美国FDA批准Eisa公司的磷丙泊福钠注射液（fospropofol disodium 商品名：Lusedra）上市，对正在诊断或治疗的成人静脉注射监控麻醉。在此项批准中，美国FDA要求使用本品的医务人员需经全身性麻醉培训过，所有用药患者需持续监控。 本品系一丙泊酚的水溶性专利前体药物，静脉注射后在体内经碱性硫酸酯酶转换成丙泊酚。每毫摩尔磷丙泊福钠产生1毫摩尔丙泊酚（磷丙泊福钠1.86mg相当于丙泊酚1mg）。 本品获准上市是基于对患者结肠镜检查的Ⅱ、Ⅲ期临床研究、支气管镜检查的Ⅲ期临床研究和对患者开放式进行各种外科小手术等一系列数据。共对1611例患者进行的21项临床研究结果符合常规医疗实践。 批准日期：2008年12月12日；公司：Eisai Corporation of North America Lusedra (磷丙泊酚钠(fospropofol disodium))注射剂 - 以前名Aquavan 一般描述： LUSEDRA是一种注射溶液意向静脉给药作为镇静催眠剂。LUSEDRA是一种水性，消毒，无热原，透明，无色等张溶液，含35 mg/mL磷丙泊酚钠。磷丙泊酚钠是水溶异丙酚的前药，化学描述为2,6-diisopropylphenoxymethyl phosphate, 二钠盐。分子式：C13H19O5PNa2，相对分子量：332.24 作用机理 磷丙泊酚二钠是异丙酚的前药。下列静脉注射，磷丙泊酚被碱性磷酸酶代谢。对于施用磷丙泊酚二钠每毫摩尔，异丙酚之一毫产生（1.86毫克磷丙泊酚二钠为1mg异丙酚的摩尔当量）。 适应证： LUSEDRA是一种镇静催眠剂适用监查麻醉护理(MAC)镇静在成年进行诊断或治疗操作患者。 剂量和用法： 在用LUSEDRA进行镇静所有患者用补充氧。连续监查用脉动式氧合测量器, 心电图，和频繁测量血压。 标准给药方案：初始静脉推注6.5 mg/kg需要时接着通过补充剂量1.6 mg/kg。初始剂量不应超过16.5 mL；补充剂量不应超过4 mL。 修改给药方案[对≥65岁患者或有严重全身疾病(ASA P3或P4)]：标准给药方案的75 %。 给予补充剂量只有当患者可显示对语音或光触觉刺激反应有目的运动和频率不大与每4分钟。 体重>90 kg成年应给予如同他们是90 kg；成年体重<60 kg应给药如同60 kg。 仅意向单次给药使用。 禁忌证： 无。 警告和注意事项： 全身麻醉管理中受训人员和不涉及进行诊断/治疗操作应处理的用LUSEDRA治疗患者。 呼吸压抑。 低氧血症。 高血压。 不良反应：最常见不良反应(> 20 %)是感觉异常和瘙痒。 药物相互作用： 当与其它心-呼吸压抑剂如苯二氮卓类和麻醉性镇痛药，当与其它镇静催眠剂联用，LUSEDRA可能产生相加性心-呼吸效应。 在特殊人群中的使用： 患者65岁应接受修订给药方案。 患者有全身疾病(ASA P3或P4)应接受修订给药方案。 ---------------------------------------------- 【原产地英文商品名】LUSEDRA 1050mg/30ml/vial 8vials/box 【原产地英文药品名】FOSPROPOFOL DISODIUM 【生产厂家中文参考译名】卫材药业 【生产厂家英文名】EISAI INC LUSEDRA (fospropofol disodium) Injection, for intravenous use, CIV Initial U.S. Approval: 2008 Generic Name: fospropofol disodium Date of Approval: December 12, 2008 Company: Eisai Corporation of North America FDA Approves Lusedra The U.S. Food and Drug Administration (FDA) has approved Lusedra (fospropofol disodium) Injection, an intravenous sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures. About Lusedra (fospropofol disodium) Injection Lusedra (fospropofol disodium) Injection is a proprietary water-soluble prodrug of propofol that, after intravenous injection, is converted by alkaline phosphatase enzymes in the body into propofol. Lusedra is an intravenous sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures. Important Safety Information Lusedra should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the diagnostic or therapeutic procedure. Patients should be continuously monitored during sedation and through the recovery process for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. Facilities for providing cardiopulmonary resuscitation must be immediately available. The following serious adverse reactions have been reported with the use of Lusedra. Hypotension Hypotension was reported in 18/455 (4%) patients treated with Lusedra using the standard or modified dosing regimen. Patients with compromised myocardial function, reduced vascular tone, or who have reduced intravascular volume may be at an increased risk for hypotension. Hypoxemia