VENTOLIN HFA- albuterol sulfate aerosol, metered

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

GlaxoSmithKline LLC

INN (Internationale Bezeichnung):

ALBUTEROL SULFATE

Zusammensetzung:

ALBUTEROL 90 ug

Verabreichungsweg:

RESPIRATORY (INHALATION)

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

VENTOLIN HFA is supplied in the following boxes of 1 as a pressurized aluminum canister fitted with a counter and supplied with a blue plastic actuator with a blue cap: Each inhaler is packaged with a Patient Information leaflet. The blue actuator supplied with VENTOLIN HFA should not be used with any other product canisters, and actuators from other products should not be used with a VENTOLIN HFA canister. Counter VENTOLIN HFA has a counter attached to the canister. The counter starts at 204 or 064 and counts down each time a spray is released. The correct amount of medication in each actuation cannot be assured after the counter reads 000, even though the canister is not completely empty and will continue to operate. The inhaler should be discarded when the counter reads 000. Contents Under Pressure Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw canister into fire or incinerator. Storage Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use.

Berechtigungsstatus:

New Drug Application

Fachinformation

VENTOLIN HFA- ALBUTEROL SULFATE AEROSOL, METERED
GLAXOSMITHKLINE LLC
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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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2
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. (2.3)