AI Article Synopsis

  • Indigenous drug manufacturers in India and China are combining β-lactam antibiotics with β-lactamase inhibitors in fixed doses without proper studies.
  • These combinations often use sulbactam or tazobactam with cephalosporins, mirroring approved ratios but lacking rigorous testing.
  • This practice can lead to poor clinical outcomes and may increase the risk of antibiotic resistance.

Article Abstract

In India and China, indigenous drug manufacturers market arbitrarily combined parenteral β-lactam and β-lactamase inhibitors (BL-BLIs). In these fixed-dose combinations, sulbactam or tazobactam is indiscriminately combined with parenteral cephalosporins, with BLI doses kept in ratios similar to those for the approved BL-BLIs. Such combinations have been introduced into clinical practice without mandatory drug development studies involving pharmacokinetic/pharmacodynamic, safety, and efficacy assessments being undertaken. Such unorthodox combinations compromise clinical outcomes and also potentially contribute to resistance development.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7179625PMC
http://dx.doi.org/10.1128/AAC.00168-20DOI Listing

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