FLECTOR®PATCH（双氯芬酸 diclofenac epolamine）外用贴剂 1.3％，局部使用
批准日期：2016年5月  公司：辉瑞公司和IBSA
最初美国批准：1988年
警告：
完整黑框警告严重心血管和胃肠道EVENTSSee完整的处方信息的危险。
非甾体抗炎药（NSAIDs）事业严重心血管血栓事件，心肌梗塞和中风，包括可能会致命的风险增加。这种风险可能发生在治疗早期，可与使用时间增加
FLECTOR PATCH在冠状动脉旁路移植的设定禁忌术（CABG）
NSAIDs的原因严重的胃肠道（GI）不良事件包括出血，溃疡，和胃或肠，这可能是致命的穿孔风险增加。这些事件可以在使用过程中，无预警症状发生在任何时间。老年患者和患有消化性溃疡和/或胃肠道出血的病史是在严重胃肠道事件的风险更大。
目前的主要变化
黑框警告 5/2016
警告和注意事项，心血管血栓事件 5/2016
警告和注意事项，心力衰竭和水肿 5/2016
作用机理
双氯灭痛具有止痛，抗炎和退热性能。
双氯芬酸的作用机制，像其它NSAID的，不完全的理解呼叫，但涉及环加氧酶（COX-1和COX-2）的抑制。
双氯灭痛是体外的前列腺素合成的有效抑制剂。治疗过程中达到了双氯芬酸的浓度已在体内作用产生的。前列腺素敏感传入神经和使可能缓激肽的作用，在动物模型中诱导的疼痛。前列腺素是炎症介质。因为二氯苯胺苯乙酸是前列腺素合成抑制剂，其作用方式可能是由于外周组织中前列腺素的降低。
适应症和用法
FLECTOR贴包含双氯芬酸epolamine，非类固醇抗炎药（NSAID），并且被指示为急性疼痛的局部治疗由于轻微的菌株，扭伤，挫伤和。
用法用量
对于使用时间最短的最低有效剂量与由个别患者的治疗目标
FLECTOR贴剂的推荐剂量为一张最痛苦的地区，一天两次。
FLECTOR PATCH不应适用于破损或不完整的皮肤。
剂型和规格
FLECTOR®PATCH（双氯芬酸epolamine补丁）1.3％，局部使用的每个单独的贴浮雕。
禁忌症
已知过敏双氯芬酸或药物产品的任何组件.
哮喘，荨麻疹​​，或其它过敏型反应的历史服用阿司匹林或其他NSAID后
在CABG手术的设置.
对于在非完整或受损的皮肤使用.
警告和注意事项
肝毒性：通知的警告标志和肝中毒症状的患者。如果停止不正常的肝功能持续或恶化，或者肝脏疾病的临床症状和体征开发.
高血压：患者服用某些降压药可能已经受损的响应疗法论文在拍摄的NSAIDs。监测血压.
心脏衰竭和水肿：避免患者严重心脏衰竭使用FLECTOR补丁，除非收益预计将超过加重心脏衰竭的危险.
肾毒性：在患者的肾或肝功能损害，心脏衰竭，脱水，或血容量监测肾功能。避免在晚期肾脏疾病使用FLECTOR补丁，除非收益预计将超过肾功能恶化•过敏反应的风险：如果发生过敏性反应的寻求紧急帮助.
哮喘相关的阿司匹林灵敏度恶化：FLECTOR补丁患者阿司匹林过敏性哮喘禁忌。监控与先前存在的哮喘患者（无阿司匹林灵敏度）.
严重皮肤反应：以皮疹或过敏的其他标志的首次亮相中止FLECTOR PATCH.
胎儿动脉导管过早关闭：避免在孕妇中使用开始于妊娠30周.
血液学毒性：监测患者的血红蛋白或红细胞压积任何迹象或贫血症状.
不良反应
最常见的不良反应是应用现场情况，分别发生的11％和12％，FLECTOR PATCH和安慰剂补丁治疗的患者
药物相互作用
药物就与止血（E. G.华法林，阿司匹林，SSRIs类药物/ SNRIs的）干扰：监测患者的出血谁是伴随使用FLECTOR PATCH用药物并用止血干扰。建议不要同时使用FLECTOR PATCH镇痛剂量阿司匹林的基因集会。
血管紧张素转换酶抑制剂，血管紧张素受体拮抗剂（ARB类药物），或β受体阻滞剂：与FLECTOR PATCH伴随使用可能会降低合成药物的降压作用。监测血压.
