LEVALBUTEROL HYDROCHLORIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Levalbuterol Hydrochloride (UNII: WDQ1526QJM) (Levalbuterol - UNII:EDN2NBH5SS)

Available from:

Prasco Laboratories

INN (International Name):

LEVALBUTEROL HYDROCHLORIDE

Composition:

LEVALBUTEROL 0.31 mg in 3 mL

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levalbuterol HCl 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 HCl 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 HCl 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 HCl Inhalation Solution in pregnant women. There are clinical con

Product summary:

Levalbuterol HCl Inhalation Solution 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 HCl Inhalation Solution is available in a shelf-carton containing one or more foil pouches, each containing 12 unit-dose LDPE vials. Levalbuterol HCl Inhalation Solution 0.31 mg (foil pouch label color green ) contains 0.31 mg of levalbuterol (as 0.36 mg of levalbuterol HCl) and is available in cartons of 24 unit-dose LDPE vials (NDC 66993-021-27). Levalbuterol HCl Inhalation Solution 0.63 mg (foil pouch label color yellow ) contains 0.63 mg of levalbuterol (as 0.73 mg of levalbuterol HCl) and is available in cartons of 24 unit-dose LDPE vials (NDC 66993-022-27). Levalbuterol HCl Inhalation Solution 1.25 mg (foil pouch label color red ) contains 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol HCl) and is available in cartons of 24 unit-dose LDPE vials (NDC 66993-023-27). Storage: Store Levalbuterol HCl Inhalation Solution 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.

Authorization status:

New Drug Application

Summary of Product characteristics

LEVALBUTEROL HYDROCHLORIDE- LEVALBUTEROL HYDROCHLORIDE SOLUTION
PRASCO LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVALBUTEROL HCL
INHALATION SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR LEVALBUTEROL
HCL INHALATION SOLUTION.
LEVALBUTEROL HCL INHALATION SOLUTION
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Levalbuterol HCl 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 HCl Inhalation Solution
immediately and treat with alternative therapy. (5.1)
Need for more doses of Levalbuterol HCl Inhalation Solution than usual
may be a sign of deterioration
of asthma and requires reevaluation of treatment. (5.2)
Levalbuterol HCl Inhalation Solution is not a substitute for
corticosteroids. (5.3)
Cardiovascular effects may occur. Consider discontinuation of
Levalbuterol HCl 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)
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