Proventil (Albuterol Sulfate Inhalation) - Indications and Dosage

INDICATIONS AND USAGE

PROVENTIL HFA Inhalation Aerosol is indicated in adults and children 4 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 for adults and children 4 years of age 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 PROVENTIL HFA Inhalation Aerosol delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) from the 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 2 weeks by releasing four “test sprays” into the air, away from the face.

Exercise Induced Bronchospasm Prevention: The usual dosage for adults and children 4 years of age and older is two inhalations 15 to 30 minutes before exercise.

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

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

HOW SUPPLIED

PROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations (NCD 0085-1132-01).

Rx only. Store between 15° and 25°C (59° and 77°F). For best results, canister should be at room temperature before use.

SHAKE WELL BEFORE USING.

The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product caniter, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.

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.

PROVENTIL HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant.

Developed and Manufactured by

3M Health Care Limited

Loughborough UK

or

3M Pharmaceuticals,

Northridge, CA 91324

or

Laboratoires 3M

Sante Pithiviers FR

for

Key Pharmaceuticals, Inc.

Kenilworth, NJ 07033 USA

	6203 5190 4
Copyright © 1996, 1999, Key Pharmaceuticals, Inc. All rights reserved. Rev. 11/05	29408505T B-29669503

Attention Pharmacist:

Detach Patient's Instructions for Use from package insert and dispense with the product.

PROVENTIL® HFA

(albuterol sulfate)

Inhalation Aerosol

FOR ORAL INHALATION ONLY