ALBUTEROL SULFATE HFA- albuterol sulfate aerosol, metered

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Proficient Rx LP

Njia ya uendeshaji:

RESPIRATORY (INHALATION)

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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. 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) ] . Teratogenic Effects: Pregnancy Category C: There are no adequate and well-controlled studies of Albuterol Sulfate 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 patien

Bidhaa muhtasari:

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 71205-211-85). 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). SHAKE WELL BEFORE USE. Store between 15° and 25°C (59° and 77°F). 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 red actuator supplied with Albuterol Sulfate HFA Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products. The Albuterol Sulfate HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products. Albuterol Sulfate HFA 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 pin mechanism inside the actuator. Discard the Albuterol Sulfate HFA 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 HFA Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Idhini hali ya:

New Drug Application

Tabia za bidhaa

ALBUTEROL SULFATE HFA- ALBUTEROL SULFATE AEROSOL, METERED
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALBUTEROL SULFATE HFA
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALBUTEROL
SULFATE HFA INHALATION
AEROSOL
ALBUTEROL SULFATE HFA INHALATION AEROSOL
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
Albuterol Sulfate HFA Inhalation Aerosol is a beta -adrenergic agonist
indicated for:
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DOSAGE AND ADMINISTRATION
For oral inhalation only
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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 Sulfate HFA
Inhalation Aerosol Components. (4)
WARNINGS AND PRECAUTIONS
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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
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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 Albuterol Sulfate HFA before using for the
first time, or when the inhaler
has not been used for more than 2 weeks. To prime Albuterol Sulfate
HFA, release 3 sprays into the
air away