Overview
Lamotrigine is an antiepileptic drug belonging in the phenyltriazine class. It is used in the treatment of both epilepsy and as a mood stabilizer in bipolar disorder. Lamotrigine is the first medication since lithium granted Food and Drug Administration (FDA) approval for the maintenance treatment of bipolar type I. It is approved for use in more than 30 countries. Lamotrigine has relatively few side-effects and does not require laboratory monitoring. While it is indicated for epilepsy and bipolar disorders, there is evidence that lamotrigine could have some clinical efficacy in certain neuropathic pain states.
Indication
Lamotrigine is indicated as adjunctive therapy for the following seizure types in patients ≥2 years of age: partial seizures, primary generalized tonic-clonic seizures, and generalized seizures due to Lennox-Gastaut syndrome. It is also indicated for the process of conversion to drug monotherapy for those at least 16 years of age or older with partial seizures and currently are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). In addition to the above, lamotrigine is also indicated for the maintenance treatment of bipolar I disorder, delaying the time to mood episodes (which may include mania, hypomania, depression, mixed episodes) in adults at least 18 years or older, who have been treated for acute mood symptoms with standard therapy. Limitations of use It is important to note that lamotirigine should not be used in the treatment of acute mood episodes, as efficacy has not been established in this context.
Associated Conditions
- Bipolar 1 Disorder
- Generalized Tonic-Clonic Seizures
- Partial-Onset Seizures
- Seizures, Generalized
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/26 | Not Applicable | Not yet recruiting | |||
2024/12/12 | Phase 1 | Recruiting | Karuna Therapeutics | ||
2024/01/10 | Phase 1 | Completed | |||
2023/12/28 | Phase 4 | Recruiting | Mental Health Services in the Capital Region, Denmark | ||
2023/05/31 | Phase 4 | Not yet recruiting | |||
2023/02/28 | Phase 4 | ENROLLING_BY_INVITATION | |||
2023/01/26 | Phase 4 | Recruiting | Dr Cipto Mangunkusumo General Hospital | ||
2022/12/06 | Not Applicable | Recruiting | Grete Andersen, MD | ||
2022/07/11 | N/A | Recruiting | |||
2022/07/11 | N/A | Recruiting | Gitte Moos Knudsen |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Dr. Reddy’s Laboratories Inc. | 43598-552 | ORAL | 100 mg in 1 1 | 11/3/2022 | |
| Camber Pharmaceuticals Inc | 31722-243 | ORAL | 200 mg in 1 1 | 1/9/2024 | |
| American Health Packaging | 68084-318 | ORAL | 25 mg in 1 1 | 12/11/2023 | |
| Zydus Pharmaceuticals USA Inc. | 68382-108 | ORAL | 5 mg in 1 1 | 10/30/2023 | |
| GlaxoSmithKline LLC | 0173-0776 | ORAL | 100 mg in 1 1 | 3/31/2021 | |
| GlaxoSmithKline LLC | 0173-0777 | ORAL | 200 mg in 1 1 | 3/31/2021 | |
| Actavis Pharma, Inc. | 0228-1435 | ORAL | 50 mg in 1 1 | 5/15/2023 | |
| Yiling Pharmaceutical, Inc. | 69117-0049 | ORAL | 300 mg in 1 1 | 1/22/2022 | |
| Rising Pharma Holdings, Inc. | 16571-785 | ORAL | 5 mg in 1 1 | 12/16/2023 | |
| AvKARE | 42291-443 | ORAL | 25 mg in 1 1 | 1/9/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| LAMICTAL TABLET 50 mg | SIN07497P | TABLET | 50 mg | 9/23/1993 | |
| Lamictal Tablet 25 mg | SIN14088P | TABLET | 25.0 mg | 2/3/2012 | |
| Lamotrix Tablet 100mg | SIN14028P | TABLET | 100.0 mg | 10/10/2011 | |
| LAMICTAL DISPERSIBLE TABLET 5 mg | SIN09094P | TABLET | 5 mg | 12/18/1996 | |
| Lamitor -100 | SIN13364P | TABLET | 100 mg | 10/22/2007 | |
| LAMOTRIX TABLET 50 MG | SIN14027P | TABLET | 50.0 mg | 10/10/2011 | |
| LAMICTAL TABLET 100 mg | SIN07498P | TABLET | 100 mg | 9/23/1993 | |
| Lamitor - 50 | SIN13365P | TABLET | 50 mg | 10/22/2007 | |
| Apo-Lamotrigine 25mg Tablet | SIN13554P | TABLET | 25.0 mg | 9/15/2008 | |
| Apo-Lamotrigine 100mg Tablet | SIN13555P | TABLET | 100.0 mg | 9/15/2008 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PMS-LAMOTRIGINE TAB 150MG | N/A | N/A | N/A | 7/28/2009 | |
| LAMICTAL TAB 100MG | N/A | N/A | N/A | 3/8/1994 | |