Hypoxemia was reported in 20/455 (4%) patients treated with Lusedra using the standard or modified dosing regimen. Retention of purposeful responsiveness did not prevent patients from becoming hypoxemic following administration of Lusedra. Respiratory depression Apnea was reported in 1/455 (< 1%) patients treated with Lusedra using the standard or modified dosing regimen. Loss of purposeful responsiveness Lusedra has not been studied for use in general anesthesia. However, administration of Lusedra may inadvertently cause patients to become unresponsive or minimally responsive to vigorous tactile or painful stimulation. The incidence of patients who became minimally responsive or unresponsive to vigorous tactile or painful stimulation was 7/183 (4%) for colonoscopy and 24/149 (16%) for bronchoscopy. The duration of minimal or complete unresponsiveness ranged from 2 to 16 minutes in colonoscopy patients and from 2 to 20 minutes in bronchoscopy patients. The use of supplemental oxygen is recommended in all patients receiving Lusedra. Airway assistance maneuvers may be required. As with other sedative-hypnotic agents, Lusedra may produce additive cardio-respiratory effects when administered with other cardio-respiratory depressants such as benzodiazepines and narcotic analgesics. When Lusedra is used at greater than the recommended doses, the incidence of serious adverse reactions is increased. The most common adverse reactions (reported in greater than 20%) are paresthesia and pruritis. Highlights of Lusedra Prescribing Information These highlights do not include all the information needed to use Lusedra safely and effectively. See full prescribing information for Lusedra. Indications and Usage Lusedra is a sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures. Dosage and Administration Use supplemental oxygen in all patients undergoing sedation with Lusedra. Continuously monitor with pulse oximetry, electrocardiogram, and frequent blood pressure measurements. Standard dosing regimen: initial intravenous bolus dose of 6.5mg/kg followed by supplemental doses of 1.6mg/kg as needed. No initial dose should exceed 16.5mL; no supplemental dose should exceed 4 mL. Modified dosing regimen [for patients who are ≥65 years of age or who have severe systemic disease (ASA P3 or P4)]: 75 % of the standard dosing regimen. Administer supplemental doses only when patients can demonstrate purposeful movement in response to verbal or light tactile stimulation and no more frequently than every 4minutes. Adults who weigh >90 kg should be dosed as if they are 90 kg; adults who weigh <60 kg should be dosed as if they are 60 kg. Intended for single use administration only. Dosage Forms and Strengths Injection, solution containing 1,050mg fospropofol disodium per 30 mL. Contraindications None Warnings and Precautions A person trained in the