Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
LEVALBUTEROL HYDROCHLORIDE (UNII: WDQ1526QJM) (LEVALBUTEROL - UNII:EDN2NBH5SS)
Aurobindo Pharma Limited
LEVALBUTEROL HYDROCHLORIDE
LEVALBUTEROL 1.25 mg in 0.5 mL
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
LEVALBUTEROL - LEVALBUTEROL SOLUTION, CONCENTRATE AUROBINDO PHARMA LIMITED ---------- 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 Lees het volledige document