VENTOLIN HFA albuterol sulfate aerosol metered

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

REMEDYREPACK INC.

INN (International Nazwa):

ALBUTEROL SULFATE

Skład:

ALBUTEROL 90 ug

Typ recepty:

PRESCRIPTION DRUG

Status autoryzacji:

New Drug Application

Charakterystyka produktu

VENTOLIN 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
VENTOLIN HFA SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR VENTOLIN HFA.
VENTOLIN HFA (ALBUTEROL SULFATE) INHALATION AEROSOL
FOR ORAL INHALATION
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
VENTOLIN HFA is a beta
-adrenergic agonist indicated for:
Treatment or prevention of bronchospasm in patients aged 4 years and
older with reversible obstructive airway
disease. ( 1.1)
Prevention of exercise-induced bronchospasm in patients aged 4 years
and older. (1.2)
DOSAGE AND ADMINISTRATION
For oral inhalation only. (2)
Treatment or prevention of bronchospasm in adults and children aged 4
years and older: 2 inhalations every 4 to 6
hours. For some patients, 1 inhalation every 4 hours may be
sufficient. (2.1)
Prevention of exercise-induced bronchospasm in adults and children
aged 4 years and older: 2 inhalations 15 to 30
minutes before exercise. (2.2)
Priming information: Prime VENTOLIN 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
VENTOLIN HFA, release 4 sprays into the air
away from the face, shaking well before each spray. (2.3)
Cleaning information: At least once a week, wash the actuator with
warm water and let it air-dry completely. (2.3)
DOSAGE FORMS AND STRENGTHS
Inhalation Aerosol. Inhaler containing 108 mcg albuterol sulfate (90
mcg albuterol base) as an aerosol formulation for oral
inhalation. (3)
CONTRAINDICATIONS
Hypersensitivity to any ingredient. (4)
WARNINGS AND PRECAUTIONS
Life-threatening paradoxical bronchospasm may occur. Discontinue
VENTOLIN HFA immediately and institute
alternative therapy. (5.1)
Need for more doses of VENTOLIN HFA than usual may be a sign of
deterioration of asthma and requires reevaluation
of treatment. (5.2)
VENTOLIN HFA is not a substitute for corticosteroids. (5.3)
Cardiovascular effects