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Generic lamotrigine
Lamotrigine blocks voltage-gated sodium channels and inhibits glutamate release, reducing neuronal excitability.
Lamotrigine blocks voltage-gated sodium channels and inhibits glutamate release, reducing neuronal excitability. Used for Epilepsy (adjunctive and monotherapy), Bipolar I disorder maintenance treatment, Lennox-Gastaut syndrome.
At a glance
| Generic name | Generic lamotrigine |
|---|---|
| Sponsor | University of Maryland, Baltimore |
| Drug class | Anticonvulsant / Mood stabilizer |
| Target | Voltage-gated sodium channels; glutamate release inhibition |
| Modality | Small molecule |
| Therapeutic area | Neurology / Psychiatry |
| Phase | FDA-approved |
Mechanism of action
Lamotrigine stabilizes neuronal membranes by blocking sodium channels, which prevents repetitive neuronal firing. It also inhibits the release of glutamate, an excitatory neurotransmitter, thereby reducing excessive neuronal activity. These combined effects make it effective as an anticonvulsant and mood stabilizer.
Approved indications
- Epilepsy (adjunctive and monotherapy)
- Bipolar I disorder maintenance treatment
- Lennox-Gastaut syndrome
Common side effects
- Rash (including Stevens-Johnson syndrome risk)
- Dizziness
- Ataxia
- Somnolence
- Headache
- Diplopia
- Nausea
Key clinical trials
- Lamotrigine Bioequivalence (PHASE4)
- A Bioavailability Crossover Study of Two Formulations of Lamotrigine Extended Release Tablets in Healthy Subjects (PHASE1)
- Characterization of Epilepsy Patients BEEP 2b (PHASE1)
- A Study to Evaluate the Effect of AG-881 on the Pharmacokinetics of a Single Dose of Lamotrigine in Healthy Adults (PHASE1)
- BEEP Follow Up: Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients (PHASE4)
- Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy: Single-Dose 6-Period Replicate Design (EQUIGEN Single-Dose Study) (PHASE4)
- Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy: Chronic-Dose 4-Period Replicate Design (PHASE4)
- A Trial of Generic Substitution of Antiepileptic Drugs (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |