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 |
|---|---|---|---|---|---|
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 | ||
2022/06/15 | Phase 2 | Recruiting | Dent Neuroscience Research Center |
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 |
|---|---|---|---|---|---|
| Lamotrigine Dispersible Tablets | 国药准字HJ20180093 | 化学药品 | 片剂 | 11/4/2022 | |
| Lamotrigine Dispersible Tablets | 国药准字H20233259 | 化学药品 | 片剂 | 6/25/2023 | |
| Lamotrigine Dispersible Tablets | 国药准字HJ20180094 | 化学药品 | 片剂 | 11/4/2022 | |
| Lamotrigine Dispersible Tablets | 国药准字HJ20180095 | 化学药品 | 片剂 | 11/4/2022 | |
| Lamotrigine Dispersible Tablets | 国药准字H20243090 | 化学药品 | 片剂 | 1/23/2024 | |
| Lamotrigine Dispersible Tablets | 国药准字HJ20180091 | 化学药品 | 片剂 | 11/4/2022 | |
| Lamotrigine Dispersible Tablets | 国药准字H20243091 | 化学药品 | 片剂 | 1/23/2024 | |
| Lamotrigine Dispersible Tablets | 国药准字HJ20180092 | 化学药品 | 片剂 | 11/4/2022 | |
| Lamotrigine Dispersible Tablets | 国药准字H20244887 | 化学药品 | 片剂 | 9/10/2024 | |
| Lamotrigine Dispersible Tablets | 国药准字H20244888 | 化学药品 | 片剂 | 9/10/2024 |
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 |
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