Xopenex (levalbuterol HCl) Inhalation Solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 yearsof age and older with reversible obstructive airway disease.

Children 6-11 years old: The recommended dosage of Xopenex (levalbuterol HCI) 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 HCI) 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 is supplied in 3 mL unit-dose, low-density polyethylene (LDPE) vials as a clear, colorless, sterile, preservative-free, aqueous solution, in three different strengths of levalbuterol (0.31 mg, 0.63 mg, 1.25 mg). Each strength of Xopenex Inhalation Solution is available in a shelf-carton containing one or more foil pouches, each containing 12 unit-dose LDPE vials.

Xopenex (levalbuterol HCl) Inhalation Solution, 0.31 mg (foil pouch label color green) contains 0.31 mg of levalbuterol (as 0.36 mg of levalbuterolHCl) and is available in cartons of 24 unit-dose LDPE vials (NDC 63402-511-24).

Xopenex (levalbuterol HCl) Inhalation Solution, 0.63 mg (foil pouch label color yellow) contains 0.63 mg of levalbuterol (as 0.73 mg of levalbuterolHCl) and is available in cartons of 24 unit-dose LDPE vials (NDC 63402-512-24).

Xopenex (levalbuterol HCl) Inhalation Solution, 1.25 mg (foil pouch label color red) contains 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol HCl)and is available in cartons of 24 unit-dose LDPE vials (NDC 63402-513-24).

Xopenex (levalbuterol HCl) Inhalation Solution is also available as a concentrate in individually pouched 0.5 mL unit-dose vials containing 1.25 mg of levalbuterol (NDC 63402-515-30).

Caution

Federal law (U.S.) prohibits dispensing without prescription.

Store Xopenex (levalbuterol HCl) Inhalation Solution in the protective foil pouch at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Protect fromlight and excessive heat. Keep unopened vials in the foil pouch. Once the foil pouch is opened, the vials should be used within 2 weeks. Vials removed fromthe pouch, if not used immediately, should be protected from light and used within 1 week. Discard any vial if the solution is not colorless.

Manufactured for: Sepracor 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. August 2007. FDA Rev date: 9/7/2006

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