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Aceclofenac Sustained Release Tablets Instructions

Release time:

2020-07-31

核准日期：2009年01月04日
第1次修改日期：2009年03月10日
第2次修改日期：2015年05月05日

悦意宁
醋氯芬酸缓释片说明书
请仔细阅读说明书并在医师指导下使用

[药品名称]
通用名称：醋氯芬酸缓释片
英文名称: Aceclofenac Sustained-release Tablets
汉语拼音：Culvfensuan Huanshi Pian
[成份]:本品主要成分为：醋氯芬酸
化学名称：2-[（2，6-二氯苯基）胺基]-苯乙酰氧基乙酸
化学结构式：

分子式：C16H13Cl2NO4
分子量：354.19
[性    状] 本品为白色或类白色片
[适应症]
骨关节炎、类风湿关节炎和强直性脊椎炎等引起的疼痛和炎症的症状治疗。
[规    格] 0.2g
[用法用量]
口服：必须整片吞服，勿嚼碎。每次0.2g(一片)，每日一次，或遵医嘱。
[不良反应]
根据临床试验结果及相关文献报道，本品的不良反应有：
1、常见不良反应
胃肠道系统失调：消化不良、腹痛、恶心和腹泻。
肝胆：肝酶升高
2、偶见不良反应（发生率1%-0.1%）
一般为头晕。胃肠道系统：胀气、胃炎、便秘、呕吐、溃疡性口腔粘膜炎。皮肤：瘙痒、皮疹、皮炎、湿疹。代谢和营养：尿素氮和肌酐升高。
3、罕见不良反应（发生率小于0.1%）
一般有头痛、疲倦、面部浮肿、过敏症状、体重增加。血液：贫血、粒细胞减少、血小板减少、中性粒细胞减少。心血管：、水肿、心悸、腓肠肌痉挛、潮红、紫癜。泌尿系统：间质性肾炎。中枢和外周神经系统：感觉障碍、震颤。胃肠道系统障碍方：胃肠出血和溃疡、出血性腹泻、肝炎或胰腺炎、柏油状大便、口腔粘膜炎症。皮肤：湿疹。代谢和营养：碱性磷酸酶升高，高钾血症。
精神病学方面：抑郁、多梦、嗜睡、失眠。眼睛：视觉异常。
其他：味觉倒错、脉管炎、。
如其它的非甾体抗炎药，可能发生严重的皮肤粘膜的超敏反应。
[禁忌]
以下患者禁用：
1.已知对本品过敏者；
2.病人服用与本品作用机制相似的非甾体抗炎药如阿斯匹林、双氯芬酸等引起哮喘、支气管痉挛、急性鼻炎者；
3.患有或者怀疑患有胃、十二指肠溃疡者、或有胃、十二指肠溃疡复发史的患者，胃肠道出血或者其他出血或凝血功能障碍者；
4.患有严重心衰、肝肾功能不全者；
5.妊娠最后3个月期间的孕妇禁用。
[注意事项]
1.口服时必须整片吞服，勿嚼碎。嚼碎会影响缓释效果，增加副作用发生的可能性。
2.有胃肠道疾病的患者或有消化道溃疡、脑血管出血、溃疡性结肠炎、Crobn’s病、系统性红斑狼疮(SLE)、卟啉病及造血和凝血功能障碍病史患者应慎用或在密切监控下使用；
3.轻度、中度肝、肾、心功能不全者以及有体液潴留、用利尿药治疗或其他同样有低血容量危险的患者应慎用；
4.服用非甾体消炎药后出现头晕和中枢神经系统其它障碍的患者应避免开车或从事机械操作；
5.长期服用非甾体抗炎镇痛药患者应经常检查，以防对肝肾功能和血细胞计数的不良影响。
[孕妇及哺乳期妇女用药]
