LEVALBUTEROL solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

REMEDYREPACK INC.

Vartojimo būdas:

RESPIRATORY (INHALATION)

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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) ]. Risk Summary There are no adequate and well-controlled studies of levalbuterol inhalation solution in pregnant women. There are clinical considerations with the use of levalbuterol inhalation solution in pregnant women [see Clinical Considerations]. Following oral administration of levelbuterol HCl to pregnant rabbits, there was no evidence of teratogenicity at doses up to 25 mg/kg/day [approximately 108 times the maximum recommended human daily inhalation dose (MRHDID) of levalbute

Produkto santrauka:

Levalbuterol Inhalation Solution USP, 1.25 mg (foil pouch label color maroon) contains 1.25 mg (0.042%) of levalbuterol (as 1.44 mg of levalbuterol HCl) and is available in NDC: 70518-2760-00 PACKAGING: 6 in 1 CARTON, 5 in 1 POUCH, 3 Ml in 1 VIAL SINGLE DOSE TYPE 0 Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 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.

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

REMEDYREPACK INC.
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PATIENT INFORMATION
Levalbuterol (lev al BUE ter ol)
Inhalation Solution
0.31 mg, 0.63 mg, 1.25 mg
3 mL Unit-Dose Vials
Revised: 1/2022
Document Id: d6e8466e-7189-d436-e053-2995a90a68f5
34391-3
Set id: 97f86359-9388-4ec2-95e9-65ad327a5d5b
Version: 2
Effective Time: 20220131
REMEDYREPACK INC.

Prekės savybės

LEVALBUTEROL- LEVALBUTEROL SOLUTION
REMEDYREPACK INC.
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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 hypersensitivity reactions may occur. Discont