Properties
What is it?
International Nonproprietary Name - lamotrigine Clinical-pharmacological group: Central Nervous System → Antiepileptic drugs Qualitative and quantitative composition Tablets: 25, 50, 100 or 200 mg Indications Epilepsy • Adults (over 12 years of age): Lamotrigine is indicated as adjunctive or monotherapy for the treatment of epilepsy, generalized seizures and partial seizures, including tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome. • Children (2-12 years of age): Lamotrigine is indicated as adjunctive therapy for the treatment of epilepsy, generalized seizures and partial seizures, including tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome. Following stabilization of epilepsy during adjunctive therapy, concomitant antiepileptic drugs (AEDs) may be withdrawn and patients may continue lamotrigine monotherapy. Lamotrigine is indicated as monotherapy for typical absence seizures. Bipolar disorder • Adults (18 years of age and older). Lamotrigine is indicated for the prevention of mood episodes in patients with bipolar disorder, predominantly with depressive episodes. Dosage and administration Lamotrigine tablets should be swallowed whole and not chewed or crushed. Lamotrigine dispersible/chewable tablets may be chewed, dispersed in a small amount of water (at least enough to cover the tablet), or swallowed whole with a small amount of water. If the calculated dose of lamotrigine, for example for use in children (only for epilepsy) or in patients with hepatic impairment, cannot be divided into several lower strength tablets, the dose to be administered should be approximately equal to the dose of the next lower strength tablet. Restarting therapy When restarting lamotrigine in patients who have stopped taking it for any reason, the dose titration from the starting dose to the maintenance dose must be taken into account, as the risk of severe rash is associated with high starting doses and exceeding the recommended dose titration of lamotrigine. The longer the interval since the previous dose, the more attention should be paid to dose titration to the maintenance dose. When the interval since withdrawal of Lamictal exceeds five half-lives, the dose of lamotrigine should be titrated to the maintenance dose according to the appropriate schedule. It is recommended that lamotrigine not be restarted in patients who have stopped taking it due to rash associated with prior treatment with lamotrigine, unless the potential benefit clearly outweighs the risk. Epilepsy When concomitant antiepileptic drugs are withdrawn to achieve lamotrigine monotherapy or other AEDs are added to a treatment regimen containing lamotrigine, the effect this may have on lamotrigine pharmacokinetics should be taken into account.