Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Felbamate

Generic name
Felbamate
Brand name
ATC Code
N03AX10

Pharmacokinetics in children

No information

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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

Lennox-Gastault syndrome, not responsive to other anti-epileptic drugs
  • Oral
    • 4 years up to 14 years
      • Initial dose: 7.5 - 15 mg/kg/day in 2 - 3 doses.
      • Maintenance dose: Increase at intervals of at least one week by 7.5-15 mg/kg/day to 15 - 45 mg/kg/day in 3 - 4 doses. Max: 3.600 mg/day.

      • At the start of felbamate therapy, any simultaneously administered dose of carbamazepine, phenytoin, phenobarbital and/or valproic acid should be reduced by 20 to 30%

    • 14 years up to 18 years
      • Initial dose: 600 - 1.200 mg/day in 2 - 3 doses.
      • Maintenance dose: increase the dose at intervals of approximately one week by 600 mg to 1,200 mg per day to 1.200 - 3.600 mg/day in 3 - 4 doses. Max: 3.600 mg/day.

      • At the start of felbamate therapy, any simultaneously administered dose of carbamazepine, phenytoin, phenobarbital and/or valproic acid should be reduced by 20 to 30%.

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Renal impaiment in children > 3 months

GFR 50-80 ml/min/1.73m²
dose adjustment not needed
GFR 10-50 ml/min/1.73m²
start with 50% of the normal dose and then increase the dosage at intervals of 2 weeks
GFR < 10 ml/min/1.73m²
no generalized recommendations are given.

Information
In reduced renal function, half-life and AUC of felbamate increase. The risk of side effects is elevated as a result.

Clinical consequences
Side effects include nausea, vomiting, dyspepsia, abdominal pain, anorexia, weight loss, sleepiness, sleeplessness, fatigue, headaches, dizziness, double vision, abnormal vision and ataxia.

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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

Common (1-10%): infections of the upper respiratory tract

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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
N03AX26
N03AX18
N03AX09
N03AX14
N03AX22
N03AX16
N03AX17
N03AX03
N03AX11
N03AX15

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References

  1. Werkgroep Richtlijnen Epilepsie., Epilepsie. Richtlijnen voor diagnostiek en behandeling., Nederlandse Vereniging voor Neurologie en de Nederlandse Liga tegen Epilepsie, Herziene, tweede versie, januari 2006
  2. Merck, Sharpe & Dohme BV, SPC Taloxa (RVG 16889) 12-01-2018, www.cbg-meb.nl

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Changes

Changes