Pharmacokinetic and clinical studies of s-1108 in the pediatric field

Ryochi Fujii, Toshiaki Abe, Takeshi Tajima, Itaru Terashima, Hidenori Meguro, Atsuo Mori, Hajime Sato, Kenji Niino, Hajime Sato, Kenji Niino, Keisuke Sunakawa, Takao Yokota, Hironobu Akita, Satoshi Iwata, Yoshitake Satoh, Keisuke Sunakawa, Takao Yokota, Hironobu Akita, Satoshi Iwata, Yoshitake SatohKeisuke Sunakawa, Takao Yokota, Hironobu Akita, Satoshi Iwata, Yoshitake Satoh, Keisuke Sunakawa, Takao Yokota, Hironobu Akita, Satoshi Iwata, Yoshitake Satoh, Yoshikiyo Toyonaga, Toshihide Ishihara, Tomoaki Sano, Hironori Nakamura, Yoshikiyo Toyonaga, Toshihide Ishihara, Tomoaki Sano, Hironori Nakamura, Naoichi Iwai, Haruhi Nakamura, Mitsunobu Miyazu, Yumi Watanabe, Kuniyoshi Kuno, Hitoshi Kamiya, Kenji Kitamura, Toshiaki Ihara, Minoru Sakurai, Eiichi Azuma, Masahiro Itoh, Hitoshi Kamiya, Kenji Kitamura, Toshiaki Ihara, Minoru Sakurai, Eiichi Azuma, Masahiro Itoh, Haruki Mikawa, Masaru Kubota, Tohru Momoi, Susumu Hosoi, Hidekazu Nakato, Haruki Mikawa, Masaru Kubota, Tohru Momoi, Susumu Hosoi, Hidekazu Nakato, Haruki Mikawa, Masaru Kubota, Tohru Momoi, Susumu Hosoi, Hidekazu Nakato, Tadafumi Nishimura, Kumiko Sugita, Shigeyuki Aoki, Michio Takagi, Tadafumi Nishimura, Kumiko Sugita, Shigeyuki Aoki, Michio Takagi, Tadafumi Nishimura, Kumiko Sugita, Shigeyuki Aoki, Michio Takagi, Yohnosuke Kobayashi, Hirohiko Higashi, Minoru Kino, Yutaka Kobayashi, Tsunekazu Haruta, Shigekazu Kuroki, Kan etsu Okura, Takashige Okada, Seikyo Furukawa, Yasuhiro Kuroda, Eiji Takeda, Michinori Ito, Hiroshi Matsuda, Junichi Ishikawa, Kaichi Kida, Mitsuharu Murase, Hiroshi Matsuda, Junichi Ishikawa, Kaichi Kida, Mitsuharu Murase, Takanobu Kurashige, Hideo Morita, Yutaka Morisawa, Fumihiko Hamada, Yoshiro Tsuji, Tetsuya Yokoo, Katsutoshi Hayashi, Kunio Tomimasu, Toshihiko Kido, Yutaka Uehara, Junko Mori, Goichi Mori, Tetsuya Uchida, Yuichi Ootsuka, Yoshiro Tsuji, Tetsuya Yokoo, Katsutoshi Hayashi, Kunio Tomimasu, Toshihiko Kido, Yutaka Uehara, Junko Mori, Goichi Mori, Tetsuya Uchida, Yuichi Ootsuka, Yoshiro Tsuji, Tetsuya Yokoo, Katsutoshi Hayashi, Kunio Tomimasu, Toshihiko Kido, Yutaka Uehara, Junko Mori, Goichi Mori, Tetsuya Uchida, Yuichi Ootsuka, Yoshiro Tsuji, Tetsuya Yokoo, Katsutoshi Hayashi, Kunio Tomimasu, Toshihiko Kido, Yutaka Uehara, Junko Mori, Goichi Mori, Tetsuya Uchida, Yuichi Ootsuka, Takashi Motohiro, Shoichi Handa, Shuji Yamada, Shin ichiro Oki, Yoichiro Yoshinaga, Masafumi Aramaki, Keiko Oda, Yasutaka Sakata, Hirohisa Kato, Fumio Yamashita, Shoichi Imai, Kazushige Suzuki, Sayuri Okabayashi, Shinya Kaneko, Kotaro Ichikawa, Hiroko Soda, Toko Shimizu, Yoichi Nagata, Marie Kiba, Shinsaku Ishibashi, Koichi Takahashi, Amiko Sugiyama, Takumi Miyake, Hisaaki Araki, Mitsuo Kakisako, Yasuki Maeno, Tsuyoshi Shimohida, Tomoya Takagishi, Yoshinori Matsukuma, Tomoshige Hirata, Nobuo Tanaka, Kiyotaka Nagayama, Chikai Yasuoka, Masao Hayashi, Masano Amamoto, Naoki Tsumura, Eiichiro Ono, Shintaro Kamizono, Eisuke Nakashima, Shinichiro Nagamitsu, Takayo Nomasa, Yusaku Matsuo, Emi Higuchi, Kensuke Nagai, Keiko Sueyoshi, Nobuo Hashimoto, Ken Yuge, Kaoru Kubota, Akira Kawakami, Yoriko Watanabe, Takuji Fujisawa, Toru Nishiyama, Rikako Iwanaga, Kosuke Ushijima, Ryoichi Yamakawa, Jyunichi Yamamura, Kaoru Tominaga, Syunichi Dai, Hiroshi Ando, Naoki Kuda, Tamotsu Fujimoto, Hirotaka Motoyama, Takayuki Maruoka, Yukiji Date, Toru Sugimura, Sunao Nishiyori, Yuki Asakino, Katsuhiko Yamada, Seigo Kotematsu, Hiroshi Hayakawa, Hirokazu Sasaki, Koichi Kimura, Takashi Yamada

