দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)
Proficient Rx LP
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
Albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. Albuterol sulfate inhalation aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. Albuterol sulfate inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other albuterol sulfate 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)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications during pregnancy. For more information, contact the Mothers To Baby Pregnancy Studies conducted by the Organization of Teratology Information Specialists at 1-877-311-8972 or visit http://mothertobaby.org/pre
Albuterol sulfate inhalation aerosol is supplied as a pressurized aluminum canister with a blue plastic actuator with a dose indicator and green dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 71205-732-85). 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 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120o 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 (17.9) for priming and cleaning instructions. The blue actuator supplied with albuterol sulfate inhalation aerosol should not be used with the canister from any other inhalation aerosol products. The albuterol sulfate inhalation aerosol canister should not be used with the actuator from any other inhalation aerosol products. Albuterol sulfate inhalation aerosol has a dose indicator attached to the actuator. Patients should never try to alter the numbers for the dose indicator or tamper with the dose indicator button mechanism. Discard the albuterol sulfate inhalation aerosol when the indicator displays 0 or after the expiration date on the product, whichever comes first. The labeled amount of medication in each actuation cannot be assured after the indicator displays 0, even though the canister is not completely empty and will continue to operate. Never immerse the canister into water to determine how full the canister is ("float test"). Albuterol sulfate inhalation aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.
Abbreviated New Drug Application
ALBUTEROL SULFATE- ALBUTEROL SULFATE AEROSOL, METERED PROFICIENT RX LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ALBUTEROL SULFATE INHALATION AEROSOL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALBUTEROL SULFATE INHALATION AEROSOL. ALBUTEROL SULFATE INHALATION AEROSOL, FOR ORAL USE. INITIAL U.S. APPROVAL: 1981 INDICATIONS AND USAGE Albuterol sulfate 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 albuterol sulfate inhalation aerosol before using for the first time, or when the inhaler has not been used for more than 2 weeks. To prime albuterol sulfate inhalation aerosol, 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) • Albuterol sulfate inhalation aerosol inhaler should be discarded when the dose indicator displays 0 or after the expiration date on the product, whichever comes first. (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 albuterol sulfate inhal সম্পূর্ণ নথি পড়ুন