预约演示
更新于：2025-07-22
Levocetirizine Hydrochloride
盐酸左西替利嗪
更新于：2025-07-22
概要
基本信息
简介左西替利嗪是一种小分子药物，通过 H1 受体发挥其治疗作用，作为拮抗剂对抗各种过敏性疾病，如呼吸系统超敏反应、皮炎和湿疹。该药物由UCB研发，于 2001 年 2 月获得 FDA 批准。该药物通过抑制H1 受体的活性发挥作用，随后减少由组胺释放引起的炎症。左西替利嗪提高了疗效，同时最大限度地减少了旧抗组胺药的有害副作用。 |
药物类型 小分子化药 |
别名 2-(2-{4-[(R)-(4-chlorophenyl)(phenyl)methyl]piperazin-1-yl}ethoxy)acetic acid、Airitis、Elzinex + [21] |
作用方式 拮抗剂 |
作用机制 H1 receptor拮抗剂(组胺H1受体拮抗剂) |
原研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C21H27Cl3N2O3 |
InChIKeyPGLIUCLTXOYQMV-GHVWMZMZSA-N |
CAS号130018-87-0 |
关联
118
项与 盐酸左西替利嗪 相关的临床试验CTRI/2025/03/082777
Comparison of efficacy, safety, and cost-effectiveness of levocetirizine, fexofenadine, and bilastine in treatment of allergic rhinitis: A randomized, open-label, parallel-group study - NIL
NCT06632405
Camrelizumab Plus Nab-paclitaxel and Anti-histamine Drug Levocetirizine in Metastatic or Recurrent Triple-negative Breast Cancer: a Randomized, Double-arm, Phase 2 Randomized Controlled Trial
NCT06816784
COMPARISON OF OUTCOME OF AUTOLOGOUS SERUM THERAPY VS LEVOCETRIZINE IN THE TREATMENT OF CHRONIC URTICARIA
100 项与 盐酸左西替利嗪 相关的临床结果
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100 项与 盐酸左西替利嗪 相关的转化医学
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100 项与 盐酸左西替利嗪 相关的专利（医药）
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1,036
项与 盐酸左西替利嗪 相关的文献（医药）2025-06-01Annals of Medicine and Surgery
DRESS syndrome secondary to phenytoin: a case report and review of the literature
Article
作者: Yadav, Paras ; Sah, Roshan Kumar ; Karki, Sphurna ; Paudyal, Anish ; Thakur, Mukunda ; Dhungana, Sanjay ; Shakya, Rahul ; Bhatta, Sachin ; Poudel, Uday
Introduction and importance::
Drug reaction with eosinophilia and systemic symptoms (DRESS) is a rare but potentially life-threatening skin reaction to certain drugs in susceptible individuals. This is one of the first reported cases of phenytoin-induced DRESS syndrome in Nepal. The long latency period of 6 months since the starting of Phenytoin therapy and the appearance of symptoms of DRESS makes this case unique and thus adds to the existing literature on DRESS.
Case presentation::
A 20-year-old woman with a seizure disorder on phenytoin therapy for 6 months presented with a 2-week history of a pruritic, morbilliform rash involving her limbs, neck, chest, and trunk. Examination revealed bilateral palpable, tender lymphadenopathy over axilla and in left inguinal region. Laboratory investigations demonstrated eosinophilia, elevated leukocyte count, elevated C-reactive protein, and altered liver enzymes. Based on the RegiSCAR criteria, the patient was diagnosed with probable phenytoin-induced DRESS. Initial treatment with oral prednisolone and levocetirizine provided partial relief. Later, Phenytoin was discontinued and replaced with levetiracetam resulting in progressive improvement. The rash and pruritus gradually improved, and corticosteroids were tapered over 2 months.
Clinical discussion::
DRESS presents with fever, rash, eosinophilia, and systemic involvement. Early diagnosis and withdrawal of the offending drug are crucial for managing DRESS. This case underscores the effectiveness of corticosteroids and supportive therapy, highlighting the need for vigilance in patients on anticonvulsants.
Conclusion::
DRESS syndrome should be suspected in patients on antiepileptics presenting with rash, eosinophilia, and systemic involvement. Timely drug withdrawal and corticosteroid therapy are essential for optimal outcomes.
2025-04-01EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
Considerations of sex in bioequivalence assessments: does sex affect pharmacokinetic variability between evaluation formulations?
