FLUTICASONE PROPIONATE AND SALMETEROL HFA- fluticasone propionate and salmeterol xinafoate aerosol, metered

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U), SALMETEROL XINAFOATE (UNII: 6EW8Q962A5) (SALMETEROL - UNII:2I4BC502BT)

Beschikbaar vanaf:

Prasco Laboratories

Toedieningsweg:

RESPIRATORY (INHALATION)

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Fluticasone Propionate and Salmeterol HFA is indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. Fluticasone Propionate and Salmeterol HFA should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2 -adrenergic agonist (LABA). Limitations of Use Fluticasone Propionate and Salmeterol HFA is not indicated for the relief of acute bronchospasm. Fluticasone Propionate and Salmeterol HFA is contraindicated in the following conditions: Risk Summary There are insufficient data on the use of fluticasone propionate and salmeterol HFA or individual monoproducts, fluticasone propionate and salmeterol xinafoate, in pregnant women. There are clinical considerations with the use of fluticasone propionate and salmeterol HFA in pregnant women. (See Clinical Considerations.) In animals, teratogenicity characteristic of cortic

Product samenvatting:

Fluticasone Propionate and Salmeterol HFA is supplied in the following boxes of 1 as a pressurized aluminum canister fitted with a counter and supplied with a purple plastic actuator with a light purple cap: Each inhaler is packaged with a Patient Information leaflet. The purple actuator supplied with Fluticasone Propionate and Salmeterol HFA should not be used with any other product canisters, and actuators from other products should not be used with a Fluticasone Propionate and Salmeterol HFA canister. Counter Fluticasone Propionate and Salmeterol 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.

Autorisatie-status:

New Drug Application Authorized Generic

Productkenmerken

FLUTICASONE PROPIONATE AND SALMETEROL HFA- FLUTICASONE PROPIONATE
AND SALMETEROL XINAFOATE 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
AND SALMETEROL HFA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR FLUTICASONE
PROPIONATE AND SALMETEROL HFA.
FLUTICASONE PROPIONATE AND SALMETEROL HFA INHALATION AEROSOL, FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Fluticasone Propionate and Salmeterol HFA is a combination of
fluticasone propionate, an inhaled
corticosteroid, and salmeterol, a long-acting beta ‑adrenergic
agonist (LABA), indicated for treatment of
asthma in adult and adolescent patients aged 12 years and older. (1)
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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2
For oral inhalation only. (2.1)
Adult and adolescent patients aged 12 years and older: 2 inhalations
of Fluticasone Propionate and
Salmeterol HFA 45 mcg/21 mcg, Fluticasone Propionate and Salmeterol
HFA 115 mcg/21 mcg, or
Fluticasone Propionate and Salmeterol HFA 230 mcg/21 mcg twice daily.
(2.2)
Starting dosage is based on asthma severity. (2.2)
45 mcg fluticasone propionate/21 mcg salmeterol per actuation (3)
115 mcg fluticasone propionate/21 mcg salmeterol per actuation (3)
230 mcg fluticasone propionate/21 mcg salmeterol per actuation (3)
Primary treatment of status asthmaticus or acute episodes of asthma
requiring intensive measures.
(4)
Hypersensitivity to any ingredient. (4)
LABA monotherapy increases the risk of serious asthma-related events.
(5.1)
Do not initiate in acutely deteriorating asthma or to treat acute
symptoms. (5.2)
Do not use in combination with an additional medicine containing a
LABA because of risk of overdose.
(5.3)
_Candida al