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| column | value |
|---|---|
| 類別 | 藥政管理類,藥事法 |
| 法規性質 | 行政解釋 |
| 法規名稱 | 含diclofenac成分藥品之仿單修訂事宜增修全身性Diclofenac成分藥品 |
| 條文內容 | <p><b><span style="font-family: 標楷體; font-size: 13pt;">修訂Diclofenac成分藥品（口服、注射及栓劑劑型）之仿單內容－包括禁忌、警語、注意事項、副作用、藥物交互作用、特殊族群及過量</span></b><span style="font-family: 標楷體; font-size: 13pt;">(</span><span style="font-family: 標楷體; font-size: 13pt;">劃線為新增部分)</span></p><p><span style="font-family: 標楷體;">【禁忌】 </span></p><p><span style="font-family: 標楷體;">1.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">對Diclofenac過敏之患者。 </span></p><p><span style="font-family: 標楷體;">2.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">消化性潰瘍患者。 </span></p><p><span style="font-family: 標楷體;">3.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">重症之血液異常患者。 </span></p><p><span style="font-family: 標楷體;">4.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">重症之肝障害患者。 </span></p><p><span style="font-family: 標楷體;">5.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">重症之腎障害患者。 </span></p><p><span style="font-family: 標楷體;">6.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; text-decoration: underline;">服用aspirin或其他非類固醇類消炎藥之後曾發生氣喘、蕁麻疹或其他過敏反應者。此類病人曾有嚴重(極少數為致死性)類過敏反應(anaphylactic-like reaction)發生之報告。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體;">7.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; text-decoration: underline;">於冠狀動脈繞道(CABG)手術期間投予作為止痛之用。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體;">8.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; text-decoration: underline;">懷孕第三期婦女禁用本藥。 </span></p><p><span style="font-family: 標楷體;">【注意事項】 </span></p><p><span style="font-family: 標楷體;">1.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">使用消炎鎮痛劑治療，乃為對症療法非原因療法。 </span></p><p><span style="font-family: 標楷體;">2.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">使用於治療慢性疾患（慢性風濕性關節炎、僵直性脊髓炎）時應考慮以下事項： </span></p><p><span style="font-family: 標楷體;">（1）長期投與時，須定期作臨床檢查（尿檢查、血液檢查、肝功能檢查）遇有異常現象發生時，則須採取減量或停藥等適當措施。 </span></p><p><span style="font-family: 標楷體;">（2）考慮非藥物性療法。 </span></p><p><span style="font-family: 標楷體;">3. </span><span style="font-family: 標楷體;">使用於治療急性疾患時，應考慮以下事項： </span></p><p><span style="font-family: 標楷體;">（1）對於急性炎症須考慮其病痛及發熱程度而給藥。 </span></p><p><span style="font-family: 標楷體;">（2）原則上應避免長期使用同一類藥品。 </span></p><p><span style="font-family: 標楷體;">（3）如有原因療法則應採用。 </span></p><p><span style="font-family: 標楷體;">4. </span><span style="font-family: 標楷體;">須仔細觀察患者之狀況，留意有否副作用發生。 </span></p><p><span style="font-family: 標楷體;">5. </span><span style="font-family: 標楷體;">本藥可能遮蔽感染症狀之顯現，因此用於治療感染所引起之炎症時，必須合併使用適當之抗菌劑，同時仔細觀察，慎重投與。 </span></p><p><span style="font-family: 標楷體;">6. </span><span style="font-family: 標楷體;">儘量避免與其它消炎、鎮痛劑合併使用。 </span></p><p><span style="font-family: 標楷體;">7. </span><span style="font-family: 標楷體;">對小兒及高齡患者，尤其注意有否副作用出現，並以最低之有效劑量來慎重投予。 </span></p><p><span style="font-family: 標楷體;">8. </span><span style="font-family: 標楷體;">diclofenac</span><span style="font-family: 標楷體;">可能導致胎兒動脈導管過早閉合，因此於懷孕後期應避免使用。 </span></p><p><span style="font-family: 標楷體;">9. </span><span style="font-family: 標楷體;">對以下患者須慎重投與： </span></p><p><span style="font-family: 標楷體;">（1）患有肝障礙或曾有該病史之患者。 </span></p><p class="Default"><span style="font-family: 標楷體; color: windowtext;">（2）曾有過敏性病史之患者。</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">從未接觸過diclofenac的病人亦有可能發生類過敏反應(Anaphylactoid Reactions)。具有aspirin三症狀(aspirin triad)的病人不可投予diclofenac治療。這種複合症狀主要發生在患有鼻炎(無論具有鼻息肉與否)的氣喘病人，或是使用aspirin或其他非類固醇類消炎藥之後會發生嚴重而可能致死之支氣管痙攣的病人。一旦類過敏反應發生，應立即就醫診治。 </span></p><p><span style="font-family: 標楷體;">（3）支氣管氣喘之患者。