FDA Approves Lamotrigine Tablets (lamotrigine) for Epilepsy and Bipolar Disorder Maintenance

Not reported in label.

Lamotrigine tablets are indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older for partial-onset seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome. Epilepsy—monotherapy in patients aged 16 years and older for conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness in the acute treatment of mood episodes has not been established.

Dosing is based on concomitant medications, indication, and patient age. To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations should not be exceeded. Do not restart lamotrigine tablets in patients who discontinued due to rash unless the potential benefits clearly outweigh the risks. Adjustments to maintenance doses will be necessary in most patients starting or stopping estrogen-containing products, including oral contraceptives. Discontinuation: Taper over a period of at least 2 weeks (approximately 50% dose reduction per week). For epilepsy, see tables for adjunctive therapy in patients older than 12 years and aged 2 to 12 years, and for conversion to monotherapy. For bipolar disorder, see tables. A therapeutic plasma concentration range has not been established; dosing should be based on therapeutic response.

trial data not available in label

There are suggestions that the risk of severe, potentially life-threatening rash may be increased by coadministration with valproate, exceeding the recommended initial dose, or exceeding the recommended dose escalation, but cases have occurred in the absence of these factors. The risk of nonserious rash may be increased when the recommended initial dose and/or rate of dose escalation is exceeded and in patients with a history of allergy or rash to other AEDs. It is recommended that lamotrigine tablets not be restarted in patients who discontinued due to rash unless the potential benefits clearly outweigh the risks.

Lamotrigine tablets are used as adjunctive therapy for various seizure types in epilepsy and for maintenance in bipolar disorder, with specific dosing protocols to manage risks such as rash. They are not indicated for acute mood episodes or as initial monotherapy in epilepsy, and safety and effectiveness have not been established for certain conversion scenarios.