磷酸可待因/对乙酰氨基酚(Codeine Phosphate/Acetaminophen) - 药物靶点：COXs x Opioid receptors_在研适应症：重度疼痛_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Ultracod

靶点

COXs x Opioid receptors

作用方式

抑制剂、激动剂

作用机制

COX抑制剂(环氧化酶抑制剂)、Opioid receptors激动剂(阿片样受体激动剂)

治疗领域

神经系统疾病

在研适应症

重度疼痛

非在研适应症-

原研机构-

在研机构-

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

分子式C18H26NO8P

InChIKeyJPGKFBXFEQWCAI-CCLYOLAMSA-N

CAS号41444-62-6

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关联

9

项与磷酸可待因/对乙酰氨基酚相关的临床试验

RBR-54xy8b

/ Not yet recruiting临床2期IIT

Efficacy of codeine/paracetamol-associated to a desensitizer in tooth sensitivity induced by office bleaching: a randomized, controlled, triple-blind clinical trial

开始日期2019-04-01

申办/合作机构

Universidade Federal do Rio Grande do Norte

[+1]

NCT04730297

/ Completed临床4期IIT

Comparative Analgesic Effects of Preoperative Administration of Paracetamol (Acetominophen) 500 mg Plus Codeine 30 mg and Ibuprofen 400 mg on Pain After Third Molar Surgery

To compare analgesic effects of preoperative administration of paracetamol 500 milligram plus codeine 30 milligram in single-tablet and effervescent formulation to ibuprofen 400 milligram, and placebo in the management of moderate to severe postoperative pain after mandibular third molar surgery.

开始日期2018-01-01

申办/合作机构

Sapienza University of Rome

NCT03400111

/ CompletedN/AIIT

Assessment of Low-level Laser Therapy Versus Paracetamol-caffeine Efficacy in Controlling Pain During Fixed Orthodontic Treatment and Their Role in Enhancing Oral-health-related Quality of Life: A Randomized Controlled Trial

Patients with class I malocclusion who have mild to moderate crowding will be treated in this study. The efficacy of low level laser therapy and Panadol-extra® in relieving pain due to orthodontic treatment will be assessed. The effect of these two interventions on oral-health related quality of life during all stages of orthodontic treatment will be explored, i.e. at the following stages: (1) separation between teeth, (2) archwire changing, (3) bonding of brackets, (4) removal of the fixed appliances.
There are three groups :
a group of patient being irradiated with low-level laser therapy (LLLT) at specific time points to relieve pain and discomfort.
a group of patient in which pain control will be accomplished by prescribing Panadol Extra tablets in a regular manner.
a group of patients in which nothing will be given to them during the course of treatment.

开始日期2017-09-15

申办/合作机构

Damascus University

100 项与磷酸可待因/对乙酰氨基酚相关的临床结果

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100 项与磷酸可待因/对乙酰氨基酚相关的转化医学

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100 项与磷酸可待因/对乙酰氨基酚相关的专利（医药）

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2

项与磷酸可待因/对乙酰氨基酚相关的文献（医药）

2018-03-01·Operative Dentistry3区 · 医学

Combination of Acetaminophen/Codeine Analgesics Does Not Avoid Bleaching-Induced Tooth Sensitivity: A Randomized, Triple-Blind Two-Center Clinical Trial

3区 · 医学

Article

作者: de Paula, E ; Reis, A ; Kossatz, S ; Coppla, FM ; Farago, PV ; Loguercio, AD ; Rezende, M

