Adult: Dose and route of administration may vary according to the severity of the infection, renal function and general condition of the patient. Mild to moderate cases: 1 g 12 hourly via IV inj or infusion over at least 30 minutes or IM inj. Severe cases: 2 g 12 hourly via IV inj or infusion over at least 30 minutes, may be increased to 2 g 8 hourly for very severe infections. Max: 2 g 8 hourly. Usual treatment duration: 7-10 days. Dosage recommendations may vary among countries and individual products (refer to detailed product or local treatment guidelines). Child: >2 months ≤40 kg: 50 mg/kg 12 hourly for 10 days, may increase frequency to 8 hourly in more severe cases; >40 kg: Same as adult dose. Dosage recommendations may vary among countries and individual products (refer to detailed product or local treatment guidelines).
Adult: Dose and route of administration may vary according to the severity of the infection, renal function and general condition of the patient. For complicated and uncomplicated cases: Mild to moderate cases: 0.5-1 g 12 hourly via IV inj or infusion over at least 30 minutes or IM inj. Severe cases: 2 g 12 hourly via IV inj or infusion over at least 30 minutes, may be increased to 2 g 8 hourly for very severe infections. Max: 2 g 8 hourly. Usual treatment duration: 7-10 days. Dosage recommendations may vary among countries and individual products (refer to detailed product or local treatment guidelines). Child: >2 months ≤40 kg: 50 mg/kg 12 hourly for 10 days, may increase frequency to 8 hourly in more severe cases; >40 kg: Same as adult dose. Dosage recommendations may vary among countries and individual products (refer to detailed product or local treatment guidelines).
Intramuscular, Intravenous Febrile neutropenia
Adult: Dose and route of administration may vary according to the severity of the infection, renal function and general condition of the patient. As empiric treatment: Mild to moderate cases: 1 g 12 hourly via IV inj or infusion over at least 30 minutes or IM inj. Severe cases: 2 g 12 hourly via IV inj or infusion over at least 30 minutes, may increase to 2 g 8 hourly for very severe infections. Max: 2 g 8 hourly. Usual treatment duration: 7 days or until neutropenia is resolved. Dosage recommendations may vary among countries and individual products (refer to detailed product or local treatment guidelines). Child: >2 months ≤40 kg: 50 mg/kg 8 hourly for 7-10 days; >40 kg: Same as adult dose. Dosage recommendations may vary among countries and individual products (refer to detailed product or local treatment guidelines).
Renal Impairment
In patients with mild to moderate renal insufficiency, initial dose recommended is similar in patients with normal renal function.
CrCl (mL/min)
Dosage
<11
Maintenance: 0.25-1 g 24 hourly.
11-29
Maintenance: 0.5-2 g 24 hourly.
30-60
Maintenance: 0.5-2 g 24 hourly or 2 g 12 hourly.
Patients undergoing haemodialysis: Lower respiratory tract infections; Intra-abdominal infections; Skin and skin structure infections; Urinary tract infections:
1 g as loading dose on the 1st day, followed by 0.5 g 24 hourly; administer after dialysis during dialysis days.
Febrile neutropenia:
1 g 24 hourly; administer after dialysis during dialysis days.
Reconstitution
IV: Reconstitute vials labelled as 500 mg with 5 mL and 1 g or 2 g with 10 mL of compatible IV diluent to yield a final concentration of 100 mg/mL (500 mg and 1 g vial) or 160 mg/mL (2 g vial). May further dilute in a compatible IV infusion fluid. IM: Reconstitute vials labelled as 500 mg or 1 g with 1.3 mL or 2.4 mL, respectively, of sterile water for inj, NaCl 0.9%, dextrose 5% in water, lidocaine 0.5% or 1%, or bacteriostatic water for inj to a yield a final concentration of 280 mg/mL.
Incompatibility
Incompatible with metronidazole, aminophylline, gentamicin, tobramycin, netilmicin, vancomycin, and ampicillin (at a concentration >40 mg/mL).
