VENTOLIN HFA- albuterol sulfate aerosol, metered

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

A-S Medication Solutions

طريقة التعاطي:

RESPIRATORY (INHALATION)

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

VENTOLIN HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease. VENTOLIN HFA is indicated for the prevention of exercise-induced bronchospasm in patients aged 4 years and older. VENTOLIN HFA is contraindicated in patients with a history of hypersensitivity to any of the ingredients [see Warnings and Precautions (5.6), Description (11)] . Teratogenic Effects Pregnancy Category C. There are no adequate and well-controlled trials with VENTOLIN HFA 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 being treated with albuterol. Some of the mothers were taking multiple medications during their pregnancies. No consistent pattern of defects can be discerned, and a relationship between albuterol use and congenital anomalies has not been established. Animal reproducti

ملخص المنتج:

Product: 50090-1158 NDC: 50090-1158-0 60 AEROSOL, METERED in a INHALER / 1 in a CARTON

الوضع إذن:

New Drug Application

خصائص المنتج

VENTOLIN HFA- ALBUTEROL SULFATE AEROSOL, METERED
A-S MEDICATION SOLUTIONS
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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:
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DOSAGE AND ADMINISTRATION
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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
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ADVERSE REACTIONS
Most common adverse reactions (incidence greater than or equal to 3%)
are throat irritation, viral respiratory infections,
upper respiratory inflammation, cough, and musculoskeletal pain. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT
1-888-825-5249 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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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)
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