- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Geen PK gegevens bij kinderen bekend.
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
On-label
Licensed use Licensed useA second drug has not been selected yet.
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Available formulations
Capsule 12.5 mg, 15 mg, 25 mg, 62.5 mg (doorgeleverde bereidingen)
Tablet 10 mg, 12.5 mg, 15 mg, 15.1 mg, 25 mg, 30 mg, 31.25 mg, 50 mg, 60 mg, 62,5 mg (doorgeleverde bereidingen), 250 mg
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Dosages
| Epilepsy |
|---|
|
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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
Bij kinderen kunnen gedragsstoornissen zich voordoen in de vorm van hyperactiviteit, irritatie, agressie en slaapstoornissen.
The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Adult Side Effects
Sedatie, slaperigheid en lusteloosheid, vooral in het begin van de behandeling. Verder: hoofdpijn, duizeligheid, visusstoornissen, nystagmus, misselijkheid en braken, ataxie. De meeste symptomen verdwijnen in het algemeen na enkele dagen, zelfs bij voortzetten van de therapie.
Bij ouderen is agitatie en verwardheid gezien.
Dermatologische reacties (huiduitslag, zelden toxische epidermale necrolyse), systemische lupus erythematodes, (ernstige) depressie en acute psychotische reacties zijn gemeld. Bij langdurige behandeling: verminderde minerale botdichtheid, osteopenie, osteoporose, botbreuken. Bij chronisch gebruik: osteomalacie.
Zeer zelden Stevens-Johnson-syndroom (SJS), toxische epidermale necrolyse (TEN), met name in de eerste weken van behandeling.
Verder: artralgie, persoonlijkheidsverandering, Dupuytren-contractuur, megaloblastaire anemie.
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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
- hyperkinesie bij kinderen;
The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications in adults
- acute intermitterende porfyrie;
- ernstige respiratoire insufficiëntie;
- overgevoeligheid voor barbituraten.
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 | ||
| 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 | ||
| N03AX03 | ||
| N03AX11 | ||
| N03AX15 | ||
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References
- SERB, SmPC Mysoline (RVG 00379) 19-04-2019, www. geneesmiddeleninformatiebank.nl
- Sanova Pharma GesmbH, SmPC Mysolin (Zulassung 7.676), 11.2021
- Desitin Arzneimittel GmBH, SmPC Liskantin saft (Zulassung 6001169.00.01), 07-2021
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Changes
Changes
