Bacteriological, pharmacokinetic and clinical evaluation of azithromycin in the pediatric field

H. Akita, Y. Sato, Y. Kusumoto, S. Iwata, Y. Takeuchi, T. Aoyama, T. Yokota, K. Sunakawa

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Azithromycin (AZM), a new macrolide antibiotic, in fine granules and in capsules was studied for pharmacokinetic and clinical evaluation in the pediatric patients. Antibacterial activity of AZM against 43 clinical isolates: AZM exhibited slightly lower activity against Gram-positive bacteria and 2~8-fold higher activity against Gram-negative bacteria than erythromycin or clarithromycin. Plasma or urine samples were collected from eight patients receiving the drug in fine granular form, and two patients receiving it in capsules for the determination of drug levels. The elimination half-lives of AZM after administration at dose of 10 mg/kg/day for 3 days were 50.0 and 51.2 hours for fine granules, and 41.5 hours for capsules. AUC(0~∞) was 11.7 and 24.3 μg · hr/ml for fine granules, and 8.3 μg · hr/ml for capsules. The cumulative excretion rates up to 120 hours after the start of treatment were 8.24 and 13.84% for fine granules, and 3.83% for capsules. AZM was administered to 123 patients once daily at 3.7~20.0 mg/kg body weight over 3 to 5 days with reference to the standard dose of 10 mg/kg. The drug was used to treat patients with pharyngitis, tonsillitis, scarlet fever, pneumonia, mycoplasmal pneumonia, chlamydial pneumonia, otitis media, pertussis, intestinal infection, and SSTI. The effectiveness of AZM was evaluated in 109 cases. The drug was rated 'excellent' in 65.1% of the patients and 'good' in 29.4%, resulting in an efficacy rate of 94.5%. Furthermore, AZM eradicated 43 of 46 (93.5%) bacteria that had been identified before the treatment. Three patients complained of side effects of urticaria (1 case) and diarrhea (2 cases). Abnormal laboratory changes were reported as follows: decreased leukocyte (3 cases), increased eosinophil (5), increased platelet (2), increased eosinophil and platelet, elevated GPT (1), and elevated GOT and GPT (1). The abnormalities, however, were mild enough to raise no clinically significant problems. In conclusion, AZM in once daily regimen was effective and safe in treatment of pediatric infections.

Original languageEnglish
Pages (from-to)899-916
Number of pages18
JournalJapanese Journal of Antibiotics
Volume49
Issue number10
Publication statusPublished - 1996
Externally publishedYes

Fingerprint

Azithromycin
Pharmacokinetics
Pediatrics
Capsules
Eosinophils
Pharmaceutical Preparations
Chlamydial Pneumonia
Pneumonia
Blood Platelets
Scarlet Fever
Tonsillitis
Clarithromycin
Pharyngitis
Whooping Cough
Macrolides
Urticaria
Otitis Media
Gram-Positive Bacteria
Erythromycin
Infection

ASJC Scopus subject areas

  • Pharmacology
  • Molecular Medicine

Cite this

Akita, H., Sato, Y., Kusumoto, Y., Iwata, S., Takeuchi, Y., Aoyama, T., ... Sunakawa, K. (1996). Bacteriological, pharmacokinetic and clinical evaluation of azithromycin in the pediatric field. Japanese Journal of Antibiotics, 49(10), 899-916.

Bacteriological, pharmacokinetic and clinical evaluation of azithromycin in the pediatric field. / Akita, H.; Sato, Y.; Kusumoto, Y.; Iwata, S.; Takeuchi, Y.; Aoyama, T.; Yokota, T.; Sunakawa, K.

In: Japanese Journal of Antibiotics, Vol. 49, No. 10, 1996, p. 899-916.

Research output: Contribution to journalArticle

Akita, H, Sato, Y, Kusumoto, Y, Iwata, S, Takeuchi, Y, Aoyama, T, Yokota, T & Sunakawa, K 1996, 'Bacteriological, pharmacokinetic and clinical evaluation of azithromycin in the pediatric field', Japanese Journal of Antibiotics, vol. 49, no. 10, pp. 899-916.
Akita H, Sato Y, Kusumoto Y, Iwata S, Takeuchi Y, Aoyama T et al. Bacteriological, pharmacokinetic and clinical evaluation of azithromycin in the pediatric field. Japanese Journal of Antibiotics. 1996;49(10):899-916.
Akita, H. ; Sato, Y. ; Kusumoto, Y. ; Iwata, S. ; Takeuchi, Y. ; Aoyama, T. ; Yokota, T. ; Sunakawa, K. / Bacteriological, pharmacokinetic and clinical evaluation of azithromycin in the pediatric field. In: Japanese Journal of Antibiotics. 1996 ; Vol. 49, No. 10. pp. 899-916.
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abstract = "Azithromycin (AZM), a new macrolide antibiotic, in fine granules and in capsules was studied for pharmacokinetic and clinical evaluation in the pediatric patients. Antibacterial activity of AZM against 43 clinical isolates: AZM exhibited slightly lower activity against Gram-positive bacteria and 2~8-fold higher activity against Gram-negative bacteria than erythromycin or clarithromycin. Plasma or urine samples were collected from eight patients receiving the drug in fine granular form, and two patients receiving it in capsules for the determination of drug levels. The elimination half-lives of AZM after administration at dose of 10 mg/kg/day for 3 days were 50.0 and 51.2 hours for fine granules, and 41.5 hours for capsules. AUC(0~∞) was 11.7 and 24.3 μg · hr/ml for fine granules, and 8.3 μg · hr/ml for capsules. The cumulative excretion rates up to 120 hours after the start of treatment were 8.24 and 13.84{\%} for fine granules, and 3.83{\%} for capsules. AZM was administered to 123 patients once daily at 3.7~20.0 mg/kg body weight over 3 to 5 days with reference to the standard dose of 10 mg/kg. The drug was used to treat patients with pharyngitis, tonsillitis, scarlet fever, pneumonia, mycoplasmal pneumonia, chlamydial pneumonia, otitis media, pertussis, intestinal infection, and SSTI. The effectiveness of AZM was evaluated in 109 cases. The drug was rated 'excellent' in 65.1{\%} of the patients and 'good' in 29.4{\%}, resulting in an efficacy rate of 94.5{\%}. Furthermore, AZM eradicated 43 of 46 (93.5{\%}) bacteria that had been identified before the treatment. Three patients complained of side effects of urticaria (1 case) and diarrhea (2 cases). Abnormal laboratory changes were reported as follows: decreased leukocyte (3 cases), increased eosinophil (5), increased platelet (2), increased eosinophil and platelet, elevated GPT (1), and elevated GOT and GPT (1). The abnormalities, however, were mild enough to raise no clinically significant problems. In conclusion, AZM in once daily regimen was effective and safe in treatment of pediatric infections.",
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