- 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.
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
On-label
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Available formulations
Per do inhalatiepoeder: Fluticasonfuroaat 92 µg Vilanterol (als trifenataat) 22 µg; Fluticasonfuroaat 184 µg Vilanterol (als trifenataat) 22 µg
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Dosages
| Asthma |
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Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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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.
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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.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| 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 | ||
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Reference
- GlaxoSmithKline (Ireland) Limited, SmPC Relvar Ellipta (EU/1/13/886/001-003) 13-02-2019, www.geneesmiddelinformatiebank.nl
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Changes
Changes
