PROAIR HFA- albuterol sulfate aerosol, metered

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN（国際名）:

ALBUTEROL SULFATE

構図:

ALBUTEROL 90 ug

投与経路:

RESPIRATORY (INHALATION)

処方タイプ:

PRESCRIPTION DRUG

適応症:

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

製品概要:

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.

認証ステータス:

New Drug Application

製品の特徴

PROAIR HFA- ALBUTEROL SULFATE AEROSOL, METERED
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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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.