预约演示
更新于：2025-05-16
Rupatadine Fumarate
富马酸卢帕他定
更新于：2025-05-16
概要
基本信息
原研机构 |
非在研机构 |
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C30H30ClN3O4 |
InChIKeyJYBLCDXVHQWMSU-WLHGVMLRSA-N |
CAS号182349-12-8 |
关联
62
项与 富马酸卢帕他定 相关的临床试验CTR20244954
一项多中心、随机、双盲、安慰剂对照III期临床研究，评价富马酸卢帕他定口服溶液治疗2-11岁儿童过敏性鼻炎的有效性和安全性
CTR20250675
富马酸卢帕他定片在中国健康受试者中随机、开放、交叉、空腹及餐后给药条件下的生物等效性试验
ChiCTR2500096423
A multicenter, randomized, double-blind, placebo-controlled phase III clinical study evaluating the efficacy and safety of oral solution of lupatadine fumarate in the treatment of allergic rhinitis in children aged 2-11 years old
100 项与 富马酸卢帕他定 相关的临床结果
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100 项与 富马酸卢帕他定 相关的转化医学
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100 项与 富马酸卢帕他定 相关的专利（医药）
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338
项与 富马酸卢帕他定 相关的文献（医药）2025-01-01Asian Pacific journal of allergy and immunology4区 · 医学
Efficacy and safety of rupatadine fumarate in the treatment of perennial allergic rhinitis: A multicenter, double-blinded, randomized, placebo-controlled, bridging study in Koreans
4区 · 医学
Article
作者: Kim, Hyung Gu ; Kim, Hyo Yeol ; Kim, Dae Woo ; Kim, Chang-Hoon ; Rhee, Chae-Seo ; Kim, Jin Kook ; Kim, Sung Wan ; Kim, Jeong-Whun ; Won, Tae-Bin ; Kim, Soo Whan ; Kim, Young Hyo
BACKGROUND:
The efficacy of rupatadine for the treatment of AR has been confirmed in numerous clinical studies, however there are very few studies on asian patients.
OBJECTIVE:
To assess the safety and efficacy of rupatadine fumarate in the treatment of Korean perennial allergic rhinitis (PAR) patients.
METHODS:
A multicenter, double-blind, randomized, placebo-controlled, comparative study of rupatadine fumarate and bepotastine besilate was conducted. Each group was administered rupatadine, bepotastine or placebo for 4 weeks. Primary parameters for efficacy included morning and evening symptom reduction from baseline at 4 weeks. Treatment safety and tolerability were evaluated according to a self-reported incidence and type of adverse events at each follow up visit.
RESULTS:
Rupatadine showed a significant reduction in symptoms at morning and evening evaluations, in both 5TSS (-5.69, P < 0.0006) and 4NTSS (-4.74, P < 0.0015) compared to placebo. There was a significant reduction from baseline for 5TSS (-65.4%, P = 0.002) and 4NTSS (-63.7%, P = 0.003) with rupatadine compared with placebo. At evening evaluations, there were significant reductions of 5TSS (-63.2%, P = 0.009) and 4NTSS (-61.6%, P = 0.013) for the rupatadine group. Compared with bepotastine, rupatadine showed greater reduction in the morning symptoms at 4 weeks. When individual symptoms were assessed with 12-hour reflective mean daily symptom score, rupatadine showed better efficacy than placebo in sneezing (P = 0.016) and rhinorrhea (P = 0.097). The rate of adverse events showed no statistical significance.
CONCLUSIONS:
Rupatadine is a safe and effective treatment option for Korean PAR patients and possibly a better choice over bepotastine for controlling morning symptom.
2025-01-01JOURNAL OF VETERINARY MEDICAL SCIENCE
Comparing the effectiveness of four antihistamines with olopatadine in healthy Thoroughbred horses
Article
作者: MITA, Hiroshi ; IKEDA, Yasuhiko ; TAMURA, Norihisa ; OHTA, Minoru ; KURODA, Taisuke
We compared the antihistamine effect of four new antihistamines with olopatadine, which is used to treat equine allergic diseases. Six healthy Thoroughbred horses received oral doses of olopatadine (50 mg), levocetirizine (50 mg), bilastine (200 mg), rupatadine (100 mg), and desloratadine (50 mg) at >2-week intervals. The effects were investigated by measurement of the wheal area induced by histamine intradermal injection, and inhibition rate was compared with positive and negative controls. The maximum wheal inhibition rate (mean ± SD) of olopatadine (85.3% ± 7.7%) was significantly higher than those of bilastine (51.1% ± 11.8%), rupatadine (55.3% ± 6.6%), and desloratadine (59.8% ± 6.4%), but not levocetirizine (85.4% ± 8.0%). Levocetirizine is expected to have a high antihistamine effect on horses.
2024-12-31Journal of Pharmaceutical Policy and Practice
Survey of community pharmacists’ opinions on drug scheduling in Ontario and Québec
Article
作者: Taylor, Jeff ; Nakhla, Nardine ; Richard, Francis ; Houle, Sherilyn K. D.
