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

INDICATIONS AND USAGE

Combivent Inhalation Aerosol is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

DOSAGE AND ADMINISTRATION

The dose of Combivent Inhalation Aerosol is two inhalations four times a day. Patients may take additional inhalations as required; however, the total number of inhalations should not exceed 12 in 24 hours. Safety and efficacy of additional doses of Combivent Inhalation Aerosol beyond 12 puffs/24 hours have not been studied. Also, safety and efficacy of extra doses of ipratropium or albuterol in addition to the recommended doses of Combivent Inhalation Aerosol have not been studied. It is recommended to "test-spray" three times before using for the first time and in cases where the aerosol has not been used for more than 24 hours.

HOW SUPPLIED

Combivent® Inhalation Aerosol is supplied as a metered-dose inhaler with a white mouthpiece which has a clear, colorless sleeve and an orange protective cap. The Combivent Inhalation Aerosol canister should be used with theCombivent Inhalation Aerosol actuator only. The actuator should not be used with other aerosol medications. Each actuation meters 21 mcg of ipratropium bromide and 120 mcg of albuterol sulfate from the valve and delivers 18 mcg of ipratropium bromide and 103 mcg of albuterol sulfate (equivalent to 90 mcg albuterol base) from the mouthpiece. Each 14.7 gram canister provides sufficient medication for 200 inhalations (NDC 0597-0013-14).

The canister should be discarded after the labeled number of actuations have been used. The amount of medication in each actuation cannot be assured after this point.

Store between 59°F (15° C) and 86° F (30° C). Avoid excessive humidity. For optimal results, the canister should be at room temperature before use. Shake well before using.

Note: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs):

Warning: Contains trichloromonofluoromethane (CFC-11), dichlorodifluoromethane (CFC-12) and dichlorotetrafluoroethane (CFC-114), substances which harm public health and the environment by destroying ozone in the upper atmosphere.

A notice similar to the above Warning has been placed in the information for the patient of this product under the Environmental Protection Agency's (EPA's) regulations. The patient's warning states that the patient should consult his or her physician if there are any questions about alternatives.

Rx only

Manufactured by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, USA

Ipratropium bromide licensed from: Boehringer Ingelheim International GmbH

© Copyright Boehringer Ingelheim Pharmaceuticals, Inc.

2001, ALL RIGHTS RESERVED

Revised 9/01

10000291/03                                      10000291/US/03