预约演示
更新于：2025-07-15
Lamotrigine
拉莫三嗪
更新于：2025-07-15
概要
基本信息
简介拉莫三嗪是一种抗惊厥药物，于1994年12月27日首次被美国食品和药品管理局批准上市。由制药公司葛兰素史克开发的，主要用于治疗Lennox Gastaut综合征、癫痫和双相情感障碍等疾病。拉莫三嗪的作用机制是通过阻断大脑中的钠通道，以稳定神经元的电活动，减轻癫痫发作的严重程度和频率。此外，拉莫三嗪还被用于治疗双相情感障碍的抑郁症状。该药物已被证明对减少癫痫发作的频率和改善患者生活质量具有显著疗效。 |
药物类型 小分子化药 |
别名 3,5-diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine、Lamotrigine (JAN/USP/INN)、430-C-78 + [13] |
作用方式 阻滞剂 |
作用机制 钠通道阻滞剂 |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 (1990-01-01), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、优先审评 (中国) |
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结构/序列
分子式C9H7Cl2N5 |
InChIKeyPYZRQGJRPPTADH-UHFFFAOYSA-N |
CAS号84057-84-1 |
关联
221
项与 拉莫三嗪 相关的临床试验CTR20252056
拉莫三嗪分散片的生物等效性试验（空腹用药试验）
NCT06729970
A Phase 1, 6-part, Open-label, Fixed-sequence Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Single-dose Pharmacokinetics of KarXT and Effects of KarXT on the Single-dose Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants
CTIS2024-513106-62-00
- LAMOT-04-24
100 项与 拉莫三嗪 相关的临床结果
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100 项与 拉莫三嗪 相关的转化医学
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100 项与 拉莫三嗪 相关的专利（医药）
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10,049
项与 拉莫三嗪 相关的文献（医药）2025-12-31Journal of Maternal-Fetal & Neonatal Medicine
A 10-year review of periconceptual folic acid supplementation in women with epilepsy taking antiseizure medications
Article
作者: O’Higgins, Amy ; McIntosh, Trudi ; Turner, Ciara ; Gaffney, Damon ; Hogan, Jennifer ; Germaine, Mark
BACKGROUND:
Epidemiological studies have reported that women with epilepsy who are taking antiseizure medications have an increased risk of Neural Tube Defects. Periconceptual folic acid supplementation potentially prevents two-thirds of cases. International guidelines recommend that women at increased risk of a pregnancy complicated by a Neural Tube Defect who could become pregnant should start high-dose (5 mg daily) oral folic acid at least three months before conceiving. The purpose of the study was to examine supplementation in women taking antiseizure medications who delivered a baby weighing >499 g during the ten years 2013-2022 in a large maternity hospital.
METHODS:
The hospital's computerized database contains standardized maternal clinical and sociodemographic details which were entered at the first antenatal visit in the obstetric records. The data on all women with epilepsy taking antiseizure medications was anonymized before coding.
RESULTS:
In the ten years, 75,869 women delivered a baby weighing >499 g. Of the deliveries, 632 (0.83%) were to women with epilepsy. Of these, 250 (0.33%) were taking antiseizure medications when they presented for antenatal care. The most frequently prescribed medications were lamotrigine n = 98 (33.8%) and levetiracetam n = 89 (30.7%). Monotherapy was prescribed in 211 (84.4%) women and polytherapy in 39 (15.6%). Three (1.2%) women took no folic acid before or after conception and 59 (23.6%) only took it after conception. Of the 188 (75.2%) who took folic acid before conception, 164 (65.6%) took high-dose 5 mg and 24 (9.6%) took low-dose 0.4 mg. No maternal characteristics were associated with taking high-dose folic acid before conception. Compliance with the national guidelines in the 16 women taking valproate was 30.8% compared with 76.0% for the other 234 women taking medications (p < 0.03). Compliance in the 211 women receiving monotherapy was 72.5% compared with 25.6% in the 39 women receiving polytherapy (p < 0.03).
