XOPENEX- levalbuterol hydrochloride solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

Levalbuterol Hydrochloride (UNII: WDQ1526QJM) (Levalbuterol - UNII:EDN2NBH5SS)

Saatavilla:

Akorn

INN (Kansainvälinen yleisnimi):

Levalbuterol Hydrochloride

Koostumus:

Levalbuterol 0.31 mg in 3 mL

Antoreitti:

RESPIRATORY (INHALATION)

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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) ]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medication, including XOPENEX, during pregnancy. To enroll in MotherToBaby Pregnancy Studies' Asthma & Pregnancy Study or for more information about the registry, call 1-877-311-8972 or visit www.mothertobaby.org/ongoing-study/asthma. Risk Summary There are no adequate and well-controlled studies of XOPENEX Inhalation Solution in pregnant women. There are clinical considerations with the use of XOPENEX In

Tuoteyhteenveto:

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). Storage: 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.

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

XOPENEX - LEVALBUTEROL HYDROCHLORIDE SOLUTION
AKORN
----------
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
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 to 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)
Immediate hypersensitivity reactions may occur. Disc