"Jan 3, 2011 -- The Ritedose Corporation has recalled some single-dose vials of Albuterol Sulfate Inhalation Solution because an incorrect label could lead to a possible overdose.
The recall includes 0.083% Albuterol Sulfate Inhalation S"...
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 PATIENT INFORMATION section). Keeping the plastic mouthpiece clean is very important to prevent medication buildup 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, e.g., corticosteroids.
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 (NDC 0085-1132-01).
Store between 15°-25°C (59°-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 canisters, 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 chlorofluorocarbons (CFCs) as the propellant.
Attention Health Care Professional
Detach Patient's Instructions for Use from package insert and dispense with the product.
Developed and Manufactured by: 3M Health Care Limited, Loughborough UK or 3M Drug Delivery Systems, Northridge, CA 91324, USA. Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Revised: June 2012.
Last reviewed on RxList: 8/20/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Albuterol Sulfate Information
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