</span><span style="font-family: 標楷體; text-decoration: underline;">氣喘病人可能具有aspirin敏感性氣喘。此類病人投予aspirin曾出現嚴重而可能致死的支氣管痙攣。由於aspirin與其他非類固醇消炎藥在此類病人中曾有交叉反應性的報告，因此此類aspirin過敏病人不可使用diclofenac，而對於原患有氣喘之病人也應謹慎投予。 </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">10. </span><span style="font-family: 標楷體; text-decoration: underline;">皮質類固醇藥物治療：diclofenac不能取代皮質類固醇或治療皮質類固醇不足。貿然停用皮質類固醇可能造成皮質類固醇反應性疾病的惡化。長期接受皮質類固醇治療的病人，若決定停藥，應緩慢減低劑量。 </span></p><p><span style="font-family: 標楷體;">11.</span><span style="font-family: 標楷體; text-decoration: underline;"> diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">抗發炎及退燒的藥理作用會降低利用這些診斷徵象來偵測感 染性併發症發生於一些本來推論為非感染性疼痛情形的機會。 </span></p><p><span style="font-family: 標楷體;">12.</span><span style="font-family: 標楷體; text-decoration: underline;">實驗室檢驗：由於嚴重的胃腸道潰瘍及出血可能沒有預警症狀，醫師應監測是否有胃腸出血的徵象或症狀。長期使用非類固醇類消炎藥的病人，應定期做全血球計數(CBC)及生化檢查。若肝功能或腎功能檢驗異常的情形維持或惡化，應立即停藥。 </span></p><p><span style="font-family: 標楷體;">【警語】 </span></p><p><b><span style="font-family: arial, sans-serif; text-decoration: underline;">1. </span></b><b><span style="font-family: 標楷體; text-decoration: underline;">心血管作用</span></b><b><span style="text-decoration: underline;"> </span></b></p><p><i><span style="font-family: 標楷體; text-decoration: underline;">栓塞性心血管事件</span></i><i><span style="font-family: arial, sans-serif; text-decoration: underline;"> (Cardiovascular Thrombotic Events)</span></i></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">使用非類固醇類消炎藥治療可能使發生嚴重而可能致死之栓塞性心血管事件、心肌梗塞與中風的危險性增加。對於患有心血管疾病或具有心血管疾病危險因子的病人應使用最低有效劑量，並作為期最短的治療。病人應被告知嚴重心血管毒性的徵象與症狀，及萬一發生時所應採取的步驟。</span><span style="text-decoration: underline;"> </span></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">沒有一致的證據證明同時使用</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">aspirin</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">能夠減少使用非類固醇類消炎藥時的嚴重栓塞性心血管事件風險。而同時使用</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">aspirin</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">與</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">確實會增加嚴重胃腸道事件的危險性。</span><span style="text-decoration: underline;"> </span></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">兩個大型對照性臨床試驗中，發現選擇性</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">COX-2</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">之非類固醇類消炎藥在</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">CABG</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">手術後</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">10-14</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">天用於止痛，會增加其心肌梗塞和中風之發生率。</span><span style="text-decoration: underline;"> </span></p><p><i><span style="font-family: 標楷體; text-decoration: underline;">高血壓</span></i><i><span style="text-decoration: underline;"> </span></i></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">投予非類固醇類消炎藥</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">包括</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">在內</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">治療可能導致新的高血壓發病或使原有的高血壓惡化。使用</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">thiazides</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">利尿劑或環利尿劑的病人，在服用非類固醇類消炎藥期間對這些利尿劑的反應可能會減弱。對於高血壓之病人應謹慎投予</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">，治療期間應密切監測血壓。</span><span style="text-decoration: underline;"> </span></p><p><i><span style="font-family: 標楷體; text-decoration: underline;">充血性心衰竭與水腫</span></i><i><span style="text-decoration: underline;"> </span></i></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">有些病人接受非類固醇類消炎藥</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">包括</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">在內</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">治療後曾發生體液滯留及水腫的現象。