- 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.
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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
| Epilepsy |
|---|
|
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Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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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
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].
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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 | ||
| N03AX10 | ||
| N03AX26 | ||
| N03AX18 | ||
| N03AX09 | ||
| N03AX14 | ||
| N03AX22 | ||
| N03AX16 | ||
| N03AX17 | ||
| N03AX11 | ||
| N03AX15 | ||
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References
- 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
- 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
- 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.
- 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
- Ben-Zeev B, et al, Sulthiame in childhood epilepsy, Pediatr Int., 2004, 46, 521-4
- 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
- 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
- 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
- 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
- Kramer U, et al, Carbamazepine versus sulthiame in treating benign childhood epilepsy with centrotemporal spikes, J Child Neurol, 2002, 17, 914-6
- 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
- Borusiak MG, et al, Antiepileptic drugs and bone metabolism in children: data from 128 patietnts, J Child Neurol, 2013, 28, 176-83.
- May TW, et al, Pharmcokinetics of sulthiame in epileptics patients, Ther Drug Monit, 1994, 16, 251-7
- Neuraxpharm, Fachinformation sultiam, Deutschland, 03-2019
- Phebra Pty Ltd, Product information Ospolot, Australia, 21-11-2013
- 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
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Changes
Changes
