Pharmacokinetics in children

Budesonide has a systemic clearance of approximately 0.5 l/min in asthmatic
children aged 4-6 years. Children have a clearance that is about
50% higher than in adults per kilogram of bodyweight. In asthmatic children, the elimination half-life of budesonide after inhalation is approximately 2.3 hours. This is approximately
the same as in healthy adults.
Respules:
In children aged 4 to 6 with asthma, the systemic availability of budesonide after administration of Pulmicort Respules via a nebulizer (Pari LC Jet Plus® with Pari Master® compressor) is approximately 6% of the nominal dose and 26% of the dose that is in fact given to the patient. The systemic availability in use in children is approximately half that in healthy adults.
The maximum plasma concentration that occurs about 20 minutes after the start of the
nebulization is about 2.4 nmol/l in children aged 4-6 with asthma after a dose of 1
 mg. The exposure (Cmax and AUC) of budesonide after administration of a single dose
of 1 mg by nebulization to children aged 4-6 years is comparable to that of healthy
adults receiving the same dose using the same nebulization system.

Turbuhaler
In asthmatic children who were treated with a Pulmicort Turbuhaler (800 μg single dose), the plasma concentration Cmax (4.85 nmol/l) was reached at 13.8 minutes after inhalation and fell away quickly after that. The AUC was 10.3 nmol*hours/l. The AUC value is in general comparable to that observed in adults with the same dose.
In children, however, the Cmax value tends to be higher. Lung deposition in children (31%
 of the nominal dose) is comparable to that measured in healthy adults (34%
 of the nominal dose).

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

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

Behavioral disorders, nervousness, restlessness, hyperactivity and aggressiveness [SmPC Pulmicort]

At higher doses (more than 800 mcg/day), short-term studies have 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 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

The risk of oropharyngeal candidiasis is reduced by rinsing the oropharyngeal cavity thoroughly with water after the inhalation and then spitting it out. In long-term use in children, check the growth and if there is growth inhibition attempt to reduce the dose of inhalation corticosteroids.
Administration: Pulmicort dosing aerosol can be administered using a Spacer or Nebuhaler holding chamber.

[Refer to national guidance or GINA for stepwise approach]

Interactions

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

• RESPIRATORY SYSTEM
• DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

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.

References

1. Global initiative for Asthma, Global strategy for Asthma management and prevention, 2021
2. Brand PLP et al, Werkboek Kinderlongziekten, VU Uitgeverij, 2001, 1e druk
3. Teva Nederland BV, SmPC Larbex SteriNeb (RVG 100826) 17-08-2016, www.geneesmiddeleninformatiebank.nl
4. Chiesi, SmPC Budiair® 200 Mikrogramm (40593.00.00), 03/2017
5. MEDA Pharma, SmPC Novopulmon® 200, 400 Mikrogramm Novolizer® (54750.00.00/ 63050.00.00), 11/2017
6. Novartis Pharma, SmPC Miflonide® Breezhaler® 200, 400 Mikrogramm (49491.00.00/ 49491.01.00), 07/2017
7. AstraZeneca, SmPC Pulmicort® Turbohaler® 400 μg (28528.01.00), 03/2017
8. Hexal, SmPC Budes® N 0,2 mg/Dosis Druckgasinhalation, Lösung (26057.01.00), 05/2017
9. INFECTOPHARM Arzneimittel und Consilium, SmPC BudenoBronch 0,5 mg/2 ml; 1,0 mg/2 ml (62412.00.00/62412.01.00), 04/2017
10. Orion Pharma, SmPC Budesonid Easyhaler (50235.00.00/ 50234.00.00/ 50236.00.00), 03/2017
11. PB Pharma, SmPC Cyclocaps Budesonid 200 µg/400 μg Hartkapseln mit Pulver zur Inhalation (46411.00.00/46411.01.00), 05/2017
12. TEVA, SmPC Larbex® Steri-Neb® 0,5 mg/2 ml Suspension für einen Vernebler (70568.00.00), 03/2018
13. AstraZeneca, SmPC Pulmicort® 0,5 mg/2 ml, 1,0 mg/2 ml Suspension (24715.00.00/ 24715.01.00), 08/2018
14. AstraZeneca, SmPC Pulmicort® Turbohaler® 200 µg (28528.00.00), 08/2018

Changes

Therapeutic Drug Monitoring

Overdose