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.