近日表示；美国已批准了Akten眼用凝胶3.5%，一种局部眼科麻醉剂，这是FDA近40年来批准的唯一一个眼科麻醉剂，立即将在美国上市。
Akten为一种新型的、单位剂量的、无防腐剂的利多卡因凝胶，室温储存，可用于任何需要使用麻醉剂的眼科操作中。估计Akten市场规模可达每年在1100万例眼科操作中使用。

部分中文利多卡因处方资料（仅供参考）

药品类别：局部麻醉药
                  
药理毒理：利多卡因为酰胺类中效局麻药。
药代动力学：利多卡因穿透力强、无明显扩张血管作用，药物从局部消除约需2小时。
适应症：本品为局麻药。主要用于表面麻醉。 
不良反应：
（1）本品偶可引起高敏反应和过敏反应；
（2）对呼吸道高敏病人，可引起支气管痉挛；
（3）本品剂量过大、吸收太快可导致中毒反应，表现为耳鸣、激动、烦燥等中枢神经兴奋症状，并可迅速发展为抽搐、昏迷血压下降等；
（4）血药浓度过高，可引起心房传导速度减慢、房室传导阻滞、室颤和心搏骤停。 
禁忌症：
下列情况应禁用：
①对有药物过敏史及特异质反应者；
②严重心脏阻滞，包括Ⅱ或Ⅲ度房室传导阻滞，双束支阻滞；
③严重窦房结功能障碍；
④原有室内传导阻滞者。
                  
注意事项：
（1）肝肾功能障碍、肝血流量减低、充血性心力衰竭、严重心肌受损、低血容量及休克等患者慎用。
（2）对其他局麻药过敏者，可能对本品也过敏，但利多卡因与普鲁卡因胺、奎尼丁间尚无交叉过敏反应的报道。
（3）本品严格掌握浓度和用药总量，超量可引起惊厥及心跳骤停。 
孕妇及哺乳期妇女用药：本品透过胎盘，且与胎儿蛋白结合高于成人，母亲用药后可导致胎儿心动过缓或过速，亦可导致新生儿高铁血红蛋白血症，故应禁用。
                  
儿童用药：新生儿用药可引起中毒，早产儿较正常儿半衰期长（3.16小时：1.8小时），应慎用。
老年患者用药：老年人用药应根据需要及耐受程度调整剂量。
药物相互作用：本品如被吸收后可与下列药物产生相互作用：与西咪替丁以及?
受体阻滞剂如，普萘洛尔、美托洛尔、纳多洛尔合用，利多卡因经肝脏代谢受抑制，利多卡因血浓度增加，可发生心脏和神经系统不良反应。
                  
贮藏：密闭保存.

Akten (lidocaine hydrochloride)
Company: Akorn
Approval Status: Approved October 2008
Treatment for: anesthesia during ophthalmologic procedures
Areas: Ophthalmology; Pharmacology/ToxicologyGeneral InformationAkten is a gel formulation of the local anesthetic agent
lidocaine.
Akten stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action.
Anesthesia generally occurs between 20 seconds to 1 minute and persists for 5 to 30 minutes.
Akten is specifically indicatedasalocalanestheticindicatedforocularsurfaceanesthesiaduringophthalmologic
procedures.
Akten is supplied as an ophthalmic gel (3.5%) containing 35 mg per mL of lidocaine hydrochloride designed for topical ophthalmic administration. The recommended initial dose of the drug is two drops applied to the ocular surface in the area of the planned procedure.
Akten may be reapplied to maintain anesthetic effect.
Clinical Results
FDA Approval
FDA approval of Akten was based the results of a multi-center, randomized, controlled, double-blind study. This study enrolled 209 subjects who received placebo or Akten 1.5%, 2.5% or 3.5%. Ocular anesthesia was achieved within five minutes of anesthetic application by 47 of 51 subjects (92%) in the Akten 3.5% group. The mean time to anesthesia onset ranged from 20 seconds to 5 minutes and was not affected by Akten dose.
The mean time to anesthesia onset was approximately 60 seconds, with a median onset time of 40 seconds for the Akten 3.5% group.
Among the subjects in the Akten groups who achieved anesthesia within 5 minutes, approximately 90% had achieved anesthesia within 60 seconds of application. The duration of anesthesia generally ranged from approximately 5 minutes to 30 minutes, with mean anesthesia durations of approximately 15 minutes for the Akten 3.5% group. Approximately 84% of the subjects in the Akten 3.5% group experienced anesthesia for at least 5 minutes, approximately 55% of subjects experienced anesthesia for 10 minutes or longer and 27% experienced anesthesia for 15 minutes or longer.
Side Effects
Adverse events associated with the use of Aktenmayinclude, but are not limited to, the following:
Conjunctival hyperemia
Corneal epithelial changes
Headache
Burning upon instillation
Mechanism of Action
Akten is a gel formulation of the local anesthetic agent idocaine. Akten stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action.
Anesthesia generally occurs between 20 seconds to 1 minute and persists for 5 to 30 minutes.
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原产地英文商品名:
AKTEN 3.5% DROPS 5mls/bottle
原产地英文药品名:
LIDOCAINE HCL/PF
中文参考商品译名:
AKTEN 3.5%滴剂 5毫升/瓶
中文参考药品译名:
盐酸利多卡因/PF
生产厂家中文参考译名:
AKORN
生产厂家英文名:
AKORN