抗炎药可能会阻滞子宫收缩和延迟分娩。它们可能引起宫内动脉导管收缩和闭锁，导致新生儿肺动脉高压和呼吸功能不全。抗炎药也可能降低胎儿血小板功能和抑制胎儿肾功能，从而引起羊水过少和新生儿无尿症。故孕妇在妊娠最后三个月禁用本品。本品是否会分泌到母乳中尚不清楚，故哺乳期间妇女不应使用本品，除非医生认为必要。
[儿童用药]
儿童用药的安全性和有效性尚末确定，故不推荐儿童使用。
[老年患者用药]
一般无须降低剂量。但因老年患者更容易出现副作用，也更可能造成肾、心血管和肝功能损害。在治疗期间，很多时候患者无前期症状或明显的病史，结果出现严重的胃肠出血和/或穿孔，使用时应倍加慎重。
[药物相互作用]
1.使用本品时应避免与以下药物合用：
    非甾体抗炎药会抑制甲氨喋呤在肾小管的分泌，可能具有轻微的代谢相互作用，从而导致甲氨喋呤清除率降低，故在高剂量甲氨喋呤治疗期间，应始终避免服用非甾体抗炎药物。
    某些非甾体抗炎药可抑制锂盐在肾脏的消除过程，使血中锂浓度升高，应避免与锂盐合用，若必须合用，应保证血清中锂水平可以经常测定。
    非甾体抗炎药可抑制血小板聚集和损害胃肠粘膜，可增加抗凝药物的活性，从而导致抗凝药用患者胃肠道出血的倾向。应避免本品与香豆素口服抗凝药、噻氯匹定、血栓溶解剂及肝素等合用。
2.本品与以下药物联合用药时需调整剂量或倍加注意：
    在使用本品时，即使使用低剂量甲氨喋呤，也应注意它们间可能产生药物相互作用，特别是肾功能不全的患者，如果在24小时内同时使用这两种药，更应警惕，因为甲氨喋呤血药浓度可能会增加而导致毒性增加。
    非甾体抗炎药与环孢菌素或他可利一起使用，因前者会降低肾脏前列腺素的合成，肾毒性风险增加，故联合用药时应密切监测肾功能。
    同时服用本品和阿斯匹林或其他非甾体抗炎药物会增加副作用机率，应予警惕。
    非甾体抗炎药会削弱某些利尿药如呋喃苯胺酸、丁苯胺酸等的利尿作用，也会降低噻嗪利尿药的降压作用，与保钾利尿药同时使用会升高钾水平，故应监测钾；非甾体抗炎药和ACE(血管紧张素转化酶)抑制剂同时使用，会增加失水病人急性肾功能衰竭的危险。
    本品与苄氟噻嗪(利尿降压药)联合用药末发现血压控制的影响。但也不能就此排除本品与其他抗高血压药如β-受体拮抗剂的联合使用时的相互作用。
    有报道指出，本品可能会引起低血糖，使用时应考虑调整降糖药物的剂量。
3.　本品主要通过细胞色素P4502C9代谢，因此可能与苯妥英钠、地高辛、西米替丁、甲苯磺丁脲、保泰松、胺碘酮、咪康唑和磺胺苯吡唑等发生药物相互作用的风险。
     由于本品与血浆蛋白几乎完全结合，那些与蛋白高结合率的药物可能被本品置换，故应注意，需进行监测。
[药物过量]
没有关于人超剂量使用本品的研究数据。过量使用后，可能出现的症状有恶心、呕吐、胃痛、头晕、嗜睡和头痛。此时如果需要，可洗胃，给予活性炭，必要时可使用抗酸药或其他对症治疗。
[药理毒理]
１．药理作用
　　本品为非甾体抗炎药，具有抗炎、镇痛作用。其作用机理主要是通过抑制环加氧酶活性，从而使前列腺素合成减少。
２．毒理研究
    重复给药毒性：大鼠连续经口给药1个月，剂量分别为15、50和100mg/kg/日，结果仅100mg/kg/日组出现动物死亡，并伴有大便潜血，组织病理学检查可见该组动物出现胃或肠道粘膜刺激反应。与其它非甾体抗炎药类似，试验动物对本品的耐受性较差。另外，动物与人的药代动力学差异导致其潜在毒性难以判断，但在大鼠(能将醋氯芬酸代谢为双氯芬酸)和猴(有一部分末代谢的原型药)在最大耐受剂量下给药的毒理试验结果显示，本品末见有非甾体类抗炎药常见毒性以外的其它毒性作用。
