A Randomized, Crossover Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D® 12-Hour Extended Release Tablet (Loratadine 5mg/Pseudoephedrine Sulfate 120 mg, Manufacturer-SAG) to a Single Oral Dose of Claritin-D® 12-Hour Extended Release Tablet (Loratadine 5 mg/Pseudoephedrine Sulfate 120 mg, Manufacturer-Heist) Under Fed Conditions in Healthy Adult Subjects

To evaluate the bioequivalence of one extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer HealthCare LLC by SAG Manufacturing, S.L.U. Madrid, Spain (test treatment) to the extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer SA-NV by Schering- Plough Labo NV Heist (reference treatment) which is currently marketed in Europe.

开始日期2018-04-24

申办/合作机构

Bayer AG

NCT03517930 / Completed临床1期

To evaluate the bioequivalence of one extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer HealthCare LLC by SAG Manufacturing, S.L.U. Madrid, Spain (test treatment) to the extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer SA-NV by Schering-Plough Labo NV Heist (reference treatment) which is currently marketed in Europe.

开始日期2018-04-17

申办/合作机构

Bayer AG

NCT03443843 / Completed临床4期

A Double-Blind Placebo-Controlled Crossover Study to Evaluate Objective Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure in an Environmental Exposure Unit

The purpose of the study is to evaluate changes in nasal airflow caused by loratadine 5 mg/pseudoephedrine sulfate 120 mg (Claritin D) tablet and fluticasone propionate 50 mcg per spray nasal spray (Flonase) in subjects suffering from nasal congestion and other allergy symptoms.

开始日期2018-02-21

申办/合作机构

Bayer AG

100 项与氯雷他定/硫酸伪麻黄碱相关的临床结果

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100 项与氯雷他定/硫酸伪麻黄碱相关的转化医学

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100 项与氯雷他定/硫酸伪麻黄碱相关的专利（医药）

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项与氯雷他定/硫酸伪麻黄碱相关的文献（医药）

2006-05-01·International journal of paediatric dentistry3区 · 医学

Erosive effect of an antihistamine‐containing syrup on primary enamel and its reduction by fluoride dentifrice

3区 · 医学

Article

作者: L. C. Costa Filho ; I. C. S. Almeida ; C. C. Costa

Summary. Aim. This study evaluated the action of an antihistamine‐containing syrup (Claritin D) on enamel that was subsequently submitted or not to applications of fluoride dentifrice.Methods. Two hundred sixty‐four slices (n = 44 per subgroup) prepared from exfoliated primary molars were evaluated in hardness tests. Six subgroups were submitted to different treatments for 10 days. The controls underwent pH cycling with (positive control) or without (negative control) three daily immersions in fluoride dentifrice/distilled water slurry. The test subgroups related to daytime use of the antihistamine syrup underwent pH cycling and two 5‐min applications of Claritin D, coupled or not to the three daily immersions in the fluoride slurry. The subgroups related to nocturnal use of the syrup were submitted to the same procedures of daytime subgroups, respectively, but with one of the applications of Claritin D lasting for 8 h.Results. The median hardness values obtained after use of the syrup were significantly lower than the initial ones. Equivalent values for subgroups submitted to fluoride applications in addition to treatment with the syrup were significantly higher.Conclusion. It was concluded that the antihistamine‐containing syrup reduced the hardness of primary enamel and that, in this experiment, the use of fluoride dentifrice was able to diminish this erosive effect.

2004-01-01·Pharmacoepidemiology and drug safety4区 · 医学

The risk of esophageal obstruction associated with an anti‐allergy medication (Claritin‐D® 24‐Hour—original formulation)

4区 · 医学

Article

作者: Deborah Shatin ; Bharati Manda ; Carol R. Drinkard ; David J. Graham

Abstract:

Purpose:

To investigate a possible increased risk of esophageal obstruction among users of loratadine and pseudoephedrine (Claritin‐D® 24‐Hour ‘C‐D 24’, the original, round, extended‐release formulation) compared to two other tablet formulations of loratadine.

Methods:

Pharmacy data of 12 managed care plans were screened to identify users in the three groups from 1 September 1996 to 31 December 1998. Users with a medical claim following their first loratadine prescription (Index prescription) indicating an esophageal obstruction or endoscopic procedure were considered claims‐identified cases. Medical records were reviewed to validate case status.

