LEVALBUTEROL- levalbuterol solution, concentrate

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Aurobindo Pharma Limited

ИНН (Международная Имя):

LEVALBUTEROL HYDROCHLORIDE

состав:

LEVALBUTEROL 1.25 mg in 0.5 mL

Администрация маршрут:

RESPIRATORY (INHALATION)

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Levalbuterol inhalation solution (concentrate) 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 levalbuterol inhalation solutio

Обзор продуктов:

Levalbuterol Inhalation Solution, USP (Concentrate) ( foil pouch label color red ) is supplied in 0.5 mL unit-dose, low-density polyethylene (LDPE) vials, and is a clear, colorless, sterile, preservative-free, aqueous solution. Each vial contains 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol hydrochloride USP) and is available in cartons of 30 individually pouched vials. Carton of 30 pouches        NDC 65862-942-03 Store levalbuterol inhalation solution, USP (concentrate) 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. Open the foil pouch just prior to administration. Once the foil pouch is opened, the contents of the vial should be used immediately. Discard any vial if the solution is not colorless. Dilute levalbuterol inhalation solution, USP (concentrate) with sterile normal saline before administration by nebulization.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

LEVALBUTEROL - LEVALBUTEROL SOLUTION, CONCENTRATE
AUROBINDO PHARMA LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVALBUTEROL
INHALATION SOLUTION (CONCENTRATE) SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR LEVALBUTEROL INHALATION SOLUTION (CONCENTRATE).
LEVALBUTEROL INHALATION SOLUTION (CONCENTRATE), FOR INHALATION USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Levalbuterol inhalation solution (concentrate) 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)
Dilute levalbuterol inhalation solution (concentrate) with sterile
normal saline before administration by
nebulization.
_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 Concentrate (unit-dose vial for nebulization):
1.25 mg/0.5 mL Dilute before use. (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
effe