DESCRIPTION
The active component of VENTOLIN HFA (albuterol sulfate HFA inhalation aerosol) is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator. Albuterol sulfate has the chemical name (alpha)1-[(tert -butylamino)methyl]-4-hydroxy- m -xylene-(alpha), (alpha)'-diol sulfate (2:1)(salt).
Albuterol sulfate has a molecular weight of 576.7, and the empirical formula is (C13H21NO3)2·H2SO4. Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol.
The World Health Organization recommended name for albuterol base is salbutamol.
VENTOLIN HFA 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). It contains no other excipients.
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 4 test sprays into the air, away from the face. After priming with 4 actuations, each actuation delivers 120 mcg of albuterol sulfate, USP in 75 mg of suspension from the valve and 108 mcg of albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Each 18-g canister provides 200 inhalations.
This product does not contain chlorofluorocarbons (CFCs) as the propellant.
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