PROAIR HFA albuterol sulfate aerosol metered

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

REMEDYREPACK INC.

INN (Nome Internazionale):

ALBUTEROL SULFATE

Composizione:

ALBUTEROL 90 ug

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

PROAIR HFA- ALBUTEROL SULFATE AEROSOL, METERED
REMEDYREPACK INC.
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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
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)
PROAIR HFA inhaler should be discarded when the dose counter 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 PROAIR HFA Inhalation
Aerosol Components. ( 4)
WARNINGS AND PRECAUTIONS
Life-threatening paradoxical bronchospasm may occur. Discontinue
PROAIR HFA immediately and treat wi