Drug Information for Albuterol Sulfate (Mylan Pharmaceuticals Inc.): DESCRIPTION

  • Albuterol sulfate inhalation solution is a relatively selective beta2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic form of albuterol, has the chemical name a1[(tert-Butylamino) methyl]-4-hydroxy-m-xylene-a,a´diol sulfate (2:1) (salt), and the following structural formula:

    Albuterol sulfate has a molecular weight of 576.71 and the molecular formula (C13H21NO3)2•H2SO4. Albuterol sulfate is a white or practically white powder, freely soluble in water and slightly soluble in alcohol.

    The World Health Organization recommended name for albuterol base is salbutamol.

    Albuterol sulfate inhalation solution 0.083% requires no dilution before administration.

    Each mL of albuterol sulfate inhalation solution (0.083%) contains 0.83 mg of albuterol (as 1 mg of albuterol sulfate) in an isotonic, sterile, aqueous solution containing sodium chloride, edetate disodium and sodium citrate; hydrochloric acid is used to adjust the pH between 3 and 5. Albuterol sulfate inhalation solution (0.083%) contains no sulfiting agents.

    Albuterol sulfate inhalation solution is a clear, colorless solution.

  • Drug Information Provided by National Library of Medicine (NLM).