LEVALBUTEROL HYDROCHLORIDE solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Impax Generics

INN (International namn):

LEVALBUTEROL HYDROCHLORIDE

Sammansättning:

LEVALBUTEROL 1.25 mg in 3 mL

Receptbelagda typ:

PRESCRIPTION DRUG

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

LEVALBUTEROL HYDROCHLORIDE- LEVALBUTEROL HYDROCHLORIDE SOLUTION
IMPAX GENERICS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVALBUTEROL HCL INHALATION
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LEVALBUTEROL HCL INHALATION
SOLUTION.
LEVALBUTEROL HYDROCHLORIDE INHALATION SOLUTION, FOR INHALATION USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Levalbuterol HCl 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 3 times a day, by
nebulization. Routine dosing should not exceed 0.63
mg 3 times a day. (2)
_Adults and Adolescents _≥ _12 Years Old: _0.63 mg administered 3
times a day, every 6 to 8 hours, by nebulization. The
maximum recommended dose is 1.25 mg 3 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)
Immedi