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

Interactions
PK
Renal impairment
References

Cannabidiol

Generic name
Cannabidiol
Brand name
ATC Code
N03AX24

Pharmacokinetics in children

No information is present at this moment.

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

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Available formulations

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Dosages

Adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC)
  • Oral
    • ≥ 2 years

      • Week 1: 5 mg/kg/day in 2 doses
        Week 2: 10 mg/kg/day in 2 doses
        Week 3 onwards: if necessary, according to effect and tolerance, further increase weekly in steps of 5 mg/kg/day in 2 doses up to max 25 mg/kg/day in 2 doses.

      • Directions for administration:

        Should be administered consistently with respect to meals.

      • If therapy is stopped, slow down titration is indicated (e.g. decrease the dose by 10% each day during 10 days).

    • ≥ 2 years
      [1]

      • Week 1: 5 mg/kg/day in 2 doses
        Week 2: 10 mg/kg/day in 2 doses
        Week 3 onwards: if necessary, according to effect and tolerance, further increase weekly in steps of 5 mg/kg/day in 2 doses up to max 25 mg/kg/day in 2 doses.

      • Directions for administration:

        Should be administered consistently with respect to meals.

      • If therapy is stopped, slow down titration is indicated (e.g. decrease the dose by 10% each day during 10 days).

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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

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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 in children

Caution when children are engaged in activities such as cycling or other sports, as they may feel sleepy.

The formulation contains alcohol (79 mg/ml). The effects of alcohol in children under 6 years of age may include drowsiness, behavioural changes, as well as problems concentrating and difficulty participating in school activities.

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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
N03AX10
N03AX26
N03AX18
N03AX09
N03AX14
N03AX22
N03AX16
N03AX17
N03AX03
N03AX11
N03AX15

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Reference

  1. GW Pharma (International) B.V., SmPC Epidyolex 100 mg/ml Lösung zum Einnehmen (EU/1/19/1389/001), 23. Juni 2021

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Changes

Changes