Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)
Unit Dose Services
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
VENTOLIN® HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease. VENTOLIN HFA is indicated for the prevention of exercise-induced bronchospasm in patients aged 4 years and older. VENTOLIN HFA is contraindicated in patients with a history of hypersensitivity to any of the ingredients [see Warnings and Precautions (5.6), Description (11)] . Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled trials with VENTOLIN HFA or albuterol sulfate in pregnant women. During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients being treated with albuterol. Some of the mothers were taking multiple medications during their pregnancies. No consistent pattern of defects can be discerned, and a relationship between albuterol use and congenital anomalies has not been established. Animal reprod
Product: 50436-0682 NDC: 50436-0682-1 60 AEROSOL, METERED in a INHALER
New Drug Application
VENTOLIN HFA- ALBUTEROL SULFATE AEROSOL, METERED UNIT DOSE SERVICES ---------- 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: • • DOSAGE AND ADMINISTRATION • • • • • 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 • • • • • • • ADVERSE REACTIONS Most common adverse reactions (incidence greater than or equal to 3%) are throat irritation, viral respiratory infections, upper respiratory inflammation, cough, and musculoskeletal pain. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT 1-888-825-5249 OR FDA AT 1-800- FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • • • 2 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) 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 Läs hela dokumentet