VENTOLIN HFA- albuterol sulfate aerosol, metered

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Unit Dose Services

INN (Alþjóðlegt nafn):

ALBUTEROL SULFATE

Samsetning:

ALBUTEROL 90 ug

Stjórnsýsluleið:

RESPIRATORY (INHALATION)

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

VENTOLIN HFA is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ® VENTOLIN HFA is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. VENTOLIN HFA is contraindicated in patients with a history of hypersensitivity to albuterol or any other components of VENTOLIN HFA. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. Pregnancy Category C. Teratogenic Effects: There are no adequate and well-controlled studies of 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 preg

Vörulýsing:

NDC:50436-6050-0 in a BOTTLE of 90 AEROSOL, METEREDS

Leyfisstaða:

New Drug Application

Vara einkenni

VENTOLIN HFA- ALBUTEROL SULFATE AEROSOL, METERED
UNIT DOSE SERVICES
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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 INITIAL
U.S. APPROVAL: 1981
INDICATIONS AND USAGE
VENTOLIN HFA is a beta -adrenergic agonist indicated for:
(1)
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DOSAGE AND ADMINISTRATION
FOR ORAL INHALATION ONLY. (2)
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DOSAGE FORMS AND STRENGTHS
Inhalation aerosol: 108 mcg albuterol sulfate (90 mcg albuterol base)
from mouthpiece per actuation. Supplied in 18-g
canister containing 200 actuations and 8-g canister containing 60
actuations. (3)
CONTRAINDICATIONS
Hypersensitivity to albuterol sulfate or any of the ingredients of
VENTOLIN HFA. (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)
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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SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 4/2014
2
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)
Treatment or prevention of bronchospasm in adults and children 4 years
of age 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 4
years of age 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 d