Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)
Preferred Pharmaceuticals Inc.
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
Albuterol Sulfate HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. Albuterol Sulfate HFA is indicated for the prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. Albuterol Sulfate HFA is contraindicated in patients with a history of hypersensitivity to any of the ingredients [see Warnings and Precautions (5.6), Description (11)] . 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 MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists at 1‑877-311-8972 or visit https://mothertobaby.org/ongoing-study/asthma/. Risk Summary There are no randomized clinical studies of use of albuterol sulfate during pregnancy. Available data from epidemiological studies
Albuterol Sulfate HFA Inhalation Aerosol is supplied in the following box of 1 as a pressurized aluminum canister fitted with a counter and supplied with a blue plastic actuator with a blue cap: NDC 68788-7353-2 18-g canister containing 200 actuations Each inhaler is packaged with a Patient Information leaflet. The blue actuator supplied with Albuterol Sulfate HFA should not be used with any other product canisters, and actuators from other products should not be used with an Albuterol Sulfate HFA canister. Counter Albuterol Sulfate HFA has a counter attached to the canister. The counter starts at 204 and counts down each time a spray is released. The correct amount of medication in each actuation cannot be assured after the counter reads 000, even though the canister is not completely empty and will continue to operate. The inhaler should be discarded when the counter reads 000. Contents Under Pressure Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw canister into fire or incinerator. Storage Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use.
New Drug Application Authorized Generic
ALBUTEROL SULATE HFA- ALBUTEROL SULFATE AEROSOL, METERED PREFERRED PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ALBUTEROL SULFATE HFA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALBUTEROL SULFATE HFA. ALBUTEROL SULFATE HFA INHALATION AEROSOL, FOR ORAL INHALATION USE INITIAL U.S. APPROVAL: 1981 INDICATIONS AND USAGE Albuterol Sulfate HFA is a beta -adrenergic agonist indicated for: • • DOSAGE AND ADMINISTRATION • • • • • DOSAGE FORMS AND STRENGTHS Inhalation aerosol: 108 mcg albuterol sulfate (90 mcg albuterol base) per actuation. (3) CONTRAINDICATIONS Hypersensitivity to any ingredient. (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. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PRASCO LABORATORIES AT 1-866-525-0688 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • • 2 Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. (1.1) Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. (1.2) For oral inhalation only. (2) Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation every 4 to 6 hours. For some patients, 1 inhalation every 4 hours may be sufficient. (2.1) Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation 15 to 30 minutes before exercise. (2.2) Priming information: Prime Albuterol Sulfate 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 Albuterol Sulfate HFA, release 4 sprays into the air away fro Прочитать полный документ