Pharmacokinetics of oxatomide in preterm infants.
The pharmacokinetics and tolerability of oxatomide oral suspension were investigated in preterm infants to evaluate the feasibility of planning a further study to assess its antiinflammatory effects and its effectiveness in preventing chronic lung disease (CLD). Following the administration of oxatomide 1 mg/kg, the peak plasma concentration (Cmax), the elimination half-life (t1/2), the volume of distribution (Vd), and the area under the curve (AUC) 0-36 h were measured and the following results were obtained: 42.2 +/- 15 ng/ml at 2 h after oxatomide administration, 41.4 +/- 2.0 h, 37.4 +/- 4.2 l/kg, and 468 +/- 52 ng/ml/h, respectively. Our study, therefore, demonstrated that a dose of 1 mg/kg/day oxatomide was effective in reaching therapeutic plasma levels in preterm infants without inducing adverse effects.
Dani
C
C
Division of Neonatology, Careggi University Hospital, University of Florence School of Medicine, Viale Morgagni, 85, Florence, Italy. cdani@unifi.it
Martelli
E
E
Bertini
G
G
Filippi
L
L
Pezzati
M
M
Mazzetti
L
L
Ciuffi
M
M
Zilletti
L
L
Rubaltelli
F F
FF
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000097:blood / Q000493:pharmacokinetics; D019540:Area Under Curve; D002908:Chronic Disease; D006207:Half-Life; D006634:Histamine H1 Antagonists / Q000097:blood / Q000493:pharmacokinetics*; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature / Q000378:metabolism*; D007235:Infant, Premature, Diseases / Q000517:prevention & control; D008099:Liver / Q000378:metabolism; D008171:Lung Diseases / Q000517:prevention & control; D010879:Piperazines / Q000097:blood / Q000493:pharmacokinetics*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D006634:Histamine H1 Antagonists; D010879:Piperazines; C015408:oxatomide