Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
LEVALBUTEROL HYDROCHLORIDE (UNII: WDQ1526QJM) (LEVALBUTEROL - UNII:EDN2NBH5SS)
Cardinal Health
LEVALBUTEROL HYDROCHLORIDE
LEVALBUTEROL 1.25 mg in 0.5 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
LEVALBUTEROL HYDROCHLORIDE- LEVALBUTEROL HYDROCHLORIDE SOLUTION CARDINAL HEALTH ---------- 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, USP (CONCENTRATE) FOR INHALATION USE INITIAL U.S. APPROVAL: 1999 INDICATIONS AND USAGE Levalbuterol inhalation solution, USP (concentrate) is a beta -adrenergic agonist indicated for: • DOSAGE AND ADMINISTRATION • • • • • DOSAGE FORMS AND STRENGTHS Inhalation Solution Concentrate (unit-dose vial for nebulization): 1.25 mg/0.5 mL. Dilute before use. (3) CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • • • ADVERSE REACTIONS Most common adverse reactions are: palpitations, chest pain, tachycardia, headache, dizziness, tremor and nervousness. (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN PHARMACEUTICALS INC. AT 1-877-446-3679 (1-877- 4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • • • • 2 Treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. (1) 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 3 times a day, by nebulization. Routine dosing should not exceed 0.63 mg 3 times a day. (2) _Adults and Adolescents _≥ _12 Years Old: _0.63 mg administered 3 times a day, every 6 to 8 hours, by nebulization. The maximum recommended dose is 1.25 mg 3 times a day. (2) For use with a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor. (2) Hypersensitivity to levalbuterol or racemic albuterol. (4) Life-threatening paradoxical bronchospasm may occur. Discontinue levalbuterol inhalation solution Διαβάστε το πλήρες έγγραφο