Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)
Unit Dose Services
ALBUTEROL SULFATE
ALBUTEROL 90 ug
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
VENTOLIN HFA is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ® VENTOLIN HFA is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. VENTOLIN HFA is contraindicated in patients with a history of hypersensitivity to albuterol or any other components of VENTOLIN HFA. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. Pregnancy Category C. Teratogenic Effects: There are no adequate and well-controlled studies of 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 preg
NDC:50436-6050-0 in a BOTTLE of 90 AEROSOL, METEREDS
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 INITIAL U.S. APPROVAL: 1981 INDICATIONS AND USAGE VENTOLIN HFA is a beta -adrenergic agonist indicated for: (1) • • DOSAGE AND ADMINISTRATION FOR ORAL INHALATION ONLY. (2) • • • • DOSAGE FORMS AND STRENGTHS Inhalation aerosol: 108 mcg albuterol sulfate (90 mcg albuterol base) from mouthpiece per actuation. Supplied in 18-g canister containing 200 actuations and 8-g canister containing 60 actuations. (3) CONTRAINDICATIONS Hypersensitivity to albuterol sulfate or any of the ingredients of VENTOLIN HFA. (4) WARNINGS AND PRECAUTIONS • • • • ADVERSE REACTIONS Most common adverse reactions (incidence ≥3%) are throat irritation, viral respiratory infections, upper respiratory inflammation, cough, and musculoskeletal pain. (6) 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 • • • SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 4/2014 2 Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1) Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (1.2) Treatment or prevention of bronchospasm in adults and children 4 years of age 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 4 years of age 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 d Izlasiet visu dokumentu