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

 
 



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

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

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

Dey®
A Mylan Company

Dey Pharma L.P., Napa, CA 94558

03-485-33

JUN 12

DuoNeb®

(Ipratropium Bromide 0.5 mg/Albuterol Sulfate 3.0 mg*)
Inhalation Solution

*Equivalent to 2.5 mg albuterol base

Patient's Instructions for Use

Read this patient information completely every time your prescription is filled as information may have changed. Keep these instructions with your medication as you may want to read them again.

DuoNeb should only be used under the direction of a physician. Your physician and pharmacist have more information about DuoNeb and the condition for which it has been prescribed. Contact them if you have additional questions.


Storing your Medicine

Store DuoNeb between 2°C and 25°C (36°F and 77°F). Vials should be protected from light before use, therefore, keep unused vials in the foil pouch or carton. Do not use after the expiration (EXP) date printed on the carton.


Dose

DuoNeb is supplied as a single-dose, ready-to-use vial containing 3 mL of solution. No mixing or dilution is needed. Use one new vial for each nebulizer treatment.

FOLLOW THESE DIRECTIONS FOR USE OF YOUR NEBULIZER/COMPRESSOR OR THE DIRECTIONS GIVEN BY YOUR HEALTHCARE PROVIDER. A TYPICAL EXAMPLE IS SHOWN BELOW.


Instructions for Use

  1. Remove one vial from the foil pouch. Place remaining vials back into pouch for storage.
  2. Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir (Figure 1).
  3. Connect the nebulizer to the mouthpiece or face mask (Figure 2).
  4. Connect the nebulizer to the compressor.
  5. Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 3) or put on the face mask (Figure 4); and turn on the compressor.
  6. Breathe as calmly, deeply and evenly as possible through your mouth until no more mist is formed in the nebulizer chamber (about 5-15 minutes). At this point, the treatment is finished.
  7. Clean the nebulizer (see manufacturer's instructions).

Dey®
A Mylan Company

Dey Pharma L.P., Napa, CA 94558

03-485-33

JUN 12

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