PHARMACOKINETIC AND CLINICAL STUDIES ON CEFMENOXIME IN NEONATES AND INFANTS

• Published in: Japanese journal of antibiotics 1989/12/25, Vol.42(12), pp.2641-2659
• Main Authors: IWAI, NAOICHI, SHIBATA, MOTOHIRO, MIZOGUCHI, FUMIKO, NAKAMURA, HARUHI, KATAYAMA, MICHIHIRO, TANEDA, YOICHI, INOKUMA, KAZUYO, OZAKI, TAKAO, ICHIKAWA, TAKAYUKI, MATSUI, SHOJI, TAUCHI, NOBUO, KAWAMURA, MASAHIKO, MIYAZU, MITSUNOBU, NAKAYAMA, KEIKO
• Format: Article
• Language: Japanese
• Subjects: Alanine Transaminase - blood; Aspartate Aminotransferases - blood; Bacterial Infections - drug therapy; Cefmenoxime - adverse effects; Cefmenoxime - pharmacokinetics; Cefmenoxime - therapeutic use; Drug Evaluation; Female; Humans; Infant; Infant, Newborn - metabolism; Male
• ISSN: 0368-2781; 2186-5477
• DOI: 10.11553/antibiotics1968b.42.2641

Pharmacokinetic and clinical studies on cefmenoxime (CMX) in neonates and infants were conducted. 1. CMX 20mg/kg was administered by intravenous bolus injection to 6 neonates (with ages 2 to 20 days) and 5 infants (with ages 36 to 107 days) and its serum concentration and urinary excretion rates were determined. In the neonates, serum concentrations of CMX after intravenous administration reached peak levels of 48.2 to 90.7μg/ml (mean 70.4±14.3μg/ml) in 1/4 hour, then declined with halflives of 1.27 to 5.19 hours (mean 2.28±1.56 hours), and were 3.6 to 16.9μg/ml (mean 8.3±6.0μg/ml) at 6 hours. In the infants, serum concentrations at 1/4 hour were 67.5 to 111.0μg/ml (mean 95.5±18.0μg/ml) ; half-lives were 0.64 to 0.94 hour (mean 0.81±0.13 hour) ; and the serum concentrations at 6 hours were 0.2 to 1.1μg/ml (mean 0.7±0.4μg/ml). Mean peak serum concentrations in the neonates tended to be lower than those in the infants, but higher than those in children. Regarding the age differences of serum concentrations due to age in the neonates, their peak levels tended to be lower in younger ones. Half-lives were shorter in older subjects and, in early infancy, approached values observed in children. Urinary recovery rates in the first 6 hours after intravenous administration ranged from 43.6 to 87.5% (mean 61.6±14.6%) in the neonates and from 52.1 to 90.8% (mean 78.0±15.1%) in the infants. Thus, recovery rates were high even in younger subjects and tended to be higher in older subjects. 2. CMX was administered to 27 neonates and 4 infants to investigate its clinical effect, bacteriological effect and side effects. Clinical efficacy ratings of the drug in 19 neonate cases that could be evaluated (1 with purulent meningitis, 2 with suspected septicemia, 1 with acute bronchitis, 12 with acute pneumonia, 1 with impetigo, 1 with periumbilical abscess and 1 with acute pyelonephritis) were “excellent” in 14 cases, “good” in 4, and “poor” in 1. The efficacy rate covering “excellent” and “good” was 94.7%. In 4 infants (2 with acute pneumonia, 1 with periumbilical abscess and 1 with acute pyelonephritis), “excellent” was obtained in 2 cases and “good” in 2 cases. Thus, all the cases showed “good” or higher ratings. Bacteriologically, 1 strain of Staphylococcus aureus and 3 strains of Escherichia coli in neonates were eradicated while, in infants, 1 strain of S. aureus persisted but 1 of E. coli was eradicated. Clinically, no side effect was found at all. The abnormal laboratory