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.

Children 6–11 years old

The recommended dosage of Xopenex (levalbuterol HCl) Inhalation Solution for patients 6–11 years old is 0.31 mg administered three times a day, by nebulization. Routine dosing should not exceed 0.63 mg three times a day.

Adults and Adolescents ≥ 12 years old

The recommended starting dosage of Xopenex (levalbuterol HCl) Inhalation Solution for patients 12 years of age and older is 0.63 mg administered three times a day, every 6 to 8 hours, by nebulization.

Patients 12 years of age and older with more severe asthma or patients who do not respond adequately to a dose of 0.63 mg of Xopenex Inhalation Solution may benefit from a dosage of 1.25 mg three times a day.

Patients receiving the highest dose of Xopenex Inhalation Solution should be monitored closely for adverse systemic effects, and the risks of such effects should be balanced against the potential for improved efficacy.

The use of Xopenex Inhalation Solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time, most patients gain optimal benefit from regular use of the inhalation solution.

If a previously effective dosage regimen fails to provide the expected relief, medical advice should be sought immediately, since this is often a sign of seriously worsening asthma that would require reassessment of therapy.

The drug compatibility (physical and chemical), efficacy, and safety of Xopenex Inhalation Solution when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of Xopenex Inhalation Solution have been established in clinical trials when administered using the PARI LC Jet™ and PARI LC Plus™ nebulizers, and the PARI Master®Dura-Neb®2000 and Dura-Neb®3000 compressors. The safety and efficacy of Xopenex Inhalation Solution when administered using other nebulizer systems have not been established.

Xopenex (levalbuterol HCl) Inhalation Solution Concentrate (foil pouch label color red) is supplied in 0.5 mL unit-dose, low-density polyethylene (LDPE) vials, and is a clear, colorless, sterile, preservative-free, aqueous solution. Each vial contains 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol HCl) and is available in cartons of 30 (NDC 63402515-30) individually pouched vials.

Xopenex (levalbuterol HCl) Inhalation Solution is also available in 3 mL vials in three different strengths of levalbuterol: 0.31 mg (NDC 63402-511-24), 0.63 mg (NDC 63402512-24), and 1.25 mg (NDC 63402-513-24).

Store Xopenex (levalbuterol HCl) Inhalation Solution Concentrate in the protective foil pouch at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Protect from light and excessive heat. Open the foil pouch just prior to administration. Once the foil pouch is opened, the contents of the vial should be used immediately. Discard any vial if the solution is not colorless. Xopenex (levalbuterol HCl) Inhalation Solution Concentrate should be diluted with sterile normal saline before administration by nebulization.

Manufactured for: Sunovion Pharmaceuticals Inc., Marlborough, MA 01752 USA. For customer service, call 1-888-394-7377. To report adverse events, call 1-877-737-7226. For medical information, call 1-800-739-0565. Sunovion Pharmaceuticals Inc. was formerly Sepracor Inc. Revised: September 2012.

Last reviewed on RxList: 10/17/2012
This monograph has been modified to include the generic and brand name in many instances.