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【drug-news】FDA更改药品安全标签：Ambien、 Primaxin IM/IV、 Hepsera
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FDA Safety Changes: Ambien, Primaxin IM/IV, Hepsera
News Author: Yael WaknineCME Author: 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.Zolpidem Tartrate (Ambien) Linked to Risk for "Sleep-Driving"On May 7, the FDA approved safety labeling revisions for zolpidem tartrate (A sanofi-aventis US) to warn of the risks for abnormal thinking and behavioral changes associated with use of this and other sedative-hypnotic drugs.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. 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.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. 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.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.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.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.Zolpidem is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Because sedative-hypnotics may depress respiratory drive, caution is advised when prescribing zolpidem for patients with compromised respiratory function, sleep apnea, or myasthenia gravis.Imipenem Component of Primaxin IM/IV Can Decrease Valproic Acid ConcentrationsOn May 8, the FDA approved safety labeling revisions for imipenem and cilastatin for injectable suspension (Primaxin IM) and imipenem and cilastatin for injection (Primaxin IV; Merck & Co, Inc) to warn of drug interactions with carbapenem antibiotics. Concomitant use of carbapenem antibiotics (ertapenem, imipenem, and meropenem) can reduce valproic acid concentrations to subtherapeutic levels, leading to loss of seizure control. Seizures and other central nervous system adverse events, such as myoclonic activity, have been reported as a result of this interaction.Therefore, valproic acid concentrations should be monitored frequently after initiation of imipenem-cilastatin therapy. The FDA advises that alternative antibacterial or anticonvulsant therapy be considered if serum valproic acid concentrations decrease below the therapeutic range or if a seizure occurs.Imipenem-cilastatin intramuscular injection is indicated for the treatment of serious infections of mild to moderate severity, including lower respiratory tract infections, intra-abdominal infections, skin-skin structure infections, and gynecologic infections.Imipenem-cilastatin intravenous infusion is indicated for the treatment of serious infections, including lower respiratory tract infections, urinary infections, intra-abdominal infections, gynecologic infections, bacterial septicemia, bone and joint infections, skin-skin structure infections, endocarditis, and polymicrobic infections.Valproic acid is an anticonvulsant used to control absence seizures, tonic-clonic seizures, complex partial seizures, juvenile myoclonic epilepsy, and seizures associated with Lennox-Gastaut syndrome. Recommendations for Adefovir Dipivoxil (Hepsera) Usage May Reduce Risk for ResistanceOn May 27, the FDA approved safety labeling revisions for adefovir dipivoxil (H Gilead Sciences, Inc) to advise of the potential for clinical resistance.Resistance to adefovir can result in viral load rebound and exacerbation of hepatitis B virus infection (HBV), potentially leading to liver decompensation and fatal outcome in patients with diminished hepatic function.To decrease the risk for resistance in patients with lamivudine-resistant HBV, adefovir should be administered in combination with lamivudine rather than as monotherapy. For those receiving adefovir alone, treatment modifications should be considered if serum HBV DNA levels remain above 1000 copies/mL with continued therapy.The latter recommendation is based on long-term (144-week) data from an adefovir clinical trial (n = 124), in which HBV DNA levels greater than 1000 copies/mL at week 48 were associated with an increased risk for the development of resistance.Adefovir is indicated for the treatment of HBV in patients aged 12 years and older who have evidence of active viral replication and either persistent elevations in serum aminotransferases or histologically active disease.
