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

Interactions
PK
Renal impairment
References

Clobazam

Generic name
Clobazam
Brand name
ATC Code
N05BA09

Pharmacokinetics in children

The kinetic parameters of clobazam in 414 children and adults were investigated In a study [Bun 1990]. The kinetic parameters may have been influenced by co-administration of other drugs.
Volume of distribution 194 l,
Clearance 10.17 l / h,
t½ 16 hours and t½ metabolite 15 hours.

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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

Short-term treatment of sudden extreme insomnia
  • Oral
    • 2 years up to 15 years
      • 5 - 15 mg/day in 1 - 2 doses.
    • 15 years up to 18 years
      • 20 - 30 mg/day in 2 - 3 doses. Max: 60 mg/day.

      • In psychiatric conditions, the dosage can be increased to the maximum.
Epilepsy
  • Oral
    • 1 month up to 16 years
      • Initial dose: 0.25 mg/kg/day in 1 - 2 doses.
      • Maintenance dose: Increase every 5 days to a maintenance dose of 0.5 - 1 mg/kg/day in 1 - 2 doses. Max: 40 mg/day.

      • Dosages of up to 25 mg can be given as a single daily dose in the evening to prevent drowsiness during the day.

    • 16 years up to 18 years
      • Initial dose: 0.25 mg/kg/day in 1 - 2 doses.
      • Maintenance dose: Increase every 5 days to a maintenance dose of 0.5 - 1 mg/kg/day in 1 - 2 doses. Max: 80 mg/day.

      • Dosages up to 25 mg can be given as a single daily dose in the evening to prevent drowsiness during the day
Febrile convulsions
  • Oral
    • 6 months up to 6 years
      • 0.5 mg/kg/day in 1 - 2 doses. Max: 40 mg/day.
      • Duration of treatment:

        From the moment the fever starts and throughout the entire period with fever

      • Limited studies have been carried out into the use of clobazam in febrile convulsions. The dose recommendations are based on the experience of experts.

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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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

Sleepiness, ataxia, behavioural disorders, sedation, drooling, agitation. Particularly at high doses, in children: paradoxical reactions such as acute excitement and changes in the mental condition.

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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

Do not suddenly stop long-term treatment, but instead gradually reduce the dose to prevent withdrawal symptoms.
Effectiveness and side-effects are correlated to CYP2C19 activity (the N-clobazam concentration increases with poor metabolizers)
 

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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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Benzodiazepine derivatives
N05BA12
N05BA08
N05BA01
N05BA06
N05BA04
Diphenylmethane derivatives
N05BB01
Azaspirodecanedione derivatives
N05BE01

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References

  1. Bun H, et al, Effects of age and antiepileptic drugs on plasma levels and kinetics of clobazam and N-desmethylclobazam., Pharmacol Toxicol., 1990, Aug;67(2), 136-4
  2. Kalra V, et al, Clobazam in refractory childhood epilepsy, Indian J Pediatr, 2010, Mar;77(3), 263-6
  3. Canadian Study Group for Childhood Epilepsy, Clobazam has equivalent efficacy to carbamazepine and phenytoin as monotherapy for childhood epilepsy , Epilepsia, 1998, Sep;39(9), 952-9
  4. Conry JA, et al, Clobazam in the treatment of Lennox-Gastaut syndrome, Epilepsia, 2009, May;50(5), 1158-66
  5. Kaushal S, et al, Safety and efficacy of clobazam versus phenytoin-sodium in the antiepileptic drug treatment of solitary cysticercus granulomas, Neurol India, 2006, Jun;54(2), 157-60
  6. Rose W, et al, Intermittent clobazam therapy in febrile seizures, Indian J Pediatr, 2005, Jan;72(1), 31-3
  7. Canadian Clobazam Cooperative Group, Clobazam in treatment of refractory epilepsy: the Canadian experience. A retrospective study. , Epilepsia, 1991, May-Jun;32(3):, 407-16
  8. Shimizu H, et al, Antiepileptic effects of clobazam in children. , Brain Dev, 1982, 4(1), 57-62
  9. Keene DL, et al, Clobazam as an add-on drug in the treatment of refractory epilepsy of childhood, Can J Neurol Sci., 1990, Aug;17(3), 317-9
  10. Koeppen D. , Review of clinical studies on clobazam. , Br J Clin Pharmacol. , 1979, 7, Suppl 1139S-50S
  11. Seo T, et al, Impact of CYP2C19 polymorphisms on the efficacy of clobazam therapy, Pharmacogenomics, 2008, May;9(5), 527-3
  12. Sanofi-Aventis Netherlands BV, SPC Frisium (RVG 09600) mei 2018, www.geneesmiddeleninformatiebank.nl
  13. Khosroshahi, N. et al, Diazepam versus clobazam for intermittent prophylaxis of febrile seizures, Indian J Pediatr, 2011, 78(1), 38-40
  14. Ng, Y.T. et al, Randomized, phase III study results of clobazam in Lennox-Gastaut syndrome, Neurology, 2011, 77(15), 1473-81
  15. Samanta, D. et al, Absence status after starting clobazam in a patient with syndrome of continuous spike and wave during slow sleep (CSWS)., Neurol India, 2014, 62(2), 685-7
  16. Sattar, S. et al, Intermittent prophylaxis of recurrent febrile seizures with clobazam versus diazepam, Mymensingh Med, 2014, 23(4), 676-85
  17. Incecik, F. et al, Unusual side effects due to clobazam: a case report with edema of the extremities, Acta Neurol Belg, 2018, 118(3), 521-522
  18. Koeppen D., Review of clinical studies on clobazam., Br J Clin Pharmacol., 1979, 7, Suppl 1139S-50S
  19. Canadian Study Group for Childhood Epilepsy, Clobazam has equivalent efficacy to carbamazepine and phenytoin as monotherapy for childhood epilepsy, Epilepsia, 1998, Sep;39(9), 952-9
  20. Canadian Clobazam Cooperative Group, Clobazam in treatment of refractory epilepsy: the Canadian experience. A retrospective study., Epilepsia, 1991, May-Jun;32(3):, 407-16
  21. Shimizu H, et al, Antiepileptic effects of clobazam in children., Brain Dev, 1982, 4(1), 57-62

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Changes

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