Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
ALBUTEROL SULFATE
ALBUTEROL 90 ug
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
PROAIR HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. PROAIR HFA Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. PROAIR HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other PROAIR HFA Inhalation Aerosol components. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate [see Warnings and Precautions (5.6 )] . Teratogenic Effects: Pregnancy Category C: There are no adequate and well-controlled studies of PROAIR HFA Inhalation Aerosol 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 treated with albuterol. Some of the mothers were tak
PROAIR HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 21695-851-85). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120°F may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children. See FDA-Approved Patient Labeling (17.8) for priming and cleaning instructions. The red actuator supplied with PROAIR HFA Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The PROAIR HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products. The labeled amount of medication in each actuation cannot be assured after 200 actuations, even though the canister may not be completely empty. Discard the inhaler (canister plus actuator) after 200 actuations have been used. Never immerse the canister into water to determine how full the canister is ("float test"). PROAIR HFA Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.
New Drug Application
PROAIR HFA- ALBUTEROL SULFATE AEROSOL, METERED LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PROAIR HFA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PROAIR HFA INHALATION AEROSOL. PROAIR HFA (ALBUTEROL SULFATE) INHALATION AEROSOL INITIAL U.S. APPROVAL: 1981 RECENT MAJOR CHANGES Indications and Usage 9/2008 Dosage and Administration 9/2008 INDICATIONS AND USAGE PROAIR HFA inhalation aerosol is a beta -adrenergic agonist indicated for: 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) DOSAGE AND ADMINISTRATION For oral inhalation only Treatment or prevention of bronchospasm in adults and children 4 years of age and older: 2 inhalations every 4 to 6 hours. In some patients, one 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 PROAIR HFA before using for the first time, or when the inhaler has not been used for more than 2 weeks. To prime PROAIR HFA, release 3 sprays into the air away from the face. Shake well before each spray. (2.3) Cleaning information: At least once a week, wash the actuator with warm water, shake off excess, and air dry thoroughly. (2.3) DOSAGE FORMS AND STRENGTHS Inhalation Aerosol: Each actuation delivers 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). Supplied in 8.5-g canister containing 200 actuations. (3) CONTRAINDICATIONS Hypersensitivity to albuterol and any other PROAIR HFA Inhalation Aerosol Components. (4) WARNINGS AND PRECAUTIONS Life-threatening paradoxical bronchospasm may occur. Discontinue PROAIR HFA immediately and treat with alternative therapy. Olvassa el a teljes dokumentumot