Lamodex

/ Dexcel

Epilepsy:
Monotherapy in adults and children over 12 years of age: The initial lamotrigine dose in monotherapy is 25mg once a day for two weeks, followed by 50mg once a day for two weeks. Thereafter, the dose should be increased by a maximum of 50mg-100mg every 1-2 weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 100 to 200 mg/day given once a day or as two divided doses. Some patients have required 500mg/day of Lamictal to achieve the desired response.
Add-on therapy: Adult and children over 12 years of age: In patients taking valproate with/without any other anti-epileptic drug (AED), the initial lamotrigine dose is 25mg every alternate day for two weeks, followed by 25mg once a day for two weeks. Thereafter, the dose should be increased by a maximum of 25-50mg every 1-2 weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 100-200 mg/day given once a day or in two divided doses.
In those patients taking concomitant AEDs or other medications that induce lamotrigine glucuronidation with/without other AEDs (except valproate), the initial lamotrigine dose is 50mg once a day for two weeks, followed by 100mg/day given in two divided doses for two weeks.
Thereafter, the dose should be increased by a maximum of 100mg every 1-2 weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 200 – 400 mg/day given in two divided doses. Some patients have required 700 mg/day of lamotrigine to achieve the desired response. In those patients taking other medications that do not significantly inhibit or induce lamotrigine glucuronidation, the initial lamotrigine dose is 25 mg once a day for two weeks, followed by 50 mg once a day for two weeks. Thereafter, the dose should be increased by a maximum of 50 to 100 mg every one to two weeks until the optimal response is achieved. The usual maintenance dose to achieve an optimal response is 100 to 200 mg/day given once a day or as two divided doses.
Children aged 2-12 years: In patients taking valproate with/without any other AED, the initial lamotrigine dose is 0.15mg/kg bodyweight/day given once a day for two weeks, followed by 0.3 mg/kg/day once a day for two weeks. Thereafter, the dose should be increased by a maximum of 0.3mg/kg every 1-2 weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 1-5 mg/kg/day given once a day or in two divided doses, with a maximum of 200 mg/day.
In those patients taking concomitant AEDs or other medications that induce lamotrigine glucuronidation with/without other AEDs (except valproate), the initial lamotrigine dose is 0.6 mg/kg bodyweight/day given in two divided doses for two weeks, followed by 1.2 mg/kg/day for two weeks. Thereafter, the dose should be increased by a maximum of 1.2 mg/kg every 1-2 weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 5-15 mg/kg/day given in two divided doses, with a maximum of 400 mg/day.
In patients taking other medications that do not significantly inhibit or induce lamotrigine glucuronidation, the initial lamotrigine dose is 0.3 mg/kg bodyweight/day given once a day or in two divided doses for two weeks, followed by 0.6 mg/kg/day given once a day or in two divided doses for two weeks. Thereafter, the dose should be increased by a maximum of 0.6 mg/kg every one to two weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 1 to 10 mg/kg/day given once a day or in two divided doses, with a maximum of 200 mg/day.
To ensure a therapeutic dose is maintained the weight of a child must be monitored and the dose reviewed as weight changes occur. The initial dose and subsequent dose escalation should not be exceeded to minimize the risk of rash. It is likely that patients aged 2-6 years will require a maintenance dose at the higher end of the recommended range
BIPOLAR DISORDER:
Adults (18 years of age and over): Because of the risk of rash the initial dose and subsequent dose escalation should not be exceeded. Lamotrigine is recommended for use in bipolar patients at risk for a future depressive episode. The following transition regimen should be followed to prevent recurrence of depressive episodes. The transition regimen involves escalating the dose of lamotrigine to a maintenance stabilisation dose over six weeks after which other psychotropic and/or anti-epileptic drugs can be withdrawn, if clinically indicated. Adjunctive therapy should be considered for the prevention of manic episodes, as efficacy with lamotrigine in mania has not been conclusively established.
Recommended dose escalation to the maintenance total daily stabilisation dose for adults (over 18 years of age) treated for BIPOLAR DISORDER:
Adjunct therapy with inhibitors of lamotrigine glucoronidation e.g. Valproate. In patients taking glucoronidation inhibiting concomitant drugs such as valproate the initial lamotrigine dose is 25 mg every alternate day for two weeks, followed by 25 mg once a day for two weeks. The dose should be increased to 50 mg once a day (or in two divided doses) in week 5. The usual target dose to achieve optimal response is 100 mg/day given once a day or in two divided doses. However, the dose can be increased to a maximum daily dose of 200 mg, depending on clinical response.
Adjunct therapy with inducers of lamotrigine glucoronidation in patients NOT taking inhibitors such as Valproate This dosage regimen should be used with phenytoin, carbamazepine, phenobarbitone, primidone and other drugs known to induce lamotrigine glucuronidation. In those patients currently taking drugs that induce lamotrigine glucoronidation and NOT taking valproate, the initial lamotrigine dose is 50 mg once a day for two weeks, followed by 100 mg/day given in two divided doses for two weeks. The dose should be increased to 200 mg/day given as two divided doses in week 5. The dose may be increased in week 6 to 300 mg/day however, the usual target dose to achieve optimal response is 400 mg/day given in two divided doses which may be given from week 7.
Monotherapy with lamotrigine OR adjunctive therapy in patients taking other medications that do not significantly induce or inhibit lamotrigine glucuronidation. The initial lamotrigine dose is 25 mg once a day for two weeks, followed by 50 mg once a day (or in two divided doses) for two weeks. The dose should be increased to 100 mg/day in week 5. The usual target dose to achieve optimal response is 200 mg/day given once a day or as two divided doses. However, a range of 100 to 400 mg was used in clinical trials.
Once the target daily maintenance stabilisation dose has been achieved, other psychotropic medications may be withdrawn.

Epilepsy:
Monotherapy in adults and children over 12 years of age: Simple partial seizures. Complex partial seizures. Generalised tonic clonic secondarily seizures. Primary generalised tonic clonic seizures.
Add-on therapy in adults and children over 2 years of age: Simple partial seizures. Complex partial seizures. Secondarily generalised tonic clonic seizures.
(25-200mg are also indicated for): Adults (18 years of age and over): Lamotrigine is indicated for the prevention of mood episodes in patients with bipolar disorder predominantly by preventing depressive episodes.

Lamotrigine is contra-indicated in individuals with known hypersensitivity to lamotrigine or any other ingredient of the product.

For additional information, please contact the license holder.

For additional information, please contact the license holder.

For additional information, please contact the license holder.

For additional information, please contact the license holder.

For additional information, please contact the license holder.