ALBUTEROL SULFATE HFA- albuterol sulfate aerosol, metered

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

H.J. Harkins Company, Inc.

Via di somministrazione:

RESPIRATORY (INHALATION)

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

1.1 Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. 1.2 Exercise-Induced Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. Albuterol Sulfate HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other Albuterol Sulfate HFA 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)]. 8.1 Pregnancy 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

Dettagli prodotto:

Albuterol Sulfate HFA Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator with a dose counter and white dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 0093-3174-31). Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

ALBUTEROL SULFATE HFA- ALBUTEROL SULFATE AEROSOL, METERED
H.J. HARKINS COMPANY, INC.
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1171 ALBUTEROL (PROAIR)
1.1 Bronchospasm
Albuterol Sulfate HFA Inhalation Aerosol is indicated for the
treatment or prevention of bronchospasm
in patients 4 years of age and older with reversible obstructive
airway disease.
1.2 Exercise-Induced Bronchospasm
Albuterol Sulfate HFA Inhalation Aerosol is indicated for the
prevention of exercise-induced
bronchospasm in patients 4 years of age and older.
2.1 Bronchospasm
For treatment of acute episodes of bronchospasm or prevention of
symptoms associated with
bronchospasm, the usual dosage for adults and children 4 years and
older is two inhalations repeated
every 4 to 6 hours. More frequent administration or a larger number of
inhalations is not recommended.
In some patients, one inhalation every 4 hours may be sufficient.
2.2 Exercise-Induced Bronchospasm
The usual dosage for adults and children 4 years of age or older is
two inhalations 15 to 30 minutes
before exercise.
2.3 Administration Information
Administer Albuterol Sulfate HFA by oral inhalation only. Shake well
before each spray. To maintain
proper use of this product and to prevent medication build-up and
blockage, it is important to follow the
cleaning directions carefully.
Priming: Prime the inhaler before using for the first time and in
cases where the inhaler has not been
used for more than 2 weeks by releasing three sprays into the air,
away from the face.
Cleaning: As with all HFA-containing albuterol inhalers, to maintain
proper use of this product and to
prevent medication build-up and blockage, it is important to clean the
plastic mouthpiece regularly. The
inhaler may cease to deliver medication if the plastic actuator
mouthpiece is not properly cleaned and
dried. To clean: Wash the plastic mouthpiece with warm running water
for 30 seconds, shake off excess
water, and air dry thoroughly at least once a week. If the patient has
more than one Albuterol Sulfate
HFA inhaler, the patient should wash each one s