XOPENEX- levalbuterol hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVALBUTEROL HYDROCHLORIDE (UNII: WDQ1526QJM) (LEVALBUTEROL - UNII:EDN2NBH5SS)

Available from:

REMEDYREPACK INC.

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. XOPENEX Inhalation Solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. Reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see Warnings and Precautions ( 5.6) ]. Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled studies of XOPENEX Inhalation Solution in pregnant women. Because animal reproduction studies are not always predictive of human response, XOPENEX Inhalation Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in newborns of women treated with racemic albut

Product summary:

XOPENEX 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 levalbuterol HCl) and is available in cartons of 24 unit-dose LDPE vials (NDC 17478-172-24). XOPENEX (levalbuterol HCl) Inhalation Solution, 0.63 mg (foil pouch label color yellow) contains 0.63 mg of levalbuterol (as 0.73 mg of levalbuterol HCl) and is available in cartons of 24 unit-dose LDPE vials (NDC 17478-173-24). 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 17478-174-24). XOPENEX Inhalation Solution is also available as a concentrate in individually pouched 0.5 mL unit-dose vials containing 1.25 mg of levalbuterol (NDC 17478-171-30). Store XOPENEX Inhalation Solution in the protective foil pouch at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Protect from light 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 from the pouch, if not used immediately, should be protected from light and used within 1 week. Discard any vial if the solution is not colorless.

Authorization status:

New Drug Application

Summary of Product characteristics

XOPENEX- LEVALBUTEROL HYDROCHLORIDE SOLUTION
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XOPENEX INHALATION SOLUTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XOPENEX INHALATION SOLUTION.
XOPENEX (LEVALBUTEROL HYDROCHLORIDE) INHALATION SOLUTION, FOR INHALATION USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
XOPENEX (levalbuterol hydrochloride) Inhalation Solution is a beta
-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. ( 1)
DOSAGE AND ADMINISTRATION
FOR ORAL INHALATION ONLY ( 2)
_Children 6-11 years old:_ 0.31 mg administered three times a day, by
nebulization. Routine dosing should not exceed
0.63 mg three times a day. ( 2)
_Adults and Adolescents ≥12 years old:_ 0.63 mg administered three
times a day, every 6 to 8 hours, by nebulization. The
maximum recommended dose is 1.25 mg three times a day. ( 2)
For use with a standard jet nebulizer (with a face mask or mouthpiece)
connected to an air compressor. ( 2)
DOSAGE FORMS AND STRENGTHS
Inhalation Solution (unit-dose vial for nebulization): 0.31 mg/3 mL,
0.63 mg/3 mL and 1.25 mg/3 mL. ( 3)
CONTRAINDICATIONS
Hypersensitivity to levalbuterol or racemic albuterol. ( 4)
WARNINGS AND PRECAUTIONS
Life-threatening paradoxical bronchospasm may occur. Discontinue
XOPENEX Inhalation Solution immediately and
treat with alternative therapy. ( 5.1)
Need for more doses of XOPENEX Inhalation Solution than usual may be a
sign of deterioration of asthma and requires
reevaluation of treatment. ( 5.2)
XOPENEX Inhalation Solution is not a substitute for corticosteroids. (
5.3)
Cardiovascular effects may occur. Consider discontinuation of XOPENEX
Inhalation Solution if these effects occur. Use
with caution in patients with underlying cardiovascular disorders. (
5.4)
Excessive use may be fatal. Do not exceed recommended dose. ( 5.5)
Immediat