caa a22 4500 465812368 CHVBK 20180323112120.0 cr unu---uuuuu 170327e19900701xx s 000 0 eng 10.1007/BF03190209 doi (NATIONALLICENCE)springer-10.1007/BF03190209 Pharmacokinetics of oxiracetam in patients with renal impairment after a 800 mg single oral dose [Elektronische Daten] [J. Lecaillon, J. Dubois, H. Coppens, T. Darragon, G. Reumond, N. Pozet, J. Traeger, G. Lambrey] Summary: The pharmacokinetics of oxiracetam in patients with renal impairment were investigated after administration of a 800 mg single oral dose of oxiracetam. The renal insufficiency was estimated on the basis of the creatinine clearance (CLcr) which ranged from 9 to 95 ml/min among the 20 patients. In plasma, the terminal elimination half-life (T1/2) ranged from 10.6 to 68.1 h, the highest T1/2 corresponding to the patients with a high degree of renal impairment. In urine, the amounts of oxiracetam excreted during the 48 h postdosing represented 8.3 to 82.6% of the dose. They were lower in patients with a high degree of renal impairment. The correlations between the total clearance of oxiracetam, the renal clearance, the terminal apparent elimination rate constant in plasma, and CLcr were estimated by linear regression analysis. The correlation coefficients were 0.916, 0.985 and 0.803 respectively. The apparent volume of distribution of the central compartment V(1) and the total volume of distribution at the steady-state V(SS) were not dependent on the degree of renal impairment. The mean values±SD were 25.9±13.0 litres and 48.3±21.5 litres respectively. Oxiracetam concentrations in plasma of patients were estimated for repeated administration of 800 mg of oxiracetam. The estimations showed that the steady-state concentrations would be obtained after 6-10 days of repeated administration for patients whose CLcr is 9-15 ml/min and 3-5 days for patients with CLcr between 15 and 40 ml/min. The dosage of oxiracetam in renal insufficient patients was evaluated in order to reach a mean steady-state concentration level of oxiracetam in plasma close to that in patients with normal renal function. For patients with CLcr between 40 and 60 ml/min, the adjusted daily dose would be 50% of the dose given to a patient with normal renal function. For patients with CLcr between 15 and 40 ml/min, the adjusted daily dose would be 25% of the dose given to a patient with normal renal function. For patients whose CLcr was below 40 ml/min, one daily administration in agreement with the dosage reduction, could be given. Springer-Verlag, 1990 Oxiracetam nationallicence renal impairment nationallicence pharmacokinetics nationallicence maintenance dose nationallicence Lecaillon J. Biopharmaceutical Research Center and Medical Department, Laboratoires CIBA-GEIGY, B.P. 308, F-92506, Rueil-Malmaison, France aut Dubois J. Biopharmaceutical Research Center and Medical Department, Laboratoires CIBA-GEIGY, B.P. 308, F-92506, Rueil-Malmaison, France aut Coppens H. Biopharmaceutical Research Center and Medical Department, Laboratoires CIBA-GEIGY, B.P. 308, F-92506, Rueil-Malmaison, France aut Darragon T. Biopharmaceutical Research Center and Medical Department, Laboratoires CIBA-GEIGY, B.P. 308, F-92506, Rueil-Malmaison, France aut Reumond G. Centre Hospitalier Général, Evreux, France aut Pozet N. Hôpital Edouard Herriot, Lyon, France aut Traeger J. Hôpital Edouard Herriot, Lyon, France aut Lambrey G. Centre Hospitalier, Beauvais, France aut European Journal of Drug Metabolism and Pharmacokinetics Springer-Verlag 15/3(1990-07-01), 231-237 0378-7966 15:3<231 1990 15 13318 https://doi.org/10.1007/BF03190209 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/BF03190209 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Lecaillon J. Biopharmaceutical Research Center and Medical Department, Laboratoires CIBA-GEIGY, B.P. 308, F-92506, Rueil-Malmaison, France aut NATIONALLICENCE 700 1- Dubois J. Biopharmaceutical Research Center and Medical Department, Laboratoires CIBA-GEIGY, B.P. 308, F-92506, Rueil-Malmaison, France aut NATIONALLICENCE 700 1- Coppens H. Biopharmaceutical Research Center and Medical Department, Laboratoires CIBA-GEIGY, B.P. 308, F-92506, Rueil-Malmaison, France aut NATIONALLICENCE 700 1- Darragon T. Biopharmaceutical Research Center and Medical Department, Laboratoires CIBA-GEIGY, B.P. 308, F-92506, Rueil-Malmaison, France aut NATIONALLICENCE 700 1- Reumond G. Centre Hospitalier Général, Evreux, France aut NATIONALLICENCE 700 1- Pozet N. Hôpital Edouard Herriot, Lyon, France aut NATIONALLICENCE 700 1- Traeger J. Hôpital Edouard Herriot, Lyon, France aut NATIONALLICENCE 700 1- Lambrey G. Centre Hospitalier, Beauvais, France aut NATIONALLICENCE 773 0- European Journal of Drug Metabolism and Pharmacokinetics Springer-Verlag 15/3(1990-07-01), 231-237 0378-7966 15:3<231 1990 15 13318 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer