Lamotrigine

Lamotrigine is a 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine of the phenyltriazine class. It was first licensed for clinical practice in 1991. Lamotrigine is one of the best newer AEDs, although there are now concerns for its use in women and myoclonic epilepsies.

UK-SmPC: (1) Adults and adolescents aged 13 years and above: (a) adjunctive or monotherapy treatment of focal seizures and generalised seizures, including tonic clonic seizures and (b) seizures associated with Lennox Gastaut syndrome. Lamotrigine is given as adjunctive therapy but may be the initial antiepileptic drug to start with in Lennox Gastaut syndrome. (2) Children and adolescents aged 2 to 12 years: (a) adjunctive treatment of partial seizures and generalised seizures, including tonic clonic seizures and the seizures associated with Lennox Gastaut syndrome and (b) monotherapy of typical absence seizures.

FDA-PI: (1) adjunctive therapy for focal seizures and primarily GTSC in patients ≥2 years of age; (2) adjunctive therapy for the generalised seizures of Lennox–Gastaut syndrome; and (3) conversion to monotherapy in adults (≥16 years of age) with focal seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone or valproate as the single AED.

Safety and effectiveness of lamotrigine have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from two or more concomitant AEDs.