Xopenex

Xopenex

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Questions & Answers

Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

XOPENEX (levalbuterol HCl) Inhalation Solution 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.

 

History

There is currently no drug history available for this drug.

Other Information

XOPENEX Inhalation Solution is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:

MM1

The molecular weight of levalbuterol HCl 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 187°C and solubility of approximately 180 mg/mL in water.

Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States.

XOPENEX Inhalation Solution is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg of levalbuterol (as 0.36 mg of levalbuterol HCl) or 0.63 mg of levalbuterol (as 0.73 mg of levalbuterol HCl) or 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol HCl), sodium chloride to adjust tonicity, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5).

 

Xopenex Manufacturers


  • Remedyrepack Inc.
    Xopenex (Levalbuterol Hydrochloride) Solution [Remedyrepack Inc. ]
  • Akorn, Inc.
    Xopenex (Levalbuterol Hydrochloride) Solution [Akorn, Inc.]
  • Akorn, Inc.
    Xopenex (Levalbuterol Hydrochloride) Solution, Concentrate [Akorn, Inc.]
  • Cardinal Health
    Xopenex (Levalbuterol Hydrochloride) Solution, Concentrate [Cardinal Health]
  • Physicians Total Care, Inc.
    Xopenex (Levalbuterol Hydrochloride) Solution, Concentrate Xopenex (Levalbuterol Hydrochloride) Solution [Physicians Total Care, Inc.]
  • Rebel Distributors Corp
    Xopenex (Levalbuterol Hydrochloride) Solution [Rebel Distributors Corp]
  • Remedyrepack Inc.
    Xopenex (Levalbuterol Hydrochloride) Solution [Remedyrepack Inc. ]
  • Sunovion Pharmaceuticals Inc.
    Xopenex (Levalbuterol Hydrochloride) Solution, Concentrate [Sunovion Pharmaceuticals Inc.]
  • Sunovion Pharmaceuticals Inc.
    Xopenex (Levalbuterol Hydrochloride) Solution [Sunovion Pharmaceuticals Inc.]

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