PHARMACOKINETIC AND CLINICAL STUDIES OF CEFOTIAM IN MATURE NEONATES
1986 Volume 39 Issue 9 Pages 2450-2457
Details
1986 Volume 39 Issue 9 Pages 2450-2457
Pharmacokinetic and clinical studies on cefotiam (CTM) in mature neonates were carried out. The results were summarized as follows:
1. The serum peak level of CTM after intravenous bolus injection at a single dose of 10mg/kg was found at 15 minutes after the injection. The serum peak level was 32.9μg/ml in a 1 day-old neonate and it was 17.7μg/ml in a 4 day-old neonate. Serum levels at 6 hours after injection were 4.5μg/ml and 0.7μg/ml for the 1 day-old and the 4 day-old, respectively. Half-lives were 2.1 and 1.2 hours in the 1 and 4 day-old neonates, respectively.
Serum peak levels of CTM at 15 minutes after intravenous bolus injection at a single dose of 20mg/kg were 40.9μg/ml in a 1 day-old neonate and 36.5μg/ml in a 5 day-old neonate. Serum levels of CTM at 6 hours were 8.0μg/ml in the 1 day-old neonate and 2.3μg/ml in the 5 day-old neonate. Half-lives were 2.5 and 1.5 hours in the 1 and 5 day-old neonates, respectively. With each dosage, the younger showed extended half-lives. A dose-response relationship was observed.
2. In 2 cases of 2 day-old neonates given CTM 20mg/kg by 30-minute intravenous drip infusion, the mean peak concentration at the termination of the infusion was 25.1μg/ml. Even after 6 hours the concentration was found at 8.7μg/ml. Half-lives were 2.9 and 3.7 hours.
3. Urinary excretion rates of CTM in 1 to 5 day-old neonates were as low as about 20% in any of cases subjected to a 10mg/kg intravenous bolus injection, a 20mg/kg intravenous bolus injection or a 20mg/kg 30-minute intravenous drip infusion.
4. It was possible to evaluate the efficacy of CTM in only 1 case of pneumonia. CTM was clinically and bacteriologically effective in this case. No abnormal clinical symptoms and findings were observed in all of the 5 cases.
