Therapeutic Effectiveness of the Generic Preparation of Meropenem (Mapenem®) in the Treatment of Moderate to Severe Infection in Children Warunee Punpanich MD, PhD*,**, Suchada Srisarang BSc (Statistics)***, Uraiwan Prachantasen BNS***
* Department of Pediatrics, Queen Sirikit National Institute of Child Health, Bangkok, Thailand ** College of Medicine, Rangsit University, Bangkok, Thailand *** Clinical Research Unit, Queen Sirikit National Institute of Child Health, Bangkok, Thailand
Affiliation :
Objective : To compare treatment effectiveness and tolerability between generic meropenem (Mapenem®, Siam Pharmaceutical)
and the original formulation.
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