對於體液滯留或心衰竭之病人應謹慎投予。</span><span style="text-decoration: underline;"> </span><span style="text-decoration: underline;"></span></p><p><b><span style="font-family: arial, sans-serif; text-decoration: underline;">2. </span></b><b><span style="font-family: 標楷體; text-decoration: underline;">胃腸道作用－胃腸潰瘍、出血及穿孔之危險性</span></b><b><span style="text-decoration: underline;"> </span></b></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">非類固醇類消炎藥</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">包括</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">在內</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">可能引起胃、小腸或大腸發炎、出血、潰瘍及穿孔等嚴重而可能致死之腸胃道不良反應。接受非類固醇類消炎藥治療的病人隨時可能出現這些嚴重的不良事件，且不一定有預警症狀。對於有消化性潰瘍疾病或胃腸道出血病史之病人應謹慎投予。其他會增加使用非類固醇類消炎藥治療時發生胃腸道出血的危險因子包括同時使用口服皮質類固醇或抗凝血劑、長期使用非類固醇類消炎藥、吸煙、喝酒、年長及整體健康狀況不佳等。為了降低胃腸道不良反應的潛在危險，病人應使用最低有效劑量，並作為期最短的治療。</span><span style="text-decoration: underline;"> </span></p><p class="Default"><b><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">3. </span></b><b><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">肝臟作用</span></b><b><span style="text-decoration: underline;"> </span></b></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">投予</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">治療期間可能發生一種或多種肝功能指數升高的現象。持續治療時，這些檢驗值異常可能會惡化、保持不變或僅為短暫的現象。</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">依據上市後藥物安全監測報告，</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">引起之肝毒性不良反應包括肝臟壞死、黃疸、猛暴性肝炎（無論具有黃疸與否）及肝衰竭。其中一些通報案例導致死亡或肝臟移植。長期使用</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">治療的病人應定期檢測肝臟轉氨酶（</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">transaminases</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">），依據臨床試驗數據和上市後經驗，應於治療後的第</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">4</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">到第</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">8</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">週内進行檢測。然而，嚴重肝毒性不良反應可能發生在以</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">治療的任何時間。</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;"> </span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">若肝功能指數異常的情形維持或惡化，或出現與肝病一致的臨床徵象與症狀，或出現全身性反應</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">如嗜伊性白血球增多、皮疹、腹痛、腹瀉、褐色尿液等</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">時應立即停藥。為了降低肝臟不良反應的潛在危險，病人應使用最低有效劑量，並作為期最短的治療。同時投予具有潛在肝毒性的藥物</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">例如抗生素、抗癲癇藥</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">治療時須特別注意。</span><span style="text-decoration: underline;"> </span></p><p class="Default"><b><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">4. </span></b><b><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">腎臟作用</span></b><b><span style="text-decoration: underline;"> </span></b></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">長期投予非類固醇類消炎藥可能導致腎乳頭壞死及其他腎臟損傷。對於發生這類反應的高危險族群</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">年長者、腎功能受損、心衰竭、肝功能不全及使用利尿劑與</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">ACE</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">抑制劑的病人</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">應謹慎投予。</span><span style="text-decoration: underline;"> </span></p><p><i><span style="font-family: 標楷體; text-decoration: underline;">重症腎臟疾病</span></i><i><span style="text-decoration: underline;"> </span></i></p><p><span style="font-family: 標楷體; text-decoration: underline;">目前之對照性臨床試驗中尚未有關於重症腎臟疾病病人使用</span><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenec</span><span style="font-family: 標楷體; text-decoration: underline;">的資料，因此不建議此類病人使用。