SUMMARYBleaching-induced tooth sensitivity (TS) is highly prevalent. Objective: This study aimed to determine if the combination of opioids and nonopioids analgesics (Tylex) may provide a better analgesic effect. Method: A triple-blind, parallel, randomized two-center clinical trial was conducted with 105 healthy patients who received either a placebo or a combination of acetaminophen/codeine. The first dose of Tylex 30 mg (acetaminophen 500 mg/codeine 30 mg) or placebo was administered one hour before the in-office bleaching (35% hydrogen peroxide), and extra doses were administered every six hours for 48 hours. The TS was recorded using a visual analog scale of 0 to 10 and a numeric rating scale of 0 to 4 in different periods: during bleaching, one hour up to 24 hours, and 24 hours up to 48 hours postbleaching. The color was measured before and one month after dental bleaching with a visual shade guide (Vita Classical), Vita Bleachedguide 3D-MASTER, and the spectrophotometer Vita Easyshade. The absolute risk of TS was evaluated using the Fisher exact test. Data of TS intensity with numeric rating scale of the two groups were compared with the Mann-Whitney U-test and the Friedman test, while data from the visual analog scale were evaluated by two-way repeated measures analysis of variance and the Tukey test for pairwise comparison. The color changes between groups were compared using the Student t-test (α=0.05). Results: No significant differences between the groups were observed in the risk and intensity of TS. The overall absolute risk of TS was approximately 96%. No significant differences between groups were observed in terms of color change (p>0.05) for any scale. Conclusion: The use of an acetaminophen/codeine combination prior to in-office bleaching does not reduce the risk and intensity of bleaching-induced TS.

2001-06-01·Scottish Medical Journal4区 · 医学

Mortality during the Winter Flu Epidemic — Two Cases of Death Associated with Self-Medication

4区 · 医学

Article

作者: E Wilson ; R Stevenson ; J D Harmse ; R S MacWalter

We report two cases of mortality associated with the recent winter influenza outbreak. Both cases were associated with self-medication. In one case an elderly lady died from haemorrhagic duodenitis induced by over the counter ibuprofen. In the second case the lady died from the consequences of exceeding the recommended doses of paracetamol by combining doses of the generic product with proprietary flu-remedies and Tylex (paracetamol and codeine).

2

项与磷酸可待因/对乙酰氨基酚相关的新闻（医药）

2025-01-26

·蒲公英Ouryao

3个药品，停采

转自：上海阳光医药采购网编辑：水晶近日，上海市医药集中招标采购事物管理所发布三则则通知： 2025年1月26日起暂停北京福元医药股份有限公司生产美阿沙坦钾片采购资格。暂停采购安徽永生堂药业有限公司生产的氨酚待因片（Ⅱ），河北迈德斯特医药科技有限公司生产的硝酸甘油片采购资格。 1、药品专利问题，暂停采购资格 2025年1月26日的通知显示，根据药品专利相关规定，2025年1月26日起暂停北京福元医药股份有限公司生产美阿沙坦钾片采购资格，包装规格有：80mg(按C₃₀H₂₄N₄O₈计)*15片/盒，口服固体药用高密度聚乙烯瓶包装(内置干燥剂) 和40mg(按C₃₀H₂₄N₄O₈计)*15片/盒，口服固体药用高密度聚乙烯瓶包装(内置干燥剂) 。 2、安徽永生堂药业有限公司生产的氨酚待因片（Ⅱ）包装规格为10片/盒被暂停采购资格通知显示，根据国家医疗保障局相关文件，暂停安徽永生堂药业有限公司生产的氨酚待因片（Ⅱ）（规格包装为对乙酰氨基酚0.3g,磷酸可待因15mg*10片/盒，铝塑）采购资格。值得注意的是，2024年11月11日，上海市医药集中招标采购事物管理所发布的通知显示，暂停采购安徽永生堂药业有限公司生产的氨酚待因片（Ⅱ）。 2024，被暂停采购的包装规格为16片/盒通知显示，根据国家医疗保障局相关文件规定，暂停安徽永生堂药业有限公司生产的氨酚待因片（Ⅱ）（每片含对乙酰氨基酚300mg，含磷酸可待因15mg，8片/板*2板/盒,铝塑包装）采购资格。上海市医药集中招标采购事物管理所并未在通知中披露该药被暂停采购的具体原因。 3、河北迈德斯特医药科技有限公司两个包装规格（0.5mg*25片/瓶，低硼硅玻璃管制注射剂瓶；0.5mg*100片/瓶，低硼硅玻璃管制注射剂瓶包装），根据国家医疗保障局相关文件，被暂停采购资格。上海市医药集中招标采购事物管理所并未在通知中披露上面两个药被暂停采购的具体原因。

