"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"...
(albuterol sulfate) Inhalation Aerosol
The active component of PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, USP racemic α1 [(tert-Butylamino)methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1)(salt), a relatively selective beta2-adrenergic bronchodilator having the following chemical structure:
Albuterol sulfate is the official generic name in the United States. The World Health Organization recommended name for the drug is salbutamol sulfate. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C13H21NO3)2•H2SO4. Albuterol sulfate is a white to off-white crystalline solid. It is soluble in water and slightly soluble in ethanol. PROVENTIL HFA Inhalation Aerosol is a pressurized metered-dose aerosol unit for oral inhalation. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane), ethanol, and oleic acid.
Each actuation delivers 120 mcg albuterol sulfate, USP from the valve and 108 mcg albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Each canister provides 200 inhalations. 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.
This product does not contain chlorofluorocarbons (CFCs) as the propellant.
What are the possible side effects of albuterol inhalation?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- bronchospasm (wheezing, chest tightness, trouble breathing), especially after starting a new canister of this medicine;
- chest pain and fast, pounding, or uneven heart beats;
- tremor, nervousness;
- low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp...
Last reviewed on RxList: 11/22/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Albuterol Sulfate Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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