Pharmacological Class:
Pulmonary surfactant.
Active Ingredient(s):
Lucinactant 8.5mL/vial; contains phospholipids 30mg (dipalmitoylphosphatidylcholine 22.5mg, palmitoyloleoyl-phosphatidylglycerol 7.5mg, sodium salt), palmitic acid 4.05mg, sinapultide 0.862mg; per mL; susp for intratracheal administration; preservative-free.
Company
Discovery Laboratories, Inc.
Indication(s):
For the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS.
Pharmacology:
Endogenous pulmonary surfactant lowers surface tension at the air-liquid interface of the alveolar surfaces during respiration and stabilizes the alveoli against collapse at resting transpulmonary pressures. A deficiency of pulmonary surfactant in premature infants results in RDS. Surfaxin compensates for the deficiency of surfactant and restores surface activity to the lungs of these infants.
Clinical Trials:
The efficacy and safety of Surfaxin for the prevention of RDS in premature infants was demonstrated in a single randomized, double-blind, multicenter, active-controlled, multi-dose study involving 1,294 premature infants (Study 1). Within the first 30 minutes after birth, infants were randomized to receive 1 of 3 surfactants, Surfaxin (N = 527), colfosceril palmitate (N = 509), or beractant (N = 258). Surfaxin was administered at a dose of 5.8mL/kg, colfosceril palmitate at a dose of 5mL/kg, and beractant at a dose of 4mL/kg. Infants in the Surfaxin and beractant groups could be given up to 3 additional doses between 6 and 24 hours of birth, as often as every 6 hours, if they subsequently developed RDS and required mechanical ventilation with an FiO2 ≥ 0.3 and a mean airway pressure (MAP) ≥ 6cm H2O. Infants in the colfosceril palmitate group could receive up to 2 additional doses at least 12 hours apart if they met the retreatment criteria. Some infants received sham air to maintain blinding of the study.
Co-primary endpoints were the incidence of RDS (defined as having a chest x-ray consistent with RDS and an FiO2 ≥ 0.3) at 24 hours and RDS-related mortality at 14 days. The primary comparison of interest was between Surfaxin and colfosceril palmitate with the intent of demonstrating superiority. Beractant served as an additional active comparator. Compared to colfosceril palmitate, Surfaxin demonstrated a statistically significant improvement in both RDS at 24 hours (39% of patients on Surfaxin vs. 47% of patients on colfosceril palmitate) and RDS-related mortality through Day 14 (5% of patients for Surfaxin vs. 9% of patients for colfosceril palmitate).
A second multicenter, double-blind, active-controlled study involving 252 premature infants was also conducted (Study 2), however the study was terminated prematurely and can only be used to support the safety of Surfaxin relevant to another surfactant product.
Legal Classification:
Rx
Adults:
Not recommended.
Children:
See full labeling. For intratracheal administration only. 5.8mL/kg. Can give up to 4 doses in the first 48hrs of life, not more frequently than every 6hrs.
Warnings/Precautions:
Not for treating acute RDS. Should be administered only by clinicians trained and experienced in intubation, ventilator management, and general care of premature infants. Monitor respiratory status frequently. Interrupt dosing and assess status if bradycardia, oxygen desaturation, reflux of drug into endotracheal tube (ETT) or airway/ETT obstruction occurs.
Adverse Reaction(s)
Endotracheal tube reflux, pallor, endotracheal tube obstruction, need for dose interruption.
How Supplied:
Single-use vial—1
LAST UPDATED:
1/2/2014
SURFAXIN Rx
药理分类：
肺表面活性物质。
活性成分（S ） ：
Lucinactant 8.5mL/vial ;含有30毫克磷脂（二棕榈酰22.5mg ， palmitoyloleoyl -磷脂酰甘油7.5mg ，钠盐） ，棕榈酸4.05mg ， 0.862mg西那普肽;每毫升;吊坠的供气管内给药;不含防腐剂。
公司
发现实验室公司
指示（ S） ：
为预防呼吸窘迫综合征（RDS ）早产儿在高风险的RDS 。
药理作用：
内源性肺表面活性剂降低表面张力在呼吸过程中的肺泡表面的空气 - 液体界面和稳定对抗塌陷的肺泡在休息的跨肺压。肺表面活性物质对早产儿A缺乏导致的RDS 。 SURFAXIN补偿表面活性剂的不足，并恢复表面活性，这些婴儿的肺部。
临床试验：
RDS的早产儿预防的疗效和SURFAXIN的安全表现在一个单一的随机，双盲，多中心，主动控制，多剂量研究，涉及1,294例早产儿（研究1 ） 。出生后的第一个30分钟内，婴儿被随机分配接受1 3的表面活性剂， SURFAXIN （N = 527 ） ， colfosceril棕榈酸酯（N = 509 ） ，或beractant （N = 258） 。 SURFAXIN施用在5.8mL/kg ， colfosceril棕榈酸酯的剂量，剂量5ml/kg体重，以及beractant在4mL/kg的剂量。在SURFAXIN和beractant组婴儿可给予最多6小时和24小时的诞生，经常与另外3个剂量为每6小时一次，如果他们后来发展RDS和需要机械通气的氧浓度≥ 0.3和平均气道压（ MAP ） ≥ 6厘米水。该colfosceril棕榈酸酯组婴儿可能获得高达2个额外的剂量至少间隔12小时，如果他们遇到了再治疗标准。有些婴儿接受假的空气，以保持学习的致盲。
共同主要终点是RDS发生率（定义为具有胸部X光与RDS和一个氧浓度≥ 0.3一致） 24小时和RDS相关死亡率为14天。感兴趣的主要比较是SURFAXIN和colfosceril棕榈之间，展现优势的意图。 Beractant担任一个额外的比较活跃。相比colfosceril棕榈酸酯， SURFAXIN表现在既RDS具有统计学显著改善在24小时内（患者对SURFAXIN 39 ％与患者对colfosceril棕榈酸47％） ，并通过14天的患者为SURFAXIN （5 ％比RDS相关死亡率患者为colfosceril棕榈酸酯9 ％）。
第二个多中心，双盲，涉及252例早产儿主动控制的研究也进行（研究2 ） ，但该研究提前终止，并且只能用于支持SURFAXIN相关的另一个表面活性剂产品的安全性。
法律分类：
RX
成人：
不推荐。
儿童：
查看全部标记。对于气管内给药只。 5.8mL/kg 。可到4个剂量放弃生命的第一48小时，不超过6小时每更频繁。
警告/注意事项：
不用于治疗急性RDS 。只能由训练有素，经验丰富的气管插管，呼吸机管理，早产儿一般的保健医生管理。经常监视呼吸状况。中断给药，如果心动过缓，血氧饱和度下降，反流药物进入气管导管（ ETT）或气道/气管内导管梗阻时评估状态。
不良反应（ S）
气管导管返流，脸色苍白，气管导管阻塞，需要中断给药。
如何提供：
单次使用小瓶- 1
上次更新时间：
2014年1月2日