Basic and clinical studies of cefotiam in neonates and premature infants

S. Iwata, Y. Sato, Y. Kusumoto, H. Shiro, H. Akita, S. Nanri, T. Oikawa, M. Osano, K. Sunakawa

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The effect of cefotiam (CTM) on neonates and premature infants was examined. Minimum inhibitory concentrations of CTM against 190 clinically isolated strains were investigated. There was a strong antibacterial effect against Escherichia coli, Klebsiella spp., Proteus mirabilis and Streptococcus agalactiae, Staphylococcus aureus and Staphylococcus epidermidis, although some strains were resistant. CTM was given to 0~3, 4~7, and ≥ 8 day-old premature infants and neonates by iv injection at a dose of 20 mg/kg. Mean serum CTM levels were 62.3 μg/ml 15 minutes and 16.4 μg/ml 6 hours after injection, with a half-life of 3.6 hours for the 0~3 day-old premature infants. They were 38.5 μg/ml at 15 minutes and 10.1 μg/ml at 6 hours, with a half-life of 2.9 hours, for the 0~3 day-old neonates. The levels were 22.5 μg/ml at 15 minutes and 2.9 μg/ml at 6 hours, with a half-life of 1.9 hours, for th 4~7 day-old neonates, and 51.8 μg/ml at 15 minutes and 1.0 μg/ml at 6 hours, with a half-life of 1.1 hours, for the ≥ 8 day-old neonates. CTM was given to 0~3 and ≥ 8 day-old premature infants and neonates by 1-hour iv drip infusion at a dose of 20 mg/kg. The 0~3 day-old premature infant had a peak serum CTM level of 21.0 μg/ml 1 hour after the start of the infusion. The level decreased to 8.6 μg/ml at 7 hours and the half-life was 5.4 hours. The mean peak serum CTM level in 0~3 day-old neonates was 36.7 μg/ml at 1 hour, decreasing to a mean of 7.0 μg/ml at 7 hours; the half-life was 2.3 hours. The ≥ 8 day-old neonate had 2 peaks of serum CTM levels, 28.4 μg/ml at 30 minutes, decreasing to 21.7 μg/ml at 1 hour, then decreasing again to 23.7 μg/ml at 2 hours, and decreasing to 1.9 μg/ml at 7 hours, with a half-life of 1.7 hours after the completion of the infusion. Rates of CTM excretion into the urine after injection were examined. Although there were some differences in rates of CTM excretion with different ages, excretion rates 6 hours after the end of administration were about 10~20% for the 0~3 day-old group and about 40~50% for the ≥ 4 day-old group. CTM was given to 21 neonates and premature infants with bacterial infections. Clinical results were good or excellent in 20 of the 21 patients, and the efficacy rate was 95%. The bacteriological effect of CTM was studied in patients with infection caused by one of 6 strains (2 strains of S. aureus, 2 of S. epidermidis, and 2 of E. coli). Five of the 6 strains were eradicated (the exception was S. aureus), so the efficacy rate was 83%. Side effects of CTM were studied in 27 patients. Although no serious side effect was observed, diarrhea occurred in 1 patient, eosinophilia in 1, an elevated GOT level in 2 patients, elevated GOT and GPT level in 1 patient, and the protein induced by vitamin K absence of antagonist (PIVKA II) became detectable in 1 patient.

Original languageEnglish
Pages (from-to)2407-2420
Number of pages14
JournalJapanese Journal of Antibiotics
Issue number9
Publication statusPublished - 1986


ASJC Scopus subject areas

  • Pharmacology
  • Molecular Medicine

Cite this

Iwata, S., Sato, Y., Kusumoto, Y., Shiro, H., Akita, H., Nanri, S., Oikawa, T., Osano, M., & Sunakawa, K. (1986). Basic and clinical studies of cefotiam in neonates and premature infants. Japanese Journal of Antibiotics, 39(9), 2407-2420.