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Duoneb (Albuterol Sulfate / Ipratropium Bromide) - Indications and Dosage

 


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INDICATIONS AND USAGE

DuoNeb 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 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 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 have not been studied.

The use of DuoNeb 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 to each patient in one U.S. clinical study. The safety and efficacy of DuoNeb delivered by other nebulizers and compressors have not been established.

DuoNeb 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 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
NDC 49502-672-31          30 vials per carton/1 vial per foil pouch

Store between 2°C and 30°C (36°F and 86°F). Protect from light.

DuoNeb is a registered trademark of Dey, L.P.

03-485-26

JAN 06

Page last updated: 2006-05-11

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