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【drug-news】FDA更改药品安全标签：Ambien、 Primax
News Author: Yael Waknine
新闻作者： yael waknine
CME Author: Yael Waknine
CME作者： yael waknine
August 28, 2008 — The US Food and Drug Administration (FDA) has approved safety labeling revisions to advise of the risks for abnormal thinking and behavioral changes in patients receiving zolpidem tartrate and other sedative-hypnotic drugs, drug interactions between valproic acid and carbapenem antibiotics that can increase the risk for seizures and other central nervous system events, and therapeutic recommendations that may reduce the risk for resistance to adefovir dipivoxil therapy.
2008年8月28日——美国食品和药物管理局（FDA）批准了以下的安全标签的修改：病人接受酒石酸唑吡坦和其他镇静催眠药物治疗时产生异常的思想和行为变化的风险，丙戊酸和碳青霉烯类抗生素之间的相互作用可以增加癫痫及其他中枢神经系统的病变的风险，阿德福韦酯的治疗推荐量可能会减少治疗耐受性的风险。
Zolpidem Tartrate (Ambien) Linked to Risk for "Sleep-Driving"
酒石酸唑吡坦(Ambien )与“驾车梦游”的风险联系在一起。
On May 7, the FDA approved safety labeling revisions for zolpidem tartrate (Ambien; sanofi-aventis US) to warn of the risks for abnormal thinking and behavioral changes associated with use of this and other sedative-hypnotic drugs.
5月7日，美国食品药品管理局批准酒石酸唑吡坦安全标签的修改，用以警示使用本品及其他镇静催眠药物时引起异常的思想和行为变化的风险。
Because sleep disturbances can be the presenting manifestation of a physical and/or psychiatric disorder, patients with insomnia that does not remit after 7 to 10 days of therapy should be evaluated for the presence of a primary illness.
由于睡眠障碍主要表现为身体或精神的失常，失眠患者在治疗的7至10天后并不能缓和应作为主要疾病存在的评价。
Worsening of insomnia or the emergence of new thinking or behavioral abnormalities during treatment can likewise indicate an underlying physical or psychiatric disorder. Use of sedative-hypnotics in primarily depressed patients has been linked to worsening depression, including suicidal thoughts and actions and completed suicide.
失眠的日益严重或治疗期间出现新的思想或行为的异常，同样可以表明潜在的身体或精神失常。在原发抑郁症患者中使用镇静催眠药，与日益严重的抑郁症有关联，包括自杀念头和行为，甚至自杀。
Complex behaviors have been reported in treatment-naive and treatment-experienced patients who are not fully awake after taking sedative-hypnotics such as zolpidem. These events are associated with amnesia and include "sleep-driving," preparing or eating meals, making telephone calls, and having sexual intercourse.
复杂体行为已经报告——在首次治疗和反复治疗的病人，在给与镇静安眠药如唑吡坦后，并不完全清醒。这些事件和失忆症是相关的，其中包括“驾车梦游”，正在准备或吃饭，打电话和性交。
Although they can occur with normal doses, the likelihood of performing activities while asleep increases with excessive doses and concomitant use of alcohol or other central nervous system depressants.
虽然它们在正常的剂量时可能会发生，过度剂量以及在使用时伴随酒精或其他中枢神经系统抑制剂的使用，这种睡着的可能性会有所增加。
Because of the risk to the patient and the community, strong consideration should be given to discontinuing therapy in patients who report "sleep-driving" episodes.
为了病人和社会风险的缘故，应强烈的考虑对报告有“驾车梦游”发作的病人给予中断治疗。
All newly emergent behaviors should be evaluated, although it may not be possible to discern whether they are of spontaneous origin, drug induced, or the result of an underlying disorder. Because of the risk for withdrawal symptoms, treatment should not be abruptly withdrawn, and rapid dose decreases should be avoided. Some events related to sedative or hypnotic use appear to be dose related, necessitating use of the lowest effective dose, particularly in elderly people.
虽然所有的新建应急行为可能无法辨别他们是否是自然发生，药物造成的，或者是一个潜在的紊乱造成的结果，但也应加以评估。因为戒断症状的风险，不应该突然停止治疗，也应加以避免快速剂量的减少。镇静剂或催眠药的使用是和剂量相关的，特别是老年人应使用最低有效剂量。
The FDA also warned that rare cases of angioedema involving the tongue, glottis, or larynx have been reported in patients taking the first or subsequent doses of sedative-hypnotics. In some cases, these symptoms were accompanied by dyspnea, throat closing, or nausea and vomiting that suggested anaphylaxis and required emergency care. Because airway obstruction can cause death, patients in whom angioedema develops after taking zolpidem should not be rechallenged with the drug.
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作者:admin@医学,生命科学 2011-06-12 05:11
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