LYMPHAZURIN 1%（isosulfan blue 异硫蓝）注射液是一种用于结直肠肿瘤前哨淋巴结定位的1％淋巴天青vs10％荧光素，Lymphazuirn™1％（异硫蓝）描绘了引流注射部位的淋巴管。它是淋巴造影的辅助手段：四肢的原发性和继发性淋巴水肿；乳糜尿，乳突性腹水或乳糜胸；原发性或继发性肿瘤累及淋巴结；和淋巴结对治疗方式的反应。
批准日期：2012年1月12日 公司：
LYMPHAZURIN 1% （异硫蓝[isosulfan blue]）注射液，皮下使用溶液
美国初次批准：1981年 最近的重大变化
警告和注意事项，对氧饱和度和高铁血红蛋白测量的干扰。 10/2007
适应症和用途
皮下给药1％的Lymphazurin™（异硫蓝）描绘了引流注射部位的淋巴管。它是淋巴造影的辅助手段：四肢的原发性和继发性淋巴水肿；乳糜尿，乳突性腹水或乳糜胸；原发性或继发性肿瘤累及淋巴结；淋巴结对治疗方式的反应。
剂量和给药
每次研究应将1％的Lymphazurin™皮下注射，将一半（1/2）毫升皮下注射到每个肢体的三（3）个趾间间隙中。因此，注射的最大剂量为3ml（30mg）异硫蓝。
剂量形式和强度
1％水溶液（异硫蓝）。
禁忌症
对三苯甲烷或相关化合物过敏。
警告和注意事项
给予1％的淋巴嘧啶后会发生危及生命的过敏反应。给予1％的淋巴嘧啶后，至少要密切监测患者至少60分钟。
1％的淋巴天青与局部麻醉剂的混合物导致4-9％的药物复合物立即沉淀。使用单独的注射器进行麻醉。
1％的淋巴天青干扰外周脉搏血氧饱和度测定。可能需要进行动脉血气分析。
不良反应
超敏反应：超敏反应发生在大约2％的患者中，包括威胁生命的过敏反应，包括呼吸窘迫，休克，血管性水肿，荨麻疹，瘙痒。据报道，在静脉内注射类似化合物后死亡。
要报告可疑不良反应，请致电1-800-522-0263选项5和网站或FDA通过1-800-FDA-1088或www.fda.gov/medwatch与美国外科医师联系。
药物相互作用
对于1％的淋巴天青，尚未发现药物相互作用。
在特定人口中使用
给哺乳母亲服用1％的利巴祖林时应格外小心。
尚不确定1％的淋巴天青对儿童的安全性和有效性。
包装供应/存储和处理方式
1％的淋巴天青以5毫升单剂量药瓶的形式提供，在磷酸盐缓冲液中的1％水溶液通过适当的制备制成，以无菌且不含热原。
LYMPHAZURIN injection, solution for subcutaneous use
Initial U.S. Approval: 1981
Lymphazurin Description
The chemical name of Lymphazurin 1% (isosulfan blue) is N-[4-[[4-(diethylamino)phenyl](2,5-disulfophenyl) methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylehananamunium hydroxide, inner salt, sodium salt.Its structural formula is:
Lymphazurin 1% is a sterile aqueous solution for subcutaneous administration. Phosphate buffer in sterile, pyrogen free water is added in sufficient quantity to yield a final pH of 6.8-7.4. Each ml of solution contains 10 mg Isosulfan blue, 6.6 mg sodium monohydrogen phosphate and 2.7mg potassium dihydrogen phosphate. The solution contains no preservative. Lymphazurin 1% is a contrast agent for the delineation of lymphatic vessels.
Lymphazurin - Clinical Pharmacology
Pharmacodynamics
Following subcutaneous administration, Lymphazurin 1% binds to serum proteins and is picked up by the lymphatic vessels. Thus, the lymphatic vessels are delineated by the blue dye.
Pharmacokinetics
Up to 10% of the subcutaneously administered dose of Lymphazurin 1% is excreted unchanged in the urine in 24 hours in human.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to eva luate the carcinogenic potential of Lymphazurin 1%. Reproduction studies in animals have not been conducted and, therefore, it is unknown if a problem concerning mutagenesis or impairment of fertility in either males or females exists.
Teratogenic Effects
Pregnancy Category C. Animal reproduction studies have not been conducted with Lymphazurin 1%. It is not known whether Lymphazurin 1% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Lymphazurin 1% should be given to a pregnant woman only if clearly needed.
How Supplied/Storage and Handling
Lymphazurin 1% is supplied as a 5 ml single dose vial, 1% aqueous solution in a phosphate buffer prepared by appropriate manufacturing to be sterile and pyrogen-free.
Patient Counseling Information
Inform patients that urine color may be blue for 24 hours following administration of Lymphazurin 1%. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbee4532-238b-4f91-86ae-f8c0c1b6d7da
