Levalbuteroldrug info
levalbuterol 2.5 MG/ML Inhalation Solution
What it is used for
Levalbuterol inhalation solution (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. Levalbuterol inhalation solution (concentrate) is a beta 2 -adrenergic agonist indicated for:
Treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective November 11, 2019. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
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 is a relatively selective beta 2 -adrenergic receptor agonist. The chemical name for levalbuterol hydrochloride is (R)-α 1 -[[(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 is 275.8, and its molecular formula is C 13 H 21 NO 3
HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol hydrochloride is the USAN modified name for (R)-albuterol hydrochloride in the United States. Levalbuterol inhalation solution (concentrate) is supplied in 0.5 mL individually-wrapped 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), sodium chloride to adjust tonicity, edetate disodium (EDTA) as a chelating agent and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5). Levalbuterol Hydrochloride Structural Formula
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective November 11, 2019. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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