- 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 were found in children with refractory epilepsy (SmpC Kigabeq)
| Age | n |
tmax (hours) | T1/2 (hours) | Cl/F (l/h/kg) |
| Neonates (15 bis 26 days) | 6 | 2.5 | 7.5 | |
| Infants (5 bis 22 months) | 6 | 2.5 | 5.7 | 0.591 |
| Children (4,6 bis 14,2 years) | 6 | 1 | 5.5 | 0.446 |
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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
| West’s syndrome |
|---|
|
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Renal impaiment in children > 3 months
Adjustment in renal impairment as specified:
GFR 50-80 ml/min/1.73 m2
Dose adjustment not neededGFR 30-50 ml/min/1.73 m2
Dose adjustment not neededGFR 10-30 ml/min/1.73 m2
50 percentage of single dose and dosing interval : 12 up to 24 uurGFR < 10 ml/min/1.73 m2
A general recommendation for dose adjustment is not providedClinical consequences
The AUC and halflife are increased in impaired renal function. Therefore the risk of side effects is higher in impaired renal function.
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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
Agitation and excitement. Increase absences (NVN guideline)
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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
First choice in West’s syndrome. Can be used for multifocal epilepsy, but the side effect profile (limitation of the visual field, excitation, agitation, sleep disorders and increased appetite) means that vigabatrin is not the first choice. Visual field examinations (preferably standardized static perimetry) should be carried out before the start of treatment and every six months during treatment. If the visual field narrows, cutting back the treatment should be considered or the visual field should be checked more frequently. Perimetry is rarely possible in children aged less than nine and continuation of the treatment must be reconsidered regularly. Animal studies show that vigabatrin can cause taurine deficiency. Because this taurine deficiency is possibly the cause of retinal abnormalities, vigabatrin is therefore sometimes combined with taurine [Jammoul 2009].
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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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| Barbiturates and derivatives | ||
|---|---|---|
| N03AA02 | ||
| N03AA03 | ||
| Hydantoin derivatives | ||
|---|---|---|
| N03AB02 | ||
| Succinimide derivatives | ||
|---|---|---|
| N03AD01 | ||
| Benzodiazepine derivatives | ||
|---|---|---|
| N03AE01 | ||
| Carboxamide derivatives | ||
|---|---|---|
| N03AF01 | ||
| N03AF02 | ||
| N03AF03 | ||
| Fatty acid derivatives | ||
|---|---|---|
| N03AG01 | ||
| Other antiepileptics | ||
|---|---|---|
| N03AX23 | ||
| N03AX24 | ||
| N03AX10 | ||
| N03AX26 | ||
| N03AX18 | ||
| N03AX09 | ||
| N03AX14 | ||
| N03AX22 | ||
| N03AX16 | ||
| N03AX17 | ||
| N03AX03 | ||
| N03AX11 | ||
| N03AX15 | ||
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References
- Genzyme Europe BV, SmPC Sabril (RVG 15722) 13-01-2021, www.geneesmiddeleninformatiebank.nl
- Jammoul F, et al., Taurine deficiency is a cause of vigabatrin-induced retinal phototoxicity., Ann Neurol, 2009, 65, 98-107
- Nederlandse Vereniging voor Neurologie, Richtlijn epilepsie; Epilepsiesyndromen (bij kinderen) & anti-epileptica; absence epilepsie, 2013
- ORPHELIA Pharma SAS, SmPC Kigabeq (EU/1/18/1302/001-2) Rev 5; 22-11-2021, www.ema.europa.eu
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Changes
Changes
