FLUTICASONE FUROATE AND VILANTEROL powder

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

FLUTICASONE FUROATE (UNII: JS86977WNV) (FLUTICASONE - UNII:CUT2W21N7U), VILANTEROL TRIFENATATE (UNII: 40AHO2C6DG) (VILANTEROL - UNII:028LZY775B)

Saatavilla:

Prasco Laboratories

Antoreitti:

RESPIRATORY (INHALATION)

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Fluticasone Furoate/Vilanterol ELLIPTA 100/25 mcg is indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Fluticasone Furoate/Vilanterol ELLIPTA 100/25 mcg is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. Fluticasone Furoate/Vilanterol ELLIPTA 100/25 mcg once daily is the only strength indicated for the treatment of COPD. Important Limitation of Use Fluticasone Furoate/Vilanterol ELLIPTA is NOT indicated for the relief of acute bronchospasm Fluticasone Furoate/Vilanterol ELLIPTA is indicated for the once-daily treatment of asthma in patients aged 18 years and older. Fluticasone Furoate/Vilanterol ELLIPTA 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

Tuoteyhteenveto:

Fluticasone Furoate/Vilanterol ELLIPTA inhalation powder is supplied as a disposable light grey and pale blue plastic inhaler containing 2 foil strips, each with 30 blisters. One strip contains fluticasone furoate (100 or 200 mcg per blister), and the other strip contains vilanterol (25 mcg per blister). A blister from each strip is used to create 1 dose. The inhaler is packaged within a moisture‑protective foil tray with a desiccant and a peelable lid in the following packs: 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 in a dry place away from direct heat or sunlight. Keep out of reach of children. Fluticasone Furoate/Vilanterol ELLIPTA should be stored inside the unopened moisture‑protective foil tray and only removed from the tray immediately before initial use. Discard Fluticasone Furoate/Vilanterol ELLIPTA 6 weeks after opening the foil tray or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.

Valtuutuksen tilan:

New Drug Application Authorized Generic

Valmisteyhteenveto

FLUTICASONE FUROATE AND VILANTEROL- FLUTICASONE FUROATE AND
VILANTEROL POWDER
PRASCO LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUTICASONE
FUROATE/VILANTEROL ELLIPTA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
FLUTICASONE FUROATE/VILANTEROL ELLIPTA.
FLUTICASONE FUROATE/VILANTEROL ELLIPTA INHALATION POWDER, FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 2013
INDICATIONS AND USAGE
Fluticasone Furoate/Vilanterol ELLIPTA is a combination of fluticasone
furoate, an inhaled corticosteroid
(ICS), and vilanterol, a long‑acting beta -adrenergic agonist
(LABA), indicated for:
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Important limitation of use: Not indicated for relief of acute
bronchospasm. (1.1, 1.2, 5.2)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Inhalation powder: Inhaler containing 2 foil blister strips of powder
formulation for oral inhalation. One strip
contains fluticasone furoate 100 or 200 mcg per blister and the other
contains vilanterol 25 mcg per
blister. (3)
CONTRAINDICATIONS
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•
WARNINGS AND PRECAUTIONS
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•
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2
Long-term, once-daily, maintenance treatment of airflow obstruction
and reducing exacerbations in
patients with chronic obstructive pulmonary disease (COPD). (1.1)
Once-daily treatment of asthma in patients aged 18 years and older.
(1.2)
For oral inhalation only. (2)
Maintenance treatment of COPD: 1 inhalation of Fluticasone
Furoate/Vilanterol ELLIPTA inhalation
powder 100/25 mcg once daily. (2.1)
Asthma: 1 inhalation of Fluticasone Furoate/Vilanterol ELLIPTA
inhalation powder 100/25 mcg or
Fluticasone Furoate/Vilanterol ELLIPTA inhalation powder 200/25 mcg
once daily. (2.2)
Primary treatment of status asthmaticus or acute episodes of COPD or
asthma requiring intensive
measures. (4)
Severe hypersensitivity to milk proteins or any ingredients. (4)
LABA monotherapy increases the risk of serious asthma-related events.
(5.1)
Do not initiate in acutely deteriorating COPD or asthma