Proair HFA (Albuterol Sulfate HFA Inhalation) - Indications and Dosage

INDICATIONS AND USAGE

PROAIR HFA Inhalation Aerosol is indicated in adults and children 12 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

DOSAGE AND ADMINISTRATION

For treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, the usual dosage of PROAIR HFA Inhalation Aerosol for adults and children 12 years and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient.

It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than two weeks by releasing three "test sprays" into the air, away from the face.

Exercise-Induced Bronchospasm Prevention: The usual dosage for adults and children 12 years of age or older is two inhalations 15 to 30 minutes before exercise.

If a previously effective dosage regimen fails to provide the usual response, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

Cleaning: To maintain proper use of this product and to prevent medication build-up and blockage, it is important to keep the plastic mouthpiece clean. Wash the mouthpiece and air dry thoroughly at least once a week. If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage. The inhaler may cease to deliver medication if not properly cleaned and air dried. See- Information For Patients.

HOW SUPPLIED

PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 59310-579-20). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

Rx only.

SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120^oF may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children.

The red actuator supplied with PROAIR HFA Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.

The labeled amount of medication in each actuation cannot be assured after 200 actuations, even though the canister may not be completely empty. Discard the inhaler (canister plus actuator) after 200 actuations have been used. Never immerse the canister into water to determine how full the canister is ("float test").

PROAIR HFA Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Mkt by: TEVA Specialty Pharmaceuticals

Horsham, PA 19044

Mfd by: IVAX Pharmaceuticals Ireland

Waterford, Ireland

Copyright ©2007, TEVA Specialty Pharmaceuticals

All rights reserved.

PROAIR^® is a trademark of IVAX Laboratories, Inc.

Manufactured In Ireland

PE XXXX Rev. 01/08