title: Safety of intravenous infusion of doripenem.
abstract: Carbapenems remain a mainstay for the empirical treatment of serious nosocomial infection. Although the tolerance and safety profile of the carbapenems as a class is favorable, the primary safety concern is the potential for treatment-emergent seizures. In preclinical testing, doripenem, a new carbapenem antibiotic, showed negligible neurotoxic effects. The safety and tolerability of intravenous doripenem was evaluated in 1 phase 2 and in 6 phase 3 clinical trials conducted with patients with nosocomial pneumonia, including ventilator-associated pneumonia; complicated intra-abdominal infection; and complicated urinary tract infection. Safety data were available from 1817 patients who received doripenem and 1325 patients who received 1 of 4 active comparator drugs as part of this development program. Overall, intravenous doripenem was found to be safe and well tolerated, demonstrating a safety profile comparable to that of comparator agents and a limited propensity to induce seizures, including when administered via 1-h or 4-h infusion. j.
authors.affiliation: Anti-Infectives Clinical Development, Johnson & Johnson Pharmaceutical Research & Development, 6500 Paseo Padre Pkwy., Fremont, CA 94555, USA. rredman@its.jnj.com
authors.forename: Rebecca
authors.initials: R
authors.lastname: Redman
authors.forename: Thomas M
authors.initials: TM
authors.lastname: File
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000494:pharmacology; D019540:Area Under Curve; D015780:Carbapenems / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D003428:Cross Infection / Q000188:drug therapy; D000077726:Doripenem; D004355:Drug Stability; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D006967:Hypersensitivity; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D008826:Microbial Sensitivity Tests; D053717:Pneumonia, Ventilator-Associated / Q000188:drug therapy*; D011786:Quality Control
chemical_list: D000900:Anti-Bacterial Agents; D015780:Carbapenems; D000077726:Doripenem