Primidon

Generic name
Primidon
Brand name
ATC Code
N03AA03
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.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

On-label

Licensed use Licensed use

Registration Status Title

Epilepsie
1 mnd tot 18 jaar: Start 125 mg/dag in 1 dosis voor het slapen gaan;  om de 3 dagen de dagdosis ophogen met 125 mg tot maximale dosering:
1 mnd tot 2 jaar: 500 mg
2 tot 5 jaar: 750 mg
5 tot 9 jaar:1000 mg
>9 jaar: 1500 mg

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

Dosages

Epilepsy
  • Oral
    • 1 month up to 2 years
      • Initial dose: 60 - 125 mg/day in 1 dose
      • Maintenance dose: Increase the daily dose every 3 days by 125 mg (based on the effect) to on average 20 mg/kg/day in 2 doses. Max: 500 mg/day.
      • Directions for administration:

        If seizures occur at night, give the full dose or most of the dose in the evening.

    • 2 years up to 5 years
      • Initial dose: 60 - 125 mg/day in 1 dose
      • Maintenance dose: Increase the daily dose every 3 days by 125 mg (based on the effect) to on average 20 mg/kg/day in 2 doses. Max: 750 mg/day.
      • Directions for administration:

        If seizures occur at night, give the full dose or most of the dose in the evening.

    • 5 years up to 9 years
      • Initial dose: 60 - 125 mg/day in 1 dose
      • Maintenance dose: Increase the daily dose every 3 days by 125 mg (based on the effect) to on average 20 mg/kg/day in 2 doses. Max: 1.000 mg/day.
      • Directions for administration:

        If seizures occur at night, give the full dose or most of the dose in the evening.

    • 9 years up to 18 years
      • Initial dose: 125 mg/day in 1 dose
      • Maintenance dose: Increase the daily dose every 3 days by 125 mg (based on the effect) to on average 15 mg/kg/day in 2 doses. Max: 1.500 mg/day.
      • Directions for administration:

        If seizures occur at night, give the full dose or most of the dose in the evening.

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.

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.

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.

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
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

References

  1. SERB, SmPC Mysoline (RVG 00379) 19-04-2019, www. geneesmiddeleninformatiebank.nl
  2. Sanova Pharma GesmbH, SmPC Mysolin (Zulassung 7.676), 11.2021
  3. Desitin Arzneimittel GmBH, SmPC Liskantin saft (Zulassung 6001169.00.01), 07-2021

Changes

Therapeutic Drug Monitoring


Overdose