Clinical studies on clarithromycin dry syrup in the pediatric field: Pediatric Study Group of Te-031 Dry Syrup (Chairman: Ryochi Fujii)

Ryochi Fujii, Satoshi Iwata, Yoshitake Satoh, Itaru Terashima, Hidenori Meguro, Keisuke Sunakawa, Yoshinao Takeuchi, Tatsuo Aoyama, Hironobu Akita, Takao Yokota, Hironori Nakamura, Yoshikiyo Toyonaga, Toshihide Ishihara, Naoichi Iwai, Haruhi Nakamura, Tadafumi Nishimura, Takashi Motohiro

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Abstract

Clarithromycin dry syrup, a new drug preparation, was clinically evaluated in the pediatric field and the following results were obtained:1. Absorption and excretion in infants administered with single oral dose of 5 mg (potency)/kg and 10 mg/kg, the Cmax was 2.26±0.42 and 3.23μg/ml; Tmax, 1.6±0.1 and 2.0 hours; T 1/2, 3.89±0.52 and 2.06 hours; AUC (0 ~∞), 13.48±1.93 and 13.84μg-hr/ml, respectively. Urinary concentrations peaked in 2~4 hours after administration at 5 mg/kg and 0~2 hours at 10 mg/kg. Urinary recovery rates in the first 6 hours were 25.8±3.9% at 5 mg/kg and 20.7% at 10 mg/kg. 2. Clinical results the clinical efficacy of the drug was evaluated in 150 patients with various infections. Clarithromycin dry syrup was administered to all the patients at daily doses of 10~15 mg/kg divided into 2~3 equal doses. the overall clinical efficacy rate was 98.0%, and this drug was effective in 98.9% of 90 patients for whom the causative pathogens were identified and in 96.7% of the other 60 patients for whom the causative pathogens were unknown. the bacteriological eradication rate was 88.5%. the efficacy and eradication rates for 19 patients who had not responded to previous chemotherapy that lasted for more than three days were 94.7% (18/19) and 75.0%, respectively. Side effects occurred in 4 (2.4%) of 169 patients subjected to safety analyses, but none was serious. As to abnormal laboratory test results, moderate increases of eosinophils and elevations of transaminases were observed in 5.9% of the cases. No particular and serious problems were associated with administration of this drug. Based on the above results, clarithromycin dry syrup is considered to be very useful and have a good compliance at a daily dose of 10~15mg/kg divided into 2~3 doses.

Original languageEnglish
Pages (from-to)1283-1298
Number of pages16
Journalthe japanese journal of antibiotics
Volume47
Issue number10
DOIs
Publication statusPublished - 1994 Jan 1

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ASJC Scopus subject areas

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

Cite this

Fujii, R., Iwata, S., Satoh, Y., Terashima, I., Meguro, H., Sunakawa, K., Takeuchi, Y., Aoyama, T., Akita, H., Yokota, T., Nakamura, H., Toyonaga, Y., Ishihara, T., Iwai, N., Nakamura, H., Nishimura, T., & Motohiro, T. (1994). Clinical studies on clarithromycin dry syrup in the pediatric field: Pediatric Study Group of Te-031 Dry Syrup (Chairman: Ryochi Fujii). the japanese journal of antibiotics, 47(10), 1283-1298. https://doi.org/10.11553/antibiotics1968b.47.1283