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Approved for a broad spectrum of ages and seizure types including adjunctive therapy for partial and primary generalized tonic-clonic (PGTC) seizures and conversion to monotherapy for adults with partial seizures


  Adjunctive therapy Patient population
Simple and complex
partial seizures		 >2 years through adulthood
Primary generalized
tonic-clonic
seizures		 >2 years through adulthood
Generalized seizures* of
Lennox-Gastaut
syndrome (LGS)		 >2 years through adulthood

Conversion to monotherapy  Patient population
Simple and complex
partial seizures		 >16 years through adulthood

*Atonic, tonic, major myoclonic, and tonic-clonic seizures.

Safety and effectiveness of LAMICTAL and LAMICTAL ODT 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.

Proven efficacy as adjunctive therapy for partial seizures

  • Approximately one third of patients receiving LAMICTAL 500 mg/day in combination with up to 3 AEDs experienced a ≥50% reduction in the number of seizures.1
  • Primary endpoint: Median reduction in partial seizures was 8% for placebo, 20% for LAMICTAL 300 mg/day, and 36% for LAMICTAL
    500 mg/day. Only LAMICTAL 500 mg/day was significant versus placebo.1

RESULTS FROM: MATSUO ET AL. Neurology. 1993;43:2284-2291.
Study design: In a double-blind, parallel-group study, 216 patients with refractory partial seizures were studied for 6 months, placebo-controlled, on the long-term efficacy and safety of LAMICTAL (300 or 500 mg/day) when added to up to 3 currently marketed AEDs.
In this study, initial dose was higher and rate of escalation was faster than recommended in the Prescribing Information for LAMICTAL.


Proven efficacy as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures

Reduced PGTC seizure frequency from baseline in patients ≥2 years over the entire treatment period.


RESULTS FROM: BITON ET AL. Neurology. 2005, 65: 1737-1743.
Study design: Double-blind, placebo-controlled evaluation of adjunctive therapy with LAMICTAL for PGTC seizures (with or without other idiopathic generalized seizure types, including absence, myoclonic, clonic, tonic, and atonic) in patients 2 to 55 years of age. Patients with partial seizures were excluded by screening and historical EEGs. After patients were screened, the study was divided into 3 phases: baseline (8 weeks), escalation (7 or 12 weeks, depending on patient's age), and maintenance (12 weeks). Fixed doses of LAMICTAL targeting 200-400 mg/day and 3-12 mg/kg/day based on age and concomitant AEDs (induced, non-induced, valproate [VPA]).


Convert with confidence—proven control with conversion to monotherapy

In adults with uncontrolled partial seizures (≥4 seizures/month) converted from carbamazepine or phenytoin2†





The data presented here are protocol-specific secondary analyses. The per-protocol analysis included patients who either met escape criteria or completed the monotherapy phase. Those who withdrew due to adverse events were not counted.
  • More than twice as many patients in the group receiving LAMICTAL successfully completed the trial versus patients in the active control group
  • Intent-to-treat analysis results, which included all randomized patients, were similar: 37% (28/76) versus 16% (13/80). (P=0.0012)

RESULTS FROM: GILLIAM ET AL. Neurology. 1998;51:1018-1025.
Study design: In a double-blind active-control study, 156 patients with partial seizures inadequately controlled on existing monotherapy (≥4 seizures/month on carbamazepine [CBZ] or phenytoin [PHT]) were converted to monotherapy with LAMICTAL or valproate (VPA) 1000 mg/day titrated to 250 mg BID and 500 mg BID, respectively. CBZ or PHT was withdrawn over the next 4 weeks in 20% weekly decrements. LAMICTAL or VPA was maintained for 12 weeks at target dose.
Note: In this study, titration of LAMICTAL was faster than currently recommended.

†This study employed VPA 1000 mg/day as an active control for ethical reasons to provide some seizure protection. This study is not intended to imply the superiority of LAMICTAL over VPA.

‡Escape criteria included: doubling of the average monthly seizure count; doubling of the highest consecutive 2-day seizure count; emergence of new, more serious seizure type; or significant prolongation of generalized tonic-clonic seizures.

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References: 1. Matsuo F, Bergen D, Faught E, et al. Placebo-controlled study of the efficacy and safety of lamotrigine in patients with partial seizures. Neurology. 1993;43:2284-2291.
2. Gilliam F, Vazquez B, Sackellares JC, et al. An active-control trial of lamotrigine monotherapy for partial seizures. Neurology. 1998;51:1018-1025.


EFFICACY AND TOLERABILITY
Learn more about the efficacy and tolerability your pediatric patients need.




Important Safety Information About LAMICTAL and LAMICTAL ODT
• LAMICTAL ODT is another form of LAMICTAL.
• Cases of life-threatening serious rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and/or rash-related death, have been caused by LAMICTAL. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include:
– coadministration with valproate
– exceeding recommended initial dose of LAMICTAL
– exceeding recommended dose escalation of LAMICTAL
• Benign rashes are also caused by LAMICTAL; however, it is not possible to predict which rashes will prove to be serious or life-threatening. LAMICTAL should be discontinued at the first sign of rash, unless the rash is clearly not drug-related (see Boxed Warning in Prescribing Information).
• Hypersensitivity reaction may be fatal or life-threatening. Early signs of hypersensitivity (eg, fever, lymphadenopathy) may present without rash; if signs present, patient should be evaluated immediately. LAMICTAL should be discontinued if alternate etiology for hypersensitivity signs is not found.
• Prior to initiation of treatment with LAMICTAL, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (eg, fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately.
• Acute multiorgan failure has resulted (some cases fatal).
• Blood dyscrasias (eg, neutropenia, thrombocytopenia, pancytopenia) may result either with or without an associated hypersensitivity syndrome.
• Antiepileptic drugs, including LAMICTAL ODT, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.
• Patients treated with any antiepileptic drug for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
• Patients, their caregivers, and families should be informed that antiepileptic drugs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Medication Guide for LAMICTAL® (lamotrigine) Tablets and LAMICTAL® ODT™ (lamotrigine) Orally Disintegrating Tablets

Complete Prescribing Information and Medication Guide for LAMICTAL® (lamotrigine) Tablets and LAMICTAL® ODT™ (lamotrigine) Orally Disintegrating Tablets including Boxed Warning
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