PMID- 15150186
OWN - NLM
STAT- MEDLINE
DCOM- 20040831
LR  - 20181130
IS  - 0305-7453 (Print)
IS  - 0305-7453 (Linking)
VI  - 53 Suppl 2
DP  - 2004 Jun
TI  - Safety and tolerability of ertapenem.
PG  - ii75-81
AB  - Ertapenem is a Group 1 carbapenem that was licensed in the USA in November 2001 
      and in Europe in April 2002. Its safety profile has been assessed in 240 healthy 
      volunteers participating in 12 clinical pharmacology studies and in 2046 patients 
      enrolled in five Phase IIa and eight Phase IIb/III clinical trials. The most 
      common drug-related adverse events (AEs) reported in trials comparing ertapenem 
      and piperacillin-tazobactam and in trials comparing ertapenem and ceftriaxone 
      were: diarrhoea (ertapenem versus piperacillin-tazobactam 5.0% versus 7.0%; 
      ertapenem versus ceftriaxone 5.6% versus 5.9%); infused vein complications 
      (ertapenem versus piperacillin-tazobactam 4.5% versus 7.9%; ertapenem versus 
      ceftriaxone 3.2% versus 4.6%); nausea (ertapenem versus piperacillin-tazobactam 
      2.5% versus 3.4%; ertapenem versus ceftriaxone 3.4% versus 3.3%); and elevations 
      in alanine aminotransferase levels (ertapenem versus piperacillin-tazobactam 8.8% 
      versus 7.3%; ertapenem versus ceftriaxone 8.3% versus 6.9%). Most 
      ertapenem-related AEs were reported as mild-to-moderate in intensity. Ertapenem 
      was not associated with prolongation of the QTc interval. Local reactions of 
      moderate-to-severe intensity at the infusion site were infrequent and occurred 
      with similar frequency in the ertapenem and comparator treatment groups. No 
      overall differences in safety were observed between elderly (aged > or = 65 years 
      and > or = 75 years) and younger patients. Ertapenem, 1 g once a day given by 
      intravenous infusion or intramuscular injection, was generally well tolerated and 
      had overall safety and tolerability profiles similar to those of 
      piperacillin-tazobactam and ceftriaxone.
FAU - Teppler, Hedy
AU  - Teppler H
AD  - Merck Research Laboratories, West Point, PA 19486, USA.
FAU - Gesser, Richard M
AU  - Gesser RM
FAU - Friedland, Ian R
AU  - Friedland IR
FAU - Woods, Gail L
AU  - Woods GL
FAU - Meibohm, Anne
AU  - Meibohm A
FAU - Herman, Gary
AU  - Herman G
FAU - Mistry, Goutam
AU  - Mistry G
FAU - Isaacs, Robin
AU  - Isaacs R
LA  - eng
PT  - Journal Article
PT  - Review
PL  - England
TA  - J Antimicrob Chemother
JT  - The Journal of antimicrobial chemotherapy
JID - 7513617
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Lactams)
RN  - 0 (beta-Lactams)
RN  - 157044-21-8 (Piperacillin, Tazobactam Drug Combination)
RN  - 75J73V1629 (Ceftriaxone)
RN  - 87-53-6 (Penicillanic Acid)
RN  - G32F6EID2H (Ertapenem)
RN  - X00B0D5O0E (Piperacillin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anti-Bacterial Agents/administration & dosage/*adverse effects/therapeutic use
MH  - Bacteria, Aerobic/drug effects
MH  - Bacteria, Anaerobic/drug effects
MH  - Bacterial Infections/*drug therapy/microbiology
MH  - Ceftriaxone/administration & dosage/adverse effects/therapeutic use
MH  - *Clinical Trials as Topic
MH  - Community-Acquired Infections/*drug therapy/microbiology
MH  - Ertapenem
MH  - Female
MH  - Humans
MH  - Lactams/administration & dosage/*adverse effects/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Penicillanic Acid/administration & dosage/adverse effects/analogs & 
      derivatives/therapeutic use
MH  - Piperacillin/administration & dosage/adverse effects/therapeutic use
MH  - Piperacillin, Tazobactam Drug Combination
MH  - Randomized Controlled Trials as Topic
MH  - beta-Lactams
RF  - 20
EDAT- 2004/05/20 05:00
MHDA- 2004/09/01 05:00
CRDT- 2004/05/20 05:00
PHST- 2004/05/20 05:00 [pubmed]
PHST- 2004/09/01 05:00 [medline]
PHST- 2004/05/20 05:00 [entrez]
AID - 53/suppl_2/ii75 [pii]
AID - 10.1093/jac/dkh209 [doi]
PST - ppublish
SO  - J Antimicrob Chemother. 2004 Jun;53 Suppl 2:ii75-81. doi: 10.1093/jac/dkh209.