meprobamate安全性再評估未獲通過理由!!!

公告含meprobamate成分藥品安全性再評估未獲通過相關事宜。 【發布日期：2014-02-10】 ：藥品組 主旨:公告含meprobamate成分藥品安全性再評估未獲通過相關事宜。依據: 藥事法第48條。公告事項:一、含meprobamate成分藥品製劑，經本部食品藥物管理署彙集國內、外相關資料及臨床相關文獻報告，審慎評估其臨床效益及風險，評估未獲通過，理由如下：(一)依據文獻資料，該成分藥品治療劑量範圍較狹窄，且有發生嚴重甚至致命性的神經性不良反應之風險(包括昏迷)。(二)我國已核准其他較安全之替代藥品供治療選擇，病人無須承擔嚴重不良反應及可能致命之之風險，且近年臨床上已無使用該藥品。二、自公告日起，廢止含meprobamate成分製劑藥品許可證清單如下:(一)人生製藥股份有限公司之衛署藥製字第001862號「"人生" 可利靜錠」。(二)榮民製藥股份有限公司之衛署藥製字第003390號「"榮民" 美普魯巴寐錠」。(三)華盛頓製藥廠股份有限公司之衛署藥製字第036595號「"華盛頓" 息痛錠」。(四)信東生技股份有限公司之內衛藥製字第002154號「安達樂神片」及內衛藥製字第006625號之「安達樂神片」。(五)中國化學製藥股份有限公司新豐工廠之內衛藥製字第003050號「安其心片」。(六)中央藥品股份有限公司之內衛藥製字第014941號「神舒寧片」。三、藥商、藥局及醫療機構，自公告日起，應立即停止輸入、製造、批發、陳列、調劑、零售；其製造或輸入之業者，應檢送回收作業計畫書至本部食品藥物管理署備查，於1個月內收回市售品，並交付回收報告書至本部食品藥物管理署及所轄地方衛生主管機關。四、對本處分不服者，得於本處分書送達之次日起30日內，依訴願法之相關規定向行政院提起訴願。

Symptoms of meprobamate overdose include: drowsiness, sluggishness, unresponsiveness, or coma; loss of muscle control; severe impairment or cessation of breathing; or shock. Death has been reported with ingestion of as little as 12g of meprobamate and survival with as much as 40g. In an overdose, meprobamate tablets may form a gastric bezoar, requiring physical removal of the undissolved mass of tablets through an endoscope; therefore, administration of activated charcoal should be considered even after 4 or more hours or if levels are rising. Preparations which contain paracetamol may also induce severe liver toxicity resulting from paracetamol poisoning. The exact form of the preparation used should be identified immediately if possible, as patients who have also overdosed on paracetamol can reduce/avoid permanent liver damage with the administration of acetylcysteine.