Sodiumoxybate (oral)

Generic name
Sodiumoxybate (oral)
Brand name
ATC Code
N07XX04
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Sodiumoxybate (oral)

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The main pharmacokinetic properties of sodium oxybate in children are similar to those in adults.

Tmax: 0,5-2 hour
Vd: 0,2-0,4 l/kg
T½: 0,5-1 hour

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

Narcolepsy with cataplexy
  • Oral
    • 7 years up to 18 years and 15 up to 20 kg
      • Initial dose: ≤ 1 g/day in 2 doses.
      • Maintenance dose: Based on effect and tolerance, increase every 1-2 weeks with ≤ 0,5 g/day increments to max 0.2 g/kg/day in 2 doses.
    • 7 years up to 18 years and 20 up to 30 kg
      • Initial dose: ≤ 2 g/day in 2 doses.
      • Maintenance dose: Based on effect and tolerance, increase every 1-2 weeks with ≤1 g/day increments to max 0.2 g/kg/day in 2 doses.
    • 7 years up to 18 years and 30 up to 45 kg
      • Initial dose: ≤ 3 g/day in 2 doses.
      • Maintenance dose: Based on effect and tolerance, increase every 1-2 weeks with ≤1 g/day increments to max 0.2 g/kg/day in 2 doses.
    • 7 years up to 18 years and ≥ 45 kg
      • Initial dose: ≤ 4.5 g/day in 2 doses.
      • Maintenance dose: Based on effect and tolerance, increase every 1-2 weeks with ≤1,5 g/day increments to max 9 g/day in 2 doses.
CAUTION:
  • Oral
    • 7 years up to 18 years
        • In combination with valproate, reduce the dose of sodium oxybate by 20%,
        • Divide daily dose into 2 equal doses. The first dose to be taken at bedtime and the second 2.5-4 hours afterwards.
        • Dilute the dose to be taken with 60 ml of water.
        • Do not eat at least 2-3 hours before administration.

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

Very common (> 10%): bedwetting, nausea.

Common (1-10%): vomiting, weight loss, decreased appetite, headache, dizziness, suicidal thoughts, acute psychosis. Aberrant behavior, aggression and mood change is sometimes reason to stop use.

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

For each dose increase, check during titration whether sodium oxybate is tolerated; instruct parents/caregivers to monitor for breathing abnormalities during the first 2 hours after the first intake. If respiratory abnormalities are detected, medical attention should be sought and the second dose should not be administered. If in doubt whether parents/caregivers are capable of careful monitoring, arrange medical supervision or do not prescribe sodium oxybate.

Monitor weight regularly, especially during dosistitration.

Monitor for suicidal or depressive state before and during treatment.

Point out that alcohol may enhance central inhibition and respiratory depression, related to the risk of alcohol use in adolescents.

Provide educational materials, on monitoring for growth and learning ability and parental reporting of all behavioral changes in addition to side effects.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

OTHER NERVOUS SYSTEM DRUGS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Reference

  1. UCB Pharma Ltd, SmPC Xyrem (EU/1/05/312) Rev 36, 05-07-2023, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose