What is lamotrigine used for?

Indications and Usage, quoted from the label by Sun Pharmaceutical Industries, Inc. (ANDA078525). Cross-references to other label sections are left out.

Epilepsy

Adjunctive Therapy:Lamotrigine is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older:

• partial-onset seizures.
• primary generalized tonic-clonic (PGTC) seizures.
• generalized seizures of Lennox-Gastaut syndrome.

Monotherapy:Lamotrigine is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).

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

Bipolar Disorder

Lamotrigine is indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see Clinical Studies].

Limitations of Use:Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.

Source: DailyMed label, set id b829f9b2-f0ac-408a-a6f4-18b72150227d, version 22, effective June 3, 2026. NDC 51672-4130, one of 142 listings for this product.

Indications and Usage, quoted from the label by Dr.Reddy's Laboratories Limited (ANDA202383). Cross-references to other label sections are left out.

Adjunctive Therapy

Lamotrigine extended-release tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older.

Monotherapy

Lamotrigine extended-release tablets are indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED).

Safety and effectiveness of lamotrigine extended-release tablets have not been established as initial monotherapy or for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.

Limitation of Use

Safety and effectiveness of lamotrigine extended-release tablets for use in patients younger than 13 years have not been established.

Source: DailyMed label, set id a69542ea-5b6f-15c1-9e7a-90ac839971d3, version 29, effective November 21, 2025. NDC 55111-419, one of 38 listings for this product.