Atrovent (Ipratropium Bromide Monohydrate) - Indications and Dosage

INDICATIONS AND USAGE

ATROVENT (ipratropium bromide) Inhalation Aerosol is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

DOSAGE AND ADMINISTRATION

The usual starting dose of ATROVENT (ipratropium bromide) Inhalation Aerosol is two inhalations (36 mcg) four times a day. Patients may take additional inhalations as required; however, the total number of inhalations should not exceed 12 in 24 hours. 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. Avoid spraying into eyes.

HOW SUPPLIED

ATROVENT (ipratropium bromide) Inhalation Aerosol is supplied as a metered dose inhaler with a white mouthpiece which has a clear, colorless sleeve and a green protective cap. The ATROVENT Inhalation Aerosol canister is to be used with the ATROVENT Inhalation Aerosol mouthpiece only. This mouthpiece should not be used with other aerosol medications. Similarly, the canister should not be used with other mouthpieces. Each actuation meters 21 mcg of ipratropium bromide from the valve and delivers 18 mcg of ipratropium bromide from the mouthpiece. Each 14.7 gram canister provides sufficient medication for 200 inhalations (NDC 0597-0082-14).

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 with his or her physician if there are questions about alternatives.

Store between 59°F (15°C) and 86°F (30°C). Avoid excessive humidity.

Keep out of children's reach. Shake the canister well before using. Patients should be reminded to read and follow the accompanying “Patient's Instructions for Use”, which should be dispensed with the product. For optimal results, the canister should be at room temperature before use.

Warning: Discard the canister after you have used the labeled number of inhalations. The correct amount of medication in each inhalation cannot be assured after this point.

R_x Only

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

Manufactured by:
3M Pharmaceuticals
St. Paul, MN 55144 USA

Licensed from:
Boehringer Ingelheim International GmbH

© Copyright Boehringer Ingelheim
International GmbH
2002, ALL RIGHTS RESERVED

Revised 3/27/02
10001403/US/1
10001403/01