The safety profile of meropenem in the elderly (aged > 65 years, n = 8
43) and/or renally impaired (creatinine clearance < 51 ml/min, n = 436
) was assessed by evaluating data from 26 phase III studies which comp
ared the use of meropenem (0.5 or 1.0 g, i.v. every 8 h) with other an
timicrobial agents in patients with bacterial infections. The overall
pattern and frequency of adverse events following meropenem therapy in
the elderly and/or renally impaired were similar to those in younger
and/or non-renally impaired cohorts and to imipenem/cilastatin and inj
ectable third generation cephalosporins. Both dosages of meropenem (0.
5 and 1.0 g, i.v. every 8 h) were generally well tolerated. There was
no clinically significant mean change in indicators of renal flux betw
een baseline and the end of treatment in any patient sub-group. Import
antly, meropenem-related seizures were rare (0.1%), even in patients w
ith renal impairment. In summary, meropenem has an excellent safety pr
ofile and is therefore suitable for use in elderly and/or renally impa
ired patients. (C) 1998 Published by Elsevier Science B.V./Internation
al Society of Chemotherapy. All rights reserved.