美国FDA批准Eisa公司的磷丙泊福钠注射液（fospropofol disodium）（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。剂量规格：磷丙泊福钠35 mg/mL ; 30 mL/瓶。

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1.86 mg相当于丙泊酚1 mg）。

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1 611例患者进行的21项临床研究结果符合常规医疗实践。

LUSEDRA（磷丙泊酚二钠）注射液，静脉注射使用，CⅣ

最初美国批准：2008
 
适应症
（1）LUSEDRA是监测麻醉（MAC）的成年患者在接受诊断或治疗程序的镇静表示镇静催眠剂。
 
剂量和用法
使用在所有患者接受与LUSEDRA的镇静，吸氧。 连续监测脉搏血氧饱和度，心电图，和频繁的测量血压。
标准给药方案：初始剂量静脉注射6.5毫克/公斤，需要补充剂量为1.6毫克/千克。没有初始剂量应超过16.5毫升;没有补充剂量应超过4毫升。
给药方案修改患者≥65岁或有严重的全身性疾病（ASA的P3或P4）]：75％的标准给药方案。
管理的补充剂量，只有当患者能证明超过每4分钟的口头或轻触觉刺激和更频繁的针对性运动。
重达90公斤的成年人应剂量，如果他们是90公斤，好像他们是60公斤，体重<60公斤的成年人应剂量。

适用于一次性使用的管理只。
 
剂型和优势
注射液，溶液每30毫升含1,050毫克磷丙泊酚二钠。

禁忌
没有
 
注意事项：
在全身麻醉的管理培训一个人，不参与的诊断/治疗过程中的行为应管理与LUSEDRA患者的治疗。
呼吸抑制
低氧血症
低血压
 
不良反应
最常见的不良反应（> 20％），感觉异常，瘙痒。
 
药物相互作用
与其他镇静催眠药物，LUSEDRA管理与其他心肺镇静剂，如苯二氮卓类药物和麻醉性镇痛药时，可能会产生加心肺功能的影响。
 
在特殊人群中使用
患者≥65岁，应该得到修改的给药方案。
严重的全身性疾病的患者（ASA P3或P4），应该得到修改的给药方案。

日期：10/2009

LUSEDRA is a Schedule IV controlled substance indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures. LUSEDRA is an aqueous solution intended for intravenous administration as a sedative-hypnotic agent. It is sterile, nonpyrogenic, clear, colorless, and iso-osmotic. The solution contains 35 mg/mL of fospropofol disodium. Fospropofol disodium is a water-soluble prodrug of propofol, chemically described as 2,6-diisopropylphenoxymethyl phosphate, disodium salt.1

Safety and effectiveness in pediatric patients have not been established because LUSEDRA has not been studied in persons <18 years of age. LUSEDRA is not recommended for use in this population.1

This Web site is intended for US Health Care Professionals only.

INDICATION
LUSEDRA® is an intravenous sedative-hypnotic agent indicated for monitored anesthesia care (MAC) 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. Sedated patients should be continuously monitored, and facilities for maintenance of a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available. Patients should be continuously monitored during sedation and through the recovery process for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation.

The following serious adverse reactions have been reported with the use of LUSEDRA:

Respiratory Depression

LUSEDRA may cause loss of spontaneous respiration. Apnea was reported in 1/455 (<1%) patients treated with LUSEDRA using the standard or modified dosing regimen. In patients treated with greater than the recommended LUSEDRA dose, apnea was reported in 14/556 (3%).

Hypoxemia

LUSEDRA may cause hypoxemia detectable by pulse oximetry. Hypoxemia was reported in 20/455 (4%) patients treated with LUSEDRA using the standard or modified dosing regimen. Hypoxemia was reported among patients who retained the ability to respond purposefully to their health care provider following administration of LUSEDRA. Therefore, retention of purposeful responsiveness did not prevent patients from becoming hypoxemic following administration of LUSEDRA. In patients treated with greater than the recommended LUSEDRA dose, hypoxemia was reported in 151/556 (27%).

Patient Unresponsiveness to Vigorous Tactile or Painful Stimulation

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.

Hypotension

Hypotension following the use of LUSEDRA may occur. Hypotension was reported in 18/455 (4%) patients treated with LUSEDRA using the standard or modified dosing regimen. In patients treated with greater than the recommended LUSEDRA dose, hypotension was reported in 31/556 (6%). Patients with compromised myocardial function, reduced vascular tone, or who have reduced intravascular volume may be at an increased risk for hypotension.

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 cardiorespiratory effects when administered with other cardiorespiratory depressants such as benzodiazepines and narcotic analgesics. Use lower doses of LUSEDRA in patients who are ≥65 years of age or who have severe systemic disease. When LUSEDRA is used at greater than recommended doses, the incidence of serious adverse reactions is increased. The most common adverse reactions (reported in greater than 20%) are paresthesia and pruritus.

Reference: 1. LUSEDRA [package insert]. Woodcliff Lake, NJ: Eisai Inc.; 2009.
LUSEDRA® is a registered trademark used by Eisai Inc. under license from Eisai R+D Management Co., Ltd. Marketed by Eisai Inc., Woodcliff Lake, NJ 07677
©2011 Eisai Inc. All rights reserved. FOS176 Printed in USA/February 2011