Active Ingredient: Lamotrigine
For this indication, competent medicine agencies globally authorize below treatments:
Oral
0.3 - 15 mg per kg of body weight
From 0.15 To 7.5 mg per kg of body weight 2 time(s) per day every day
0.3 mg per kg of body weight
The recommended dose escalation and maintenance doses for children and adolescents aged 2 to 12 years are given below. Because of a risk of rash the initial dose and subsequent dose escalation should not be exceeded.
When concomitant AEDs are withdrawn or other AEDs/medicinal products are added on to treatment regimes containing lamotrigine, consideration should be given to the effect this may have on lamotrigine pharmacokinetics.
Children and adolescents aged 2 to 12 years – recommended treatment regimen in epilepsy (total daily dose in mg/kg body weight/day):
| Treatment regimen | Weeks 1+2 | Weeks 3+4 | Usual maintenance dose |
|---|---|---|---|
| Monotherapy of typical absence seizures: | 0.3 mg/kg/day (once a day or two divided doses) | 0.6 mg/kg/day (once a day or two divided doses) | 1–15 mg/kg/day (once a day or two divided doses). To achieve maintenance, doses may be increased by maximum of 0.6 mg/kg/day every one to two weeks until optimal response is achieved with a maximum maintenance dose of 200 mg/day |
| Adjunctive therapy WITH valproate (inhibitor of lamotrigine glucuronidation): | |||
| This dosage regimen should be used with valproate regardless of any other concomitant medicinal products | 0.15 mg/kg/day* (once a day) | 0.3 mg/kg/day (once a day) | 1–5 mg/kg/day (once a day or two divided doses). To achieve maintenance, doses may be increased by maximum of 0.3 mg/kg every one to two weeks until optimal response is achieved, with a maximum maintenance dose of 200 mg/day |
| Adjunctive therapy WITHOUT valproate and WITH inducers of lamotrigine glucuronidation: | |||
| This dosage regimen should be used without valproate but with: phenytoin, carbamazepine, phenobarbitone, primidone, rifampicin, lopinavir/ritonavir | 0.6 mg/kg/day (two divided doses) | 1.2 mg/kg/day (two divided doses) | 5-15 mg/kg/day (once a day or two divided doses) To achieve maintenance, doses may be increased by maximum of 1.2 mg/kg every one to two weeks until optimal response is achieved, with a maximum maintenance dose of 400 mg/day |
| Adjunctive therapy WITHOUT valproate and WITHOUT inducers of lamotrigine glucuronidation: | |||
| This dosage regimen should be used with other medicinal products that do not significantly inhibit or induce lamotrigine glucuronidation | 0.3 mg/kg/day (once | ||
| 0.6 mg/kg/day (once a day or two divided doses) | 1-10 mg/kg/day (once a day or two divided doses). To achieve maintenance, doses may be increased by maximum of 0.6 mg/kg every one to two weeks until optimal response is achieved, with a maximum of maintenance dose of 200 mg/day | ||
In patients taking medicinal products where the pharmacokinetic interaction with lamotrigine is currently not known, the treatment regimen as recommended for lamotrigine with concurrent valproate should be used.
* If the calculated daily dose in patients taking valproate is 1 mg or more but less than 2 mg, then 2 mg (from other lamotrigine dispersible/chewable tablets available on the market) may be taken on alternate days for the first two weeks. If the calculated daily dose in patients taking valproate is less than 1 mg, then lamotrigine should not be administered.
To ensure a therapeutic dose is maintained the weight of a child must be monitored and the dose reviewed as weight changes occur. It is likely that patients aged two to six years will require a maintenance dose at the higher end of the recommended range.
If epileptic control is achieved with adjunctive treatment, concomitant AEDs may be withdrawn and patients continued on lamotrigine dispersible tablets monotherapy.
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