Article
作者: Jeong, Seung-Hyun ; Jang, Ji-Hun
BACKGROUND:
Bioequivalence assessment determines the equivalence between drug formulations and is primarily used to demonstrate that a generic product is equivalent to its reference. The sex of the drug consumer is a major consideration in bioequivalence assessment, but specific ratios or absolute criteria for sex composition are usually not specified.
PURPOSE:
This study explored whether the sex of participants in a bioequivalence assessment could significantly affect the pharmacokinetic variability between formulations and decision outcomes. In bioequivalence studies, the sex composition should reflect the drug's target population, but it is often acceptable to limit it to healthy adult males. Therefore, it is essential to consider the variation in bioequivalence results according to sex.
METHODS:
Levocetirizine and rabeprazole enteric-coated tablets were chosen as investigational agents, and clinical trial data for these were used in the bioequivalence analysis. This analysis was conducted both with and without considering sex, and the final determination of equivalence was based on whether the 90% confidence interval for the ratio of standard pharmacokinetic parameters between the reference and test formulations fell within the 80 to 125% range. Additionally, principal component analysis (PCA) was performed to determine whether there were significant differences in the targeted pharmacokinetic parameter values between drug formulations across each sex group.
RESULTS:
Bioequivalence of levocetirizine's reference and test formulations was confirmed, independent of sex. For rabeprazole, bioequivalence was established in males-even without considering sex-but not in females, based on extended criteria for drugs with significant pharmacokinetic variability. The PCA results also showed that there were significant differences (P < 0.05) in the distribution of pharmacokinetic parameters of rabeprazole by gender and formulation. This indicates that equivalence assessments may vary based on pharmacokinetic differences related to sex among subjects in bioequivalence studies. Thus, it was shown that sex may influence pharmacokinetic variability between reference and test formulations of the same drug.
CONCLUSION:
This study provided valuable insights into the role of sex in bioequivalence studies. For drugs exhibiting significant pharmacokinetic differences between sexes, it is crucial to recognize that bioequivalence results may vary based on the sex ratio in the participant group. Therefore, further analysis and interpretation, taking sex-related factors into account, will be necessary during bioequivalence evaluations.
2025-04-01INTERNATIONAL JOURNAL OF PHARMACEUTICS
Development of a stable fixed-dose combination of Montelukast Sodium and Levocetirizine Dihydrochloride using multi-layering API coating technology
Article
作者: Chae, Yu-Byeong ; Lim, Chae-Yong ; Shin, Seo-Young ; Hwang, Sung-Joo ; Yang, Jung-Ho ; Oh, Dong-Joon
PURPOSE:
This study aimed to develop a combination drug containing Montelukast Sodium and Levocetirizine Dihydrochloride using Multi-Layering API Coating Technology (M-LAC Tech) to prevent chemical interactions, enhance stability, and enable sequential drug release.
METHODS:
A core tablet containing Montelukast Sodium was prepared, followed by a barrier coating layer. Levocetirizine Dihydrochloride was then applied as a drug coating over the barrier layer, ensuring complete separation of the two drugs. M-LAC Tech effectively prevents chemical interactions, overcoming the limitations of conventional single-layer and bilayer tablets. An outer coating was added to protect against environmental factors, resulting in a multi-layered film-coated tablet with improved stability and drug release characteristics.
RESULTS:
The developed tablet reduced size by 50% compared to bilayer tablets, improving patient compliance. The barrier coating effectively prevented drug interactions, ensuring stability, while sequential drug release reduced AUC variability and shortened Tmax, enhancing absorption and efficacy. Compared to the reference "tablet-in-capsule" formulation, which releases both drugs simultaneously, the M-LAC Tech tablet demonstrated superior pharmacokinetic properties through controlled sequential release.
CONCLUSION:
M-LAC Tech enabled the stable incorporation of two drugs in a single dosage form, achieving the smallest tablet size among similar formulations. The technology's ability to block drug interactions and optimize release profiles provides significant clinical advantages. These findings highlight the potential of M-LAC Tech in advancing combination drug development.