administration of general anesthesia and not involved in the conduct of the diagnostic/therapeutic procedure should manage treatment of patients with Lusedra. Respiratory depression Hypoxemia Hypotension Adverse Reactions Most common adverse reactions (>20 %) are paresthesia and pruritus. Drug Interactions As with other sedative-hypnotic agents, Lusedra may produce additive cardio-respiratory effects when administered with other cardio-respiratory depressants such as benzodiazepines and narcotic analgesics. Use in Specific Populations Patients ≥65 years of age should receive the modified dosing regimen. Patients with severe systemic disease (ASA P3 or P4) should receive the modified dosing regimen. Patient Counseling Information Paresthesias (including burning, tingling, stinging) and/or pruritus, usually manifested in the perineal region are frequently experienced upon injection of the initial dose of Lusedra. Inform the patient that these sensations are typically mild to moderate in intensity, last a short time, and require no treatment. Requirement for a patient escort should be considered. The decision as to when patients who have received Lusedra, particularly on an outpatient basis, may again engage in activities requiring complete mental alertness, coordination and/or physical dexterity (e.g. operate hazardous machinery, sign legal documents or drive a motor vehicle) must be individualized. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8cc837aa-14f0-4809-9ca1-6cc7ff84646b FDA批准Lusedra（磷丙泊酚二钠）注射监测麻醉护理镇静 Eisai公司的北美公司今天宣布，美国食品和药物管理局FDA已批准Lusedra（磷丙泊酚二钠）注射液，静脉注射镇静催眠剂，用于监测麻醉护理（MAC）在接受诊断或治疗程序的成年患者的镇静。 在审批中，FDA要求，Lusedra只在全身麻醉的管理和训练，所有的患者，应不断监测不是在参与​​的过程中的行为者的人使用。 2008年5月7日，对麻醉剂和生命支持药品FDA咨询委员会投票批准使用静脉镇静催眠剂在接受诊断或治疗程序的成年患者的镇静Lusedra的6票赞成，3（1票弃权） 。该委员会建议Lusedra使用那些受过适当训练的医疗保健提供商。 辛西娅Schwalm，总统，卫材公司说：“我们很高兴，与FDA的决定批准Lusedra，因为它提供了一个新的选项监测麻醉护理（MAC），在成年患者镇静，”随着Lusedra批准，卫材继续履行其对人类健康保健的使命，以解决患者未满足的需求。“ FDA还建议，Lusedra被列为受控物质。预计从美国缉毒局（DEA）在联邦纪事上发布拟议的规则，并允许公众意见后，最后一个调度决策。 Lusedra一旦获得最终的调度指定，标签会被修改。 关于Lusedra注射液（磷丙泊酚二钠） Lusedra磷丙泊酚二钠注射异丙酚是一种专有的水溶性前体药物，静脉注射后，在体内转换成异丙酚碱性磷酸酶酶。Lusedra是静脉镇静催眠剂，监测麻醉护理（MAC）在接受诊断或治疗程序的成年患者的镇静表示。 安全信息 Lusedra应只能由受过训练的人员，在全身麻醉的管理进行管理，而不是涉及的诊断或治疗过程中的行为。患者应在镇静和恢复过程中，通过连续监测，低血压，呼吸，气道阻塞，和/或血氧饱和度下降的早期迹象。提供心肺复苏的设施，必须立即可用。 Lusedra使用，已报告有下列严重不良反应： •低血压-低血压据报道四百五十五分之一十八（4％）与使用标准的或修改后的给药方案Lusedra治疗的患者。 - 患者受损的心肌功能，降低血管张力，减少血管内容量可能增加低血压的风险。 •低氧血症 - 低氧血症报道四百五十五分之二十零（4％）与使用标准的或修改后的给药方案Lusedra治疗的患者。保留针对性的响应并没有阻止成为低氧血症Lusedra以下管理的患者。 •呼吸抑制 - 据报道，在使用标准的或修改的给药方案Lusedra治疗的1 / 455（<1％）患者呼吸。 •尚未丧失针对性的响应 - Lusedra研究中采用全身麻醉。然而，Lusedra管理可能会在无意中造成患者成为强有力的触觉或疼痛刺激反应迟钝或最小响应。成为微创强有力的触觉或疼痛刺激反应或反应迟钝的患者的发病率是7 / 183（4％）用于结肠镜检查和149分之24支气管镜（16％）。在结肠镜检查的患者，在支气管镜检查患者的2至20分钟，最小的或完整的反应迟钝的持续时间从2至16分钟不等。 建议在所有接收Lusedra的患者使用补充氧气。气道援助演习可能是必需的。至于与其他镇静催眠剂，Lusedra可能产生添加剂心肺影响心肺与其他镇静剂，如苯二氮卓类药物和麻醉性镇痛药时。 Lusedra大于推荐剂量使用时，严重不良反应的发生率增加。 最常见的不良反应（大于20％的报道），感觉异常和瘙痒。