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Levalbuterol inhalation solution USP (concentrate) is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.
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Levalbuterol inhalation solution USP (concentrate) is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol hydrochloride, USP is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol hydrochloride, USP is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:
The molecular weight of levalbuterol hydrochloride, USP is 275.8, and its empirical formula is C13H21NO3•HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 188°C and is soluble in water and slightly soluble in ethanol.
Levalbuterol hydrochloride, USP is the USAN modified name for (R)-albuterol hydrochloride in the United States.
Levalbuterol inhalation solution USP (concentrate) is supplied in 0.5 mL unit-dose vials that must be diluted with normal saline before administration by nebulization. Each 0.5 mL unit-dose vial contains 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol hydrochloride, USP), 4 mg sodium chloride to adjust tonicity, and 0.055 mg edetate sodium dihydrate, 1 mg of trisodium citrate dihydrate, and sulfuric acid to adjust pH to 4 (3.3 to 4.5).