LEVALBUTEROL INHALATION SOLUTION solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

NorthStar RxLLC

Toedieningsweg:

RESPIRATORY (INHALATION)

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 levalbuterol inhalation solution in pregnant women. There are clinical considerations with

Product samenvatting:

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 shelf carton containing five foil pouches, each containing 5 unit-dose LDPE vials. The strength 0.31 mg/3 mL of levalbuterol inhalation solution, USP is also available in a shelf carton containing six foil pouches, each containing 5 unit-dose LDPE vials. Levalbuterol inhalation solution, USP, 0.31 mg contains 0.31 mg of levalbuterol (as 0.36 mg of levalbuterol HCl) and is available in cartons of 25 unit-dose LDPE vials (NDC 16714-094-25) and 30 unit-dose LDPE vials (NDC 16714-094-30). Levalbuterol inhalation solution, USP, 0.63 mg contains 0.63 mg of levalbuterol (as 0.73 mg of levalbuterol HCl) and is available in cartons of 25 unit-dose LDPE vials (NDC 16714-095-25). Levalbuterol inhalation solution, USP, 1.25 mg contains 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol HCl) and is available in cartons of 25 unit-dose LDPE vials (NDC 16714-096-25). Storage: Store levalbuterol inhalation solution, USP in the protective foil pouch at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°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.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

LEVALBUTEROL INHALATION SOLUTION - LEVALBUTEROL INHALATION
SOLUTION SOLUTION
NORTHSTAR RXLLC
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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
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 hypersensitivit