Fluticasone inhalation

Generic name
Fluticasone inhalation
Brand name
ATC Code
R03BA05
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Fluticasone inhalation

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Inhalation corticosteroids are inactivated rapidly after absorption. At lower doses, the systemic effects are minor or absent.

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

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Asthma
  • Inhalation
    • 1 year up to 4 years
      [1] [5]
      • 50 - 250 microg./day in 2 doses.

      • Increase (double) the dose when asthma is insufficiently controlled. Decrease the dose to lowest effective dose when possible (see warnings and precautions for stepwise approach for astmacontrol).

        Suitable formulation:
        Dosing aerosol + inhalation chamber with a mask.

        ...read more
    • 4 years up to 16 years
      [5]
      • 50 - 500 microg./day in 2 doses.

      • Increase (double) the dose when asthma is insufficiently controlled. Decrease the dose to lowest effective dose when possible (see warnings and precautions for stepwise approach for astmacontrol).

        Suitable formulations:
        4-6 years: dosing aerosol + inhalation chamber with a mouthpiece.
        > 6 years: dosing aerosol + inhalation chamber with a mouthpiece, breath activated dose aerosol or dry powder inhaler.

        ...read more
    • ≥ 16 years
      [5]
      • 100 - 1.000 microg./day in 2 doses. Max: 2.000 microg./day.

      • Increase (double) the dose when asthma is insufficiently controlled. Decrease the dose to lowest effective dose when possible. (see warnings and precautions for stepwise approach for astmacontrol).

        Suitable formulation:
        Dosing aerosol (with or without inhalation chamber or mouthpiece) or dry powder inhaler.

        ...read more
Acute asthma attack
  • Inhalation
    • Suspension for nebulization
      • 4 years up to 16 years
        [4]
        • 1.000 - 2.000 microg./day in 2 doses.
        • Duration of treatment:

          Up to a maximum of 7 days after the exacerbation

      • ≥ 16 years
        [4]
        • 1.000 - 4.000 microg./day in 2 doses.
        • Duration of treatment:

          Up to a maximum of 7 days after the exacerbation.

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

At doses ≥1000 mcg more systemic side effects occur. 

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 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

Stepwise approach to control asthma:
Start the treatment at the step that best suits the clinical assessment of the severity
Step 1: SABA if necessary
Step 2: start ICS
Step 3: double the initial dose of ICS, then add LABA and lower the ICS to the smallest effective dose, in any event down to the initial dose
• LTRA as an alternative to LABA if there are side effects or in children aged < 4-6 years
Step 4:
if LABA has an effect but not enough to control the asthma: continue LABA and double the ICS dose or add LTRA
If LABA has no effect: stop LABA and double the ICS dose or add LTRA
Step 5: double the ICS dosage (to 4x the initial dose) and continue LABA and LTRA

SABA = short-acting beta agonist; LABA = long-acting beta agonist; ICS= inhalation corticosteroids; LTRA = leukotriene receptor antagonist

In long-term use in children, check the growth and if there is growth inhibition attempt to reduce the dose of inhalation corticosteroids. Children are more sensitive to the systemic effects than adults, in particular the psychological and behavioural effects as well as suppression of the adrenal cortex.  In children and adolescents aged < 16 years who use a high dose of fluticasone propionate (≥ 1,000 mcg/day), occurrences of adrenal function suppression and acute adrenal crisis in particular can be dangerous.

Interactions

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

OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, 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.

Glucocorticoids
R03BA01
R03BA02
R03BA08

References

  1. NVK , Richtlijn Astma bij kinderen, www.nvk.nl, okt 2013
  2. Global initiative for Asthma, Pocket guide for asthma management and prevention in Children, Revised 2006
  3. Nederlands Bijwerkingen Centrum Lareb, Fluticasone inhalation and behavioual changes in children, www.lareb.nl, 2007, http://www.lareb.nl/documents/kwb_2006_2_fluti.pdf (geraadpleegd 13 nov 2009)
  4. GlaxoSmithKline BV, SmPC Flixotide Nebules (RVG 21835) 24-08-2013, www.geneesmiddelinformatiebank.nl
  5. GlaxoSmithKline BV, Flixotide Inhalator CFK-vrij (RVG 16212) 16-04-2020, www.geneesmiddeleninformatiebank.nl

Changes

Therapeutic Drug Monitoring


Overdose