Therapeutic effectiveness of the generic preparation of meropenem (Mapenem) in the treatment of moderate to severe infection in children.
OBJECTIVE
To compare treatment effectiveness and tolerability between generic meropenem (Mapenem, Siam Pharmaceutical) and the original formulation.


METHODS
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.


CONCLUSIONS
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.
Department ofPediatrics, Queen Sirikit National Institute of Child Health, Bangkok, Thailand. warunee@vandepitte.eu
Warunee
W
Punpanich
Suchada
S
Srisarang
Uraiwan
U
Prachantasen
D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D016022:Case-Control Studies; D002648:Child; D002675:Child, Preschool; D016568:Drugs, Generic / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D000077731:Meropenem; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013785:Thailand; D013845:Thienamycins / Q000627:therapeutic use*
D000900:Anti-Bacterial Agents; D016568:Drugs, Generic; D013845:Thienamycins; D000077731:Meropenem