若必須開始</span><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">治療，建議應該密切監測病人的腎功能。</span><span style="text-decoration: underline;"> </span></p><p><b><span style="font-family: arial, sans-serif; text-decoration: underline;">5. </span></b><b><span style="font-family: 標楷體; text-decoration: underline;">皮膚反應</span></b><b><span style="text-decoration: underline;"> </span></b></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">非類固醇類消炎藥</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">包括</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">在內</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">可能引發嚴重而可能致死的皮膚不良反應，例如剝落性皮膚炎、</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">史蒂文生氏</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">-</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">強生症候群</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(SJS)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">和毒性表皮壞死溶解</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(TENS)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">。一旦出現皮疹或其他過敏徵象時應立即停藥。</span><span style="text-decoration: underline;"> </span></p><p><b><span style="font-family: arial, sans-serif; text-decoration: underline;">6. </span></b><b><span style="font-family: 標楷體; text-decoration: underline;">血液作用</span></b><b><span style="text-decoration: underline;"> </span></b></p><p><span style="font-family: 標楷體; text-decoration: underline;">接受非類固醇類消炎藥治療的病人有時會發生貧血。長期使用</span><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">治療的病人若出現任何貧血或失血的徵象或症狀，應進行血紅素及血比容之檢測。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">非類固醇類消炎藥會抑制血小板凝集，某些病人可能出現出血時間延長的情形。患有凝血疾病或正在使用抗凝血劑的病人應密切監測血小板功能。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體;">【不良反應】</span> </p><p><span style="font-family: 標楷體; text-decoration: underline;">使用</span><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">治療之病人較為常見的不良反應為</span><span style="font-family: 標楷體; text-decoration: underline;">胃腸道的影響，包括腹痛、便祕、腹瀉、消化不良、脹氣、大出血</span><span style="font-family: arial, sans-serif; text-decoration: underline;">/</span><span style="font-family: 標楷體; text-decoration: underline;">穿孔、心灼熱感、噁心、胃腸道潰瘍</span><span style="font-family: arial, sans-serif; text-decoration: underline;">(</span><span style="font-family: 標楷體; text-decoration: underline;">胃</span><span style="font-family: arial, sans-serif; text-decoration: underline;">/</span><span style="font-family: 標楷體; text-decoration: underline;">十二指腸</span><span style="font-family: arial, sans-serif; text-decoration: underline;">)</span><span style="font-family: 標楷體; text-decoration: underline;">與嘔吐。其他反應包括腎功能異常、貧血、頭暈、水腫、肝酵素升高、頭痛、延長出血時間、搔癢、紅疹及耳鳴。</span><span style="text-decoration: underline;"> </span></p><p><i><span style="font-family: 標楷體; text-decoration: underline;">曾在治療期間被報告過的不良反應包括：</span></i><i><span style="text-decoration: underline;"> </span></i></p><p><span style="font-family: 標楷體; text-decoration: underline;">全身：發燒、感染、敗血症。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">心血管系統：充血性心衰竭、高血壓、心搏過速、暈厥。</span><span style="font-family: arial, sans-serif; text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">消化系統：口乾、食道炎、胃</span><span style="font-family: arial, sans-serif; text-decoration: underline;">/</span><span style="font-family: 標楷體; text-decoration: underline;">腸潰瘍、胃炎、胃腸出血、舌頭發炎、吐血、肝炎、黃疸。</span><span style="font-family: arial, sans-serif; text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">血液及淋巴系統：瘀血、嗜伊性白血球增多、白血球過低、黑便、紫斑、直腸出血、口腔炎、血小板過低。