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Indications & Usage Section 1.1 Epilepsy Adjunctive Therapy: Lamotrigine Tablets Are Indicated As Adjunctive Therapy For The Following Seizure Types In Patients ≥ 2 Years Of Age: Partial Seizures Primary Generalized Tonic-Clonic Seizures Generalized Seizures Of Lennox-Gastaut Syndrome Monotherapy: Lamotrigine Tablets Are Indicated For Conversion To Monotherapy In Adults (≥16 Years Of Age) With Partial Seizures Who Are Receiving Treatment With Carbamazepine, Phenytoin, Phenobarbital, Primidone, Or Valproate As The Single Antiepileptic Drug (Aed). Safety And Effectiveness Of Lamotrigine Tablets 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 2 Or More Concomitant Aeds. 1.2 Bipolar Disorder Lamotrigine Tablets Are Indicated For The Maintenance Treatment Of Bipolar I Disorder To Delay The Time To Occurrence Of Mood Episodes (Depression, Mania, Hypomania, Mixed Episodes) In Adults (≥18 Years Of Age) Treated For Acute Mood Episodes With Standard Therapy. The Effectiveness Of Lamotrigine Tablets In The Acute Treatment Of Mood Episodes Has Not Been Established. The Effectiveness Of Lamotrigine Tablets As Maintenance Treatment Was Established In 2 Placebo-Controlled Trials In Patients With Bipolar I Disorder As Defined By Dsm-Iv [See Clinical Studies (14.2)]. The Physician Who Elects To Prescribe Lamotrigine Tablets For Periods Extending Beyond 16 Weeks Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient.
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