Biomedicine Discovery Institute, Infection & Immunity Program and Department of Microbiology, Monash University, Clayton Campus, Melbourne, VIC, Australia.
School Pharmacy and Medical Sciences, University of South Australia, Adelaide, SA, Australia.
Adv Exp Med Biol. 2019;1145:133-141. doi: 10.1007/978-3-030-16373-0_10.
Two different labelling conventions for the contents of colistin methanesulfonate (i.e. colistin base activity [CBA] and international unit [IU]) are used in different parts of the world, and have caused prescribing errors and patient safety issues. This chapter discusses the key issues on the conversion between CBA and IU, and highlights that in pharmacokinetic analyses only the absolute mass of the chemical colistin methanesulfonate should be employed, but not the CBA or IU values. The scientific evidence is unknown for the limits specified for the pharmacopeial standards of the major components of colistin methanesulfonate and polymyxin B. The package information of parenteral colistin methanesulfonate in Europe has now been significantly improved by incorporating the latest pharmacokinetic/pharmacodynamic data. However, the current package information of almost all different brands of parenteral polymyxin B products is substantially out of date without solid pharmacological data. Updating the package information of different products of both polymyxins requires the coordination between major regulatory authorities and will significantly facilitate the optimisation of their use in patients.
两种不同的黏菌素甲磺酸盐（即黏菌素碱效价[CBA]和国际单位[IU]）含量标注规范在世界不同地区被使用，这导致了处方错误和患者安全问题。本章讨论了 CBA 和 IU 之间转换的关键问题，并强调在药代动力学分析中，仅应使用化学黏菌素甲磺酸盐的绝对质量，而不是 CBA 或 IU 值。黏菌素甲磺酸盐和多黏菌素 B 主要成分的药典标准规定的限值的科学证据尚不清楚。欧洲的黏菌素甲磺酸盐注射剂的包装信息现在已经通过纳入最新的药代动力学/药效学数据得到了显著改善。然而，几乎所有不同品牌的多黏菌素 B 注射剂产品的当前包装信息都严重过时，缺乏可靠的药理学数据。更新这两种多黏菌素产品的不同产品的包装信息需要主要监管机构之间的协调，这将极大地促进其在患者中的使用优化。
