Material and Method: A retrospective review using historical control of children hospitalized at Queen Sirikit National Institute of Child Health was conducted. The demographics, clinical, and treatment outcomes of 180 children receiving generic meropenem were compared with that of 180 children receiving original meropenem.

Results: Baseline demographics, clinical characteristics were comparable between both groups. The treatment outcomes on day 3, 7, and 14 of treatment were comparable between the two groups with overall improvement rates of 73.9% and 71.7% for generic and original meropenem, respectively (absolute difference: 2.2%, 95% CI: -6.9%, 11.4%). Both drugs were well tolerated, with only 1.6% of patients in each group who experienced adverse reactions.

Conclusion: Mapenem® exhibited comparable therapeutic effectiveness and tolerability with that of the brand-name formulation in the treatment of moderate to severe infections in a pediatric population.

Keywords: Generic drug, Meropenem, Pediatrics, Therapeutic equivalence