Pharmacokinetic Study of an Oral Cephalosporin, Cefdinir, in Hemodialysis Patients

Abstract

The pharmacokinetics of cefdinir were investigated in six hemodialysis patients. For the present study, two tests were carried out, one with 4 h of hemodialysis and the other without hemodialysis. Cefdinir was given orally to each patient in a dose of 100 mg, and blood was collected serially for 48 h after dosing in the test without dialysis and for 72 h in the test with dialysis. In the test without dialysis, the maximum plasma concentration (C max) was 2.36 ± 0.53 μg/ml (mean ± standard deviation) and the time to C max was 9.00 ± 2.45 h. The terminal elimination half-life (t 1/2) and area under the concentration-time curve (AUC) were 16.95 ± 1.20 h and 69.05 ± 14.84 μg · h/ml, respectively. In the test with dialysis,t 1/2 during hemodialysis decreased approximately to one-sixth of that obtained in the test without dialysis, although t 1/2 in the latter elimination phase did not differ from that in the nondialysis test. AUC was reduced to 43% of that in the test without dialysis. The fractional removal of cefdinir by hemodialysis was 61%. These findings indicate that clearance of cefdinir is prolonged in patients with renal failure, and cefdinir is well removed by introduction of hemodialysis, although t 1/2 (during hemodialysis) and AUC were two and eight times higher than the data previously reported for healthy volunteers, respectively. The pharmacokinetic data suggest that 100 mg of oral cefdinir once a day would result in a sufficient concentration in plasma in hemodialysis patients, but this remains to be confirmed by multiple-dose studies.

Simultaneous determination of cefdinir and cefixime in human plasma by RP-HPLC/UV detection method: Method development, optimization, validation, and its application to a pharmacokinetic study

“…These results were consistent with the previous results [10,16]. The solid-phase extraction procedure has also been reported for the extraction of the cefdinir from plasma samples [11]. Although, solid-phase extraction offers comparable recovery and clear chromatograms; however, it is a much more expensive procedure than liquid-liquid extraction and protein precipitation methods, so it was not utilized in this study.…”

“…The LODs and LLOQs for the two analytes are also given in Table 1, showing that the proposed method was more sensitive than the previously reported methods for determination of cefdinir in biological samples [10][11][12] and that it can used to determine the concentration of cefdinir and cefixime in the plasma even after 36 h of single 300 and 400 mg oral dose, respectively. Chromatograms Table 2 Recovery and precision of the proposed method for simultaneous determination of cefdinir and cefixime.…”

“…To our knowledge, only three papers [10][11][12] have been reported so far on the liquid-chromatographic determination of cefdinir in biological samples. However, one of these methods [10] have utilized very expensive mass spectrometric detector, one involves tedious and expensive solid-phase extraction technique and it is not validated according to international guidelines [11], and the third one, which is not very much sensitive, hardly involves any sample pre-treatment technique [12].…”

“…However, one of these methods [10] have utilized very expensive mass spectrometric detector, one involves tedious and expensive solid-phase extraction technique and it is not validated according to international guidelines [11], and the third one, which is not very much sensitive, hardly involves any sample pre-treatment technique [12]. Thus it is not suitable for selective extraction of cefdinir from plasma samples.…”

Selective method for the determination of cefdinir in human plasma using liquid chromatography electrospray ionization tandam mass spectrometry

“…Cefdinir were quantitated by either reversed-phase highperformance liquid chromatography (RP-HPLC) [6][7][8][9] or microbiological assay [10]. Up to now, there has no publication on the determination of cefdinir using LC-MS/MS.…”