Pharmacological Class:
Pediculicide.

Active Ingredient(s):
Spinosad 0.9%; topical ­suspension; contains benzyl alcohol.

Indication(s):
Head lice.

Pharmacology:
Spinosad causes neuronal excitation in insects. After periods of hyperexcitation, lice become paralyzed and die.

Clinical Trials:
Two studies were conducted in 1038 subjects ≥6 months of age with head lice infestation. A total of 552 subjects were treated with Natroba.

In Study 1, 91 primary subjects were randomized to Natroba, and 89 primary subjects were randomized to permethrin 1%. In Study 2, 83 and 84 primary subjects were randomized to Natroba and permethrin 1%, respectively.

In both studies, all subjects who were treated on Day 0 returned for efficacy evaluation at Day 7. Subjects with live lice present at Day 7 received a second treatment. Subjects who were lice free on Day 7 were to return on Day 14 for evaluation. Subjects with live lice and who received a second treatment were to return on Days 14 and 21.

Efficacy was assessed as the proportion of subjects who were free of live lice 14 days after the final treatment. In Study 1, 84.6% of Natroba subjects were free of lice compared to 44.9% of permethrin 1% subjects. In Study 2, 86.7% of Natroba subjects were free of lice compared to 42.9% of permethrin 1% subjects.

Legal Classification:
Rx

Adults & Children:
<4yrs: not recommended. ≥4yrs: apply to dry scalp and hair until adequately covered; use up to 120mL (one bottle). Leave on for 10 minutes, then rinse off thoroughly with warm water. May repeat treatment once if live lice is seen after 7 days. May remove dead lice and nits with nit comb. Wash hands after application. Wash or dryclean bedding or clothing appropriately.

Warnings/Precautions:
For use on dry scalp and hair only. Avoid eyes, mouth, mucous membranes. Neonates, infants <6months: not recommended. Pregnancy (Cat.B). Nursing mothers.

Adverse Reaction(s):
Application site erythema, ocular erythema.

How Supplied:
Susp—4oz

Last Updated:
10/6/2011

制造商：
ParaPRO

类药物：
Pediculicide。

活性成分（S）：
多杀菌素的0.9％;局部悬挂;含有苯甲醇。

指示（S）：
头虱。

药理学：
杀菌素导致昆虫神经元激发。后的hyperexcitation时期，虱子瘫痪和死亡。

临床试验：
头虱≥6个月的年龄在1038科目进行了两项研究。共有552科共收治Natroba。

在研究1中，有91所小学科目，随机Natroba，89小学的受试者随机菊酯1％。在研究2中，83和84的主要科目是随机Natroba和氯菊酯1％，分别为。

在这两项研究中，返回0天，治疗的所有科目在第7天进行疗效评价。目前在第7天的活虱接受第二次治疗。谁是虱子第7天免费到第14天返回评价。与活的虱子和是谁的受试者接受第二次治疗，14日和21天返回。

疗效评定为科目最终处理后的14天免费活虱的比例。在研究1，Natroba受试者的84.6％，44.9％氯菊酯1％的研究对象相比虱子。在研究2中，86.7％Natroba科目相比，42.9％的氯菊酯1％科目的虱子。

法律分类：
接收

成年人和儿童：
<4yrs：不推荐。 ≥4yrs：适用于干燥的头皮和头发，直到充分覆盖;使用最多为120毫升（1瓶）。离开10分钟，然后用温水彻底冲洗掉。可重复治疗一次，如果活虱是7天之后。 NIT梳子可能会删除死虱和虱卵。施药后洗手。洗或干洗的被褥或衣物适当。

警告/注意事项：
在干燥的头皮和头发只有上使用。避免眼睛，嘴巴，粘膜。新生儿，婴儿<6个月：不推荐。怀孕（Cat.B）。哺乳的母亲。

不良反应（S）：
应用网站红斑，眼红斑。

如何提供：
SUSP -4盎司

Natroba（spinosad）外用混悬液用于4岁及以上患者的头虱感染治疗。

FDA药品评价与研究中心药品评价办公室III的主任Julie Beitz博士说，Natroba为头虱感染的典型治疗提供了另一种选择，头虱在儿童中非常普遍，是美国学龄儿童中的一种常见问题。

Natroba是一种外用制剂，只适用于儿童头皮或毛发。本产品应由专业卫生保健人员开具处方并正确使用。

两项多中心、随机、有效性-对照研究证实了0.9% Natroba外用混悬液的安全性和有效性。552例受试者接受了Natroba 10分钟治疗。如一周后发现活头虱则进行第二次治疗。86%的Natroba组患者在最后一次治疗后保持14天无头虱状态，而对照组为44%。

报告的常见不良反应包括眼睛和皮肤发红或刺激。

该药对4岁以下儿童患者的安全性尚未确定。FDA未批准Natroba用于4岁以下儿童，因其含有苯甲醇，所以不将其用于婴幼儿尤其重要。当外用于6个月以下儿童皮肤时，包括死亡的严重不良反应的发生与苯甲醇有关