Clinical studies on clarithromycin dry syrup in the pediatric field

R. Fujii, S. Iwata, Y. Satoh, I. Terashima, H. Meguro, K. Sunakawa, Y. Takeuchi, T. Aoyama, H. Akita, T. Yokota, H. Nakamura, Y. Toyonaga, T. Ishihara, N. Iwai, H. Nakamura, T. Nishimura, T. Motohiro

Research output: Contribution to journalArticle

6 Citations (Scopus)

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 C(max) was 2.26 ± 0.42 and 3.23 μg/ml; T(max), 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 13.84 μg · 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 10~15 mg/kg divided into 2~3 doses.

Original languageEnglish
Pages (from-to)1283-1298
Number of pages16
JournalJapanese Journal of Antibiotics
Volume47
Issue number10
Publication statusPublished - 1994
Externally publishedYes

Fingerprint

Clarithromycin
Pediatrics
Pharmaceutical Preparations
Drug Compounding
Transaminases
Eosinophils
Area Under Curve
Clinical Studies
Safety
Drug Therapy
Infection

ASJC Scopus subject areas

  • Pharmacology
  • Molecular Medicine

Cite this

Fujii, R., Iwata, S., Satoh, Y., Terashima, I., Meguro, H., Sunakawa, K., ... Motohiro, T. (1994). Clinical studies on clarithromycin dry syrup in the pediatric field. Japanese Journal of Antibiotics, 47(10), 1283-1298.

Clinical studies on clarithromycin dry syrup in the pediatric field. / 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.

In: Japanese Journal of Antibiotics, Vol. 47, No. 10, 1994, p. 1283-1298.

Research output: Contribution to journalArticle

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', Japanese Journal of Antibiotics, vol. 47, no. 10, pp. 1283-1298.
Fujii R, Iwata S, Satoh Y, Terashima I, Meguro H, Sunakawa K et al. Clinical studies on clarithromycin dry syrup in the pediatric field. Japanese Journal of Antibiotics. 1994;47(10):1283-1298.
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. / Clinical studies on clarithromycin dry syrup in the pediatric field. In: Japanese Journal of Antibiotics. 1994 ; Vol. 47, No. 10. pp. 1283-1298.
@article{0cb254adf8ce4862845a74cb2f806ac3,
title = "Clinical studies on clarithromycin dry syrup in the pediatric field",
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 C(max) was 2.26 ± 0.42 and 3.23 μg/ml; T(max), 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 13.84 μg · 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 10~15 mg/kg divided into 2~3 doses.",
author = "R. Fujii and S. Iwata and Y. Satoh and I. Terashima and H. Meguro and K. Sunakawa and Y. Takeuchi and T. Aoyama and H. Akita and T. Yokota and H. Nakamura and Y. Toyonaga and T. Ishihara and N. Iwai and H. Nakamura and T. Nishimura and T. Motohiro",
year = "1994",
language = "English",
volume = "47",
pages = "1283--1298",
journal = "The Journal of antibiotics. Ser. B",
issn = "0368-2781",
publisher = "Japan Antibiotics Research Association",
number = "10",

}

TY - JOUR

T1 - Clinical studies on clarithromycin dry syrup in the pediatric field

AU - Fujii, R.

AU - Iwata, S.

AU - Satoh, Y.

AU - Terashima, I.

AU - Meguro, H.

AU - Sunakawa, K.

AU - Takeuchi, Y.

AU - Aoyama, T.

AU - Akita, H.

AU - Yokota, T.

AU - Nakamura, H.

AU - Toyonaga, Y.

AU - Ishihara, T.

AU - Iwai, N.

AU - Nakamura, H.

AU - Nishimura, T.

AU - Motohiro, T.

PY - 1994

Y1 - 1994

N2 - 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 C(max) was 2.26 ± 0.42 and 3.23 μg/ml; T(max), 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 13.84 μg · 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 10~15 mg/kg divided into 2~3 doses.

AB - 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 C(max) was 2.26 ± 0.42 and 3.23 μg/ml; T(max), 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 13.84 μg · 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 10~15 mg/kg divided into 2~3 doses.

UR - http://www.scopus.com/inward/record.url?scp=0027972054&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0027972054&partnerID=8YFLogxK

M3 - Article

VL - 47

SP - 1283

EP - 1298

JO - The Journal of antibiotics. Ser. B

JF - The Journal of antibiotics. Ser. B

SN - 0368-2781

IS - 10

ER -