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:

NuCare Pharmaceuticals,Inc.

Stjórnsýsluleið:

RESPIRATORY (INHALATION)

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. Albuterol sulfate inhalation aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. Albuterol sulfate inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other albuterol sulfate inhalation aerosol components. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate [see Warnings and Precautions (5.6)] . 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 Mothers To Baby Pregnancy Studies conducted by the Organization of Teratology Information Specialists at 1-877-311-8972 or visit http://mothertob

Vörulýsing:

Albuterol sulfate inhalation aerosol is supplied as a pressurized aluminum canister with a white plastic actuator with a dose counter and red dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 68071-5206-2). SHAKE WELL BEFORE USE. Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120°F may cause bursting. For best results, canister should be at room temperature before use. Avoid spraying in eyes. Keep out of reach of children. See FDA-Approved Patient Labeling (17.9) for priming and cleaning instructions. The white actuator supplied with albuterol sulfate inhalation aerosol should not be used with the canister from any other inhalation aerosol products. The albuterol sulfate inhalation aerosol canister should not be used with the actuator from any other inhalation aerosol products. Albuterol sulfate inhalation aerosol inhaler has a dose counter attached to the actuator. Patients should never try to alter the numbers for the dose counter or tamper with the parts inside the actuator. Discard the albuterol sulfate inhalation aerosol inhaler when the counter displays 0 or after the expiration date on the product, whichever comes first. The labeled amount of medication in each actuation cannot be assured after the counter displays 0, even though the canister is not completely empty and will continue to operate. Never immerse the canister into water to determine how full the canister is ("float test"). Albuterol sulfate inhalation aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

ALBUTEROL SULFATE- ALBUTEROL SULFATE AEROSOL, METERED
NUCARE PHARMACEUTICALS,INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALBUTEROL SULFATE
INHALATION AEROSOL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR ALBUTEROL
SULFATE INHALATION AEROSOL.
ALBUTEROL SULFATE INHALATION AEROSOL
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
Albuterol sulfate inhalation aerosol is a beta
-adrenergic agonist indicated for: (1)
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)
DOSAGE AND ADMINISTRATION
For oral inhalation only (2)
Treatment or prevention of bronchospasm in adults and children 4 years
of age and older: 2 inhalations
every 4 to 6 hours. In some patients, one 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 albuterol sulfate inhalation aerosol before
using for the first time, or when
the inhaler has not been used for more than 2 weeks. To prime
albuterol sulfate inhalation aerosol,
release 3 sprays into the air away from the face. Shake well before
each spray. (2.3)
Cleaning information: At least once a week, wash the actuator with
warm water, shake off excess, and
air dry thoroughly. (2.3)
Albuterol sulfate inhalation aerosol inhaler should be discarded when
the dose counter displays a solid
red background with a large 0 or after the expiration date on the
product, whichever comes first. (2.3)
DOSAGE FORMS AND STRENGTHS
Inhalation Aerosol: Each actuation delivers 108 mcg of albuterol
sulfate from the actuator mouthpiece
(equivalent to 90 mcg of albuterol base). Supplied in 8.5-g canister
containing 200 actuations. (3)
CONTRAINDICATIONS
Hypersensitivity to albuterol and any other Albuterol sul