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  • Title: [Fundamental and clinical studies on intravenous drip infusion of dibekacin in the pediatric field].
    Author: Motohiro T, Tanaka K, Koga T, Shimada Y, Nishiyama T, Ishimoto K, Tominaga K, Yamashita F, Sakaguchi Y, Kimura K.
    Journal: Jpn J Antibiot; 1985 Aug; 38(8):2068-86. PubMed ID: 4079001.
    Abstract:
    Dibekacin (DKB), an antibiotic of aminoglycoside group, was administered at 4 different dosages of 0.5, 1.0, 1.5 and 2.0 mg/kg as intravenous drip infusion taking 30 minutes or 1 hour. For each dose level, 3 cases each were used out of 24 boys from 1 year and 1 month to 14 years and 7 months of age, and serum concentrations as well as urinary concentrations and recovery rate were determined. After removed of 4 cases unassessable of therapeutic efficacy, 7 cases consisting of 1 case of chronic bronchitis, 1 case of lung abscess and 5 cases of urinary tract infections were treated with DKB at a mean daily dosage of 3.3 mg/kg in 2 or 3 divided doses as intravenous drip infusion taking 30 minutes or 1 hour. The mean treatment period was 7 days. The clinical and bacteriological results were analyzed in these cases and for analysis of side effects drop out cases were also included. The following results were obtained. Following 30 minutes intravenous drip infusion of DKB at 0.5, 1.0, 1.5 and 2.0 mg/kg, the serum concentration peaked at the end of infusion for all dose levels. The highest peak concentration of 9.17 mcg/ml was obtained for the dose level of 2.0 mg/kg. The highest dosage with which serum concentration does not exceed concentrations of 10 to 12 mcg/ml was found to be 2.0 mg/kg. The mean highest serum concentrations obtained were 1.65, 3.49, 5.40 and 8.67 mcg/ml for the dosages of 0.5, 1.0, 1.5 and 2.0 mg/kg, respectively, and the mean AUCs determined by the two-compartment model were 2.99, 6.04, 10.5 and 14.2 mcg X hr/ml, respectively, showing dose response relation in terms of peak concentration and AUC among groups. The mean T1/2 values for each dosage were 1.55, 1.54, 1.77 and 2.03 hours, respectively, with a longer tendency in T1/2 for the dose level of 2.0 mg/kg with unknown cause. When 0.5, 1.0, 1.5 and 2.0 mg/kg of DKB were infused taking 1 hour, the peak of serum concentration appeared also at the end of the infusion. The highest concentration was obtained with 2.0 mg/kg and it was 7.02 mcg/ml. Considering from the concentrations obtained for 0.5 mg/kg and 1.0 mg/kg groups the highest dosage at which the serum concentration does not exceed 10 to 12 mcg/ml was estimated to be 2.5 mg/kg.(ABSTRACT TRUNCATED AT 400 WORDS)
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