LEVALBUTEROL solution, concentrate

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Mylan Pharmaceuticals Inc.

INN (nume internaţional):

LEVALBUTEROL HYDROCHLORIDE

Compoziție:

LEVALBUTEROL 1.25 mg in 0.5 mL

Calea de administrare:

RESPIRATORY (INHALATION)

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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)] . 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. There are no adequate and well-controlled studies of levalbuterol inhalation solution (concentrate) in pregnant women. There are clinical considerations with the use of le

Rezumat produs:

Levalbuterol Inhalation Solution, USP (Concentrate) is supplied in 0.5 mL unit-dose, low-density polyethylene (LDPE) vials as a clear, colorless, sterile, preservative-free, aqueous solution. Each vial contains 1.25 mg/0.5 mL of levalbuterol (as 1.44 mg of levalbuterol hydrochloride) and is available in a shelf-carton containing 30 (NDC 0378-6993-93) individually wrapped foil pouches, each containing one unit-dose vial. Store levalbuterol inhalation solution (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 (concentrate) with sterile normal saline before administration by nebulization.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

LEVALBUTEROL- LEVALBUTEROL SOLUTION, CONCENTRATE
MYLAN PHARMACEUTICALS INC.
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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)
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Levalbuterol inhalation solution (concentrate) is a beta -adrenergic
agonist indicated for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Inhalation Solution Concentrate (unit-dose vial for nebulization):
1.25 mg/0.5 mL. Dilute before use. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions are: palpitations, chest pain,
tachycardia, headache, dizziness, tremor and nervousness.
(6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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2
Treatment or prevention of bronchospasm in adults, adolescents, and
children 6 years of age and older with
reversible obstructive airway disease. (1)
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)
Hypersensitivity to levalbuterol or racemic albuterol. (4)
Life-threatening paradoxical bronchospasm may occur. Discontinue
levalbuterol inhalation solution immediately and
treat with alternative