| LAMICTAL TAB 50MG | N/A | N/A | N/A | 3/8/1994 | |
| LAMEPIL-100 TABLETS 100MG | N/A | N/A | N/A | 1/25/2019 | |
| LAMICTAL DISPERSIBLE TAB 5MG | N/A | N/A | N/A | 10/24/1995 | |
| LAMICTAL DISPERSIBLE TAB 25MG | N/A | N/A | N/A | 10/24/1995 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| LAMICTAL lamotrigine 100 mg tablet blister pack | 46266 | Medicine | A | 12/2/1993 | |
| LOGEM 100 lamotrigine 100mg chewable/dispersible tablet blister pack | 99062 | Medicine | A | 3/17/2005 | |
| LAMIDUS lamotrigine 25 mg chewable and dispersible tablet blister pack | 116720 | Medicine | A | 6/7/2006 | |
| MUNATREP 5 lamotrigine 5 mg dispersible/chewable tablets bottle | 187256 | Medicine | A | 5/3/2012 | |
| TORLEMO DT 200 lamotrigine 200mg dispersible tablet blister pack | 150766 | Medicine | A | 9/29/2008 | |
| SANDOZ LAMOTRIGINE lamotrigine 50mg tablet blister pack | 291470 | Medicine | A | 9/14/2017 | |
| APX-LAMOTRIGINE lamotrigine 200 mg dispersible/chewable tablet blister pack | 340910 | Medicine | A | 8/27/2020 | |
| SEAZE 100 lamotrigine 100mg tablet blister pack | 99038 | Medicine | A | 2/16/2005 | |
| LAMOTRIGINE CH lamotrigine 100 mg dispersible/chewable tablets bottle | 187264 | Medicine | A | 5/3/2012 | |
| TORLEMO DT 50 lamotrigine 50mg dispersible tablet blister pack | 150764 | Medicine | A | 9/29/2008 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| TEVA-LAMOTRIGINE | teva canada limited | 02248232 | Tablet - Oral | 25 MG | 1/16/2004 |
| MYLAN-LAMOTRIGINE | Mylan Pharmaceuticals ULC | 02265494 | Tablet - Oral | 25 MG | 4/1/2005 |
| AURO-LAMOTRIGINE | auro pharma inc | 02381354 | Tablet - Oral | 25 MG | 6/13/2012 |
| APO-LAMOTRIGINE | 02245209 | Tablet - Oral | 100 MG | 3/18/2002 | |
| PMS-LAMOTRIGINE | 02246898 | Tablet - Oral | 100 MG | 4/14/2003 | |
| PMS-LAMOTRIGINE | 02246897 | Tablet - Oral | 25 MG | 4/14/2003 | |
| TEVA-LAMOTRIGINE | teva canada limited | 02248234 | Tablet - Oral | 150 MG | 1/16/2004 |
| APO-LAMOTRIGINE | 02245210 | Tablet - Oral | 150 MG | 3/18/2002 | |
| PMS-LAMOTRIGINE | 02246899 | Tablet - Oral | 150 MG | 4/14/2003 | |
| LAMOTRIGINE | sivem pharmaceuticals ulc | 02428210 | Tablet - Oral | 100 MG | 10/8/2014 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| LAMOTRIGINA PHARMA COMBIX 25 MG COMPRIMIDOS MASTICABLES Y DISPERSABLES EFG | Laboratorios Combix S.L.U. | 89456 | COMPRIMIDO MASTICABLE Y DISPERSABLE | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
| CRISOMET 25 mg COMPRIMIDOS MASTICABLES/DISPERSABLES | 63747 | COMPRIMIDO MASTICABLE Y DISPERSABLE | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
| LAMICTAL 100 mg COMPRIMIDOS MASTICABLES/DISPERSABLES | 33122.03.00 | COMPRIMIDO MASTICABLE Y DISPERSABLE | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
| LAMOTRIGINA COMBIX 200 mg COMPRIMIDOS DISPERSABLES/MASTICABLES EFG | Laboratorios Combix S.L.U. | 68645 | COMPRIMIDO MASTICABLE Y DISPERSABLE | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| LAMOTRIGINA NORMON 200 mg COMPRIMIDOS DISPERSABLES/MASTICABLES EFG | Laboratorios Normon S.A. | 67321 | COMPRIMIDO MASTICABLE Y DISPERSABLE | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| LAMOTRIGINA NORMON 25 mg COMPRIMIDOS DISPERSABLES/MASTICABLES EFG | Laboratorios Normon S.A. | 67318 | COMPRIMIDO MASTICABLE Y DISPERSABLE | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| LABILENO 25 mg COMPRIMIDOS MASTICABLES/DISPERSABLES | 63288 | COMPRIMIDO MASTICABLE Y DISPERSABLE | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
| LAMOTRIGINA TEVA 50 mg COMPRIMIDOS MASTICABLES Y DISPERSABLES EFG | Teva Pharma S.L.U. | 67352 | COMPRIMIDO MASTICABLE Y DISPERSABLE | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| LAMOTRIGINA KERN PHARMA 50 mg COMPRIMIDOS DISPERSABLES/MASTICABLES EFG | 67176 | COMPRIMIDO MASTICABLE Y DISPERSABLE | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
| LABILENO 200 mg COMPRIMIDOS MASTICABLES/DISPERSABLES | 65283 | COMPRIMIDO MASTICABLE Y DISPERSABLE | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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