關於Exelon®貼片(rivastigmine經皮貼片)安全性的最新資訊 Latest safety update on Exelon® patch(rivastigmine transdermal patch)

     諾華公司(Novartis)與加拿大衛生部(Health Canada)通知衛生專業人士, 錯誤使用Exelon®貼片(rivastigmine經皮貼片)可造成rivastigmine過量的吸收, 引致嚴重的不良事故, 包括死亡。基於此, 諾華公司提醒衛生專業人士適當使用Exelon®貼片的重要性, 同時需教導病人及其照護者正確使用Exelon®貼片的技巧。而諾華公司亦對Exelon®貼片的說明書作出以下修改, 進一步強化該藥的安全性資訊:

  • 於開始治療前, 醫生﹑藥劑師及相關衛生專業人士應教導病人及其照護者使用Exelon®貼片的適當方法, 並建議他們嚴格按指示用藥。
  • 每天只應使用一塊Exelon®貼片, 建議固定用藥於背部的上/下部﹑手臂上部或胸部。
  • 貼片使用了24小時之後, 必須將舊有貼片移除, 才能將另一塊貼片貼於新處。
  • 不應將貼片剪成小塊。
  • 當發生用藥過量(症狀包括噁心﹑嘔吐﹑腹瀉﹑高血壓﹑幻覺﹑流汗﹑呼吸抑制及驚厥等)的情況, 應將所有Exelon®貼片移除下來, 並送醫就診。                                                                                                                                                                                                                                                                                    

    Novartis Pharmaceuticals Canada Inc., in consultation with Health Canada, would like to inform health professionals that serious adverse events including death, have occurred following rivastigmine overdose due to medication errors /misuse of Exelon® patch. Therefore, Novartis would like to remind health professionals of the importance of the proper use and application of Exelon® patch and the need to instruct patients and caregivers on correct application techniques for the use of Exelon® patch. The Exelon® patch Product Monograph is being revised to further emphasize the following safety information:

  • Physicians, pharmacists and other healthcare professionals should inform patients and caregivers on the proper use of Exelon® patch prior to initiating therapy, and advise them to strictly follow instructions on patch usage.
  • Only one transdermal patch should be applied per day to healthy skin on one of the recommended locations: the upper or lower back, or upper arm or chest..
  • The previous day's patch must be removed before applying a new patch to a different skin location after 24 hours of use
  • The patch should not be cut into pieces.
  • In case of overdose(symptoms including nausea, vomiting, diarrhea, hypertension, hallucinations, salivation, sweating, respiratory depression and convulsions), all Exelon® transdermal patches should be immediately removed and the patient should be evaluated by a physician.

 

參考資料/Reference and website:

https://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/exelon_hpc-cps-eng.php

https://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/medeff/advisories-avis/prof/2010/exelon_hpc-cps-eng.pdf


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