Sultiam

Generic name
Sultiam
Brand name
ATC Code
N03AX03
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The study of  May et al. (n=10, 2-17 years) shows a halflife varying between 4.7 and 10.9 hours. Young children have a decreased halflife compared with older children.  

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
  • Oral
    • 1 month up to 18 years
      • Initial dose: 1 - 2 mg/kg/day in 2 doses.
      • Maintenance dose: if needed, increase initital dose weekly up to  3 - 6 mg/kg/day in 2 doses. Max: 10mg/kg/day, but not exceeding 600 mg/day.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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

Hypocalcemia is reported in 5 out of 11 users of sultiam (ages 1-18 years). In 4 out of 11 users a hypophosphatemia was reported [Borusiak 2013].

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
N03AX18
N03AX09
N03AX14
N03AX22
N03AX16
N03AX17
N03AX11
N03AX15

References

  1. Tacke M, et al, Effects of Levetiracetam and Sulthiame on EEG in benign epilepsy with centrotemporal spikes: A randomized controlled trial, Seizure, 2018, 56, 115-250
  2. Borggraefe I, et al, Levetiracetam vs. sulthiame in benign epilepsy with centrotemporal spikes in childhood: a double-blinded, randomized, controlled trial (German HEAD Study),, Eur J Paediatr Neurol., 2013, 17, 507-14
  3. Shamdeen MG, et al, Effect of sulthiame on EEG pathology, behavior and school performance in children with Rolandic epileptiform discharges, Pediatr Int, 2012, 54, 98-800.
  4. Swiderska N, et al, Sulthiame in refractory paediatric epilepsies: an experience of an ‘old’ antiepileptic drug in a tertiary paediatric neurology unit, Seizure, 2011, 20, 805-8
  5. Ben-Zeev B, et al, Sulthiame in childhood epilepsy, Pediatr Int., 2004, 46, 521-4
  6. Debus OM, et al, Sulthiame in the primary therapy of West syndrome: a randomized double-blind placebo-controlled add-on trial on baseline pyridoxine medication, 2004, 45, 103-8
  7. Bast T, et al, The influence of sulthiame on EEG in children with benign childhood epilepsy with centrotemporal spikes (BECTS), Epilepsia, 2003, 44, 215-20
  8. Engler F, et al, Treatment with Sulthiame (Ospolot) in benign partial epilepsy of childhood and related syndromes: an open clinical and EEG study, Neuropediatrics, 2003, 34, 105-9
  9. Debus OM, et al, Add-on treatment with pyridoxine and sulthiame in 12 infants with West syndrome: an open clinical study, 2002, 11, 381-3
  10. Kramer U, et al, Carbamazepine versus sulthiame in treating benign childhood epilepsy with centrotemporal spikes, J Child Neurol, 2002, 17, 914-6
  11. Rating D, et al, Sulthiame as monotherapy in children with benign childhood epilepsy with centrotemporal spikes: a 6-month randomized, double-blind, placebo-controlled study, Epilepsia, 2000, 41, 1284-8
  12. Borusiak MG, et al, Antiepileptic drugs and bone metabolism in children: data from 128 patietnts, J Child Neurol, 2013, 28, 176-83.
  13. May TW, et al, Pharmcokinetics of sulthiame in epileptics patients, Ther Drug Monit, 1994, 16, 251-7
  14. Neuraxpharm, Fachinformation sultiam, Deutschland, 03-2019
  15. Phebra Pty Ltd, Product information Ospolot, Australia, 21-11-2013
  16. Borggraefe I, et al, Levetiracetam vs. sulthiame in benign epilepsy with centrotemporal spikes in childhood: a double-blinded, randomized, controlled trial (German HEAD Study),, Eur J Paediatr Neurol., 2013, 17, 507-14

Changes

Therapeutic Drug Monitoring


Overdose