Lacosamide

Generic name
Lacosamide
Brand name
ATC Code
N03AX18
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Lacosamide

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

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

Epilepsy, monotherapy
  • Intravenous
    • ≥ 2 years and < 40 kg
      • Initial dose: 2 mg/kg/day in 2 doses.
      • Maintenance dose: increase weekly based on clinical response in steps of 2 mg/kg/day to a maximum of 12 mg/kg/day in 2 doses.

      • When discontinuing treatment gradually reduce the dosage.

    • ≥ 2 years and 40 up to 50 kg
      • Initial dose: 2 mg/kg/day in 2 doses.
      • Maintenance dose: increase weekly based on clinical response in steps of 2 mg/kg/day to a maxium of 10 mg/kg/day in 2 doses.

      • When discontinuing treatment gradually reduce the dosage.

  • Oral
    • ≥ 2 years and < 40 kg
      • Initial dose: 2 mg/kg/day in 2 doses.
      • Maintenance dose: increase weekly based in clinical respons in steps of 2 mg/kg/day to a maximum of 12 mg/kg/day in 2 doses.

      • When discontinuing treatment gradually reduce the dosage.

    • ≥ 2 years and 40 up to 50 kg
      • Initial dose: 2 mg/kg/day in 2 doses.
      • Maintenance dose: increase weekly based on clinical response in steps of 2 mg/kg/day to a maximum of 10 mg/kg/day in 2 doses.

      • When discontinuing treatment gradually reduce the dosage.

    • ≥ 2 years and ≥ 50 kg
      • Initial dose: 100 - 200 mg/day in 2 doses.
      • Maintenance dose: increase weekly based on clinical response by 100 mg/day to a maximum of 600 mg/day in 2 doses.

      • When discontinuing treatment gradually reduce the dosage.
Epilepsy, adjuvant therapy
  • Oral
    • ≥ 2 years and ≥ 50 kg
      • Initial dose: 100 mg/day in 2 doses.
      • Maintenance dose: increase weekly based on clinical response by 100 mg/day to a maximum of 400 mg/day in 2 doses.

      • When discontinuing treatment gradually reduce the dosage.

  • Intravenous
    • ≥ 2 years and ≥ 50 kg
      [1]
      • Initial dose: 100 mg/day in 2 doses.
      • Maintenance dose: increase weekly based on clinical response by 100 mg/day to a maxium of 400 mg/day in 2 doses.

      • When discontinuing treatment gradually reduce the dosage.

    • ≥ 2 years and < 20 kg
      • Initial dose: 2 mg/kg/day in 2 doses.
      • Maintenance dose: increase weekly based on clinical respons in steps of 2 mg/kg/day to a maximum of  12 mg/kg/day in 2 doses.

      • When discontinuing treatment gradually reduce the dosage.

    • ≥ 2 years and 20 up to 30 kg
      • Initial dose: 2 mg/kg/day in 2 doses.
      • Maintenance dose: increase weekly based on clinical response in steps of 2 mg/kg/day to a maximum of  10 mg/kg/day in 2 doses.

      • When discontinuing treatment gradually reduce the dosage.

    • ≥ 2 years and 30 up to 50 kg
      • Initial dose: 2 mg/kg/day in 2 doses.
      • Maintenance dose: increase weekly based on clinical response in steps of 2 mg/kg/day to a maximum of 8 mg/kg/day in 2 doses.

      • When discontinuing treatment gradually reduce the dosage.

    • ≥ 2 years and < 20 kg
      • Initial dose: 2 mg/kg/day in 2 doses.
      • Maintenance dose: increase weekly based on clinical respons in steps of 2 mg/kg/day to a maximum of  12 mg/kg/day in 2 doses.

      • When discontinuing treatment gradually reduce the dosage.

    • ≥ 2 years and 20 up to 30 kg
      • Initial dose: 2 mg/kg/day in 2 doses.
      • Maintenance dose: increase weekly based on clinical response in steps of 2 mg/kg/day to a maximum of  10 mg/kg/day in 2 doses.

      • When discontinuing treatment gradually reduce the dosage.

    • ≥ 2 years and 30 up to 50 kg
      • Initial dose: 2 mg/kg/day in 2 doses.
      • Maintenance dose: increase weekly based on clinical response in steps of 2 mg/kg/day to a maximum of 8 mg/kg/day in 2 doses.

      • When discontinuing treatment gradually reduce the dosage.

    • ≥ 2 years and ≥ 50 kg
      • Initial dose: 100 mg/day in 2 doses.
      • Maintenance dose: increase weekly based on clinical response by 100 mg/day to a maxium of 400 mg/day in 2 doses.

      • When discontinuing treatment gradually reduce the dosage.

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


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. 

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.

Interactions

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

ANTIEPILEPTICS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

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

Reference

  1. UCB Pharma S.A., SmPC Vimpat (EU/1/08/470/001-031) Rev.38. 23-03-2022, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose