FLUTICASONE PROPIONATE HFA- fluticasone propionate aerosol, metered

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)

Tillgänglig från:

Prasco Laboratories

Administreringssätt:

RESPIRATORY (INHALATION)

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Fluticasone Propionate HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. Limitations of Use Fluticasone Propionate HFA is not indicated for the relief of acute bronchospasm. Fluticasone Propionate HFA is contraindicated in the following conditions: Risk Summary There are insufficient data on the use of fluticasone propionate HFA in pregnant women. There are clinical considerations with the use of fluticasone propionate HFA in pregnant women. (See Clinical Considerations.) In animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations in rats, mice, and rabbits, was observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the maximum recommended human daily inhaled dose (MRHDID) on a mcg/m2 basis. (See Data.) However, fluticasone propionate administered via inhalation to rats decreased fetal body weight but did not induce terat

Produktsammanfattning:

Fluticasone Propionate HFA is supplied in the following boxes of 1 as a pressurized aluminum canister fitted with a counter and supplied with a dark orange actuator with a peach cap: Each inhaler is packaged with a Patient Information leaflet. The dark orange actuator supplied with Fluticasone Propionate HFA should not be used with any other product canisters, and actuators from other products should not be used with a Fluticasone Propionate HFA canister. Counter Fluticasone Propionate HFA has a counter attached to the canister. The counter starts at 124 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. 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. Storage 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.

Bemyndigande status:

New Drug Application Authorized Generic

Produktens egenskaper

FLUTICASONE PROPIONATE HFA- FLUTICASONE PROPIONATE AEROSOL, METERED
PRASCO LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUTICASONE PROPIONATE
HFA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FLUTICASONE PROPIONATE HFA.
FLUTICASONE PROPIONATE HFA INHALATION AEROSOL, FOR ORAL INHALATION USE
INITIAL U.S. APPROVAL: 1994
INDICATIONS AND USAGE
Fluticasone Propionate HFA is an inhaled corticosteroid indicated for:
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Limitations of use: Not indicated for relief of acute bronchospasm.
(1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Inhalation aerosol:
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (incidence >3%) are upper respiratory
tract infection or inflammation,
throat irritation, sinusitis, dysphonia, candidiasis, cough,
bronchitis, and headache. (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
Maintenance treatment of asthma as prophylactic therapy in adult and
pediatric patients aged 4
years and older. (1)
For oral inhalation only. (2.1)
Starting dosage is based on prior asthma therapy and disease severity.
(2.2)
Adult and adolescent patients aged 12 years and older: 88 mcg twice
daily up to a maximum dosage
of 880 mcg twice daily. (2.2)
Pediatric patients aged 4 to 11 years: 88 mcg twice daily. (2.2)
44 mcg fluticasone propionate per actuation (3)
110 mcg fluticasone propionate per actuation (3)
220 mcg fluticasone propionate per actuation (3)
Primary treatment of status asthmaticus or acute episodes of asthma
requiring intensive measures.
(4)
Hypersensitivity to any ingredient. (4)
_Candida albicans_ infection of the mouth and pharynx may occur.
Monitor patients periodically. Advise
the patient to rinse his/her mouth with water without swallowing after
inhalation to help reduce the
risk. (