Results:

There were 233 901 users (61% female) and 245 claims‐identified cases occurring within 30 days after the first prescription. The incidence rate per 10 000 users of claims‐identified cases occurring on the Index prescription date was higher among C‐D 24 users (IR = 1.4) than Claritin® Regular (C‐R) users (IR = 0.07; p < 0.002) or Claritin‐D® 12‐Hour (C‐D 12) users (IR = 0.3; p > 0.05). Medical record review of 15 claims‐identified cases confirmed two cases of acute esophageal obstruction, both among C‐D 24 users.

Conclusions:

Claims‐based analysis suggested an increased risk of endoscopic procedures on the Index date among C‐D 24 users compared to C‐R users. However, after medical record review, the study did not provide conclusive evidence of an association between C‐D 24 use and esophageal obstruction. This study highlights the importance of validating findings from claims data using medical records. Copyright © 2003 John Wiley & Sons, Ltd.

1998-07-01·American journal of therapeutics4区 · 医学

Comparative Efficacy and Safety of Once-Daily Versus Twice-Daily Loratadine-Pseudoephedrine Combinations Versus Placebo in Seasonal Allergic Rhinitis

4区 · 医学

Article

作者: Harrison, J E ; Danzig, M R ; Stricker, W W ; Bernstein, D I ; Berkowitz, R R ; Rooklin, A R ; Georgitis, J W ; Kaiser, H B ; Bronsky, E A ; Lorber, R R ; Banov, C H ; Sholler, L J ; Mendelson, L M

The objective of this study was to compare the efficacy and safety of Claritin-D 24 Hour (once daily) with that of Claritin-D 12 Hour (twice daily) and placebo in the treatment of patients with seasonal allergic rhinitis (SAR). In this double-blind, placebo-controlled, multicenter study, 469 patients with moderate-to-severe SAR symptoms were treated for 2 weeks with one of the following: Claritin-D 24 Hour (a combination tablet formulation of loratadine 10 mg in the coating and pseudoephedrine sulfate 240 mg in an extended-release core), Claritin-D 12 Hour (a combination tablet formulation of loratadine 5 mg in the tablet coating and 120 mg pseudoephedrine sulfate, 60 mg in the coating and 60 mg in the core), or placebo. Claritin-D 24 Hour and Claritin-D 12 Hour were consistently superior to placebo (P < 0.01) in reducing total, nasal, and nonnasal symptom scores. Patients in the Claritin-D 24 Hour and Claritin-D 12 Hour groups also had significantly greater (P