带量采购专利到期

2024-11-11

·微信

新事 | 一家药企被暂停采购资格

11月11日，上海阳光医药采购网发布一则通知：根据国家医疗保障局相关文件规定，暂停安徽永生堂药业有限公司生产的氨酚待因片（Ⅱ）采购资格。通知中未提及暂停原因。氨酚待因片是乙酰氨基酚和磷酸可待因的复方制剂，是中等强度镇痛药，并有一定的解热、镇咳作用，为处方药、医保乙类用药。其中磷酸可待因是罂粟生物碱之一，具有成瘾性。根据磷酸可待因含量不同，氨酚待因片分为(I)、（Ⅱ）两类，氨酚待因片（Ⅱ）的磷酸可待因含量更高，为15mg。健识局查询到，氨酚待因片（Ⅱ）有三个批准文号，除安徽永生堂药业外，汕头经济特区鮀滨制药厂、国药集团工业有限公司也有生产。安徽永生堂药业位于安徽临泉县，前身为临泉县制药厂，其霍山石斛胶囊制剂在石斛中药领域属于独家产品。公开媒体报道显示，2014年前后，在国家药监局的帮扶下，永生堂药业获得了十几项生产批准文号，其中包括霍山石斛深加工。该企业负责人曾表示，没有国家药监局的帮扶，就没有永生堂药业的今天。 2023年8月，安徽永生堂药业因制售不合格药品伤科跌打片被安徽省药监局罚款33万元。撰稿丨李傲编辑丨江芸贾亭运营｜韩瑾睿声明：健识局原创内容，未经许可请勿转载诺和盈美团首发预约；无锡虹桥医院注销；药店售价省际联动红斑狼疮能治好吗？百万一针的CAR-T或许有用 2024进博会 | 爱施健“米库氯铵注射液”回归再上市

带量采购细胞疗法免疫疗法

100 项与磷酸可待因/对乙酰氨基酚相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	N02AA59	-

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
重度疼痛	美国	-	-

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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


NCT01229449 (CTgov)	临床3期	牙痛 \| 术后疼痛	678	Nurofen Plus® (Nurofen Plus®)	範鏇製選鹹窪築鏇構顧(壓蓋醖顧顧製鹹艱齋願) = 窪願窪繭壓範鹽觸簾壓齋淵簾淵觸網築鹽網觸 (壓窪壓鹹鏇鑰壓蓋壓壓, 淵簾窪齋襯膚獵齋鏇夢 ~ 糧遞糧衊醖顧顧膚鬱鹹) 更多	-	2018-09-17
				Panadeine® Extra (Panadeine® Extra)	範鏇製選鹹窪築鏇構顧(壓蓋醖顧顧製鹹艱齋願) = 淵觸積膚顧襯製鹹顧獵齋淵簾淵觸網築鹽網觸 (壓窪壓鹹鏇鑰壓蓋壓壓, 餘壓築簾築餘膚簾網壓 ~ 淵獵齋顧製糧襯膚壓鏇) 更多
NCT02455518 (CTgov)	临床4期	肌肉骨骼疼痛	416	Oxycodone/acetaminophen (Oxycodone/Acetaminophen)	網築繭憲糧膚製積夢衊(製繭繭艱遞餘齋衊構壓) = 憲憲夢鏇顧齋艱襯糧願廠膚夢夢選齋壓膚醖齋 (範鏇憲鑰鑰蓋構蓋膚窪, 鹽顧糧願選餘遞積簾鑰 ~ 築築餘憲構艱顧壓範廠) 更多	-	2018-02-13
				Hydrocodone/acetaminophen (Hydrocodone/Acetaminophen)	網築繭憲糧膚製積夢衊(製繭繭艱遞餘齋衊構壓) = 觸齋窪簾淵築觸艱蓋顧廠膚夢夢選齋壓膚醖齋 (範鏇憲鑰鑰蓋構蓋膚窪, 蓋網鑰衊鑰獵夢鹹選鹽 ~ 積鬱壓範鑰鹽餘衊繭積) 更多