</span><span style="font-family: arial, sans-serif; text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">代謝及營養：體重改變。</span><span style="font-family: arial, sans-serif; text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">神經系統：焦慮、衰弱、精神錯亂、憂鬱、作夢異常、</span><span style="font-family: 標楷體; text-decoration: underline;">睏倦、</span><span style="font-family: 標楷體; text-decoration: underline;">失眠、疲倦、緊張、感覺異常、嗜睡、顫抖、眩暈。</span><span style="font-family: arial, sans-serif; text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">呼吸系統：氣喘、呼吸困難。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">皮膚及附屬組織：禿髮、光敏感、排汗增加。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">特殊感官：視力模糊。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">泌尿系統：</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">膀胱炎、排尿困難、血尿、間質性腎炎、少尿</span><span class="longtext1" style="font-family: arial, sans-serif; text-decoration: underline;">/</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">多尿、蛋白尿、腎衰竭。</span><span style="text-decoration: underline;"> </span></p><p><i><span style="font-family: 標楷體; text-decoration: underline;">其他少見之不良反應包括：</span></i><i><span style="text-decoration: underline;"> </span></i></p><p><span style="font-family: 標楷體; text-decoration: underline;">全身：過敏反應、食欲改變、死亡。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">心血管系統：心律不整、低血壓、心肌梗塞、心悸、血管炎。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">消化系統：</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">結腸炎、噯氣、肝衰竭、胰臟炎。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">血液及淋巴系統：顆</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">粒性白血球缺乏、溶血性貧血、再生不良性貧血、淋巴結病變、全血球減少。</span><span class="longtext1" style="text-decoration: underline;"> </span><span style="text-decoration: underline;"></span></p><p><span style="font-family: 標楷體; text-decoration: underline;">代謝及營養：高血糖。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">神經系統：</span><span style="font-family: 標楷體; text-decoration: underline;">痙攣<span class="longtext1">、昏迷、幻覺、腦膜炎。</span></span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">呼吸系統：</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">呼吸抑制、肺炎。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">皮膚及附屬組織：</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">血管性水腫、毒性表皮壞死溶解、多形性紅斑，</span><span class="longtext1" style="text-decoration: underline;"> </span><span style="font-family: arial, sans-serif; text-decoration: underline;"><br /></span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">剝落性皮膚炎、</span><span style="font-family: 標楷體; text-decoration: underline;">史蒂文生氏</span><span style="font-family: arial, sans-serif; text-decoration: underline;">-</span><span style="font-family: 標楷體; text-decoration: underline;">強生症候群、</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">蕁麻疹。</span><span class="longtext1" style="text-decoration: underline;"> </span><span style="text-decoration: underline;"></span></p><p><span style="font-family: 標楷體; text-decoration: underline;">特殊感官：</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">結膜炎、聽覺受損。 </span></p><p><span style="font-family: 標楷體;">【藥物交互作用】 </span></p><p><b><span style="font-family: 標楷體;">1.<span style="text-decoration: underline;"> Aspirin</span></span></b><b><span style="font-family: 標楷體; text-decoration: underline;">：</span></b><span style="font-family: 標楷體; text-decoration: underline;">由於可能增加不良反應(包括腸胃道出血)發生的風險，一般而言不 </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">建議同時使用aspirin與diclofenac進行治療。 </span></p><p><span style="font-family: 標楷體;">2.