- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Bij de meerderheid van de patiënten is fluticasonfuroaat na intranasale dosering van eenmaal daags 110 microgram niet meetbaar (< 10 pg/ml). Na intranasale dosering van eenmaal daags 110 microgram werden meetbare spiegels waargenomen in 15,1% van de kinderen en na eenmaal daags 55 microgram slechts 6,8% van kinderen. Er was geen bewijs voor hogere meetbare spiegels van fluticasonfuroaat bij jongere kinderen (jonger dan 6 jaar). De mediane fluticasonfuroaatconcentraties bij deze personen met meetbare spiegels na 55 microgram waren 18,4 pg/ml en 18,9 pg/ml bij respectievelijk 2 tot 6 jarige en 6 tot 12 jarigen. Bij 110 microgram, waren mediane concentraties in personen met meetbare concentraties 14,3 pg/ml en 14,4 pg/ml voor respectievelijk 2 tot 6 jarigen en 6 tot 12 jarigen.
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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
Neusspray (furoaat) 27.5 µg/do 120 do
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Dosages
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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
Adult Side Effects
Zeer vaak (> 10%): bloedneus. Vaak (1-10%): neus-ulceratie.
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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
No information available on specific contra indications in children.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions in children
Bij kinderen de lengtegroei regelmatig controleren. Wanneer groei wordt geremd, behandeling opnieuw overwegen of de dosering verlagen.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Alerts And Precautions Adults
Voorzichtigheid is geboden bij overschakeling van systemische naar nasale toepassing bij patiënten met gestoorde bijnierfunctie. Bij langdurig gebruik van nasale corticosteroïden in hoge doseringen kunnen systemische bijwerkingen optreden.
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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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| Sympathomimetics, plain | ||
|---|---|---|
| R01AA08 | ||
| R01AA05 | ||
| R01AA09 | ||
| R01AA07 | ||
| Sympathomimetics, combinations excl. corticosteroids | ||
|---|---|---|
| R01AB01 | ||
| Antiallergic agents, excl. corticosteroids | ||
|---|---|---|
| R01AC03 | ||
| R01AC01 | ||
| R01AC02 | ||
| Corticosteroids | ||
|---|---|---|
| R01AD58 | ||
| R01AD01 | ||
| R01AD05 | ||
| R01AD08 | ||
| R01AD12 | ||
| R01AD09 | ||
| R01AD59 | ||
| R01AD11 | ||
| Other nasal preparations | ||
|---|---|---|
| R01AX10 | ||
| OTHER NASAL PREPARATIONS | ||
|---|---|---|
| R01AX10 | ||
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Reference
- Glaxo group Ltd, SPC Avamys (EU/1/07/434/003), www.ema.europa.eu, Geraadpleegd 27 mei 2010, http://www.ema.europa.eu/humandocs/PDFs/EPAR/avamys/emea-combined-h770nl.pdf
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Changes
Changes
