Description
EPILEPSY: Adults and Adolescents: LAMICTAL is indicated for use as adjunctive or monotherapy in the treatment of epilepsy, for partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome.
Children (2 to 12 years of age): LAMICTAL is indicated as adjunctive therapy in the treatment of epilepsy, for partial seizures and generalised seizures including tonic-clonic seizures and the seizures associated with Lennox-Gastaut syndrome (above 3 years of age only).
Initial monotherapy treatment in newly diagnosed paediatric patients is not recommended.
After epileptic control has been achieved during adjunctive therapy, concomitant anti-epileptic drugs (AEDs) may be withdrawn and patients continued on LAMICTAL monotherapy.
If LAMICTAL 2 mg Chewable Dispersible Tablet is not available and the calculated dose in children is less than 2.5 mg daily, then LAMICTAL cannot be used. DO NOT attempt to administer partial quantities of the dispersible tablets.
BIPOLAR DISORDER: Adults (18 years of age and over): LAMICTAL is indicated for the prevention of mood episodes in patients with bipolar disorder, predominantly by preventing depressive episodes.
LAMICTAL tablets should be swallowed whole, and should not be chewed or crushed. LAMICTAL dispersible tablets may be dispersed in a small volume of water (at least enough to cover the whole tablet) or swallowed whole with a little water. DO NOT attempt to administer partial quantities of the dispersible tablets.
Dosage in Epilepsy Monotherapy: Adults and Adolescents (over 16 years of age) (see Table 1): The initial LAMICTAL dose in monotherapy 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 optimal response is 100 to 200 mg/day given once a day or as two divided doses. Some patients have required 500 mg/day of LAMICTAL to achieve the desired response.
Because of a risk of rash the initial dose and subsequent dose escalation should not be exceeded (see Precautions).
Dosage in Epilepsy Add-On Therapy: Adults and Adolescents (over 12 years of age) (see Table 1): In patients taking valproate with/without any other AED, the initial LAMICTAL dose is 25 mg every alternate day for two weeks, followed by 25 mg once a day for two weeks.
Thereafter, the dose should be increased by a maximum of 25 to 50 mg every one to two 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 in two divided doses.
