Labelling Conventions and Product Package Insert of Parenteral Polymyxins: Factors Causing Potential Medication Errors and Impeding Optimal Clinical Use

Jian Li, Kingsley Coulthard, Roger L. Nation

Research output: Chapter in Book/Report/Conference proceedingChapter (Book)Otherpeer-review

10 Citations (Scopus)


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the current package information of almost all different brands of parenteral polymyxin B products is substantially out of date without solid pharmacological data.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.

Original languageEnglish
Title of host publicationPolymyxin Antibiotics
Subtitle of host publicationFrom Laboratory Bench to Bedside
EditorsJian Li, Keith S. Kaye, Roger L. Nation
Place of PublicationSwitzerland
Number of pages9
ISBN (Electronic)9783030163730
ISBN (Print)9783030163716
Publication statusPublished - 2019

Publication series

NameAdvances in Experimental Medicine and Biology
ISSN (Print)0065-2598
ISSN (Electronic)2214-8019


  • Colistin
  • Labelling convention
  • Pharmacopeial standard
  • Polymyxin B
  • Product information

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