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:

Actavis Pharma, Inc.

INN (International Name):

LEVALBUTEROL HYDROCHLORIDE

Composition:

LEVALBUTEROL 0.31 mg in 3 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVALBUTEROL HYDROCHLORIDE- LEVALBUTEROL HYDROCHLORIDE SOLUTION
ACTAVIS PHARMA, INC.
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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 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 HCl inhalation solution immediately
and treat with alternative therapy. (5.1)
Need for more doses of levalbuterol HCl inhalation solution than usual
may be a sign of deterioration of asthma and
requires reevaluation of treatment. (5.2)
Levalbuterol HCl inhalation solution is not a substitute for
corticosteroids. (5.3)
Cardiovascular effects may occur. Consider discontinuation of
levalbuterol HCl inhalation solution if these effects occur.
Use with caution in patients with underlying cardiovascular disorders.
(5.4)
Excessive use may be fatal. Do not e