Is cefixime (Cefixime) safe for use in patients with impaired renal function undergoing hemodialysis (HD)?

From the Guidelines

Cefixime is not the recommended antibiotic for hemodialysis patients, and alternative antibiotics such as amoxicillin or clindamycin should be considered. The choice of antibiotics for patients on hemodialysis should be made based on comments from the patient’s nephrologist before any procedure, taking into account the degree of elimination impairment and potential side effects 1.

• Key considerations for antibiotic use in hemodialysis patients include:
  • Avoiding nephrotoxic drugs such as aminoglycoside antibiotics and tetracyclines
  • Avoiding drugs that can produce toxic metabolites, such as nitrofurantoin
  • Choosing antibiotics that are safe for patients with impaired kidney function, such as amoxicillin or clindamycin
• For patients on hemodialysis, the American Heart Association (AHA) recommends using prophylactic antibiotics such as amoxicillin or ampicillin before invasive dental procedures 1.
• If the patient is allergic to penicillin, clindamycin is the drug of choice, and 600 mg of clindamycin should be administered orally 1 h before the intervention 1.
• It is essential to inform the nephrologist about any medication, including antibiotics, to ensure proper coordination with the dialysis schedule and to monitor for any drug interactions with other medications the patient may be taking.

From the FDA Drug Label

1. 6 Renal Impairment The dose of cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD). Patients on dialysis should be monitored carefully [see Dosage and Administration ( 2.3)] .
2. 3 Dose Adjustment in Renal Impairment The dose of cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD). Patients on dialysis should be monitored carefully [see Dosage and Administration ( 2)] .

Cefixime can be used in hemodialysis patients, but the dose should be adjusted according to the patient's renal impairment. Additionally, patients on dialysis should be monitored carefully. It is essential to follow the dosage and administration guidelines for patients with renal impairment and those undergoing hemodialysis, as indicated in the drug label 2 and 2.

From the Research

Cefixime Safety in Hemodialysis Patients

• Cefixime is an extended-half-life, broad-spectrum oral cephalosporin antibiotic used to treat various bacterial infections.
• Studies have investigated the pharmacokinetics of cefixime in patients with renal insufficiency, including those undergoing hemodialysis.
• The pharmacokinetics of cefixime are altered in patients with renal insufficiency, with decreased clearance and increased elimination half-life as creatinine clearance falls below 20 ml/min per 1.73 m2 3, 4, 5, 6.
• Hemodialysis removes an insignificant fraction of cefixime from the body, suggesting that supplemental doses are not necessary at the end of hemodialysis 3, 4.
• The dose of cefixime may need to be reduced in patients with severe renal failure, but the exact dosage adjustment is not clearly established 4, 5.
• A systematic review of cefixime pharmacokinetics found that clearance decreases with the degree of renal insufficiency in hemodialysis patients, and that a dose-dependent increase in area under the curve (AUC) and peak plasma concentration (Cmax) is observed in healthy volunteers 7.

Key Findings

• Cefixime concentrations in urine exceed the minimum inhibitory concentrations (MICs) for most urinary tract pathogens for up to 24 hours post-dose, even in patients with severe renal insufficiency 3.
• The apparent volume of distribution at steady state is not significantly altered by renal insufficiency 3.
• Cefixime has a biphasic decline in serum concentrations when taken without probenecid, and its clearance is decreased in the fed state compared to the fasted state 7.

Pharmacokinetic Parameters

• Peak serum concentration (Cmax): 2.50 micrograms/ml at 2.83 hours (tmax) in normal subjects 5.
• Apparent elimination half-life (t1/2): 3.73 hours in normal subjects, increased to 12-14 hours in patients with endogenous creatinine clearance below 20 ml/min per 1.73 m2 5.
• Apparent total body clearance (CL/f): 154 ml/min in normal subjects, decreased in proportion to the degree of renal insufficiency 5.