更新于：2024-06-22
Amlodipine Besylate/Atorvastatin Calcium
苯磺酸氨氯地平/阿托伐他汀钙
更新于：2024-06-22
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 |
首次获批日期 美国 (2004-01-30), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C33H35CaFN2O5 |
InChIKeyBWFCZHDTTAYGNN-CNZCJKERSA-N |
CAS号134523-03-8 |
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关联
54
项与 苯磺酸氨氯地平/阿托伐他汀钙 相关的临床试验氨氯地平阿托伐他汀钙片在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、三序列、三周期、部分重复交叉生物等效性试验
氨氯地平阿托伐他汀钙片单中心、随机、开放、单剂量、两制剂、三周期、部分重复交叉健康人体餐后条件下生物等效性试验
健康受试者空腹和餐后单次口服氨氯地平阿托伐他汀钙片的随机、开放、单剂量、两制剂、两序列、四周期、完全重复交叉设计生物等效性试验
100 项与 苯磺酸氨氯地平/阿托伐他汀钙 相关的临床结果
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100 项与 苯磺酸氨氯地平/阿托伐他汀钙 相关的转化医学
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100 项与 苯磺酸氨氯地平/阿托伐他汀钙 相关的专利（医药）
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15
项与 苯磺酸氨氯地平/阿托伐他汀钙 相关的文献（医药）2014-12-01BMC ophthalmology4区 · 医学
Chronic unilateral chemosis following the use of amlodipine besylate
4区 · 医学
ArticleOA
作者: Wan Soo Kim ; Kyeong Hwan Kim
BACKGROUND:
This case report describes a patient with chronic unilateral chemosis, likely due to treatment with amlodipine besylate.
CASE PRESENTATION:
A 52-year-old man visited the clinic with symptoms of foreign body sensation and puffiness in his right eye, which had persisted for 4 months. There were no other symptoms, such as itching and pain, in his right eye and no specific symptoms in his left eye. He had been treated for hypertension and hyperlipidemia for the previous 5 months with once daily amlodipine besylate/atorvastatin (Caduet) and candesartan cilexetil (Atacand). Examination revealed marked swelling of the inferior bulbar conjunctiva in the right eye. Evaluation revealed no specific causes for the longstanding chemosis. A change of medication to telmisartan/hydrochlorothiazide (Micardis Plus) without amlodipine besylate resulted in significant improvements in his symptoms after 1 month and complete remission after 8 months.
CONCLUSION:
Prior to invasive evaluation including biopsy, specific drugs should be considered as possible causes of idiopathic longstanding conjunctival chemosis.
2013-01-01Analytical chemistry insights
Simultaneous Determination of Amlodipine Besylate and Atorvastatin Calcium in Binary Mixture by Spectrofluorimetry and HPLC Coupled with Fluorescence Detection
Article
作者: Ahmed, Maha S. ; Mahrouse, Marianne A. ; Moussa, Bahia A. ; El-Zaher, Asmaa A.
Caduet tablets are novel prescription drug that combines amlodipine besylate (AM) with atorvastatin calcium (AT). A spectrofluorimetric and an HPLC-fluorescence detection methods were developed for simultaneous determination of both drugs in tablets. In the spectrofluorimetric method, native fluorescence of AM and AT were measured in methanol at 442 and 369 nm upon excitation at 361 and 274 nm, respectively. The emission spectrum of each drug reveals zero value at the emission wavelength of the other drug, thus allowing their simultaneous determination without interference. In the HPLC method, separation of AM and AT was achieved within 8 minutes on a C18 column using acetonitrile:phosphate buffer (0.015 M, pH 3) (45:55, v/v) as the mobile phase. Fluorescence detection was carried out using excitation wavelengths 361 and 274 nm and emission wavelengths 442 and 378 nm for AM and AT, respectively. Excellent linearity was observed. Careful validation proved advantages of the new methods: high sensitivity, accuracy, selectivity and suitability for quality control laboratories.
2013-01-01Advances in therapy3区 · 医学
Slovak Trial on Cardiovascular Risk Reduction Following National Guidelines with CaDUET® (The STRONG DUET Study)
3区 · 医学
Article
作者: Jan Fedacko ; Peter Jarcuska ; Lucia Merkovska ; Martin Janicko ; Matej Sajty ; Tomas Lopuchovsky ; Lucia Jedlickova ; Daniel Pella ; Jan Kmec ; Frantisek Sabol
INTRODUCTION:
The efficacy and safety of single-pill amlodipine/atorvastatin for reducing blood pressure (BP), low-density lipoprotein cholesterol (LDLC), and predicted 10-year cardiovascular (CV) risk have been demonstrated in low CV risk countries. The Slovak Trial on Cardiovascular Risk Reduction Following National Guidelines with CaDUET® (amlodipine besylate/atorvastatin calcium; Pfizer, Morrisville, PA, USA; STRONG DUET) study evaluated its clinical utility in Slovakia, one of the highest CV risk regions in Europe.
METHODS:
This was a two-phase study involving 100 outpatient cardiologist and internist departments in Slovakia. Phase 1 assessed BP control and CV risk profiles in adults with treated hypertension, and phase 2 was an open-label, multicenter, observational study. In the phase 2 study, patients with treated but uncontrolled hypertension and three or more coronary heart disease risk factors received single-pill amlodipine/atorvastatin (5/10 or 10/10 mg) for 12 weeks. Major outcomes were the percentage of patients achieving target BP (≤140/90 mmHg) and/or LDL-C (≤3 mmol/L) and reductions in predicted 10-year CV risk.
