus™ nebulizer (with face mask or mouthpiece) connected to a PRONEB™ compressor was used to deliver DuoNeb (ipratropium bromide and albuterol sulfate) to each patient in one U.S. clinical study. The safety and efficacy of DuoNeb (ipratropium bromide and albuterol sulfate) delivered by other nebulizers and compressors have not been established.

DuoNeb (ipratropium bromide and albuterol sulfate) should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask.

HOW SUPPLIED

DuoNeb (ipratropium bromide and albuterol sulfate) is supplied as a 3-mL sterile solution for nebulization in sterile low-density polyethylene unit-dose vials. Store in pouch until time of use. Supplied in cartons as listed below.

NDC 49502-672-30 30 vials per carton/5 vials per foil pouch

NDC 49502-672-60 60 vials per carton/5 vials per foil pouch

Store between 2°C and 25°C (36°F and 77°F). Protect from light.

DEY®, Napa, CA 94558. FEB 09

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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