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DESCRIPTION:

Maxum (Cefepime) Injection is sterile, injectable product consisting of Cefepime Hydrochloride, a semi-synthetic, broad spectrum, cephalosporin antibiotic for parenteral administration.

  • Maxum 500mg Injection IM/IV
  • Maxum 1g Injection IM/IV
  • Maxum 2g Injection IV

INDICATIONS:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Maxum (Cefepime) Injection and other antibacterial drugs, Maxum Injection should be used only to teat or prevent infections that are proven to strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy. It is used in the following conditions:

Pneumonia:

‘Maxum (Cefepime) Injection is indicated for pneumonia (moderate to severe) caused by Streptococcus pneumoniae, inducing cases associated with ‘concurrent bacteremia, Pseudomonas aeruginosa, Klebsiela pneumoniae, Enterobacter species.

Empiric Therapy for Febrile Neutropenic Patents:

Maxum (Cefepime) Injection as monotherapy indicated for empiric treatment of febrile neutropenic patents. In paints a high risk for severe infection including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate.

Uncomplicated and Complicated Urinary Tract Infections (Including pyelonephritis):

Maxum (Cefepime) Injection is indicated for uncomplicated and complicated urinary tract infections caused by Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, inducing cases associated with concurrent bacteremia with these bacteria.

Uncomplicated Skin and kin Structure Infections:

Maxum (Cefepime) is indicated for uncomplicated skin and skin structure infections caused by staphylococcus aureus or Streptococcus pyogenes,

Complicated Intra-Abdominal Infections:

Maxum (Cefepime) Injection is indicated for complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli viridians group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis.

DOSAGE AND ADMINISTRATION:

Adult and Pediatric Population:

The recommended adult and pediatric dosages and routes of administration are outlined below. Maxum (Cefepime) Injection should be administered intravenously over approximately 30 minutes. Recommended dosage Schedule for Cefepime Injection in patients with CrCL greater than 60 mL/min.

Site and Type of InfectionDoseFrequencyDuration (days)
Adults Moderate to Severe Pneumonia1-2g IVEvery 12 hours10
Empiric therapy for febrile neutropenic patients2 g IVEvery 8 hours7
Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis0.5-1 g IV / IMEvery 12 hours7-10
Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis2 g IVEvery 12 hours10
Moderate to Severe Uncomplicated Skin and Skin Structure Infections2 g IVEvery 12 hours10
Complicated Intra-abdominal Infections (used in combination with metronidazole)2 g IVEvery 12 hours7-10

Pediatric Patients (2 Months up to 16 Years):

The maximum dose for pediatric patients should not exceed the recommended adult dose. The usual recommended adult dose. The usual recommended dosage in pediatric patients up to 40 kg in weight for durations as given above for adults is:

  • 50 mg per kg per dose, administered every 12 hours for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia (see below).
  • For moderate to severe pneumonia due to P. aeruginosa give 50mg per kg per dose, every 8 hours.
  • 50 mg per kg per dose, every 8 hours for febrile neutropenic patients.

 Patients with Hepatic Impairment:

No adjustment is necessary for patients with hepatic impairment.

Patients with Renal Impairment:

In patients with creatinine clearance less than or equal to 60 mL/min, the dose of Maxum (Cefepime) Injection should be adjusted to compensate for the slower rate of renal elimination. The recommended initial dose of Maxum (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 Maxum Injection in patients with renal impairment are: Recommended Dosing Schedule for Cefepime Injection in Adult Patients (Normal Renal Function, Renal Impairment, and Hemodialysis).

Creatinine Clearance (Ml/min)Recommended Maintenance Schedule
Greater than 60500 mg every 12 hours1 g every 12 hours2 g every 12 hours2 g every 8 hours
30-60500 mg every 24 hours1 g every 24 hours2 g every 24 hours2 g every 12 hours
11-29500 mg every 24 hours500 mg every 24 hours1 g every 24 hours2 g every 24 hours
Less than 11250 mg every 24 hours250 mg every 24 hours500 mg every 24 hours1 g every 24 hours
Continuous Ambulatory Peritoneal Dialysis (CAPD)500 mg every 48 hours1 g every 48 hours2 g every 48 hours2 g every 48 hours
Hemodialysis1 g on day 1500 mg every 24 hours1 g every 24 hours

In patients undergoing continuous ambulatory peritoneal dialysis, Maxum (Cefepime) Injection may be administered at normally recommended doses at a dosage interval of every 48 hours. The dosage of Maxum (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. Maxum (Cefepime) Injection should be administered intravenously over approximately 30 minutes. Intermittent intravenous infusion with a Y-type administration set can be accomplished with compatible solutions. However, during infusion of Maxum (Cefepime) Injection, it is desirable to discontinue the other solution. Solutions of cefepime, like those of most beta-lactam antibiotics, should not be added to solutions of ampicillin at a concentration greater than 40 mg per mL, and should not be added to metronidazole, vancomycin, gentamicin, tobramycin, netilmicin sulfate or aminophylline because of potential interaction. However, if concurrent therapy with cefepime is indicated, each of these antibiotics can be administered separately.

PRESENTATION:

Maxum is supplied in following dosage forms, strengths and pack sizes:

Maxum 500mg InjectionIM/IV:

1 vial of 500mg Cefepime and 1 ampoule of 5mL of water for injection 

Maxum 1g Injection IM/IV:

1 vial of 1g Cefepime and 1 ampoule of 10mL of water for injection 

Maxum 1g Injection IV:

1 vial of 2g Cefepime and 1 ampoule of 10mL of water for injection 

Patients should consult with their physician before taking any medicine.

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