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

INDICATIONS & USAGE SECTION

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.

DOSAGE & ADMINISTRATION SECTION

The recommended dose of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution 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 Ipratropium Bromide and Albuterol Sulfate Inhalation Solution 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 Ipratropium Bromide and Albuterol Sulfate Inhalation Solution have not been studied.

The use of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution 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 Ipratropium Bromide and Albuterol Sulfate Inhalation Solution to each patient in one U.S. clinical study. The safety and efficacy of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution delivered by other nebulizers and compressors have not been established.

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution 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 SECTION

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is supplied as a 3 mL sterile solution for nebulization in sterile low-density polyethylene unit-dose vials. Store vials in pouch until time of use. Supplied in cartons as listed below.

NDC 0487-0201-01 30 vials per carton / 1 vial per foil pouch

NDC 0487-0201-06 60 vials per carton / 1 vial per foil pouch

NDC 0487-0201-02 30 vials per carton / 1 vial per foil pouch / robot ready

NDC 0487-0201-03 30 vials per carton / 6 vials per foil pouch

NDC 0487-0201-60 60 vials per carton / 6 vials per foil pouch

STORAGE AND HANDLING

PROTECT FROM LIGHT. The unit-dose vial should remain stored in the protective foil pouch until time of use.

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

IC 235

REV 07-02-08

Rx Only

Manufactured By:
Nephron Pharmaceuticals Corporation
Orlando, FL 32811