    遗传毒性：本品遗传毒性试验结果阴性。
    生殖毒性：据报道，抗炎药抑制前列腺素合成的作用可能导致严重的胚胎毒性。能抑制子宫收缩，从而导致分娩延迟。可引起子宫内胎儿动脉导管狭窄或关闭，导致新生儿肺动脉高血压和呼吸功能不全。抗炎药还能抑制胎儿血小板功能并影响其肾功能，导致羊水过少和新生儿无尿症。因此，在妊娠最后三个月禁止使用抗炎药。但有文献报道，在妊娠的中、早期本品同样会影响胎儿发肓。目前尚不清楚本品是否经人的乳汁排泄，因此，除非医生认为必要时，哺乳期妇女不应使用本品。
    致癌性：在小鼠和大鼠进行的致癌性研究中末见本品有致癌作用。
[药代动力学]
（一）Beagle犬的药代动力学
    单剂量灌胃200mg后，本缓释片的Tmax，T1/2，MRT，Cmax分别为：5.0±2.7h,6.03±1.95h,9.79±1.71h,61.36±20.75g/ml。而醋氯芬酸普通片的相应值为：2.3±0.6h,4.97±1.95h,7.41±1.90h,81.35±15.63g/ml。说明本品具有缓释效果。且两制剂的AUC24和AUC生物等效，相对生物利用度为91.42±11.17%。
    多剂量灌胃（200mg/天，5天）后，本缓释片与醋氯芬酸普通片稳态的峰浓度、坪浓度、谷浓度、波动系数均无显著差异，稳态情况下的相对生物利用度为93.4%。
（二）人体药代动力学
单剂量口服醋氯芬酸缓释片，经时血药浓度变化过程，符合一级吸收的一房室模型。主要药动学参数为：T1/2Ka(h)=1.30±0.39，T1/2Ke(h)=4.66±0.29，Tmax(h)=4.00±0.46，Cmax(μg·mL-1)=10.87±1.04，MRT(h)=7.52±0.40，AUC0～24(μg·h-1·mL-1)=73.23±10.35， AUC0～∞(μg·h-1·mL-1)=81.81±11.00。多剂量口服醋氯芬酸缓释片，连续9天达稳态血药浓度，经时血药浓度变化过程，符合一级吸收的一房室模型。第9天主要药动学参数为：T1/2Ka(h)=1.33±0.27，T1/2Ke=4.64±中0.29，Tmax(h) =3.40±0.50，Cmax(μg·mL-1)=14.41±1.34，Cmin (μg·mL-1)=0.97±0.19，MRT(h)=7.15±0.31，AUCSS(μg·h-1·mL-1)=100.60±14.81， Cav(μg·mL-1)=4.19±0.62，DF(%)=323.98±31.86。
[贮    藏] 密封，在干燥处保存。
[包    装] 铝塑包装，6片/板，1板/盒；6片/板，2板/盒；12片/板，1板/盒。
[有效期] 24个月
[执行标准] YBH00212009
[批准文号]国药准字H20090011
[生产企业]
企业名称：浙江尖峰药业有限公司
地    址：浙江省金华市婺城区白汤下线高畈段58号
电    话：0579－82661998（咨询） 0579－82131973（销售）
传    真：0579－82661998
邮    编：321075
网    址：www.zjjfyy.com.cn

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