Cefepime

Visa No.: 893110832524

Product: Maxapin 1g

API: Cefepim

Product Category: Antibiotics

Version approved leaflet: 607/QĐ-QLD_23/08/2024_208

INDICATIONS

Pneumonia
Cefepime is indicated for the treatment of moderate to severe pneumonia caused by susceptible strains of Streptococcus pneumonia, including cases with concomitant bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter.

Empirical treatment of febrile neutropenia
Cefepime is indicated as monotherapy for the empirical treatment of febrile neutropenic patients.
In patients at high risk of severe infection (including those with recent bone marrow transplantation, hypotension, hematologic malignancies, or severe or prolonged neutropenia), monotherapy with a single antibacterial agent may be inadequate.
There are insufficient data to support the efficacy of cefepime monotherapy in these high-risk patients.

Complicated and uncomplicated urinary tract infections (including pyelonephritis)
Cefepime is indicated for the treatment of complicated and uncomplicated urinary tract infections, including pyelonephritis, caused by susceptible isolates of Escherichia coli or Klebsiella pneumoniae.
For mild to moderate infections, cefepime is indicated when caused by E. coli, K. pneumoniae, or Proteus mirabilis, including cases with associated bacteremia.

Uncomplicated skin and skin structure infections
Cefepime is indicated for the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible strains only) or Streptococcus pyogenes.

Complicated intra-abdominal infections (in combination with metronidazole)
Cefepime, in combination with metronidazole, is indicated for the treatment of complicated intra-abdominal infections in adults caused by susceptible isolates of Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis.

DOSAGE AND ADMINISTRATION

To reduce the development of drug-resistant bacteria and to maintain the effectiveness of cefepime and other antibacterial agents, cefepime should be used only for the treatment or prophylaxis of infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility data are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric treatment selection.

Dosage
Adults
The recommended dose and route of administration for adults with creatinine clearance (CrCL) > 60 mL/min are presented in Table 1. Cefepime should be administered by intravenous infusion over approximately 30 minutes.
Table 1. Recommended dosage of cefepime in adult patients with creatinine clearance (CrCL) > 60 mL/min 

*    * Or until resolution of neutropenia. In patients who become afebrile but remain neutropenic for more than 7 days, the need for continued antibiotic therapy should be reassessed regularly.
*    ** Intramuscular administration is indicated only for mild to moderate complicated or uncomplicated urinary tract infections caused by Escherichia coli.
*    # For Pseudomonas aeruginosa, administer 2 g IV every 8 hours
*    Pediatric patients (2 months to 16 years)
*    The maximum dose in pediatric patients should not exceed the recommended adult dose.
*    For pediatric patients weighing up to 40 kg, with the same treatment duration as adults, the usual recommended doses are:
- 50 mg/kg per dose every 12 hours for complicated and uncomplicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia (see below).
- Moderate to severe pneumonia caused by Pseudomonas aeruginosa: 50 mg/kg per dose every 8 hours.
- Febrile neutropenia: 50 mg/kg per dose every 8 hour

Dose adjustment in patients with renal impairment
Adults
Dose adjustment of cefepime is required in patients with creatinine clearance (CrCL) ≤ 60 mL/min to compensate for the reduced rate of renal elimination. In these patients, the recommended initial dose is the same as that for patients with CrCL > 60 mL/min, except for patients undergoing hemodialysis. The recommended cefepime doses in patients with renal impairment are presented in Table 2..
When only serum creatinine values are available, the following formula (Cockcroft–Gault equation) may be used to estimate creatinine clearance. Serum creatinine should reflect stable renal function:

Table 2: Recommended dosing of cefepime in adult patients with creatinine clearance (CrCL) ≤ 60 mL/min

In patients undergoing continuous ambulatory peritoneal dialysis (CAPD), cefepime may be administered at the same doses recommended for patients with normal renal function, with a dosing interval of 48 hours (see Table 2)
In patients receiving hemodialysis, approximately 68% of the total amount of cefepime present in the body at the start of dialysis is removed after 3 hours of dialysis. The recommended dosage for hemodialysis patients is as follows: 1 g cefepime on Day 1, followed by 500 mg every 24 hours for all infections, except febrile neutropenia, for which the dose is 1 g every 24 hours.
Cefepime should be administered at the same time each day and after completion of the hemodialysis session on dialysis days (see Table 2).
Pediatric patients
No clinical data are available for this patient population. However, as the pharmacokinetics of cefepime are similar in children and adults, the dose adjustment recommendations for adults are also recommended for pediatric patients (see Tables 1 and 2).

