国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)
REMEDYREPACK INC.
ALBUTEROL SULFATE
ALBUTEROL 90 ug
PRESCRIPTION DRUG
New Drug Application
VENTOLIN HFA- ALBUTEROL SULFATE AEROSOL, METERED REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VENTOLIN HFA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VENTOLIN HFA. VENTOLIN HFA (ALBUTEROL SULFATE) INHALATION AEROSOL FOR ORAL INHALATION INITIAL U.S. APPROVAL: 1981 INDICATIONS AND USAGE VENTOLIN HFA is a beta -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease. ( 1.1) Prevention of exercise-induced bronchospasm in patients aged 4 years and older. (1.2) DOSAGE AND ADMINISTRATION For oral inhalation only. (2) Treatment or prevention of bronchospasm in adults and children aged 4 years and older: 2 inhalations every 4 to 6 hours. For some patients, 1 inhalation every 4 hours may be sufficient. (2.1) Prevention of exercise-induced bronchospasm in adults and children aged 4 years and older: 2 inhalations 15 to 30 minutes before exercise. (2.2) Priming information: Prime VENTOLIN HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime VENTOLIN HFA, release 4 sprays into the air away from the face, shaking well before each spray. (2.3) Cleaning information: At least once a week, wash the actuator with warm water and let it air-dry completely. (2.3) DOSAGE FORMS AND STRENGTHS Inhalation Aerosol. Inhaler containing 108 mcg albuterol sulfate (90 mcg albuterol base) as an aerosol formulation for oral inhalation. (3) CONTRAINDICATIONS Hypersensitivity to any ingredient. (4) WARNINGS AND PRECAUTIONS Life-threatening paradoxical bronchospasm may occur. Discontinue VENTOLIN HFA immediately and institute alternative therapy. (5.1) Need for more doses of VENTOLIN HFA than usual may be a sign of deterioration of asthma and requires reevaluation of treatment. (5.2) VENTOLIN HFA is not a substitute for corticosteroids. (5.3) Cardiovascular effects 阅读完整的文件