Arbekacin postmarketing clinical study

Keisuke Sunakawa, Hiroshi Sakata, Yoshitake Sato, Itaru Terashima, Kouya Shiba, Satoshi Iwata, Hironobu Akita, Tetsuo Yokoyama, Hiroyuki Shiro, Ayumu Sunaoshi, Syunkichi Baba, Naoichi Iwai, Kazunobu Ouchi, Takashi Motohiro, Naoki Tsumura, Nobuo Sato, Shigeki Shibasaki

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Abstract

We conducted a multicenter postmarketing clinical study to obtain arbekacin sulfate (ABK) pharmacokinetic parameters in children younger than 6 years, with the following results: Patients were divided into group A; neonates and low-birth-weight (LBW) infants (n=7) and group B; infants and children (n=3). A dose of 2-3 mg/kg of ABK was administered intravenously by infusion for 30 min, and pharmacokinetic parameters were obtained. Two LBW infants and one neonate were excluded because of infusion errors and administration of a steroid drug that may affect ABK efficacy. Maximum plasma concentrations (Cmax) were 6.64±1.13 (μg/mL) for group A (n=4) and 7.91±1.43 (μg/mL) for group B (n=3), indicating no significant difference (p=0.2429). Steady-state volume of distributions (Vdss) were 0.382±0.045 (L/kg) and 0.304±0.060 (L/kg), and plasma half-lives (t1/2) 3.20±0.91 (h) and 1.73 ±0.43 (h) for groups A and B. Although these were not significant different between groups (p=0.1049 and 0.0515), group A means were larger. Total body clearance (Cltot) was 0.091±0.017 (L/h/kg) and 0.154 ±0.030 (L/h/kg) for groups A and B. The group B mean was significantly larger (p=0.0148). Predicted plasma concentrations 12 h after infusion (trough), calculated ABK pharmacokinetic parameters, were 0.42±0.25 (μg/mL) for groups A and B. ABK plasma concentration profiles of these children were similar to those of adults, which were recommended in consideration of clinical effects and safety.

Original languageEnglish
Pages (from-to)91-96
Number of pages6
JournalJapanese Journal of Chemotherapy
Volume51
Issue number2
Publication statusPublished - 2003 Feb 1
Externally publishedYes

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ASJC Scopus subject areas

  • Pharmacology

Cite this

Sunakawa, K., Sakata, H., Sato, Y., Terashima, I., Shiba, K., Iwata, S., Akita, H., Yokoyama, T., Shiro, H., Sunaoshi, A., Baba, S., Iwai, N., Ouchi, K., Motohiro, T., Tsumura, N., Sato, N., & Shibasaki, S. (2003). Arbekacin postmarketing clinical study. Japanese Journal of Chemotherapy, 51(2), 91-96.