Active Ingredient: Lamotrigine
For this indication, competent medicine agencies globally authorize below treatments:
Oral
25 - 400 mg
From 12.5 To 200 mg 2 time(s) per day every day
25 mg
The recommended dose escalation and maintenance doses for adults and adolescents aged 13 years and above 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When concomitant AEDs are withdrawn or other AEDs/medicinal products are added on to treatment regimes containing lamotrigine, consideration should be given to the effect this may have on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.
Adults and adolescents aged 13 years and above – recommended treatment regimen in epilepsy:
| Treatment regimen | Weeks 1+2 | Weeks 3+4 | Usual maintenance dose |
|---|---|---|---|
| Monotherapy: | 25 mg/day (once a day) | 50 mg/day (once a day) | 100-200 mg/day (once a day or two divided doses). To achieve maintenance, doses may be increased by maximum of 50-100 mg every one to two weeks until optimal response is achieved. 500 mg/day has been required by some patients to achieve desired response |
| Adjunctive therapy WITH valproate (inhibitor of lamotrigine glucuronidation): | |||
| This dosage regimen should be used with valproate regardless of any concomitant medicinal products | 12.5 mg/day (given as 25 mg on alternate days) | 25 mg/day (once a day) | 100-200 mg/day (once a day or two divided doses). To achieve maintenance, doses may be increased by maximum of 25-50 mg every one to two weeks until optimal response is achieved |
| 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 | 50 mg/day (once a day) | 100 mg/day (two divided doses) | 200-400 mg/day (two divided doses). To achieve maintenance, doses may be increased by maximum of 100 mg every one to two weeks until optimal response is achieved. 700 mg/day has been required by some patients to achieve desired response |
| 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 | 25 mg/day (once a day) | 50 mg/day (once a day) | 100-200 mg/day (once a day or two divided doses). To achieve maintenance, doses may be increased by maximum of 50-100 mg every one to two weeks until optimal response is achieved |
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.
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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