LEVALBUTEROL solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Teva Pharmaceuticals USA, Inc.

INN (Internationale Bezeichnung):

LEVALBUTEROL HYDROCHLORIDE

Zusammensetzung:

LEVALBUTEROL 0.31 mg in 3 mL

Verabreichungsweg:

RESPIRATORY (INHALATION)

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Levalbuterol 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. Levalbuterol 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) ]. Risk Summary There are no adequate and well-controlled studies of levalbuterol inhalation solution in pregnant women. There are clinical considerations with the use of levalbuterol inhalation solution in pregnant women [see Clinical Considerations]. Following oral administration of levelbuterol HCl to pregnant rabbits, there was no evidence of teratogenicity at doses up to 25 mg/kg/day [approximately 108 times the maximum recommended human daily inhalation dose (MRHDID) of levalbuterol HCl for adults on a mg/m2 basis]; however, racemic a

Produktbesonderheiten:

Levalbuterol Inhalation Solution USP 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 levalbuterol inhalation solution USP is available in a shelf-carton containing 6 foil pouches, each containing 5 unit-dose LDPE vials. Levalbuterol Inhalation Solution USP , 0.31 mg (foil pouch label color green) contains 0.31 mg (0.0103%) of levalbuterol (as 0.36 mg of levalbuterol HCl) and is available in cartons of 30 unit-dose LDPE vials. Each carton contains 6 foil pouches, each containing 5 unit-dose LDPE vials (NDC 0093-4145-56). Levalbuterol Inhalation Solution USP , 0.63 mg (foil pouch label color orange) contains 0.63 mg (0.021%) of levalbuterol (as 0.73 mg of levalbuterol HCl) and is available in cartons of 30 unit-dose LDPE vials. Each carton contains 6 foil pouches, each containing 5 unit-dose LDPE vials (NDC 0093-4146-56). Levalbuterol Inhalation Solution USP , 1.25 mg (foil pouch label color maroon) contains 1.25 mg (0.042%) of levalbuterol (as 1.44 mg of levalbuterol HCl) and is available in cartons of 30 unit-dose LDPE vials. Each carton contains 6 foil pouches, each containing 5 unit-dose LDPE vials (NDC 0093-4148-56). Storage: Store Levalbuterol Inhalation Solution USP 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.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

LEVALBUTEROL- LEVALBUTEROL SOLUTION
TEVA PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVALBUTEROL INHALATION SOLUTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LEVALBUTEROL INHALATION SOLUTION.
LEVALBUTEROL INHALATION SOLUTION
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Levalbuterol 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
levalbuterol inhalation solution immediately and
treat with alternative therapy. (5.1)
Need for more doses of levalbuterol inhalation solution than usual may
be a sign of deterioration of asthma and requires
reevaluation of treatment. (5.2)
Levalbuterol inhalation solution is not a substitute for
corticosteroids. (5.3)
Cardiovascular effects may occur. Consider discontinuation of
levalbuterol 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. Discon