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

Interactions
PK
Renal impairment
References

Beclomethasone (inhalation)

Generic name
Beclomethasone (inhalation)
Brand name
ATC Code
R03BA01

Pharmacokinetics in children

Pharmacokinetic studies in children show that the A.U.C. (17-BMP) at a dose of 200 µg Extrafine Aerosol administered via the Autohaler is similar to the A.U.C. of a dose of 400 µg with a CFC-BDP inhaler with spacer.

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

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Asthma
  • Inhalation
    • Aerosol
      • 1 month up to 18 years
        [2] [3] [5]
        • 100 - 1.000 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)

    • Aerosol, extra fine
      • 1 month up to 18 years
        [2] [3] [6]
        • 50 - 400 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)

    • Inhalation powder
      • 6 years up to 18 years
        [2] [3] [4] [7]
        • 100 - 1.000 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)

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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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

At higher doses (more than 800 mcg/day), short-term studies shown effect on the bone metabolism, minor effects on growth in terms of height and (only biochemically detectable) adrenal gland suppression. Individual sensitivity to this varies greatly. The clinical significance of the changes in the longer term that have been described is difficult to tell. The following can also occur: psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural changes

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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

Stepped approach to control astma <refer to GINA guideline or nationale protocol>

With long-term use in children, monitor growth and if growth is inhibited, try to reduce the dose of inhaled corticosteroid. Children are more sensitive to the systemic effects than adults, particularly to the psychological and behavioral effects as well as to adrenal suppression. 

 

 

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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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Glucocorticoids
R03BA02
R03BA08
R03BA05

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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. NVK, Richtlijn Astma bij Kinderen, www.nvk.nl, okt 2013
  3. Global initiative for Asthma, Global strategy for asthma management and prevention, Revised 2024
  4. Teva BV, SmPC Beclometason cyclocaps (RVG 13390) 13--09-2019, www.geneesmiddeleninformatiebank.nl
  5. Sandoz BV, SmPC Beclometason Aerosol (RVG 34151) 23-03-2017, www.geneesmiddeleninformatiebank.nl
  6. Teva BV, SmPC Qvar Extrafijn (RVG 21937-40) 13-02-2020, www.geneesmiddeleninformatiebank.nl
  7. Orion Pharma, SmPC Beclomet Easyhaler (49276-00-02), April 2017

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Changes

Changes