- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The paediatric pharmacokinetic profile of lacosamide was determined in a population pharmacokinetic analysis using sparse plasma concentration data The administered lacosamide doses ranged from 2 to 17,8 mg/kg/day in twice daily intake, not to exceed 600 mg/day.
| 10 kg | 20 kg | 30 kg | 50 kg | 70 kg | |
| Clearance (l/hour) | 0,46 | 0,81 | 1,03 | 1,34 | 1,74 |
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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
| Epilepsy, monotherapy |
|---|
|
| Epilepsy, adjuvant therapy |
|---|
|
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Renal impaiment in children > 3 months
In reduced renal function, the AUC of lacosamide increases. This increases the risk of side effects.
Children of ≥ 4 years and < 50 kg
GFR 10-30 ml/min/1.73m²
Reduce the maximum maintenance dose by 25%
GFR < 10 ml/min/1.73m²
Generalized recommendations cannot be given
Children of ≥ 4 years and ≥ 50 kg
GFR 10-30 ml/min/1.73m²
Maintenance dose max. 250 mg per day
GFR < 10 ml/min/1.73m²
Generalized recommendations cannot be given
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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
The safety profile observed in children is similar to that observed in adults, although sleepiness is more common in children. The following additional adverse reactions have been reported in paediatric patients: pyrexia, nasopharyngitis, pharyngitis, decreased appetite, abnormal behaviour and lethargy.
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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
No information available on specific warnings and precautions in children.
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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 | ||
| N03AG04 | ||
| Other antiepileptics | ||
|---|---|---|
| N03AX23 | ||
| N03AX24 | ||
| N03AX10 | ||
| N03AX26 | ||
| N03AX09 | ||
| N03AX14 | ||
| N03AX22 | ||
| N03AX16 | ||
| N03AX17 | ||
| N03AX03 | ||
| N03AX11 | ||
| N03AX15 | ||
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Reference
- UCB Pharma S.A., SmPC Vimpat (EU/1/08/470/001-031) Rev.38. 23-03-2022, www.ema.europa.eu
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Changes
Changes
