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Albuterol extended-release tablets contain albuterol sulfate, the racemic form of albuterol and a relatively selective beta₂-adrenergic bronchodilator, in an extended-release formulation. Albuterol sulfate has the chemical name (±) α₁-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α, α-diol sulfate (2:1) (salt), and the following structural formula:

Albuterol sulfate has a molecular weight of 576.7, and the molecular 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.

Each tablet for oral administration contains 4 mg or 8 mg of albuterol as 4.8 mg or 9.6 mg, respectively, of albuterol sulfate in a cellulosic material that serves as a diffusion-release membrane. In addition each tablet contains the following inactive ingredients: Calcium sulfate, carnauba wax, ethylcellulose, ferric oxide black, hypromellose, ink-thinner XI, lactose monohydrate, magnesium stearate, polyethylene glycol, propylene glycol, shellac, stearic acid, titanium dioxide, triacetin, D&C Yellow #10, (4 mg only) and FD&C Blue #1 (4 mg only).

Last reviewed on RxList: 8/8/2008
This monograph has been modified to include the generic and brand name in many instances.