- 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 |
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
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Available formulations
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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
Very rare (<0.01%) growth inhibition in children and adolescents.
Behavioural disorders
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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
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.
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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 | ||
|---|---|---|
| R03AK11 | ||
| R03AK10 | ||
| R03AK07 | ||
| R03AK06 | ||
| Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids | ||
|---|---|---|
| R03AL01 | ||
| R03AL02 | ||
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References
- Bindels PJE et al, NHG Standaard Astma bij Kinderen (derde herziening), Huisarts Wet, 2014, 57(2), 70-80
- Nederlandse Vereniging voor Kindergeneeskunde, Richtlijn Astma bij Kinderen, 2013
- 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
- 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
- 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
- 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
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Changes
Changes