Research output: Contribution to journalArticlepeer-review

11 Citations (Scopus)

Abstract

S-1108 in granules, a new oral cephem antibiotic, was pharmacokinetically and clinically evaluated in the pediatric field and the following results were obtained. 1. Pharmacokinetics S-1108 was administered at single doses of 2, 3, 4, 6 mg/kg orally and the following results were obtained on Cmax, T 1/2 and AUC, respectively: Cmax: 0.79, 1.03, 1.39, 1.06 µg/ml, T 1/2: 1.28 ±0.40, 1.27±0.65, 1.10±0.29, 1.83 hrs., AUC: 2.65±0.63, 3.99±2.77, 5.25±1.83, 5.15 µg·hr/ml. These values indicated a dose-dependent pharmacokinetic behavior. Urinary recovery rates were 12.5-30.0% in the first 8(6) hours after administration. 2. Clinical results The clinical efficacy of S-1108 was evaluated in 456 patients with various infections. S-1108 was administered at a dose of 2–4mg/kg three time a day to most patients. The overall clinical efficacy rate was 95.0%. In 294 cases with identified causative pathogen, the clinical efficacy rate was 96.9%, and the bacteriological eradication rate was 89.0%. Side effects occurred in 18 (3.23%) of 558 patients subjected to safety analyses. The main side effect was diarrhea but those side effects were mild and reversible. Abnormal laboratory test results were observed in 25 cases, (eosinophilia and elevated GOT and GPT). These abnormalities were not dose-dependent and also seen with other cephems to a similar extent. No particular and serious problems were associated with administration of this drug. Based on the above results, S-1108 is considered to be very useful at a standard dose of 2–4 mg/kg t.i.d. against most infections encountered in the pediatric field out-patient clinic.

Original languageEnglish
Pages (from-to)921-941
Number of pages21
Journalthe japanese journal of antibiotics
Volume48
Issue number7
DOIs
Publication statusPublished - 1995 Jul

ASJC Scopus subject areas

  • Microbiology (medical)
  • Pharmacology (medical)
  • Infectious Diseases

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