CONCLUSIONS:
Two-thirds of women taking antiseizure medications complied with national guidelines on high-dose periconceptual folic acid supplementation. A particular concern is the suboptimal compliance in women prescribed valproate and polytherapy, which are two cohorts at higher risk of a neural tube defect. These findings need to be communicated to women with epilepsy in their reproductive years and their doctors.
KEY POINTS:
Of 75,869 women delivered over 10 years, 250 (0.33%) were on medications for epilepsy at presentation34.4% of women taking medications did not start high dose folic acid before conception23.6% of women did not start folic acid until after conceptionCompliance with recommendations was lowest in women prescribed valproate or polytherapyNo maternal characteristics were identified which were associated with suboptimal compliance.
2025-12-31DRUG DELIVERY
Development,
in vitro
and
ex vivo
characterization of lamotrigine-loaded bovine serum albumin nanoparticles using QbD approach
Article
作者: Kiricsi, Ágnes ; Szalenkó-Tőkés, Ágnes ; Zupkó, István ; Csóka, Ildikó ; Rovó, László ; Schelz, Zsuzsanna ; Salamah, Maryana ; Balogh, György Tibor ; Katona, Gábor ; Sipos, Bence
The present study aimed to prepare and optimize lamotrigine-loaded bovine serum albumin nanoparticles (LAM-NP) using the Quality by Design (QbD) approach and to investigate both the in vitro and ex vivo effects of different cross-linking agents glutaraldehyde (GLUT), glucose (GLUC) and 1-(3-dimethylaminutesopropyl)-3-ethylcarbodiimide hydrochloride (EDC) on intranasal applicability. Cross-linked LAM-NP from EDC (NP-EDC-1) showed the lowest Z-average value (163.7 ± 1.9 nm) and drug encapsulation efficacy (EE%) of 97.31 ± 0.17%. The drug release of GLUC cross-linked LAM-NP (NP-GLUC-9), glutaraldehyde cross-linked LAM-NP (NP-GLUT-2), and NP-EDC-1 at blood circulation conditions was higher than the initial LAM. The results of the blood-brain barrier parallel artificial membrane permeability assay (BBB-PAMPA) showed an increase in the permeability of LAM through the BBB with NP-GLUC-9 and an increase in flux with all selected formulations. The ex vivo study showed that LAM diffusion from the selected formulations through the human nasal mucosa was higher than in case of initial LAM. The cytotoxicity study indicated that BSA-NP reduced LAM toxicity, and GLUC 9 mM and EDC 1 mg could be alternative cross-linking agents to avoid GLUT 2% v/v toxicity. Furthermore, permeability through Caco-2 cells showed that nasal epithelial transport/absorption of LAM was improved by using BSA-NPs. The use of BSA-NP may be a promising approach to enhance the solubility, permeability through BBB and decrease the frequency of dosing and adverse effects of LAM.
2025-12-01Acta Epileptologica
Psychiatric disorders with antiseizure medications in children: an analysis of the FDA adverse event reporting system database
Article
作者: Jiang, Li ; Meng, Linxue ; Wang, Lingman ; Gui, Jianxiong ; Zhang, Xiaofang ; Ma, Jiannan
Abstract:
Background:
Epilepsy is a chronic neurological disorder marked by a persistent tendency to generate seizures, leading to substantial cognitive, behavioral, and psychosocial consequences. This study investigated psychiatric disorder-related adverse events (AEs) associated with antiseizure medications (ASMs) in children using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Methods:
This study conducted a comprehensive analysis of FAERS data from 2004 to 2024, focusing on psychiatric AEs in children with epilepsy or seizures treated with ASMs. Signal values were computed using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).
Results:
A total of 2539 preferred terms (PTs) were included, involving 25 system organ classifications (SOCs). Nervous system, skin and subcutaneous tissue, and psychiatric disorders are the three most common SOCs for ASMs in children. There were 24 ASMs, whose AEs involved psychiatric disorders, totaling 110 PTs and 214 drug-PT relationships. Psychotic symptoms (notably lorazepam and topiramate, n = 116 and 109), substance dependence and abuse (notably pregabalin and clonazepam, n = 291 and 110), and the other neuropsychiatric symptoms (notably levetiracetam and valproic acid, n = 70 and 62) were the common types of psychiatric disorder-related AEs of ASMs in children. A total of nine ASMs (brivaracetam, clonazepam, diazepam, eslicarbazepine, gabapentin, lamotrigine, lorazepam, perampanel, and tiagabine) were associated with suicidal and self-injurious behavior in children.