ACEI和ARB：在老年人，体积FLECTOR PATCH耗尽，或有肾功能损害伴随使用可能会导致肾功能恶化。在寻求高风险患者，监测肾功能恶化的迹象。
利尿剂：NSAIDs的可降低速尿和噻嗪类利尿剂排钠利尿作用。监测患者，以确保疗效利尿降压包括效果
地高辛：与FLECTOR PATCH伴随使用可能会增加血药浓度，延长地高辛的半衰期。监测血清地高辛水平
在使用特定人群
妊娠：
妊娠孕晚期NSAIDs的使用增加了胎儿动脉导管过早关闭的风险。避免孕妇使用NSAID开始于妊娠30周.
不孕：NSAIDs的与可逆不育无关。考虑谁有受孕困难的女性FLECTOR补丁撤离。
包装规格/储存与处理
该FLECTOR补丁提供。在可重复密封的信封，每个包含5补丁（10厘米×14厘米），每箱6信封（NDC60793-411-30）。每个单独的补丁刻有“FLECTOR PATCH<DICLOFENAC EPOLAMINE局部贴剂>1.3％”。
每个补丁含到wässrige基地（每克粘合剂或1.3％的13毫克的活性）180毫克双氯芬酸epolamine的。
该产品仅供外用。
请将本品放在儿童和宠物够不到的地方。
信封shoulderstand在任何时候都在不使用时密封。
Curad®保持泰特™是MEDLINE工业公司和Surgilast®筒状弹性敷料的商标是超凡科学公司的商标。
存储
商店在20°C至25°C（68°C至77°F）; 15℃之间允许到30°C（59°F至86°F）游览[见USP控制室温。

Flector® Patch(diclofenac epolamine topical patch) 1.3%
Important Safety Information
•FLECTOR Patch, like other NSAIDs, may increase the chance of a heart attack or stroke that can lead to death. This chance increases with longer use of NSAID medicines, and in people who have heart disease or risk factors such as high blood pressure
•NSAID medicines, including FLECTOR Patch, should never be used right before or after a heart surgery called "coronary artery bypass graft" (CABG)
•FLECTOR Patch, like other NSAID medicines, can cause ulcers and bleeding in the stomach and intestines at any time during treatment. These can happen without symptoms and may cause death. The chance of a person getting an ulcer or bleeding increases with: taking blood-thinning medicines or medicines called steroids; longer use; smoking; drinking alcohol; older age; having poor health
Do not use FLECTOR Patch if you've had aspirin-sensitive asthma or allergic reactions from taking aspirin or other NSAIDs.
FLECTOR Patch should not be applied to broken or damaged skin due to any cause, such as cuts, burns, infected wounds, or rash with oozing fluid.
Before using FLECTOR Patch, tell your healthcare professional about the following:
•Any and all other health or medical problems you may have, such as heart disease including high blood pressure or heart failure, history of ulcers or bleeding in the stomach or intestines, kidney or liver problems, asthma or allergic-type reactions, and skin reactions
•All other medications (prescription and nonprescription) you are taking. Do not take oral NSAIDs while on FLECTOR Patch. Do not take other medicines without your healthcare professional's approval
•If you are breastfeeding
FLECTOR Patch should not be used late in pregnancy.
Serious side effects include life-threatening skin and allergic reactions. Get emergency help right away if you have any of the following symptoms: shortness of breath or trouble breathing, chest pain, weakness in one part or side of your body, slurred speech, or swelling of the face or throat.
Stop using FLECTOR Patch and call your healthcare professional right away if you have any of the following symptoms: nausea, more tired or weaker than usual, itching, your skin or eyes look yellow, stomach pain, flu-like symptoms, vomiting blood, bowel movement contains blood or is black and sticky like tar, unusual weight gain, skin rash or blisters with fever, or swelling of the arms, legs, hands, or feet.
FLECTOR Patch should be used exactly as prescribed at the lowest dose possible and for the shortest time needed.
The most common side effects seen with FLECTOR Patch were skin reactions (including itching, inflamed skin, burning) at the site of treatment, stomach discomfort or intestinal problems (including nausea, altered taste, upset stomach), and nervous disorders (including headache, tingling of the skin, sleepiness).
Avoid contact of FLECTOR Patch with eyes, nose, or mouth, and wash hands after applying, handling, or removing FLECTOR Patch. FLECTOR Patch still contains medicine even after use. Keep FLECTOR Patch out of the reach of children and pets. If a child or pet puts FLECTOR Patch in their mouth, seek medical help immediately. Children should not use FLECTOR Patch.
Other information about NSAIDs: aspirin can cause bleeding in the brain, stomach, and intestines and ulcers in the stomach and intestines.
Indication
FLECTOR Patch contains diclofenac epolamine, a nonsteroidal anti-inflammatory drug (NSAID) and is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.
Please see Full Prescribing Information and Patient Medication Guide, including boxed warning.
FLECTOR is a registered trademark of IBSA Institut Biochimique SA, licensed by Alpharma Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
All other trademarks are the property of their respective owners
1）https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=16133
2）https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f103f7e8-1253-43cb-9667-cd0d8f4d5500