项与氯雷他定/硫酸伪麻黄碱相关的新闻（医药）

2022-08-19

·赛柏蓝

大批药品无法正常供应（附名单）

集采对医药产业链的影响已经不容忽视来源 | 赛柏蓝（未经授权禁止转载）撰稿 | 颜色牧之01 42个药品取消中标挂网资格8月18日，甘肃省公共资源交易中心发布《关于对申请撤废药品取消中标挂网资格有关事宜的通知（第46批）》（以下简称《通知》）。根据《通知》，近期有32家企业的42个药品因生产线改造、成本上涨、原料短缺、停产等原因提交撤废申请，无法保障甘肃省医疗机构的正常供应。为保障医疗机构正常采购，自2022年8月24日起，取消撤废药品的中标挂网资格，并按照《甘肃省药品集中采购诚信管理办法》的相关规定报省医保局参照以下规则对相关企业进行诚信处理。《通知》提出，对此次撤废品种，鼓励其他企业同功能主治药品申请阳光挂网，甘肃省对性价比优于平台已中标挂网的药品实行免备案阳光挂网。02大批中成药撤网本次甘肃省申请撤废的42个药品中有近半数是中成药，包括：安宫牛黄丸、二益丸、六味地黄丸颗粒、九味羌活颗粒等常见品种。除了甘肃之外，近期已有多地相继发布药品取消挂网的通知，中成药产品占有相当比重。4月1日，山西省药械集中竞价采购网发布了《关于公示部分企业撤销平台挂网采购资格的通知》，42家药品生产企业、77个药品品规申请撤网，超过一半以上的为中成药，其中红花注射液也被撤网。5月24日，广西药械集中采购网发布通知显示，71个药品申请撤网，超过一半为中成药，包括小儿豉翘清热颗粒、肾宝糖浆、小儿止咳糖浆、川贝枇杷糖浆等常用药。6月15日，湖北省医保局发布《关于公示首批中成药省际联盟集中带量采购非中选品种挂网价和医保支付标准等相关信息的通知》，累计有227个中成药将被暂停挂网。从官方和药企给出的说法来看，这些中成药废撤的原因主要集中在两个方面——成本上涨和产能不足。与化药不同，中成药的成本受原材料价格波及较大。中药材的特性也决定了，植株一旦生长欠佳就会直接影响到中成药企业的产能情况。但有专家告诉赛柏蓝，近期中成药大批撤网，或有可能是为了规避即将到来的中成药集采。长期以来，中药依赖传统经销商渠道销售，大型老字号基本都有自家的零售药店，挂网招采销售份额较小。撤网意味着全省公立医院渠道无法采购这些中成药，但对一些中药企业来说，影响可能并不大。一名医药行业研究员告诉赛柏蓝，目前来看中成药集采已是大势所趋，并且很有可能先在那些价高量大的品种上下手。随着生存空间不断被挤压，中成药企必须尽快转变思路，去谋求新的市场。03利润低、产能受限大批常见化药撤网本次甘肃省申请撤废的42个药品中，不乏一些化药。例如：碳酸钙咀嚼片、注射用利巴韦林等均属于集采平台产品，企业不再生产；氨酚氯雷伪麻缓释片等因价格上涨而撤网；蒙脱石混悬液等因企业产能不足而撤网。国内某药企市场总监董泽成对赛柏蓝表示，化药撤网的原因有很多，一方面因药品利润低，企业销售动力不足；另一方面，因为很多集采中标产品销量的上升，加上疫情导致生产不稳定，产能受限。健康服务运营管理专家仲崇明补充说道：“地区临床需求不明显也可能是其中原因之一。”此前，甘肃省已经多次发布过药品撤网的通知，囊括大批药品。上述专家认为，因为甘肃处于边陲地区，物流成本更高，对于中标价低的药品，利润确实较为微薄。长此以往，一些集采药品自然出现撤网。从本次撤网的药品来看，现所属的大多是集采平台。众所周知，集采后中标药品价格大幅下降，产业链条随之生变。企业想要保证产能和利润空间，原料药成为需要考虑的主要问题。“因为不可预测的因素太多，所以集采药品的成本很难预测。比如很多产品的原料药不是自家的，中标后原料药涨价就是问题。未来的仿制药开发一般会和原料药捆绑在一起，是否有原料药对于集采中标很重要。”上述专家说道。国务院办公厅印发《“十四五”全民医疗保障规划》提到，药品带量采购品种数2025年预期目标大于500个。也就是说，未来几年内集采将会覆盖500多个药品，集采对医药产业链的影响已经不容忽视。对于如何避免因成本上涨、原料短缺等问题出现的药品撤网，上述药企专家认为，要从原料药企业入手，其面临环保、竞争、成本等问题，需要符合环保要求，延伸产业链做制剂，出海，扩大产能降低成本。同时，标外市场也不容忽视。中标价高的，厂家会通过寻找代理商促进标外市场的销售。赛柏蓝梳理发现，近几年来，黑龙江、河南、广西等省市均发布过关于药品撤网的申请，其中不乏罗红霉素、头孢抗菌素等常见药品。按照《甘肃省药品集中采购诚信管理办法》的相关规定，大多药品撤网都会给予对应企业相关处分。例如：新增阳光挂网药品在1年内撤废的，1个药品给企业记不良记录1次，撤废后1年内不得再次申报；1年至2年之间撤废的，按照每批次申请撤废品种数量处理等。总的来看，除了因药监局撤销批准文号、企业关停并转等原因造成无法供应的，根据企业提交的申请，原则上可免于处理，其他原因造成的撤网，企业都会有一定的政策压力。附名单-留言讨论，更多观点 -医药政策：带量采购 | 医保目录 | 三明TOP企业：恒瑞医药 | 阿斯利康 | 云南白药市场观察：公立医院 | 科创板 | 医药商业话题品种：PD-1 | 创新药 | 中药 | 生物药专家撰稿：张自然博士专栏 | 董泽成专栏 | 月下独酌专栏 | 郭泰鸿会长专栏人事变动：医药代表 | 董事长 | 高管变动‍‍

