Vol.59 No.5 September 2011

Evaluation of faropenem (Farom^®) dry syrup efficacy, safety, and palatability in pediatric patients with acute otitis media

Toshiyuki Fujisawa¹⁾, Kenji Suzuki¹⁾, Yasuhiro Ito²⁾, Kiyotaka Kondo³⁾, Masanori Oshika⁴⁾, Masashi Ozeki⁵⁾, Tetsuya Kasashima⁶⁾, Masaki Sakai⁷⁾, Kunimitsu Sakai⁸⁾, Ken Sawada⁹⁾, Junichiro Shimada¹⁰⁾, Akio Suzuki¹¹⁾, Masaki Tone¹²⁾, Hirokazu Hattori¹³⁾, Teruaki Hattori¹⁴⁾, Futoshi Matsuda¹⁵⁾, Naoya Miyamoto¹⁶⁾, Hisato Motai¹⁷⁾ and Masatomo Yamada¹⁸⁾

¹⁾Department of Otolaryngology, Banbuntane Hotokukai Hospital, Fujita Health University, 3-6-10 Otobashi, Nakagawa-ku, Nagoya, Aichi, Japan
²⁾Ito ENT Clinic
³⁾Ueda ENT Clinic
⁴⁾Oshika ENT Clinic
⁵⁾Ozeki ENT Clinic
⁶⁾Kasashima ENT Clinic
⁷⁾Sakai ENT Clinic
⁸⁾Sakai ENT Clinic
⁹⁾Sawada ENT Clinic
¹⁰⁾Shimada ENT Clinic
¹¹⁾Suzuki ENT Clinic
¹²⁾Tone ENT Clinic
¹³⁾Hattori Otorhinolaryngology Clinic
¹⁴⁾Hattori ENT Clinic
¹⁵⁾Matsuda ENT Clinic
¹⁶⁾Miyamoto ENT Clinic
¹⁷⁾Motai ENT Clinic
¹⁸⁾Yamada ENT Clinic

Abstract

We evaluated Farom^® dry syrup(FRPM) efficacy, safety, and palatability in 207 pediatric patients with acute otitis media, conducting a postmarketing study at 17 Aichi prefectural medical institutions from August 2009 to March 2010. Among subjects 167 were analyzed for safety and 125 for efficacy.
Efficacy based on Evaluation Standards (reference 1) was 92.0% (115/125). Efficacy by organism in monomicrobial infection was Streptococcus pneumoniae 100% (27/27), Haemophilus influenzae 83.3% (10/12), and Moraxella catarrhalis 75.0% (3/4).
Bacterial eradication by strain number was S. pneumoniae 93.8% (15/16), H. influenzae 90.0% (9/10), and M. catarrhalis 100.0% (4/4).
The MIC₉₀ for S. pneumoniae was 0.5 μg/mL, for penicillin-intermediate S. pneumoniae(PISP) 0.25 μg/mL, and for penicillin-resistant S. pneumoniae(PRSP) was 0.5 μg/mL.
The incidence of adverse drug reactions per case was 4.8% (8/167). Diarrhea, none of which was serious, was reported in 8.
An evaluation of "difficult" or "impossible" was made by 4.6% (5/108) of patients.
These findings indicate that this drug was clinically useful in pediatric patients with acute otitis media.

Key word

faropenem, acute otitis media, child, postmarketing surveillance

Received

November 26, 2010

Accepted

June 20, 2011

Jpn. J. Chemother. 59 (5): 474-485, 2011