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

Interactions
PK
Renal impairment
References

Stiripentol

Generic name
Stiripentol
Brand name
ATC Code
N03AX17

Pharmacokinetics in children

The following PK data was shown in a paediatric population pharmacokinetic study in children (n=35, median age: 7,3 years (range: 1 - 17,6 years) receiving a median daily dose of 45.4 mg/kg/day (range: 27.1 to 89.3 mg/kg/day) in 2-3 doses and valproate and clobazam.

weight 10 kg 60 kg
T1/2 (hour) 8,5 23,5
Cl (l/hour) 2,60 5,65
Vd (l) 32,0 191,8

[EPAR Diacomit]

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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

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Dosages

(Adjuvant treatment for) epilepsy
  • Oral
    • 6 months up to 6 years
      • Initial dose: 20 mg/kg/day in 2 - 3 doses.
      • Maintenance dose: 30 - 50 mg/kg/day in 2 - 3 doses.
      • Dose titration:

        Week 1: 20 mg/kg/day
        Week 2: 30 mg/kg/day
        Week 3: 50 mg/kg/day

      • Directions for administration:

        Take with food (but not with dairy products, fruit juice or carbonated or caffeinated drinks or drinks containing theophylline) because the substance is broken down in acidic conditions.

    • 6 years up to 12 years
      • Initial dose: 20 mg/kg/day in 2 - 3 doses.
      • Maintenance dose: 30 - 50 mg/kg/day in 2 - 3 doses.
      • Dose titration:

        Week 1: 20 mg/kg/day
        Week 2: 30 mg/kg/day
        Week 3: 40 mg/kg/day
        Week 4: 50 mg/kg/day

      • Directions for administration:

        Take with food (but not with dairy products, fruit juice or carbonated or caffeinated drinks or drinks containing theophylline) because the substance is broken down in acidic conditions.

    • 12 years up to 18 years
      • Initial dose: 20 mg/kg/day in 2 - 3 doses.
      • Maintenance dose: 30 - 50 mg/kg/day in 2 - 3 doses.
      • Dose titration:

        Week 1: 20 mg/kg/day
        Week 2: 30 mg/kg/day, then increased depending on the clinical picture to
        Week 3: 35 mg/kg/day, then increased depending on the clinical picture to
        Week 4: 40 mg/kg/day, then increased depending on the clinical picture to
        Week 5: 45 mg/kg/day, then increased depending on the clinical picture to
        Week 6: 50 mg/kg/day

      • Directions for administration:

        Take with food (but not with dairy products, fruit juice or carbonated or caffeinated drinks or drinks containing theophylline) because the substance is broken down in acidic conditions.

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Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
Adjustment not necessary
GFR 30-50 ml/min/1.73 m2
Not recommended to be used
GFR 10-30 ml/min/1.73 m2
Not recommended to be used
GFR < 10 ml/min/1.73 m2
Not recommended to be used

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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

Very common (> 10%): anorexia, decrease in appetite, weight loss, insomnia, drowsiness, ataxia, hypotonia, dystonia.

Common (1-10%): neutropenia, aggression, irritability, behavioral disturbances, hyperkinesia, nausea, vomiting, elevated γ-GT.

Uncommon (0.1-1%): double vision, photosensitization, rash, skin allergy, hives, fatigue.

Rare (0.01-0.1%): thrombocytopenia, increase in liver enzyme levels.

 

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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 in children

  • medical history of delirium.

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

Administer under the supervision of a pediatrician or neurologist experienced in diagnosing epilepsy in infants and children.

Monitor children's growth during use because of gastrointestinal side effects.

Monitor liver function before and during treatment every six months and, because of the risk of neutropenia, blood cell counts. Do not use in cases of impaired hepatic and/or renal function due to lack of clinical data.

Research data: The main clinical evaluation of stiripentol was in children 3 years of age and older. Limited data are available in children less than 12 months of age. In adults 18 years of age and older, there are insufficient data to confirm maintenance of efficacy in this age group.

 

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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
N03AX18
N03AX09
N03AX14
N03AX22
N03AX16
N03AX03
N03AX11
N03AX15

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Reference

  1. Biocodex, SmPC DIacomit (EU/1/06/367/001-003) 07-12-2018, www.geneesmiddeleninformatiebank.nl

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Changes

Changes