Cefepime
Dosing in kidney impairment
Dosage Adjustments in Patients with Renal Impairment Adult Patients Adjust the dose of Cefepime Injection in patients with creatinine clearance less than or equal to 60 mL/min to compensate for the slower rate of renal elimination. In these patients, the recommended initial dose of Cefepime Injection should be the same as in patients with CrCL greater than 60 mL/min except in patients undergoing hemodialysis.
The recommended doses of Cefepime Injection in patients with renal impairment are presented in Table 2 . When only serum creatinine is available, the following formula (Cockcroft and Gault equation) 1 may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function: [See table below.] [See table below.] 2 g every 24 hours 2 g every 12 hours 11–29 500 mg every 24 hours 500 mg every 24 hours 1 g every 24 hours 2 g every 24 hours Less than 11 250 mg every 24 hours 250 mg every 24 hours 500 mg every 24 hours 1 g every 24 hours Continuous Ambulatory Peritoneal Dialysis CAPD 500 mg every 48 hours 1 g every 48 hours 2 g every 48 hours 2 g every 48 hours Hemodialysis On hemodialysis days, Cefepime Injection should be administered following hemodialysis.
Whenever possible, Cefepime Injection should be administered at the same time each day. 1 g on day 1, then 500 mg every 24 hours thereafter 1 g every 24 hours In patients undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD), Cefepime Injection may be administered at the recommended doses at a dosage interval of every 48 hours (see Table 2 ).
In patients undergoing hemodialysis, approximately 68% of the total amount of cefepime present in the body at the start of dialysis will be removed during a 3-hour dialysis period. The dosage of Cefepime Injection for hemodialysis patients is 1 g on Day 1 followed by 500 mg every 24 hours for the treatment of all infections except febrile neutropenia, which is 1 g every 24 hours.
Cefepime Injection should be administered at the same time each day and following the completion of hemodialysis on hemodialysis days (see Table 2 ). Pediatric Patients Data in pediatric patients with impaired renal function are not available; however, since cefepime pharmacokinetics are similar in adults and pediatric patients [see Clinical Pharmacology ] , changes in the dosing regimen proportional to those in adults (see Table 1 and Table 2 ) are recommended for pediatric patients.
| Recommended Dosage in Adults With Creatinine Clearance (CrCL) Greater Than 60 mL/min (2.1) | |||
|---|---|---|---|
| Site and Type of Infection (Adults) | Dose (IV) | Frequency | Duration (Days) |
| Moderate to Severe PneumoniaFor Pseudomonas aeruginosa, use 2 g IV every 8 hours (2.1) | 1-2 g | Every 8-12 hours | 10 |
| Empiric therapy for febrile neutropenic patients | 2 g | Every 8 hours | 7Or until resolution of neutropenia (2.1) |
| Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections | 0.5-1 g | Every 12 hours | 7-10 |
| Severe Uncomplicated or Complicated Urinary Tract Infections | 2 g | Every 12 hours | 10 |
| Moderate to Severe Uncomplicated Skin and Skin Structure Infections | 2 g | Every 12 hours | 10 |
| Complicated Intra-abdominal Infections (used in combination with metronidazole) | 2 g | Every 8-12 hours | 7-10 |
| Site and Type of Infection | Dose | Frequency | Duration (days) |
|---|---|---|---|
| Adults | |||
| Moderate to Severe Pneumonia due to S. pneumoniae, P. aeruginosaFor Pseudomonas aeruginosa, use 2 g IV every 8 hours, K. pneumoniae, or Enterobacter species | 1-2 g IV | Every 8-12 hours | 10 |
| Empiric therapy for febrile neutropenic patients [see Indications and Usage (1) and Clinical Studies (14)] | 2 g IV | Every 8 hours | 7or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re-evaluated frequently. |
| Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis | 0.5-1 g IV | Every 12 hours | 7-10 |
| Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae | 2 g IV | Every 12 hours | 10 |
| Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes | 2 g IV | Every 12 hours | 10 |
| Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa, K. pneumoniae, Enterobacter species, or B. fragilis. [see Clinical Studies (14)] | 2 g IV | Every 8-12 hours | 7-10 |
| Males: Creatinine Clearance (mL/min) = | Weight (kg) x (140 – age) | |
| 72 x serum creatinine (mg/dL) | ||
| Females: 0.85 x above value |
| Creatinine Clearance (mL/min) | Recommended Maintenance Schedule | |||
|---|---|---|---|---|
| Greater than 60 | 500 mg every 12 hours | 1 g every 12 hours | 2 g every 12 hours | 2 g every 8 hours |
| 30–60 | 500 mg every 24 hours | 1 g every 24 hours | 2 g every 24 hours | 2 g every 12 hours |
| 11–29 | 500 mg every 24 hours | 500 mg every 24 hours | 1 g every 24 hours | 2 g every 24 hours |
| Less than 11 | 250 mg every 24 hours | 250 mg every 24 hours | 500 mg every 24 hours | 1 g every 24 hours |
| Continuous Ambulatory Peritoneal Dialysis CAPD | 500 mg every 48 hours | 1 g every 48 hours | 2 g every 48 hours | 2 g every 48 hours |
| HemodialysisOn hemodialysis days, Cefepime Injection should be administered following hemodialysis. Whenever possible, Cefepime Injection should be administered at the same time each day. | 1 g on day 1, then 500 mg every 24 hours thereafter | 1 g every 24 hours | ||
Preparation and administration
Dosage for Adults The recommended adult dosages and routes of administration are outlined in Table 1 below for patients with creatinine clearance greater than 60 mL/min. Administer Cefepime Injection intravenously over approximately 30 minutes. [See table below.] Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae 2 g IV Every 12 hours 10 Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes 2 g IV Every 12 hours 10 Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa , K. pneumoniae, Enterobacter species, or B. fragilis . [see Clinical Studies ] 2 g IV Every 8-12 hours 7-10