Fixed-dose combination antibiotics: The search for evidence using the example of ampicillin–cloxacillin

Ben Sayer, Barbara Bortone, Mike Sharland, Yingfen Hsia*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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High consumption of irrational fixed-dose combination (FDC) antibiotics may pose a threat of antimicrobial resistance. In India, ampicillin–cloxacillin was the second highest sold FDC antibiotic behind amoxicillin and clavulanic acid. There remain, however, questions about its efficacy and safety and a lack of regulatory approval. We undertook a literature review for ampicillin–cloxacillin to identify available data on the safety and efficacy of its used as FDC. We identified 1071 studies for screening and 81 studies were considered for inclusion. Only 12 studies in English language were accessible full texts for final review. None of the studies identified provided strong evidence that ampicillin–cloxacillin differed in safety or efficacy to other treatments used, and in particular to the component antibiotics used alone. To fully assess the efficacy and safety of ampicillin–cloxacillin and other FDCs, a standardised search format would be required. This should include broad international collaboration, including contacting the relevant regulatory authorities to facilitate a more evidence-based approach to their use.

Original languageEnglish
JournalBritish Journal of Clinical Pharmacology
Early online date11 Jan 2021
Publication statusEarly online date - 11 Jan 2021

Bibliographical note

Publisher Copyright:
© 2020 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.

Copyright 2021 Elsevier B.V., All rights reserved.


  • antibiotics
  • antimicrobial resistance
  • fixed-dose combination
  • literature review

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)


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