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FDA的安全性变化: Ambien, Primaxin IM/IV, HepseraNews Author: Yael Waknine新闻作者： yael waknineCME Author: Yael Waknine CME作者： yael waknineAugust 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.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 (A 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.FDA还警告说，病人首次或其后服用镇静安眠药的剂量，涉及舌头，声门或喉部的血管性水肿的罕见案件已经有所报告。在某些情况下，这些症状伴随着呼吸困难，咽喉堵塞，或恶心和呕吐等过敏反应，并需要紧急的处理。由于气道堵塞可能导致死亡，有血管性水肿的患者在服用唑吡坦后不应再次给药。 Zolpidem is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Because sedative-hypnotics may depress respiratory drive, caution is advised when prescribing zolpidem for patients with compromised respiratory function, sleep apnea, or myasthenia gravis.唑吡坦用于以入睡困难为特点的的失眠症短期治疗。因为镇静催眠药可能抑制呼吸动力，为病人开唑吡坦的处方时应考虑到以下情况：缺乏抵抗力的呼吸功能，睡眠性呼吸暂停，或重症肌无力。 Imipenem Component of Primaxin IM/IV Can Decrease Valproic Acid Concentrations亚胺培南组成的伊米配能-西司拉丁钠IM/IV可降低丙戊酸浓度 On May 8, the FDA approved safety labeling revisions for imipenem and cilastatin for injectable suspension (Primaxin IM) and imipenem and cilastatin for injection (Primaxin IV; Merck & Co, Inc) to warn of drug interactions with carbapenem antibiotics. 5月8日，美国食品药品管理局批准亚胺培南和西司他丁注射用混悬液和亚胺培南西司他丁注射液安全标签的修改，以警示与碳青霉烯类抗生素类药物相互作用。 Concomitant use of carbapenem antibiotics (ertapenem, imipenem, and meropenem) can reduce valproic acid concentrations to subtherapeutic levels, leading to loss of seizure control. Seizures and other central nervous system adverse events, such as myoclonic activity, have been reported as a result of this interaction.伴随碳青霉烯类抗生素的使用，可以减少丙戊酸浓度到亚治疗范围水平，从而导致癫痫发作。由于这种相互作用的导致的癫痫和其他中枢神经系统的不良事件已有报道，如肌阵挛的活动。Therefore, valproic acid concentrations should be monitored frequently after initiation of imipenem-cilastatin therapy. The FDA advises that alternative antibacterial or anticonvulsant therapy be considered if serum valproic acid concentrations decrease below the therapeutic range or if a seizure occurs.因此，开始使用亚胺培南-西司他丁治疗后，丙戊酸浓度应当经常监测。FDA的意见是，如果血清中丙戊酸浓度下降到有效药浓度范围以下或者癫痫发作，替代的抗菌剂或抗惊厥疗法应加以考虑。Imipenem-cilastatin intramuscular injection is indicated for the treatment of serious infections of mild to moderate severity, including lower respiratory tract infections, intra-abdominal infections, skin-skin structure infections, and gynecologic infections.亚胺培南-西司他丁肌肉注射是用于治疗轻度至中度的严重感染，包括下呼吸道感染，腹腔内感染，皮肤-皮肤结构感染以及妇科感染。 Imipenem-cilastatin intravenous infusion is indicated for the treatment of serious infections, including lower respiratory tract infections, urinary infections, intra-abdominal infections, gynecologic infections, bacterial septicemia, bone and joint infections, skin-skin structure infections, endocarditis, and polymicrobic infections.亚胺培南-西司他丁静脉输液是用于治疗严重的感染，包括下呼吸道感染，泌尿系感染，腹腔内感染，妇科感染，细菌性败血病，骨与关节感染，皮肤-皮肤结构感染，心内膜炎，和多微生物感染。Valproic acid is an anticonvulsant used to control absence seizures, tonic-clonic seizures, complex partial seizures, juvenile myoclonic epilepsy, and seizures associated with Lennox-Gastaut syndrome. 丙戊酸是一种抗癫痫药物，用来治疗癫痫小发作，强直阵挛性发作，复杂部分性癫痫发作，青年型肌阵挛性癫痫，以及与Lennox-Gastaut综合征相关的癫痫。