LEVALBUTEROL- levalbuterol hydrochloride solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

NuCare Pharmaceuticals,Inc.

Toedieningsweg:

RESPIRATORY (INHALATION)

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Levalbuterol Inhalation Solution, USP 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, USP 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 Levalbuterol Inhalation Solution, USP in pregnant women. Because animal reproduction studies are not always predictive of human response, Levalbuterol Inhalation Solution, USP 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 reporte

Product samenvatting:

Levalbuterol Inhalation Solution, USP, 1.25 mg/3 mL ( foil pouch label color red ) contains 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl) and is available in cartons as listed below. NDC 68071-5027-5 vials per carton / 25 vials per foil pouch Store Levalbuterol Inhalation Solution, USP in the protective foil pouch at 20°- 25°C (68°- 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. Rx only

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

LEVALBUTEROL- LEVALBUTEROL HYDROCHLORIDE SOLUTION
NUCARE PHARMACEUTICALS,INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
LEVALBUTEROL INHALATION SOLUTION, USP
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVALBUTEROL
INHALATION SOLUTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
LEVALBUTEROL INHALATION SOLUTION, USP.
LEVALBUTEROL INHALATION SOLUTION, USP, FOR INHALATION USE
INITIAL U.S. APPROVAL: 1999
RX ONLY
INDICATIONS AND USAGE
Levalbuterol Inhalation Solution, USP 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
Levalbuterol Inhalation Solution,
USP immediately and treat with alternative therapy. ( 5.1)
Need for more doses of Levalbuterol Inhalation Solution, USP than
usual may be a sign of deterioration
of asthma and requires reevaluation of treatment. ( 5.2)
Levalbuterol Inhalation Solution, USP is not a substitute for
corticosteroids. ( 5.3)
Cardiovascular effects may occur. Consider discontinuation of
Levalbuterol Inhalation Solution, USP if
these effects occur. Use with caution in patients with underlying
cardiovascular disorde