title: [Results of a post-marketing surveillance of meropenem administered over 2 g/day for serious infectious diseases].
abstract: The post-marketing surveillance of meropenem (Meropen®) administered over 2g/day for serious infectious diseases was conducted between August 2011 and June 2013 to evaluate safety and efficacy under actual clinical use. There were 382 and 322 evaluable cases for safety and efficacy respectively, of 399 case cards collected from 87 institutions. In safety analysis, the incidence of adverse drug reactions (ADRs) associated with use of meropenem (including abnormal laboratory findings) was 19.1% (73/382 cases), and the main ADRs were hepatic function abnormal, aspartate aminotransferase increased, alanine aminotransferase increased, liver disorder, and diarrhoea, which were similar to these observed in the post-marketing surveillances of meropenem conducted before. In efficacy analysis, the efficacy was 73.6% (237/322 cases), which is as same as 71.4% (3214/4504 cases) of post-marketing surveillance of meropenem conducted after first approval under 2 g/day for infectious diseases. These results confirmed meropenem (Meropen®) is one of the useful antimicrobial agents for serious infectious diseases.
authors.forename: Koji
authors.initials: K
authors.lastname: Wakisaka
authors.forename: Shunsuke
authors.initials: S
authors.lastname: Tani
authors.forename: Kazuo
authors.initials: K
authors.lastname: Ishibashi
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nukui
authors.forename: Munehiko
authors.initials: M
authors.lastname: Nagao
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology; D003967:Diarrhea / Q000139:chemically induced; D006801:Humans; D007239:Infections / Q000188:drug therapy*; D000077731:Meropenem; D011358:Product Surveillance, Postmarketing; D013845:Thienamycins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000900:Anti-Bacterial Agents; D013845:Thienamycins; D000077731:Meropenem