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Relationship between renal function and disposition of oral cefixime
European Journal of Clinical Pharmacology
|January 1, 1991
Summary
Cefixime pharmacokinetics were studied in healthy individuals and patients with kidney issues. Dosage reduction is only necessary for cefixime in patients with severe renal failure.
Area of Science:
- Pharmacology
- Clinical Pharmacy
- Nephrology
Background:
- Cefixime is an antibiotic requiring pharmacokinetic evaluation.
- Renal insufficiency can significantly alter drug metabolism and excretion.
Purpose of the Study:
- To investigate the pharmacokinetics of cefixime in subjects with normal and impaired renal function.
- To determine the impact of renal insufficiency on cefixime dosage requirements.
Main Methods:
- Oral administration of 200 mg cefixime to 6 healthy subjects and 22 patients with varying renal insufficiency.
- Serum and urine sample analysis using bioassay and High-Performance Liquid Chromatography (HPLC).
- Pharmacokinetic parameter calculation including Cmax, tmax, t1/2, CL/f, CLR, and CLCR.
Main Results:
- Normal subjects exhibited a peak serum level (Cmax) of 2.50 µg/mL at 2.83 h (tmax) with an elimination half-life (t1/2) of 3.73 h.
- In patients with creatinine clearance < 20 mL/min, t1/2 increased to 12-14 h, with decreased volume of distribution and clearances.
- Linear relationships were observed between apparent total body clearance (CL/f), renal clearance (CLR), and creatinine clearance (CLCR).
Conclusions:
- Cefixime pharmacokinetics are altered in patients with renal insufficiency, particularly in severe cases.
- Antibacterial activity was not found in cefixime metabolites, even in uraemic patients.
- Dosage adjustment of cefixime is recommended only for patients experiencing severe renal failure.