Fluticasonfuroaat + Vilanterol

Generic name
Fluticasonfuroaat + Vilanterol
Brand name
ATC Code
R03AK10
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Fluticasonfuroaat + Vilanterol

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information is present at this moment.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

On-label

Licensed use Licensed use

Registration Status Title

Astma:
> 12 jaar: fluticasonfuroaat/vilanterol 92/22 microg -184/22 microg 1 dd

Available formulations

Per do inhalatiepoeder: Fluticasonfuroaat 92 µg Vilanterol (als trifenataat) 22 µg; Fluticasonfuroaat 184 µg Vilanterol (als trifenataat) 22 µg 

Dosages

Asthma
  • Inhalation
    • ≥ 12 years

      • 1 x per dag 1 inhalatie fluticasonfuroaat/vilanterol 92/22 microg. Zo nodig ophogen naar 1 inhalatie 184/22 1x per dag.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

More systemic side effects occur at fluticasone doses ≥1000 mcg. 

Very rarely (< 0.01%): Growth retardation. Anxiety, sleep disorder, change in behaviour (including hyperactivity and irritability).

Depression, aggression have also been reported.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Adult Side Effects

Zeer vaak (> 10%): hoofdpijn. Nasofaryngitis.

Vaak (1-10%): pneumonie (soms fataal), bronchitis, bovenste luchtweginfecties, griep, orofaryngeale candidiase. Heesheid, hoesten, keelpijn, faryngitis, sinusitis, rinitis. Buikpijn. Gewrichtspijn, spierspasmen, rugpijn, botbreuken. Koorts.

Soms (0,1-1%): extrasystolen. Wazig zien.

Zelden (0,01-0,1%): overgevoeligheidsreacties (zoals anafylaxe, angio-oedeem, huiduitslag, urticaria). Paradoxaal bronchospasme. Hartkloppingen, tachycardie. Tremor. Angst.

Bij de behandeling van COPD zijn pneumonie en botbreuken vaker gezien dan bij astma. Bij astma komt pneumonie vaker voor bij de hogere dosis van fluticason.

Bij langdurig gebruik van hoge doses inhalatiecorticosteroïden kunnen systemische effecten als bijnierschorssuppressie, het syndroom van Cushing, groeivertraging bij kinderen en adolescenten, afname botdichtheid, cataract en glaucoom optreden.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in adults

Er zijn van dit middel geen (relevante) contra-indicaties bekend.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

ADRENERGICS, INHALANTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Alpha- and beta-adrenoreceptor agonists
R03AA01
Selective beta-2-adrenoreceptor agonists
R03AC13
R03AC02
R03AC12
R03AC03
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
R03AK08
R03AK11
R03AK07
R03AK06
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
R03AL01
R03AL02

Reference

  1. GlaxoSmithKline (Ireland) Limited, SmPC Relvar Ellipta (EU/1/13/886/001-003) 13-02-2019, www.geneesmiddelinformatiebank.nl

Changes

Therapeutic Drug Monitoring


Overdose