</span><span style="font-family: 標楷體;">抗凝血劑：<span style="text-decoration: underline;">抗凝血劑(如warfarin)與非類固醇類消炎藥對胃腸道出血的影響 </span></span></p><p><span style="font-family: 標楷體; text-decoration: underline;">是加成性的，合併使用這兩類藥品的病人發生嚴重胃腸道出血之風險較單獨使用任一類藥品者為高。 </span></p><p><b><span style="font-family: 標楷體; text-decoration: underline;">3.ACE</span></b><b><span style="font-family: 標楷體; text-decoration: underline;">抑制劑：</span></b><span style="font-family: 標楷體; text-decoration: underline;">非類固醇類消炎藥會減弱血管張力素轉換酶(angiotensin c onverting enzyme (ACE))抑制劑的降血壓作用。同時投予非類固醇類消炎藥與ACE抑制劑時應考慮二者間可能發生之交互作用。 </span></p><p><span style="font-family: 標楷體;">4.</span><span style="font-family: 標楷體;">利尿劑：臨床研究指出，有些病人在同時接受非類固醇類消炎藥治療時，會使得furosemide及thiazides的利鈉尿作用減弱。<span style="text-decoration: underline;">合併使用期間應密切觀察是否有腎衰竭之徵象，</span>並確保利尿劑之效用。 </span></p><p><span style="font-family: 標楷體;">5.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">鋰鹽：<span style="text-decoration: underline;">非類固醇類消炎藥可能提高鋰鹽的血漿中濃度及降低其腎排除。合併使用期間應密切觀察是否有鋰鹽中毒之徵象。<b> </b></span></span></p><p><span style="font-family: 標楷體;">6.<span style="font: 7pt times new roman;"> </span></span><b><span style="font-family: 標楷體; text-decoration: underline;">Methotrexate</span></b><b><span style="font-family: 標楷體; text-decoration: underline;">：</span></b><span style="font-family: 標楷體; text-decoration: underline;">非類固醇類消炎藥可能使methotrexate毒性增加，合併使用期間須特別注意。<b> </b></span></p><p><span style="font-family: 標楷體;">7.<span style="font: 7pt times new roman;"> </span></span><b><span style="font-family: 標楷體; text-decoration: underline;">Cyclosporine</span></b><b><span style="font-family: 標楷體; text-decoration: underline;">：</span></b><span style="font-family: 標楷體; text-decoration: underline;">合併使用diclofenac治療時可能會增加cyclosporine之腎毒性，同時投予時須特別注意。 </span></p><p><b></b></p><p><b><span style="font-family: 標楷體;">【特殊族群】 </span></b></p><ol> <li><span style="font-family: 標楷體;">孕婦及授乳婦人之投與：對孕婦及授乳婦人之安全性尚未建立。對於孕婦及可能懷孕之婦女或授乳之婦人，須判斷其治療效益超過危險性時，方予投與。 </span></li> <li><span style="font-family: 標楷體;">懷孕最後3個月的婦女使用本品須特別注意（因可能造成子宮收縮無 </span></li></ol><p><span style="font-family: 標楷體;">力及/或胎兒動脈閉鎖過早）。 </span></p><p><span style="font-family: 標楷體;">3. FDA Pregnancy Category</span><span style="font-family: 標楷體;">（懷孕用藥級數）：C</span> </p><p><b><span style="font-family: arial, sans-serif;">4. </span></b><span style="font-family: 標楷體; text-decoration: underline;">兒童使用</span><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">的安全性及有效性尚未建立。</span><span style="text-decoration: underline;"> </span></p><p><b><span style="font-family: arial, sans-serif; text-decoration: underline;">5. </span></b><span style="font-family: 標楷體; text-decoration: underline;">臨床研究中老年與年輕受試者之有效性或安全性並無整體差異，然而不能排除某些老年人會對非類固醇類消炎藥的作用更加敏感。由於老年人的腎功能可能較差，在使用</span><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">時須特別注意監測腎功能。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體;">【過量】</span> </p><p><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">過量之症狀通常侷限於嗜睡、疲倦、噁心、嘔吐及上腹痛，一般予以支持性照護後可恢復。</span><span style="font-family: 標楷體;">另可能發生胃腸道出血、高血壓、急性腎衰竭、呼吸抑制和昏迷。<span style="text-decoration: underline;">服藥過量時亦可能發生類過敏反應。</span></span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體;">若有</span><span style="font-family: arial, sans-serif;">diclofenac</span><span style="font-family: 標楷體;">過量並導致顯著全身性副作用時，建議採取催吐或洗胃。<span style="text-decoration: underline;">強迫利尿措施理論上有助益，而透析或血液灌洗的效用則尚未證實。</span>除支持性措施外，口服活性碳可能幫助減低</span><span style="font-family: arial, sans-serif;">diclofenac</span><span style="font-family: 標楷體;">的吸收。對於併發症如腎衰竭、痙攣、胃腸道刺激及呼吸抑制等，應給予支持療法與症狀處理。</span> </p> |
| 發佈日期 | 2013-12-16 |
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