ALBUTEROL SULFATE HFA- albuterol sulfate aerosol, metered

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)

Доступна с:

Prasco Laboratories

Администрация маршрут:

RESPIRATORY (INHALATION)

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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

Обзор продуктов:

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 66993-019-68     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.

Статус Авторизация:

New Drug Application Authorized Generic

Характеристики продукта

ALBUTEROL SULFATE HFA- ALBUTEROL SULFATE AEROSOL, METERED
PRASCO LABORATORIES
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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:
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DOSAGE AND ADMINISTRATION
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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
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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
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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 from the face