免疫疗法抗体创新药带量采购

2022-08-18

·蒲公英Ouryao

42个药品取消挂网8月24日起执行、触及诚信处理！

转自：甘肃公共资源中心整理：wangxinglai20042022年08月18日，甘肃公共资源中心发布了关于对申请撤废药品取消中标挂网资格有关事宜的通知（第46批），共计32家企业的42个药品因生产线改造、成本上涨、原料短缺、停产等原因提交撤废申请，自2022 年8月24日起执行并对相关企业进行诚信处理。重点内容健民集团叶开泰国药（随州）有限公司因撤销供应小儿宝泰康颗粒（国药准字Z42020598）被记录不良信用一次；江西东风药业股份有限公司因撤销供应注射用青霉素钠（国药准字H36020261）被记录不良信用一次；苏州二叶制药有限公司因撤销供应罗红霉素胶囊（国药准字H20067378）被记录不良信用一次；浙江万晟药业有限公司因撤销供应芪明颗粒（国药准字Z20090036）被警告一次；通知主要内容各医疗机构、相关企业：近期有32家企业的42个药品因生产线改造、成本上涨、原料短缺、停产等原因提交撤废申请，无法保障我省医疗机构的正常供应。为维护正常采购秩序，做好保障供应工作，现就有关事宜通知如下：一、撤废后保障供应措施本批次共有32家企业的42个药品申请撤废药品，其中35个药品平台有同品种不同规格中标挂网药品可保障供应；有7个药品平台无中标，请医疗机构使用同功能主治的替代药品（见附件）。二、其他事宜为保障医疗机构正常采购，自2022 年8月24日起，取消撤废药品的中标挂网资格，并按照《甘肃省药品集中采购诚信管理办法》的相关规定报省医保局参照以下规则对相关企业进行诚信处理：新增阳光挂网药品在1年内撤废的，1个药品给企业记不良记录1次，撤废后1年内不得再次申报；1年至2年之间撤废的，按照每批次申请撤废品种数量处理；2年以后撤废的免于处理；2017-2018年公开招标企业确认接续品种及国家（含省级、联盟）集采采购中选及联动周期内品种申请撤废的，给企业记不良记录1次；因药监局撤销批准文号、企业关停并转等原因造成无法供应的，根据企业提交的申请，原则上可免于处理；企业提供虚假资料申请免于处理的，一经核实，对企业从重追加处理，执行前接受申诉质疑。对此次撤废品种，鼓励其他企业同功能主治药品申请阳光挂网，我省对性价比优于平台已中标挂网的药品实行免备案阳光挂网。医疗机构在执行过程中存在问题的，请及时向省公共资源交易中心、省医疗保障局、省卫生健康委反馈。联系电话：省公共资源交易中心0931-2909266、0931-2909383省卫生健康委0931-4818123省医疗保障局0931-8127072涉及品种：注射用利巴韦林、蒙脱石混悬液、通宣理肺颗粒、六味地黄颗粒、小儿泻速停颗粒、化积口服液、百宝丹胶囊、甲磺酸罗哌卡因注射液、甲磺酸罗哌卡因氯化钠注射液、碳酸钙咀嚼片、氨酚氯雷伪麻缓释片、芪明颗粒、肝素钠注射液、小儿宝泰康颗粒、阿替洛尔片、替加氟注射液、健脾生血颗粒、注射用磷霉素钠、注射用氢化可的松琥珀酸钠、二益丸、安宫牛黄丸、心脑宁胶囊、金珍滴眼液、川黄口服液、注射用青霉素钠、罗红霉素胶囊、对乙酰氨基酚片、盐酸莫西沙星片、右佐匹克隆片、曲昔派特胶囊、甲磺酸二氢麦角碱、枸橼酸托瑞米芬片、九味羌活颗粒、来曲唑片、谷胱甘肽片；扫描二维码查看原文第46批撤废药品一览表

100 项与氯雷他定/硫酸伪麻黄碱相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	氯雷他定/硫酸伪麻黄碱	R01BA52	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
普通感冒	美国	Bayer Healthcare LLC	1996-08-23
发热	美国	Bayer Healthcare LLC	1996-08-23
季节性过敏性鼻炎	美国	Bayer Healthcare LLC	1994-11-14
上呼吸道过敏	美国	Bayer Healthcare LLC	1994-11-14

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03443843 (Pubmed \| Ann Allergy Asthma Immunol)	临床4期	过敏性鼻炎	82	Loratadine-Pseudoephedrine tablet	蓋淵鬱齋簾鹹襯鹽選廠(簾製鬱構簾築構獵憲簾) = 襯壓窪夢選壓鹹鹽齋鹽築積構齋構獵膚衊鬱選 (簾鏇製壓遞糧構淵積鏇 )	-	2021-05-14
				Fluticasone propionate nasal spray	蓋淵鬱齋簾鹹襯鹽選廠(簾製鬱構簾築構獵憲簾) = 範餘憲膚遞製醖簾選遞築積構齋構獵膚衊鬱選 (簾鏇製壓遞糧構淵積鏇 )