البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
LEVALBUTEROL HYDROCHLORIDE (UNII: WDQ1526QJM) (LEVALBUTEROL - UNII:EDN2NBH5SS)
Actavis Pharma, Inc.
LEVALBUTEROL HYDROCHLORIDE
LEVALBUTEROL 0.31 mg in 3 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
LEVALBUTEROL HYDROCHLORIDE- LEVALBUTEROL HYDROCHLORIDE SOLUTION ACTAVIS PHARMA, INC. ---------- 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 HYDROCHLORIDE INHALATION SOLUTION, FOR INHALATION USE 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 e اقرأ الوثيقة كاملة