Recommendations for Adefovir Dipivoxil (Hepsera) Usage May Reduce Risk for Resistance推荐阿德福韦酯的使用可以减少耐药性的风险On May 27, the FDA approved safety labeling revisions for adefovir dipivoxil (H Gilead Sciences, Inc) to advise of the potential for clinical resistance.5月27日，美国食品药品管理局批准了阿德福韦酯安全标签的修改，具有潜在的临床耐药性。Resistance to adefovir can result in viral load rebound and exacerbation of hepatitis B virus infection (HBV), potentially leading to liver decompensation and fatal outcome in patients with diminished hepatic function.阿德福韦的耐药性可能会导致病毒载量反弹，并加重乙型肝炎病毒的感染，可能对肝功能减弱的患者导致肝代偿失调和致命的结果。 To decrease the risk for resistance in patients with lamivudine-resistant HBV, adefovir should be administered in combination with lamivudine rather than as monotherapy. For those receiving adefovir alone, treatment modifications should be considered if serum HBV DNA levels remain above 1000 copies/mL with continued therapy.为减少患者拉米夫定耐药HBV的耐药性风险，阿德福韦应联合拉米夫定给药，而不是作为单一疗法。对于那些单独接受阿德福韦的患者，如果血清中乙型肝炎病毒DNA水平仍然高于1000 copies/mL时，在继续治疗时应考虑修改治疗方案。The latter recommendation is based on long-term (144-week) data from an adefovir clinical trial (n = 124), in which HBV DNA levels greater than 1000 copies/mL at week 48 were associated with an increased risk for the development of resistance.后者的建议是基于阿德福韦临床试验的长期数据，在48周时乙型肝炎病毒 DNA水平大于1000copies/mL，相关耐药性的风险增加。 Adefovir is indicated for the treatment of HBV in patients aged 12 years and older who have evidence of active viral replication and either persistent elevations in serum aminotransferases or histologically active disease.阿德福韦用于年龄12岁和老年人患者乙肝病毒的治疗，年龄12岁和老年人的患者在有证据显示有较强活性的乙肝病毒的复制、血清氨基转换酶或组织学上的活动性疾病也持续升高。
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FDA的安全性变化: Ambien, Primaxin IM/IV, Hepsera新闻作者： yael waknineCME作者： yael waknine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。酒石酸唑吡坦(Ambien )与“驾车梦游”的风险联系在一起。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。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。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。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。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。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。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。FDA还警告说，病人首次或其后服用镇静安眠药的剂量，涉及舌头，声门或喉部的血管性水肿的罕见案件已经有所报告。在某些情况下，这些症状伴随着呼吸困难，咽喉堵塞，或恶心和呕吐等过敏反应，并需要紧急的处理。由于气道堵塞可能导致死亡，有血管性水肿的患者在服用唑吡坦后不应再次给药。唑吡坦用于以入睡困难为特点的的失眠症短期治疗。因为镇静催眠药可能抑制呼吸动力，为病人开唑吡坦的处方时应考虑到以下情况：缺乏抵抗力的呼吸功能，睡眠性呼吸暂停，或重症肌无力。亚胺培南组成的伊米配能-西司拉丁钠IM/IV可降低丙戊酸浓度5月8日，美国食品药品管理局批准亚胺培南和西司他丁注射用混悬液和亚胺培南西司他丁注射液安全标签的修改，以警示与碳青霉烯类抗生素类药物相互作用。伴随碳青霉烯类抗生素的使用，可以减少丙戊酸浓度到亚治疗范围水平，从而导致癫痫发作。由于这种相互作用的导致的癫痫和其他中枢神经系统的不良事件已有报道，如肌阵挛的活动。因此，开始使用亚胺培南-西司他丁治疗后，丙戊酸浓度应当经常监测。FDA的意见是，如果血清中丙戊酸浓度下降到有效药浓度范围以下或者癫痫发作，替代的抗菌剂或抗惊厥疗法应加以考虑。亚胺培南-西司他丁肌肉注射是用于治疗轻度至中度的严重感染，包括下呼吸道感染，腹腔内感染，皮肤-皮肤结构感染以及妇科感染。亚胺培南-西司他丁静脉输液是用于治疗严重的感染，包括下呼吸道感染，泌尿系感染，腹腔内感染，妇科感染，细菌性败血病，骨与关节感染，皮肤-皮肤结构感染，心内膜炎，和多微生物感染。丙戊酸是一种抗癫痫药物，用来治疗癫痫小发作，强直阵挛性发作，复杂部分性癫痫发作，青年型肌阵挛性癫痫，以及与Lennox-Gastaut综合征相关的癫痫。推荐阿德福韦酯的使用可以减少耐药性的风险5月27日，美国食品药品管理局批准了阿德福韦酯安全标签的修改，具有潜在的临床耐药性。阿德福韦的耐药性可能会导致病毒载量反弹，并加重乙型肝炎病毒的感染，可能对肝功能减弱的患者导致肝代偿失调和致命的结果。为减少患者拉米夫定耐药HBV的耐药性风险，阿德福韦应联合拉米夫定给药，而不是作为单一疗法。对于那些单独接受阿德福韦的患者，如果血清中乙型肝炎病毒DNA水平仍然高于1000 copies/mL时，在继续治疗时应考虑修改治疗方案。后者的建议是基于阿德福韦临床试验的长期数据，在48周时乙型肝炎病毒 DNA水平大于1000copies/mL，相关耐药性的风险增加。阿德福韦用于年龄12岁和老年人患者乙肝病毒的治疗，年龄12岁和老年人的患者在有证据显示有较强活性的乙肝病毒的复制、血清氨基转换酶或组织学上的活动性疾病也持续升高。
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