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

       Lamotrigine為治療二歲以上兒童的驚厥(seizures)和成年人的雙極(燥狂-抑鬱)症(bipolar disorder)的藥物, 美國食物及藥物管理局(USFDA)回顧該藥的不良反應報告後, 發現自該藥於1994年上市, 至2009年11月期間, 共有40宗兒童和成年病人使用lamotrigine後出現無菌性腦膜炎(aseptic meningitis)的個案, 症狀包括頭痛﹑發熱﹑頸部僵硬﹑噁心﹑嘔吐﹑皮疹以及對光過敏。

       基於腦膜炎的嚴重性以及必須儘快診斷其病因和進行治療, 對於正在服用lamotrigine的病人, 醫生﹑藥劑師及其他衛生專業人士應注意該藥可引起無菌性腦膜炎, 教導病人腦膜炎的相關症狀, 如病人出現上述症狀, 應仔佃評估其他可能引致病人出現腦膜炎的原因以及對症治療。如沒有其他引致腦膜炎的明確原因, 應考慮停止使用lamotrigine。

備註:獲准在本澳市場供應lamotrigine的藥物包括APO-lamotrigine Tab 100mg﹑Lamictal Dispersible Tab 5mg/25mg﹑Lamictal Tab 50mg/100mg﹑Latrigine Tab 100mg “Kingdom”﹑PMS-Lamotrigine Tab 25mg/100mg以及U-CHU Lamogin Tab 100mg。

                                                                                                                                                                                                                                                             

       Lamotrigine is a medication commonly used for seizures in children two years and older, and bipolar disorder in adults. Based on United Stated Food and Drug Administration(USFDA)'s review of adverse event reports submitted to the agency from December 1994 (when the drug was approved) through November 2009, a total of 40 cases of aseptic meningitis occurring in pediatric and adult patients taking lamotrigine were identified. Symptoms of meningitis may include headache, fever, stiff neck, nausea, vomiting, rash, and sensitivity to light.

       In light of the severity of meningitis, it is important to rapidly diagnose the underlying cause so that treatment can be promptly initiated. For those patients taking lamotrigine, physicians, Pharmacists and other healthcare professionals should be aware that lamotrigine can cause aseptic meningitis and educate their patients signs and symptoms of meningitis. If meningitis is suspected, patients should also be evaluated for other causes of meningitis and treated as indicated. Discontinuation of lamotrigine should be considered if no other clear cause of meningitis is identified.

 

Note:The lamotrigine authorized for distribution in the Macao market include APO-lamotrigine Tab 100mg﹑Lamictal Dispersible Tab 5mg/25mg﹑Lamictal Tab 50mg/100mg﹑Latrigine Tab 100mg “Kingdom”﹑PMS-Lamotrigine Tab 25mg/100mg and U-CHU Lamogin Tab 100mg.


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