Beclometason+Formoterol (combinatiepreparaat)

Generic name
Beclometason+Formoterol (combinatiepreparaat)
Brand name
ATC Code
R03AK08
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Beclometason+Formoterol (combinatiepreparaat)

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The following pharmacokinetic parameters have been found when using 200/24 µg combination product in children 6-11 years [Chawes 2014] [Govoni 2015]:

Beclometasone-17-monopropionate

  Pressurized metered dose inhaler with valved holding chamber Dry powder inhaler
Mean Cmax (pg/ml) 572 ± 214 740 ± 224
Median tmax (hour) 0,5 0,5
Mean t1/2 (hour) 2,1 ± 1,0 2,6 ± 0,7

Formoterol

  Pressurized metered dose inhaler with valved holding chamber Dry powder inhaler
Mean Cmax (pg/ml) 19,1 ± 6,8 74,7 ± 20,2
Median tmax (hour) 0,5 0,3
Mean t1/2 (hour) 4,3 ± 1,7 3,6 ± 0,7

Chawes (2014) shows a doubling of the exposure to formoterol in children from 6 to 11 years compared to adults when using a dry powder inhaler. Systemic exposure to a halved dose of beclometasone (200/24 µg versus 400/24 µg) is comparable to adults.

Govoni (2015) shows equivalent systemic exposure to aerosolized formoterol in children 6-11 years and adults. Systemic exposure to a halved of beclometasone (200/24 µg compared to 400/24 µg) is halved compared to adults which is in accordance with the halved dose.  Systemic exposure to aerosolized beclometasone and formoterol was the same in adolescents and adults.

The following pharmacokinetic parameters were found when using 400/24 µg combination product in adolescents 12-17 years [Chawes 2014] [Govoni 2015]:

Beclometasone-17-monopropionate

  Pressurized metered dose inhaler with valved holding chamber Dry powder inhaler
Mean Cmax (pg/ml) 878 ± 320 998
Median tmax (hour) 0,5 0,5
Mean t1/2 (hour) 3,0 ± 0,7 2,6

Formoterol

  Pressurized metered dose inhaler with valved holding chamber Dry powder inhaler
Mean Cmax (pg/ml) 21,4 ± 7,1 52,3 ± 18,3
Median tmax (hour) 0,5 0,3
Mean t1/2 (hour) 4,6 ± 1,4 4,0 ± 0,9

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
    • Aerosol
      • 6 years up to 18 years
        • 6 microg. formoterol(fumarate)/100 microg. beclometasone(dipropionate): 1 - 2 puff(s)/dose BID.
    • Inhalation powder
      • 7 years up to 18 years
        • 6 microg. formoterol(fumarate)/100 microg. beclometasone(dipropionaate): 1 - 2 puff(s)/dose BID.
          • Dry powder inhalator should only be used when the inhalation technique is adequate.

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

Very rare (<0.01%) growth inhibition in children and adolescents.

Behavioural disorders

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

Use of the 200/6 product is not recommended  for children due to a relatively high dose of inhaled corticosteroid compared to the dose of the long-acting β2 sympathomimetic.

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
R03AK11
R03AK10
R03AK07
R03AK06
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
R03AL01
R03AL02

References

  1. Bindels PJE et al, NHG Standaard Astma bij Kinderen (derde herziening), Huisarts Wet, 2014, 57(2), 70-80
  2. Nederlandse Vereniging voor Kindergeneeskunde, Richtlijn Astma bij Kinderen, 2013
  3. Kuna, P., et al, Pharmacokinetics and pharmacodynamics of an extrafine fixed pMDI combination of beclometasone dipropionate/formoterol fumarate in adolescent asthma, Br J Clin Pharmacol, 2015, 80(3), 569-80
  4. Govoni, M., et al, The systemic exposure to inhaled beclometasone/formoterol pMDI with valved holding chamber is independent of age and body size, Pulm Pharmacol Ther, 2015, 30, 102-9
  5. Chawes, B. L., et al, Pharmacokinetic comparison of inhaled fixed combination vs. the free combination of beclomethasone and formoterol pMDIs in asthmatic children, Br J Clin Pharmacol, 2013, 75(4), 1081-8
  6. Chawes, B. L., et al, Systemic exposure to inhaled beclometasone/formoterol DPI is age and body size dependent., Respir Med, 2014, 108(8), 1108-16

Changes

Therapeutic Drug Monitoring


Overdose