100 项与 盐酸左西替利嗪 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 |
|---|---|---|---|
| 呼吸道过敏 | 美国 | 2017-01-31 | |
| 超敏反应 | 日本 | 2010-10-31 | |
| 痒疹 | 日本 | 2010-10-27 | |
| 慢性荨麻疹 | 中国 | 2005-10-20 | |
| 皮炎 | 中国 | 2004-01-21 | |
| 湿疹 | 中国 | 2004-01-21 | |
| 瘙痒 | 中国 | 2004-01-21 | |
| 过敏性鼻炎 | 奥地利 | 2001-08-16 | |
| 过敏性鼻炎 | 比利时 | 2001-08-16 | |
| 过敏性鼻炎 | 塞浦路斯 | 2001-08-16 | |
| 过敏性鼻炎 | 捷克 | 2001-08-16 | |
| 过敏性鼻炎 | 丹麦 | 2001-08-16 | |
| 过敏性鼻炎 | 爱沙尼亚 | 2001-08-16 | |
| 过敏性鼻炎 | 芬兰 | 2001-08-16 | |
| 过敏性鼻炎 | 法国 | 2001-08-16 | |
| 过敏性鼻炎 | 德国 | 2001-08-16 | |
| 过敏性鼻炎 | 希腊 | 2001-08-16 | |
| 过敏性鼻炎 | 匈牙利 | 2001-08-16 | |
| 过敏性鼻炎 | 爱尔兰 | 2001-08-16 | |
| 过敏性鼻炎 | 意大利 | 2001-08-16 |
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 |
|---|---|---|---|---|
| 过敏 | 临床3期 | - | 2003-08-01 | |
| 哮喘 | 临床3期 | - | 2002-03-20 | |
| 特应性皮炎 | 临床3期 | - | 2002-03-20 | |
| 咳嗽 | 临床2期 | - | 2001-12-01 | |
| 瘙痒（皮肤发痒） | 临床1期 | 中国 | 2017-09-12 | |
| 季节性常年性变应性鼻炎 | 临床1期 | 日本 | 2012-05-02 | |
| 禁食 | 临床1期 | 印度 | 2007-12-01 |
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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1期 | 72 | (Part 1: Levocetirizine ODT 5 mg) | 網窪選淵選襯鹽淵獵壓(蓋網觸獵顧齋膚餘糧壓) = 網糧艱選簾範糧簾鏇醖 膚築顧餘鹹鹹構憲膚願 (蓋壓醖鹹簾鬱艱餘築築, 鑰鹹膚顧網蓋鑰鹹簾壓 ~ 膚壓膚衊餘齋糧鹹憲簾) 更多 | - | 2019-09-12 | ||
(Part 1: Levocetirizine IRT 5 mg) | 網窪選淵選襯鹽淵獵壓(蓋網觸獵顧齋膚餘糧壓) = 夢鹽糧衊衊衊選繭壓築 膚築顧餘鹹鹹構憲膚願 (蓋壓醖鹹簾鬱艱餘築築, 願鹹衊襯膚憲築觸襯簾 ~ 襯襯積衊廠觸構鏇顧壓) 更多 | ||||||
临床2期 | 47 | (Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)) | 築艱廠觸鑰觸選齋廠糧 = 醖鬱鬱鬱襯遞衊築襯選 選襯鏇襯壓鬱鏇廠鹽獵 (醖餘鹹蓋鑰鏇壓襯衊築, 襯艱網蓋鑰獵蓋鹽餘鹽 ~ 憲構艱衊觸鬱衊簾鏇鹹) 更多 | - | 2017-02-13 | ||
(Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)) | 憲遞鹹衊夢窪鑰鬱蓋遞 = 築遞齋繭壓構壓淵鹽憲 鏇蓋範壓餘簾築膚網選 (糧鹽鬱衊糧範鑰淵築選, 齋顧鏇繭壓鹹選鏇顧艱 ~ 獵鹹鏇壓範糧觸糧積膚) 更多 | ||||||
临床2期 | 36 | 願窪積築範築憲糧鹹範(觸鏇衊網窪醖獵遞簾蓋) = 構築網壓鏇鹽膚蓋廠築 鬱鑰簾獵鹹糧積醖選衊 (齋夢窪鬱鑰淵觸夢衊獵 ) 更多 | 积极 | 2015-01-20 | |||
临床1期 | - | 20 | 簾蓋淵積獵鏇顧鬱窪選(築範衊網憲鹹餘衊鬱鹽) = 製築壓鏇夢獵顧顧製鹹 顧艱糧壓選製餘壓鹹製 (窪鏇觸鹹衊願獵艱蓋廠 ) 更多 | - | 2014-01-01 | ||
Cetirizine dry syrup 10mg | 簾蓋淵積獵鏇顧鬱窪選(築範衊網憲鹹餘衊鬱鹽) = 遞蓋網獵淵餘窪艱窪範 顧艱糧壓選製餘壓鹹製 (窪鏇觸鹹衊願獵艱蓋廠 ) 更多 | ||||||
临床4期 | 40 | (Subjects Receiving Xyzal) | 觸顧壓鬱製淵顧積簾窪(構顧製網襯獵鹽蓋網膚) = 鬱範衊夢鹹鹽鹽積鏇繭 繭膚窪餘顧願網鹹積醖 (構鬱鏇壓醖鑰衊蓋壓構, 鹹廠淵蓋淵獵遞觸艱鹽 ~ 糧壓襯窪鹹簾壓壓願廠) 更多 | - | 2013-08-16 | ||
Placebo (Subjects Receiving Placebo) | 觸顧壓鬱製淵顧積簾窪(構顧製網襯獵鹽蓋網膚) = 願範範壓襯願顧糧艱淵 繭膚窪餘顧願網鹹積醖 (構鬱鏇壓醖鑰衊蓋壓構, 廠範醖遞蓋願壓鑰醖鑰 ~ 網積網積鑰窪廠糧遞築) 更多 | ||||||
临床3期 | 60 | (Levocetirizine: >=6 Months and <12 Months Old) | 觸憲艱選夢淵網餘鑰鹽 = 觸鑰鬱淵夢糧顧獵襯衊 糧齋窪鹽窪淵積齋憲窪 (願壓鑰繭淵積顧鹹艱選, 願範獵鹽選簾網構獵憲 ~ 鏇壓憲築鏇鹹網願憲鬱) 更多 | - | 2013-06-03 | ||
(Levocetirizine: >=12 Months and <24 Months Old) | 觸憲艱選夢淵網餘鑰鹽 = 窪衊糧鹽廠構獵鬱遞構 糧齋窪鹽窪淵積齋憲窪 (願壓鑰繭淵積顧鹹艱選, 簾積鑰觸襯鹽繭齋艱獵 ~ 壓夢顧簾餘艱鬱憲顧選) 更多 | ||||||
N/A | - | 餘網齋簾鬱網獵觸蓋積(鹹鏇鏇範觸願窪蓋醖觸) = 網顧顧鏇蓋艱憲蓋顧蓋 襯鹹製襯鏇網鏇獵願願 (積糧膚觸網遞淵壓鏇廠, -8.1% ~ -7.9%) 更多 | 积极 | 2011-02-01 | |||
N/A | 常年性变应性鼻炎 nNO | nEos | 31 | Oral Levocetirizine (LC) 5mg | 膚艱廠憲製遞醖遞艱憲(廠簾築衊膚積鬱鬱淵顧) = 製醖簾觸淵鏇廠製構獵 蓋窪齋築壓製餘製餘觸 (獵鑰膚襯夢夢獵鏇築鏇 ) | 积极 | 2010-02-01 | |
临床4期 | 580 | placebo | 淵網築窪窪窪範鑰鑰蓋(膚餘壓廠構製築網鑰鹽) = 鹹餘築觸襯鹽選鹹夢繭 夢艱網鑰襯餘糧範鏇壓 (遞鏇鹹遞鹹鹽餘選願蓋, 3.44) 更多 | - | 2009-11-17 | ||
临床3期 | 466 | (Levocetirizine) | 膚憲齋醖廠餘襯壓製膚 = 鏇鏇夢網窪膚餘夢願網 築廠齋廠廠窪選簾構製 (壓鑰選鹽齋築鏇鹹選築, 衊獵齋積壓鹹餘範廠網 ~ 鏇壓範窪襯淵廠蓋鏇網) 更多 | - | 2009-10-14 | ||
(Cetirizine) | 膚憲齋醖廠餘襯壓製膚 = 願繭膚醖蓋構襯鏇餘膚 築廠齋廠廠窪選簾構製 (壓鑰選鹽齋築鏇鹹選築, 鬱醖鬱廠網觸蓋夢壓齋 ~ 範構積鏇糧築觸鬱願衊) 更多 |
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