Vol.57 No.S-1 March 2009
Safety profile of tebipenem pivoxil, a new oral carbapenem, in pediatric patients
1)Department of Pharmacology, Jikei University School of Medicine, 3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo, Japan
2)Laboratory of Infectious Diseases Science, Graduate School of Infection Control Sciences, Kitasato University
Abstract
We assessed the clinical safety of tebipenem pivoxil(TBPM-PI), a new oral carbapenem, in 440 pediatric patients with respiratory tract infections, acute otitis media, and rhinosinusitis.
1. Adverse events (AEs) related to subjective symptoms and objective findings
We evaluated safety in 440 patients. The incidence of AEs was 46.6% (205/440) and adverses drug reactions (ADRs) 23.0% (101/440). Over 90% of AEs were mild or moderate and all severe AEs were stools watery. Three serious adverse events reported in 3 subjects were all incidental to viral infection and judged by the investigator to be unrelated to TBPM-PI. The most common AE was diarrhea (including loose bowel, mushy stool, and stools watery) and vomiting and nasopharyngitis. No convulsions were reported.
2. Diarrhea associated with TBPM-PI
The incidence of diarrhea related to TBPM-PI was 19.5% (86/440). A higher incidence was observed in patients less than 3 years old, and the rate of moderate and severe events was higher in this age group. No event such as dehydration adversely affected systemic conditions and only one subject discontinued therapy due to moderate drug-related diarrhea.
3. Abnormal laboratory test values
The incidence of AEs related to laboratory abnormalities evaluated in 432 subjects was 6.3% (27/432) and the incidence of ADRs 5.3% (23/432). Major AEs were increased platelet count, blood urea, and eosinophil percentage.
Results suggest that the safety profile of TBPM-PI does not differ from that of other beta-lactams, including carbapenems, and no event was clinically significant. TBPM-PI could thus be used safely in treating pediatric infectious diseases.
Key word
tebipenem pivoxil, child, adverse event
Received
September 26, 2008
Accepted
December 15, 2008
Jpn. J. Chemother. 57 (S-1): 192-204, 2009
