VENTOLIN HFA- albuterol sulfate aerosol, metered

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Lake Erie Medical DBA Quality Care Products LLC

INN（国际名称）:

ALBUTEROL SULFATE

组成:

ALBUTEROL SULFATE 108 ug

给药途径:

RESPIRATORY (INHALATION)

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 reprod

產品總結:

VENTOLIN HFA Inhalation Aerosol 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 strapcap: 35356-166-08 35356-166-02 35356-166-01 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. VENTOLIN HFA has a counter attached to the canister. The counter starts at 204 or 64 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 or 12 months after removal from the moisture-protective foil pouch, whichever comes first. Keep out of reach of children. Avoid spraying in eyes. 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. 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. SHAKE WELL BEFORE EACH SPRAY.

授权状态:

New Drug Application

产品特点

VENTOLIN HFA- ALBUTEROL SULFATE AEROSOL, METERED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS 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
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)
Cl