關於metoclopramide 安全性的最新資訊 Latest safety update on metoclopramide

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            加拿大衛生部(Health Canada)於近期的藥物安全性通告中作出警告, 不管在總劑量或療程上, 過度使用metoclopramide引起遲發性運動障礙(tardive dyskinesia, T.D.)的風險會增加, 導致肌肉出現不正常的動作。遲發性運動障礙是metoclopramide已知的副作用之一, 可影響臉部﹑口部或下巴, 如出現嘴唇拍打﹑咀嚼、皺起或舌頭伸出的動作, 以及軀幹和四肢出現像抖腳一樣的動作。因此, 當使用metoclopramide時, 醫生﹑藥劑師及其他衛生專業人士應特別注意:
  1. 出現遲發性運動障礙的風險可能隨metoclopramide療程的延長和給藥總量的增加而上升;
  2. 除非經評估後效益高於風險, 否則metoclopramide的療程應避免多於12個星期;
  3. 任何人士服用metoclopramide 都可能出現遲發性運動障礙, 而老年人﹑特別是老年婦人出現的風險較高;
  4. 雖然機率較低, 然而, 服用較低劑量﹑較短療程的metoclopramide也可出現遲發性運動障礙, 但停止服用藥物後, 症狀較易隨時間部分或全部消失;
  5. 遲發性運動障礙的症狀於早期可能並不容易察覺;
  6. 當長時間使用metoclopramide (如12周), 出現的遲發性運動障礙可能不可逆

 備註:獲准在本澳市場供應含metoclopramide的藥物包括Apo-metoclop tab 10mg﹑Balon S.C tab 5mg﹑Chiaowelgen inj 10mg/2ml﹑Geneprami-d tab 10mg﹑H-peran inj 10mg/2ml﹑Linwels inj 10mg/2ml﹑Ma-10 tab 10mg﹑Metoclopramida tab 10mg 40’s(Medinfar)﹑Metoclopramide Monohydrochloride tab 5mg “Karen” ﹑Metoclopramide Tablets 10mg “Actavs” ﹑Metomide syrup 5mg/5ml﹑Metomide tab 10mg “Vickmans”﹑Metoperan injection 2ml﹑Primperan inj 10mg/2ml﹑Primperan solution for injection﹑Primperan tab 10mg “Sanofi-winthrop industrie”﹑Primperan tab 10mg 20’s “Synthelabo” (Portugal) and Promeran F.C tablets 3.84mg。

 

        Latest drug safety release from Health Canada announced stronger warnings on increased usage of metoclopramide, either in total dose or treatment duration, is associated with elevating the risk of developing ‘tardive dyskinesia’ (T.D.), an abnormal muscle movement disorder.  T.D. is one of the side effects known to occur with metoclopramide that could involve the face, mouth or jaw, inclusive of lip smacking, chewing, or puckering, or sticking out of the tongue, or if located at the torso or limbs, this will lead to leg-shaking.  Physicians, pharmacists and healthcare professionals should recognize the following strengthened warnings associating tardive dyskinesia with the use of metoclopramide because:

  1. risks of developing of T.D. apparently increases with increases of the treatment duration and total amount of metoclopramide being taken;
  2. metoclopramide treatment longer than 12 weeks should be avoided unless benefit outweighs the risk;
  3. T.D. may develop in any patients being treated with metoclopramide.  Elderly, especially elderly women, appear to be at higher risk;
  4. T.D. can also develop less frequently in patients with short term treatment at low doses.  Upon discontinuation of metoclopramide, symptoms are more likely to disappear either partially or completely over time;
  5. T.D. may not be easy to recognize in its early stages;
  6. T.D. is more likely to be irreversible when metoclopramide is used on long-term (i.e. 12 weeks) therapy.

 

Note: The brand names of metoclopramide-containing products available in Macao include Apo-metoclop tab 10mg , Balon S.C tab 5mg , Chiaowelgen inj 10mg/2ml , Geneprami-d tab 10mg , H-peran inj 10mg/2ml , Linwels inj 10mg/2ml, Ma-10 tab 10mg , Metoclopramida tab 10mg 40’s(Medinfar) , Metoclopramide Monohydrochloride tab 5mg “Karen” , Metoclopramide Tablets 10mg “Actavs” , Metomide syrup 5mg/5ml , Metomide tab 10mg “Vickmans” , Metoperan injection 2ml, Primperan inj 10mg/2ml , Primperan solution for injection , Primperan tab 10mg “Sanofi-winthrop industrie”, Primperan tab 10mg 20’s “Synthelabo” (Portugal) and Promeran F.C tablets 3.84mg.

 

 

參考資料/Reference and website:                                                         

https://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_99-eng.php


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