LEVALBUTEROL- levalbuterol solution

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Aurobindo Pharma Limited

INN (Међународно име):

LEVALBUTEROL HYDROCHLORIDE

Састав:

LEVALBUTEROL 0.31 mg in 3 mL

Пут администрације:

RESPIRATORY (INHALATION)

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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) ]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medication, including levalbuterol inhalation solution, 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 levalbu

Резиме производа:

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 carton containing two foil pouches, each containing 12 unit-dose LDPE vials. Levalbuterol Inhalation Solution USP, 0.31 mg (foil pouch label color green) contains 0.31 mg of levalbuterol (as 0.36 mg of levalbuterol hydrochloride USP) and is available in cartons of 24 unit-dose LDPE vials.      NDC 65862-943-24 Levalbuterol Inhalation S olution USP, 0.63 m g (foil pouch label color yellow) contains 0.63 mg of levalbuterol (as 0.73 mg of levalbuterol hydrochloride USP) and is available in cartons of 24 unit-dose LDPE vials.      NDC 65862-944-24 Levalbuterol Inhalation S olution USP, 1.25 mg (foil pouch label color blue) contains 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol hydrochloride USP) and is available in cartons of 24 unit-dose LDPE vials.      NDC 65862-945-24 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.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

LEVALBUTEROL - LEVALBUTEROL SOLUTION
AUROBINDO PHARMA LIMITED
----------
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, FOR INHALATION USE
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