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Medically reviewed by Fedorchenko Olga Valeryevna, PharmD. Last updated on 26.06.2023
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Similar to other beta-lactam antimicrobial agents, the time that the unbound plasma concentration of cefepime exceeds the MIC of the infecting organism has been shown to best correlate with efficacy in animal models of infection. However, the pharmacokinetic/pharmacodynamics relationship for cefepime has not been evaluated in patients.
Pharmacokinetic parameters for cefepime in healthy adult male volunteers (n=9) following single 30-minute infusions (IV) of cefepime 500 mg, 1 g, and 2 g are summarized in Table 7. Elimination of cefepime is principally via renal excretion with an average (±SD) half-life of 2 (±0.3) hours and total body clearance of 120 (±8) mL/min in healthy volunteers. Cefepime pharmacokinetics are linear over the range 250 mg to 2 g. There is no evidence of accumulation in healthy adult male volunteers (n=7) receiving clinically relevant doses for a period of 9 days.
Table 7: Mean Pharmacokinetic Parameters for Cefepime (±SD), Intravenous Administration
| Cefepima Vitalis | |||
| Parameter | 500 mg IM | 1 g IM | 2 g IM |
| Cmax, mcg/mL | 39.1 (3.5) | 81.7 (5.1) | 163.9 (25.3) |
| AUC, h•mcg/mL | 70.8 (6.7) | 148.5 (15.1) | 284.8 (30.6) |
| Number of subjects (male) | 9 | 9 | 9 |
Pharmacokinetic parameters for cefepime following a single intramuscular injection are summarized in Table 8. The pharmacokinetics of cefepime are linear over the range of 500 mg to 2 g intramuscularly and do not vary with respect to treatment duration.
Table 8: Mean Pharmacokinetic Parameters for Cefepime (±SD), Intramuscular Administration
| Cefepima Vitalis | |||
| Parameter | 500 mg IM | 1 g IM | 2 g IM |
| Cmax, mcg/mL | 13.9 (3.4) | 29.6 (4.4) | 57.5 (9.5) |
| Tmax, h | 1.4 (0.9) | 1.6 (0.4) | 1.5 (0.4) |
| AUC, h•mcg/mL | 60 (8) | 137 (11) | 262 (23) |
| Number of subjects (male) | 6 | 6 | 12 |
Absorption
Following intramuscular (IM) administration, cefepime is completely absorbed.
Distribution
The average steady-state volume of distribution of cefepime is 18 (±2) L. The serum protein binding of cefepime is approximately 20% and is independent of its concentration in serum.
Cefepime is excreted in human milk at a concentration of 0.5 mcg/mL. A nursing infant consuming approximately 1000 mL of human milk per day would receive approximately 0.5 mg of cefepime per day.
Concentrations of cefepime achieved in specific tissues and body fluids are listed in Table 9.
Table 9: Mean Concentrations of Cefepime in Specific Body Fluids (mcg/mL) or Tissues (mcg/g) Mean Time of Sample Mean Tissue or Fluid Dose/Route # of Patients Post-Dose Concentration
| Tissue or Fluid | Dose/Route | # of Patients | Mean Time of Sample Post-Dose (h) | Mean Concentration |
| Blister Fluid | 2 g IV | 6 | 1.5 | 81.4 mcg/mL |
| Bronchial Mucosa | 2 g IV | 20 | 4.8 | 24.1 mcg/g |
| Sputum | 2 g IV | 5 | 4 | 7.4 mcg/mL |
| Urine | 500 mg IV | 8 | 0 to 4 | 292 mcg/mL |
| 1 g IV | 12 | 0 to 4 | 926 mcg/mL | |
| 2 g IV | 12 | 0 to 4 | 3120 mcg/mL | |
| Bile | 2 g IV | 26 | 9.4 | 17.8 mcg/mL |
| Peritoneal Fluid | 2 g IV | 19 | 4.4 | 18.3 mcg/mL |
| Appendix | 2 g IV | 31 | 5.7 | 5.2 mcg/g |
| Gallbladder | 2 g IV | 38 | 8.9 | 11.9 mcg/g |
| Prostate | 2 g IV | 5 | 1 | 31.5 mcg/g |
Data suggest that cefepime does cross the inflamed blood-brain barrier. The clinical relevance of these data is uncertain at this time.
Metabolism And Excretion
Cefepime is metabolized to N-methylpyrrolidine (NMP) which is rapidly converted to the N-oxide (NMP-N-oxide). Urinary recovery of unchanged cefepime accounts for approximately 85% of the administered dose. Less than 1% of the administered dose is recovered from urine as NMP, 6.8% as NMP-N-oxide, and 2.5% as an epimer of cefepime. Because renal excretion is a significant pathway of elimination, patients with renal dysfunction and patients undergoing hemodialysis require dosage adjustment.
- R52.1 – Chronic intractable pain
- R52.2 – Other chronic pain
- R52.9 – Unspecified pain
- R52.1 – Chronic intractable pain
- R52.2 – Other chronic pain
- R52.9 – Unspecified pain
However, we will provide data for each active ingredient