Method of administration
Reconstitute 0.5 g, 1 g, or 2 g of cefepime with one of the following diluents:
•    Sterile water for injection
•    Sodium chloride 0.9% solution
•    Dextrose 5% solution
•    Lidocaine solution 0.5% or 1%
•    Sterile bacteriostatic water for injection with parabens or benzyl alcohol
-    Prior to intravenous infusion, further dilute the reconstituted solution with one of the following compatible infusion solutions:
•    Sodium chloride 0.9% solution
•    Dextrose 5% or 10% solution
•    Sodium lactate M/6 solution
•    Dextrose 5% with sodium chloride 0.9%
•    Ringer’s lactate with dextrose 5%
-    Parenteral drug products should be inspected visually for particulate matter prior to administration. If visible particulates are observed in the reconstituted solution, the solution should be discarded.
-    Administer by intravenous infusion over approximately 30 minutes.
-    Intermittent intravenous infusion using a Y-site set may be performed with compatible solutions. However, during infusion of solutions containing cefepime, administration of other solutions should be discontinued.

In patients undergoing continuous ambulatory peritoneal dialysis (CAPD), cefepime may be administered at the same doses recommended for patients with normal renal function, with a dosing interval of 48 hours (see Table 2)
In patients receiving hemodialysis, approximately 68% of the total amount of cefepime present in the body at the start of dialysis is removed after 3 hours of dialysis. The recommended dosage for hemodialysis patients is as follows: 1 g cefepime on Day 1, followed by 500 mg every 24 hours for all infections, except febrile neutropenia, for which the dose is 1 g every 24 hours.
Cefepime should be administered at the same time each day and after completion of the hemodialysis session on dialysis days (see Table 2).
Pediatric patients
No clinical data are available for this patient population. However, as the pharmacokinetics of cefepime are similar in children and adults, the dose adjustment recommendations for adults are also recommended for pediatric patients (see Tables 1 and 2).
Method of administration
        Reconstitute 0.5 g, 1 g, or 2 g of cefepime with one of the following diluents:
•    Sterile water for injection
•    Sodium chloride 0.9% solution
•    Dextrose 5% solution
•    Lidocaine solution 0.5% or 1%
•    Sterile bacteriostatic water for injection with parabens or benzyl alcohol
-    Prior to intravenous infusion, further dilute the reconstituted solution with one of the following compatible infusion solutions:
•    Sodium chloride 0.9% solution
•    Dextrose 5% or 10% solution
•    Sodium lactate M/6 solution
•    Dextrose 5% with sodium chloride 0.9%
•    Ringer’s lactate with dextrose 5%
-    Parenteral drug products should be inspected visually for particulate matter prior to administration. If visible particulates are observed in the reconstituted solution, the solution should be discarded.
-    Administer by intravenous infusion over approximately 30 minutes.
-    Intermittent intravenous infusion using a Y-site set may be performed with compatible solutions. However, during infusion of solutions containing cefepime, administration of other solutions should be discontinued.
Table 3. Preparation of reconstituted solutions for injection        

 
Stability of reconstituted solution
Chemical and physical stability: Demonstrated for up to 4 hours at 15–25 °C.
Microbiological stability: The product should be used immediately after reconstitution, unless reconstitution has been performed under controlled and validated aseptic conditions.        
 

CONTRAINDICATIONS

Patients with a history of immediate hypersensitivity reactions to cefepime or to cephalosporin antibiotics, penicillins, or other beta-lactam antibiotics.

Patients with hypersensitivity to L-arginine.
 

WARNINGS AND PRECAUTIONS

This medicinal product is for prescription use only.

Read the instructions for use carefully before use.

If further information is required, consult a physician or pharmacist.

Keep out of the reach of children.