Albuterol HFA (Albuterol Sulfate) - Indications and Dosage

INDICATIONS AND USAGE

Albuterol Sulfate 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.

DOSAGE AND ADMINISTRATION

For treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, the usual dosage 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.

Each actuation of Albuterol Sulfate HFA Inhalation Aerosol delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) from the actuator mouthpiece. 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.

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.

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

Albuterol Sulfate HFA 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.

Store between 15°and 25°C (59° and 77°F). Avoid exposure to extreme heat and cold. For best results, canister should be at room temperature before use.

SHAKE WELL BEFORE USE

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

Once the labeled number of actuations (i.e. 200) has been used, the labeled amount of medication delivered from a canister cannot be assured. As a result, the inhaler should be discarded after 200 actuations, even though the canister may not be completely empty. Never immerse the canister into water to determine how full the canister is (“float test”).

WARNING:

Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.

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

Manufactured By:
IVAX Pharmaceuticals Ireland
Waterford, Ireland
For:
IVAX Laboratories, Inc.
Miami, FL 33137 USA

Copyright ©2004, IVAX Laboratories, Inc.
All rights reserved.

Rev. 11/04
PE1521