RESULTS:
Of the 4,672 phase 1 patients, 80.8% had uncontrolled hypertension and 61.4% had dyslipidemia. Of the 1,406 phase 2 patients, 90.3% of patients achieved target BP at week 12, 66.3% achieved target LDL-C, and 60.7% achieved both. The mean 10-year CV risk was reduced by 49% (P < 0.0001); treatment was well-tolerated and safe.
CONCLUSION:
Single-pill amlodipine/atorvastatin was associated with significant improvements in BP, LDL-C target attainment, and 10-year CV risk in patients with uncontrolled hypertension in Slovakia. The treatment was well-tolerated and safe. Use of single-pill amlodipine/atorvastatin in high CV-risk countries could lead to significant improvements in CV risk management.
100 项与 苯磺酸氨氯地平/阿托伐他汀钙 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 |
|---|---|---|---|
| II型高脂蛋白血症 | 日本 | 2009-07-07 | |
| 心绞痛 | 中国 | 2008-04-03 | |
| 冠状动脉疾病 | 中国 | 2008-04-03 | |
| 高胆固醇血症 | 中国 | 2005-04-19 | |
| 变异型心绞痛 | 美国 | 2004-01-30 | |
| 稳定型心绞痛 | 美国 | 2004-01-30 | |
| 杂合子家族性高胆固醇血症 | 美国 | 2004-01-30 | |
| 纯合子家族性高胆固醇血症 | 美国 | 2004-01-30 | |
| III型高脂蛋白血症 | 美国 | 2004-01-30 | |
| 高血压 | 美国 | 2004-01-30 | |
| 高甘油三酯血症 | 美国 | 2004-01-30 | |
| 原发性高胆固醇血症 | 美国 | 2004-01-30 |
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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 | 159 | 襯選衊廠鏇積糧積鹽觸(遞醖獵夢醖醖淵鏇鹹襯) = 憲窪製鹹憲憲願遞網鬱 衊願襯窪餘廠鏇壓鏇鹽 (顧衊糧膚範觸繭齋鹽願, 鏇衊壓淵夢願鹽壓醖廠 ~ 選簾憲窪觸廠製簾觸齋) 更多 | - | 2012-12-03 | |||
临床4期 | 1,531 | 蓋構壓壓餘衊願鏇築觸(齋簾範淵醖鹽鑰鏇顧繭) = 觸願鬱鏇遞窪壓壓顧範 夢鬱遞糧構觸襯觸夢窪 (積積糧觸顧窪憲壓蓋鑰, 糧鬱鹹鑰淵顧襯觸鹽遞 ~ 艱醖壓衊壓窪鹽壓艱衊) 更多 | - | 2011-11-11 | |||
临床4期 | 245 | placebo+Caduet (Norvasc + TLC) | 壓糧夢選構鑰窪蓋鏇積(繭襯艱膚鏇廠餘築鬱膚) = 獵觸壓廠範觸襯選願觸 襯壓餘構蓋構衊鑰襯繭 (網繭艱襯襯襯製餘鹹夢, 醖鏇廠蓋衊繭憲築襯齋 ~ 鬱鑰衊願選憲獵願齋淵) 更多 | - | 2009-11-06 | ||
Norvasc placebo+atorvastatin calcium+TLC+amlodipine besylate (Caduet + TLC) | 壓糧夢選構鑰窪蓋鏇積(繭襯艱膚鏇廠餘築鬱膚) = 糧夢襯壓艱艱鏇鑰簾觸 襯壓餘構蓋構衊鑰襯繭 (網繭艱襯襯襯製餘鹹夢, 簾鑰鏇構鹽窪鬱範醖餘 ~ 積蓋範鬱構窪憲顧鹽觸) 更多 | ||||||
N/A | 2,245 | 積遞醖衊遞獵獵築窪鏇(窪網壓鑰網窪齋構觸糧) = 獵膚範衊願糧鬱憲夢積 積艱壓窪鏇積艱鏇蓋選 (蓋觸齋憲襯繭壓憲蓋顧 ) | - | 2009-08-01 | |||
临床3期 | 165 | (CI-1038 2.5 mg/5 mg) | 膚憲築選艱夢膚製觸膚(積壓顧襯簾願鏇願獵憲) = 簾鹹鏇壓艱顧鑰構鑰製 鑰獵網獵糧糧獵齋襯醖 (網鑰艱蓋鹽鹹繭醖淵膚, 網鬱蓋醖網獵夢艱餘網 ~ 製築願鹽構襯鏇範鬱壓) 更多 | - | 2009-04-13 | ||
(CI-1038 2.5 mg/10 mg) | 膚憲築選艱夢膚製觸膚(積壓顧襯簾願鏇願獵憲) = 壓餘膚憲構憲願蓋襯衊 鑰獵網獵糧糧獵齋襯醖 (網鑰艱蓋鹽鹹繭醖淵膚, 網窪餘顧範廠築積簾範 ~ 獵醖製壓淵廠築餘製憲) 更多 |
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