Cefepime is indicated for the treatment of the following infections caused by susceptible strains of the listed microorganisms:

• Pneumonia (moderate to severe): caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.
• Febrile Neutropenia: Cefepime as monotherapy is indicated for the empiric treatment of febrile neutropenic patients. However, in patients at high risk for severe infection, including those with a recent history of bone marrow transplantation, hypotension at presentation, underlying hematologic malignancy, or severe or prolonged neutropenia, antimicrobial monotherapy may not be appropriate. There are insufficient data to support the efficacy of cefepime monotherapy in such patients.
• Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis): 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, including cases associated with concurrent bacteremia due to these microorganisms.
• Uncomplicated Skin and Skin Structure Infections: caused by Staphylococcus aureus (methicillin-susceptible strains only) or Streptococcus pyogenes.
• Complicated Intra-abdominal Infections (used in combination with metronidazole): caused by Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis.

Cephalosporins are bactericidal antibiotics and act in a manner similar to other beta-lactam antibiotics, such as penicillins. They interfere with the synthesis of the peptidoglycan layer of the bacterial cell wall, which is essential for maintaining cell wall structural integrity, particularly in Gram-positive organisms. The final transpeptidation step in peptidoglycan synthesis is mediated by transpeptidase enzymes known as penicillin-binding proteins (PBPs). By inhibiting these PBPs, cefepime disrupts cell wall formation, ultimately leading to bacterial cell death.

Cefepime should be administered intravenously over approximately 30 minutes.

• *Moderate to Severe Pneumonia due to S. pneumoniae, P. aeruginosa, K. pneumoniae, or Enterobacter species:
• 1-2 gm IV 12 hourly for 10 days.
• Empiric therapy for febrile neutropenic patients:
• 2 gm IV 8 hourly for 7** days.
• Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis:*
• 0.5-1 gm IV/IM*** 12 hourly for 7-10 days.
• Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae:*
• 2 gm IV 12 hourly for 10 days.
• Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes:
• 2 gm IV 12 hourly for 10 days.
• 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:
• 2 gm IV 12 hourly for 7-10 days.

Note:
including cases associated with concurrent bacteremia.
or 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.
*** IM route of administration is indicated only for mild to moderate, uncomplicated or complicated UTls due to E. coli when the IM route is considered to be a more appropriate route of drug administration.

Renal function should be monitored carefully when high doses of aminoglycosides are administered together with cefepime, due to the increased risk of nephrotoxicity and ototoxicity associated with aminoglycoside antibiotics. Nephrotoxicity has also been reported when other cephalosporins are given concomitantly with potent diuretics such as furosemide.

Cefepime is contraindicated in patients with a history of immediate hypersensitivity reactions to cefepime, cephalosporin antibiotics, penicillin, or other beta-lactam antibiotics.

Common side effects of cefepime may include gastrointestinal disturbances, hypersensitivity reactions, and local reactions at the injection site. As with other cephalosporins, allergic reactions may occur in susceptible individuals.

Cefepime is classified as Pregnancy Category B. However, there are no adequate and well-controlled studies of cefepime use in pregnant women. Since animal reproduction studies do not always predict human response, cefepime should be used during pregnancy only if clearly needed. Cefepime is excreted in human breast milk in very low concentrations (0.5 µg/mL). Therefore, caution should be exercised when cefepime is administered to a nursing woman.

• Cefepime should not be prescribed unless there is a confirmed or strongly suspected bacterial infection or a valid prophylactic reason, as unnecessary use may promote the development of drug-resistant bacteria.
• Prolonged therapy with cefepime, like other antibiotics, may lead to overgrowth of non-susceptible organisms; therefore, regular assessment of the patient’s condition is important.
• A decrease in prothrombin activity has been reported with cephalosporins, including cefepime. Patients at higher risk include those with renal or hepatic impairment, poor nutritional status, or those receiving long-term antimicrobial therapy. Monitoring of prothrombin time is advised in such patients.
• Use cefepime cautiously in patients with a history of gastrointestinal disorders, especially colitis.
• High doses of arginine have been associated with temporary alterations in glucose metabolism and increased serum potassium levels; however, the effects at lower doses remain unclear.

Pediatric Use (2 months up to 16 years): The maximum dose for pediatric patients should not exceed the recommended adult dose. In pediatric patients weighing up to 40 kg, the usual recommended dosage for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg/kg per dose every 12 hours. For febrile neutropenic patients, the recommended dosage is 50 mg/kg per dose every 8 hours. The duration of therapy should follow the recommendations given above.

Geriatric Use: Serious adverse events have occurred in elderly patients with renal insufficiency who received unadjusted doses of cefepime. These events include life-threatening or fatal encephalopathy, myoclonus, and seizures. Because cefepime is substantially excreted by the kidneys, the risk of toxic reactions is greater in patients with impaired renal function. Since elderly patients are more likely to have reduced renal function, careful dose selection and monitoring of renal function are required.

Impaired Hepatic Function: No dosage adjustment is necessary in patients with impaired hepatic function.

Impaired Renal Function: In patients with impaired renal function (creatinine clearance <60 mL/min), the dose of cefepime should be adjusted to compensate for the reduced rate of renal elimination.

Patients who receive an overdose of cefepime should be monitored carefully and provided with appropriate supportive treatment. In patients with renal insufficiency, hemodialysis rather than peritoneal dialysis is recommended to help remove cefepime from the body. Accidental overdose has occurred when high doses were administered to patients with impaired renal function. Symptoms of overdose may include encephalopathy, manifested by disturbances of consciousness such as confusion, hallucinations, stupor, and coma, as well as myoclonus, seizures, and neuromuscular excitability.

Fourth-generation cephalosporin antibiotic.

Do not use after the expiry date. Keep all medicines out of the reach of children. Dispense only on the prescription of a registered physician.