ALBUTEROL SULATE 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:

NuCare Pharmaceuticals,Inc.

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 aged 4 years and older with reversible obstructive airway disease. Albuterol Sulfate HFA is indicated for the prevention of exercise-induced bronchospasm in patients aged 4 years and older. Albuterol Sulfate 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 albuterol sulfate 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 an

Bidhaa muhtasari:

Albuterol Sulfate HFA Inhalation Aerosol is supplied in the following box of 1 as a pressurized aluminum canister fitted with a counter and supplied with a blue plastic actuator with a blue strapcap: Each inhaler is sealed in a moisture-protective foil pouch with a desiccant that should be discarded when the pouch is opened. Each inhaler is packaged with a Patient Information leaflet. The blue actuator supplied with Albuterol Sulfate HFA should not be used with any other product canisters, and actuators from other products should not be used with an Albuterol Sulfate HFA canister. Albuterol Sulfate HFA has a counter attached to the canister. The counter starts at 204 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.

Idhini hali ya:

New Drug Application Authorized Generic

Tabia za bidhaa

ALBUTEROL SULATE HFA- ALBUTEROL SULFATE AEROSOL, METERED
NUCARE PHARMACEUTICALS,INC.
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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.
ALBUTEROL SULFATE HFA INHALATION AEROSOL
FOR ORAL INHALATION
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
Albuterol Sulfate HFA is a beta
-adrenergic agonist indicated for:
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)
DOSAGE AND ADMINISTRATION
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 Albuterol Sulfate 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 Albuterol
Sulfate HFA, release 4 sprays into the air away from the face, shaking
well before each spray. (2.3)
Cleaning information: At least once a week, wash the actuator with
warm water and let it air-dry
completely. (2.3)
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
Life-threatening paradoxical bronchospasm may occur. Discontinue
Albuterol Sulfate HFA immediately
and institute alternative therapy. (5.1)
Need for more doses of Albuterol Sulfate HFA than usual may be a sign
of deterioration of asthma and
requires reevaluation of treatment. (5.2)
Albuterol Sul