ALBUTEROL SULFATE HFA- 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:

Preferred Relabeled By: Preferred Pharmaceuticals Inc.

Stjórnsýsluleið:

RESPIRATORY (INHALATION)

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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)] . 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 MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists at 1‑877-311-8972 or visit https://mothertobaby.org/ongoing-study/asthma/. Risk Summary There are no randomized clinical studies of use of albuterol sulfate during pregnancy. Available data from epidemiological studies and postmarketing case reports of pregna

Vörulýsing:

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 cap: 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. 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.

Leyfisstaða:

New Drug Application

Vara einkenni

ALBUTEROL SULFATE HFA- ALBUTEROL SULFATE AEROSOL, METERED
PREFERRED RELABELED BY: PREFERRED 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 USE
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
Albuterol Sulfate HFA is a beta -adrenergic agonist indicated for:
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DOSAGE AND ADMINISTRATION
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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
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ADVERSE REACTIONS
Most common adverse reactions (incidence ≥3%) are throat irritation,
viral respiratory infections, upper
respiratory inflammation, cough, and musculoskeletal pain. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PRASCO LABORATORIES AT
1-866-525-0688
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 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)
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, shak