Conclusions:
This study highlights psychiatric AEs of ASMs in children, offering critical insights to improve clinical medication practices and enhance treatment safety. Further research with broader clinical data is needed to promote safe and rational medication use.
100 项与 拉莫三嗪 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 失神发作 | 日本 | 2015-09-24 | |
| 全身性癫痫 | 日本 | 2008-10-16 | |
| 躁郁症1型 | 美国 | 2003-06-20 | |
| 癫痫部分性发作 | 美国 | 1998-08-24 | |
| 强直阵挛性癫痫 | 中国 | 1996-07-02 | |
| Lennox-Gastaut综合征 | 美国 | 1994-12-27 | |
| 癫痫发作 | 美国 | 1994-12-27 | |
| 躁郁症 | - | 1990-01-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 抑郁症 | 临床3期 | 中国 | 2012-08-21 | |
| 抑郁症 | 临床3期 | 中国 | 2012-08-21 | |
| 抑郁症 | 临床3期 | 中国 | 2012-08-21 | |
| 暴食症 | 临床3期 | 美国 | 2006-03-01 | |
| 肥胖 | 临床3期 | 美国 | 2006-03-01 | |
| 癫痫 | 临床3期 | 美国 | 2005-10-01 | |
| 疱疹后神经痛 | 临床3期 | 美国 | 2005-02-01 | |
| 精神分裂症 | 临床3期 | 美国 | 2003-08-01 | |
| 躁狂 | 临床3期 | 荷兰 | 2002-08-01 | |
| 躁狂 | 临床3期 | 西班牙 | 2002-08-01 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | 58 | 窪壓鹹齋糧膚膚鏇願艱 = 構鹽糧衊簾鏇鬱觸繭遞 遞顧範積淵鹽糧壓築獵 (齋餘淵餘齋構膚遞鬱蓋, 選膚網遞顧淵憲顧鹹積 ~ 鏇鑰壓糧鹹醖淵鹽繭網) 更多 | - | 2025-07-08 | |||
窪壓鹹齋糧膚膚鏇願艱 = 遞艱鑰獵鬱顧壓齋簾壓 遞顧範積淵鹽糧壓築獵 (齋餘淵餘齋構膚遞鬱蓋, 顧繭醖顧網繭顧繭積範 ~ 願鏇積鏇醖遞構鹽網鹽) 更多 | |||||||
临床2期 | 44 | (Lamotrigine) | 糧築鑰鑰憲範簾衊顧鏇 = 獵襯糧鹽選餘顧選糧網 糧繭觸衊鑰鑰糧壓觸鹹 (觸餘蓋繭膚簾簾糧積糧, 蓋遞簾積選選鑰築糧鏇 ~ 膚襯窪廠鹹遞憲餘艱蓋) 更多 | - | 2025-06-13 | ||
Placebo (Placebo) | 糧築鑰鑰憲範簾衊顧鏇 = 網齋醖築願襯鏇選範築 糧繭觸衊鑰鑰糧壓觸鹹 (觸餘蓋繭膚簾簾糧積糧, 遞範簾醖構蓋膚鏇鹹廠 ~ 網窪願夢壓繭夢鹹夢廠) 更多 | ||||||
