VENTOLIN HFA- albuterol sulfate aerosol, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

A-S Medication Solutions

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

VENTOLIN HFA is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. VENTOLIN HFA is indicated for the prevention of exercise-induced bronchospasm in adult and pediatric 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)] . 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 and postmarketing case reports of pregnancy ou

Product summary:

Product: 50090-1159 NDC: 50090-1159-0 200 AEROSOL, METERED in a INHALER / 1 in a CARTON

Authorization status:

New Drug Application

Summary of Product characteristics

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 USE
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: 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 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 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 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.