Pharmacokinetic studies on oral antibiotics in pediatrics. V. A pharmacokinetic study on cefdinir in pediatrics
Nakamura, H.; Iwai, N.
Japanese Journal of Antibiotics 45(1): 12-27
1992
ISSN/ISBN: 0368-2781 PMID: 1495194 Document Number: 392257
A pharmacokinetic study was performed on cefdinir (CFDN, FK482) 5% fine granules for pediatric use, and pharmacokinetic parameters were calculated. Twenty school children were administered orally a dose level of 3 mg/kg of CFDN fine granules either at 30 minutes before meal (14 children) or 30 minutes after meal (6 children). Plasma concentrations and urinary recovery rates of CFDN were measured. Tmax, Cmax, T 1/2 and urinary recovery rate (0.apprx.8 hours) following the administration before meal were 2.00 .+-. 0.00 hours, 1.14 .+-. 0.11 .mu.g/ml, 1.63 .+-. 0.14 hours and 23.68 .+-. 2.92%, respectively, Tmax, Cmax, T 1/2 and urinary recovery rate following the administration after meal were 3.67 .+-. 0.33 hours, 0.71 .+-. 0.06 .mu.g/ml, 2.18 .+-. 0.16 hours and 21.76 .+-. 2.36%, respectively. Earlier Tmax and higher Cmax were observed when the drug was administered before meal than when administered after meal. There was no statistically significant difference between the 2 groups in urinary recovery rates. However, statistically significant difference was found between the 2 groups when the cross-over technique was used in 6 school children. Nineteen younger children (before meal) and 6 younger children (after meal) were administered with the drug in the same way, and several parameters were measured. Tmax, Cmax, T 1/2 and urinary recovery rate following the administration before meal were 2.11 .+-. 0.11 hours, 0.98 .+-. 0.14 .mu.g/ml, 1.71 .+-. 0.23 hours and 23.60 .+-. 1.72%, respectively, Tmax, Cmax, T 1/2 and urinary recovery rate following the administration after meal were 3.33 .+-. 0.42 hours, 0.47 .+-. 0.14 .mu.g/ml, 2.35 .+-. 0.27 hours and 12.24 .+-. 2.02%, respectively. Earlier Tmax, higher Cmax and higher urinary recovery rate were observed when the drug was administered before meal than when administered after meal. Seven infants (before meal) and 8 infants (after meal) were administered with the drug in the same way, and several parameters were measured. Tmax, Cmax, and T 1/2 following the administration before meal were 4.00 .+-. 0.62 hours, 0.61 .+-. 0.13 .mu.g/ml and 3.14 .+-. 0.62 hours, respectively, Tmax, Cmax and T 1/2 following the administration after meal were 3.75 .+-. 0.25 hours, 0.25 hours, 0.79 .+-. 0.13 .mu.g/ml and 2.44 .+-. 0.42 hours, respectively. These was no statistically significant difference between the 2 groups. Twenty one school children were administered orally with CFDN fine granules at 30 minutes before meal at a dose level of either 3 mg/kg (14 children) or 6 mg/kg (7 children). Plasma concentrations and urinary recovery rate of CFDN were measured. Cmax and AUC were 1.14 .+-. 0.11 .mu.g/ml and 4.44 .+-. 0.41 .mu.g .cntdot. hr/ml, respectively, at a dose level of 3 mg/kg. Cmax and AUC were 1.37 .+-. 0.23 .mu.g/ml and 6.14 .+-. 0.88 .mu.g .cntdot. hr/ml, respectively, at a dose level of 6 mg/kg. Dose-response was observed only in AUC. However, using a cross-over technique in 6 school children, dose-responses were observed in AUC and Cmax. Fourteen school children, 19 younger children and 7 infants were administered orally with CFDN fine granules at 30 minutes before meal at a dose level of 3 mg/kg. Plasma concentrations and urinary recovery rate of CFDN were measured. Tmax in school children, younger children and infants were 2.00 .+-. 0.00, 2.11 .+-. 0.11 and 4.00 .+-. 0.62 hours, respectively. Delayed Tmax were observed in infants compared to the other children. Cmax in school children, younger children and infants were 1.14 .+-. 0.11, 0.98 .+-. 0.14 and 0.61 .+-. 0.13 .mu.g/ml, respectively. Lower Cmax were observed in infants. T 1/2 in school children, younger children and infants were 1.63 .+-. 0.14, 1.71 .+-. 0.23 and 3.14 .+-. 0.62 hours, respectively. Longer T 1/2 were observed in infants. No differences was observed in AUC's among the 3 groups. Six school children, 6 younger children and 8 infants were administered orally with CFDN fine granules at 30 minutes after meal at a dose level of 3 mg/kg. Plasma concentrations and urinary recovery rate of CFDN.