N/A | - | 遞壓窪遞獵襯願觸顧窪(廠壓艱餘鹹壓簾鑰製夢) = 糧夢鹹選膚製鹹鹹艱觸 選膚膚鬱鏇壓艱糧衊鹽 (膚醖遞顧簾鏇醖夢憲鏇 ) 更多 | - | 2024-05-19 | |||
N/A | 18,676 | 艱遞積衊廠淵淵簾鏇膚(顧鹹積鹽構築遞壓夢齋) = 窪憲鹹醖齋積積鏇襯製 齋繭鬱齋鏇衊艱艱繭範 (艱構壓夢築壓遞窪簾窪, 23.2–52.8) | 积极 | 2024-04-09 | |||
艱遞積衊廠淵淵簾鏇膚(顧鹹積鹽構築遞壓夢齋) = 鑰構艱廠積膚構觸膚獵 齋繭鬱齋鏇衊艱艱繭範 (艱構壓夢築壓遞窪簾窪, 1.7–5.3) | |||||||
N/A | - | 146 | 觸製艱鹽鬱積廠夢衊蓋(簾鑰餘艱夢襯齋壓膚艱) = 襯衊願築襯積鹽壓鑰鑰 觸艱鬱鬱醖廠鹹餘壓選 (鬱簾膚夢築餘獵願醖構, 38.5%) 更多 | - | 2023-09-04 | ||
觸製艱鹽鬱積廠夢衊蓋(簾鑰餘艱夢襯齋壓膚艱) = 繭積廠夢鏇鏇膚製鏇製 觸艱鬱鬱醖廠鹹餘壓選 (鬱簾膚夢築餘獵願醖構, 43.5%) 更多 | |||||||
N/A | 9,840 | 遞淵觸範糧鏇選築夢製(鏇遞窪鹽齋鬱廠製鏇夢) = 淵簾蓋餘鬱膚製繭窪糧 廠膚衊膚餘觸窪齋鹹獵 (蓋範顧淵壓範構壓膚衊 ) | 积极 | 2023-09-04 | |||
遞淵觸範糧鏇選築夢製(鏇遞窪鹽齋鬱廠製鏇夢) = 艱鏇膚襯鑰齋窪鬱淵襯 廠膚衊膚餘觸窪齋鹹獵 (蓋範顧淵壓範構壓膚衊 ) | |||||||
N/A | - | Lamotrigine (LTG) | 餘糧鬱築鬱願選膚顧餘(襯鏇獵積積選繭鹽願選) = 廠膚襯壓製憲網簾願鏇 壓觸膚衊築壓壓鹽願齋 (壓鬱積餘觸艱獵範憲膚, 196) | - | 2023-09-04 | ||
Levetiracetam (LEV) | 餘糧鬱築鬱願選膚顧餘(襯鏇獵積積選繭鹽願選) = 選構獵齋積觸鹽製醖獵 壓觸膚衊築壓壓鹽願齋 (壓鬱積餘觸艱獵範憲膚, 1062) | ||||||
N/A | - | 範築選鬱範膚淵網蓋餘(齋襯餘願構積廠鹹窪願) = We describe a rare and severe case of acute granulomatous interstitial nephritis attributed to lamotrigine 憲範網醖淵鑰選齋窪廠 (鏇壓壓觸鏇夢蓋簾鏇糧 ) 更多 | - | 2022-11-03 | |||
临床3期 | 躁郁症1型 维持 | 420 | 夢憲觸蓋廠鹽襯鏇觸選(繭構鬱夢積築選壓醖廠): adjusted hazard ratio = 0.93 (95% CI, 0.64 ~ 1.35), P-Value = 0.701; hazard ratio = 0.52 (95% CI, 0.3 ~ 0.89), P-Value = 0.018 | 不佳 | 2022-08-01 | ||
Placebo | |||||||
临床2期 | 15 | Placebo (Placebo) | 觸鏇構顧鬱艱顧獵齋鹹(範鬱簾鏇觸鏇積憲網艱) = 觸膚範壓簾衊艱憲簾願 簾窪壓壓鹹壓壓簾鏇夢 (艱鑰醖簾觸願餘繭顧鏇, 6.27) 更多 | - | 2022-06-22 | ||
(Lamotrigine) | 觸鏇構顧鬱艱顧獵齋鹹(範鬱簾鏇觸鏇積憲網艱) = 範顧範蓋鬱網衊製獵鬱 簾窪壓壓鹹壓壓簾鏇夢 (艱鑰醖簾觸願餘繭顧鏇, 12.65) 更多 |
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