Background:
Over the past decade, Canada has witnessed a shift of several drugs from prescription-only to behind-the-counter (BTC) and over-the-counter (OTC) status. This work examined community pharmacists' agreement with the current scheduling of agents used in the management of allergic rhinitis, heartburn, and vulvovaginitis.
Methods:
From September to October 2022, an online survey was administered to pharmacists practicing in in Ontario and Québec. The survey aimed to gather insights into their preferred scheduling for 15 medicines commonly used to manage the three selected conditions. Pharmacists were asked whether they agreed with the current scheduling status of each and, if not, how they feel it should be scheduled.
Results:
715 pharmacists completed the survey, 462 from Ontario and 253 from Québec. Most were staff pharmacists working 30 or more hours per week, having been a pharmacist for 1-10 years. Ontario pharmacists expressed a preference for scheduling change for five drugs (four prescription [terconazole for intravaginal use, famotidine, rupatadine, mometasone nasal spray] and one unscheduled [ranitidine 75 mg]), while Québec pharmacists expressed preference for scheduling change for three prescription drugs (terconazole for intravaginal use, famotidine, rupatadine).
Discussion:
As pharmacy practice continues to evolve, pharmacists' comfort with initiating previously prescription-only therapy independently or assisting patients with self-selection may similarly evolve. Of the five drugs identified as having a discrepancy between current status and pharmacist preference, four are prescription and may be candidates to consider for prescription to OTC switch.
Conclusion:
Pharmacists in Ontario and Québec have expressed preference for most products used in the treatment of allergic rhinitis, heartburn, and vulvovaginitis to be categorised as Schedule II (BTC) or Schedule III (OTC) available only in pharmacies.
100 项与 富马酸卢帕他定 相关的药物交易
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研发状态
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 |
|---|---|---|---|
| 皮炎 | 日本 | 2017-09-27 | |
| 皮炎 | 日本 | 2017-09-27 | |
| 湿疹 | 日本 | 2017-09-27 | |
| 湿疹 | 日本 | 2017-09-27 | |
| 湿疹 | 日本 | 2017-09-27 | |
| 瘙痒 | 日本 | 2017-09-27 | |
| 慢性荨麻疹 | 加拿大 | 2017-01-16 | |
| 常年性变应性鼻炎 | 加拿大 | 2017-01-16 | |
| 季节性过敏性鼻炎 | 加拿大 | 2016-07-20 | |
| 过敏性鼻炎 | 奥地利 | 2001-10-30 | |
| 过敏性鼻炎 | 比利时 | 2001-10-30 | |
| 过敏性鼻炎 | 保加利亚 | 2001-10-30 | |
| 过敏性鼻炎 | 克罗地亚 | 2001-10-30 | |
| 过敏性鼻炎 | 塞浦路斯 | 2001-10-30 | |
| 过敏性鼻炎 | 捷克 | 2001-10-30 | |
| 过敏性鼻炎 | 丹麦 | 2001-10-30 | |
| 过敏性鼻炎 | 爱沙尼亚 | 2001-10-30 | |
| 过敏性鼻炎 | 法国 | 2001-10-30 | |
| 过敏性鼻炎 | 希腊 | 2001-10-30 | |
| 过敏性鼻炎 | 匈牙利 | 2001-10-30 |
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临床结果
临床结果
适应症
分期
评价
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N/A | - | 鏇選衊壓鑰窪獵衊餘繭(醖蓋鏇鑰製窪網顧窪膚) = Rupatadine is the likely cause of sleep terrors due to temporal association. Discontinuation of Rupatadine and initiation of Bilastine (20 mg daily) led to immediate and profound improvement in sleep quality, cessation of sleep terrors, and continued anaphylaxis remission. Night terrors are a rare Rupatadine side effect with significant impact on quality of life. 顧齋艱襯獵膚齋範鏇醖 (膚選遞齋衊餘壓選艱壓 ) | 积极 | 2024-10-24 | |||
N/A | - | - | Standard Premedications | 淵選獵壓壓鑰艱糧齋遞(蓋遞襯獵膚鑰範網糧蓋) = 積壓蓋遞觸範窪鏇齋糧 夢顧醖憲衊艱淵壓襯繭 (築鹹製醖夢築遞鹽簾衊, 0 ~ 63) 更多 | - | 2019-06-12 | |
淵選獵壓壓鑰艱糧齋遞(蓋遞襯獵膚鑰範網糧蓋) = 鹹鏇網遞鹹顧構憲醖簾 夢顧醖憲衊艱淵壓襯繭 (築鹹製醖夢築遞鹽簾衊, 0 ~ 50) 更多 | |||||||
临床2期 | 248 | 醖範積醖鹹繭選築衊醖(範膚觸衊鏇簾繭鏇鹹壓) = 4.35% for placebo, 2.86% for 5 mg-, 4.05% for 10 mg- and 4.29% for 20 mg-rupatadine-treated group 淵膚艱選襯鑰憲繭餘醖 (積願夢鏇憲膚淵鑰窪艱 ) 更多 | - | 2007-06-30 | |||
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