HIGHLIGHTS OF PRESCRIBING INFORMATION

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

RPK Pharmaceuticals, Inc.

Designación común internacional (DCI):

ALBUTEROL SULFATE

Composición:

ALBUTEROL 90 ug

Vía de administración:

RESPIRATORY (INHALATION)

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

PROAIR 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. PROAIR HFA Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. PROAIR HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other PROAIR 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) ] . Teratogenic Effects: Pregnancy Category C: There are no adequate and well-controlled studies of PROAIR HFA Inhalation Aerosol 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 treated with albuterol. Some of the mothers were tak

Resumen del producto:

Product: 53002-1550 NDC: 53002-1550-1 200 AEROSOL, METERED in a INHALER

Estado de Autorización:

New Drug Application

Ficha técnica

PROAIR HFA- ALBUTEROL SULFATE AEROSOL, METERED
RPK PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROAIR HFA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PROAIR HFA INHALATION AEROSOL
PROAIR HFA (ALBUTEROL SULFATE) INHALATION AEROSOL
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
PROAIR HFA Inhalation Aerosol is a beta -adrenergic agonist indicated
for:
•
•
DOSAGE AND ADMINISTRATION
For oral inhalation only
•
•
•
•
•
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 PROAIR HFA Inhalation
Aerosol Components. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (≥3.0% and >placebo) are headache,
tachycardia, pain, dizziness, pharyngitis, and rhinitis.
(6 .1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TEVA RESPIRATORY, LLC
AT 1-888-482-9522 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
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. 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 PROAIR HFA before using for the first time,
or when the inhaler has not been used for
more than 2 weeks. To prime PROAIR HFA, release 3 sprays into the air
away from the face. Shake well before each
spray. (2.3)
Cle