Contraindications
Hypersensitivity to cefepime or other cephalosporins; history of severe hypersensitivity reactions (e.g. anaphylactic reaction) to other β-lactam antibacterial agents (e.g. penicillins, carbapenems, monobactams).
Special Precautions
Patient with history of non-severe hypersensitivity to other β-lactam agents, asthma, allergic diathesis, seizure disorder, gastrointestinal disease (particularly colitis). Neonates, children, and elderly. Renal impairment. Pregnancy and lactation.
Adverse Reactions
Significant: Elevated INR; fungal or bacterial superinfection (prolonged use). Blood and lymphatic system disorders: Anaemia, eosinophilia. Gastrointestinal disorders: Diarrhoea, nausea, vomiting. General disorders and administration site conditions: Localised reactions (e.g. phlebitis, inflammation and/or pain), fever. Investigations: Increased AST, ALT, alkaline phosphatase, blood bilirubin; prolonged partial thromboplastin time. Nervous system disorders: Headache. Skin and subcutaneous tissue disorders: Rash, pruritus. Potentially Fatal: Hypersensitivity reactions; pseudomembranous colitis, Clostridium difficile-associated diarrhoea; neurotoxicity including encephalopathy, aphasia, myoclonus, seizures, non-convulsive status epilepticus (particularly in patients with renal impairment who did not receive appropriate dosage adjustment).
Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Monitor renal function. Assess for signs and symptoms of anaphylaxis during the initial dose.
Overdosage
Symptoms: Encephalopathy (disturbance of consciousness including confusion, stupor, hallucinations, and coma), myoclonus, seizures, neuromuscular excitability, nonconvulsive status epilepticus. Management: Supportive treatment. In case of severe overdose, particularly in patients with renal insufficiency, haemodialysis is recommended and not peritoneal dialysis.
Drug Interactions
May potentiate the action of coumarin anticoagulants. May enhance the nephrotoxic effects of aminoglycosides or potent diuretics (e.g. furosemide).
Lab Interference
May cause positive Coombs test (without evidence of haemolysis) and false-positive reaction for urinary glucose with copper reduction tests (e.g. Benedict's solution, Fehling's solution, Clinitest® tab).
Action
Description: Mechanism of Action: Cefepime is a broad-spectrum, bactericidal antibiotic that is active against a wide range of Gram-positive and Gram-negative bacteria, including multiple strains resistant to aminoglycosides or 3rd generation cephalosporins. It acts by inhibiting the bacterial cell wall synthesis by binding to 1 or more penicillin-binding proteins (PBP) which interrupts the final transpeptidation step of peptidoglycan synthesis, leading to bacterial cell lysis and death. It is highly resistant to most β-lactamases. Pharmacokinetics: Absorption: Rapidly and completely absorbed following IM inj. Time to peak plasma concentrations: 1-2 hours (IM); 0.5 hours (IV). Distribution: Widely distributed in body fluids and tissues; highly concentrated in bile. Crosses the placenta; enters breast milk (small amounts). Volume of distribution: 18 L. Plasma protein binding: Approx 20%. Metabolism: Metabolised in the liver to N-methylpyrrolidinium, which is rapidly converted to the N-oxide. Excretion: Via urine (85% as unchanged drug; <1% as N-methylpyrrolidinium, 6.8% as N-methylpyrrolidinium-N-oxide, 2.5% as cefepime epimer). Elimination half-life: Approx 2 hours.
Chemical Structure
Cefepime Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5479537, Cefepime. https://pubchem.ncbi.nlm.nih.gov/compound/Cefepime. Accessed Sept. 6, 2023.
Storage
Store intact vials between 20-25°C. Protect from light. Once reconstituted, may store solutions diluted in NaCl 0.9% and dextrose 5% in water solutions between 20-25°C for 24 hours or between 2-8°C for 7 days. Storage recommendations may vary among individual products. Refer to detailed product guidelines.
J01DE01 - cefepime ; Belongs to the class of fourth generation cephalosporins. Used in the systemic treatment of infections.
References
Committee on Infectious Diseases, American Academy of Pediatrics, Kimberlin DW, Barnett ED, Lynfield R, Sawyer MH. "Tables of Antibacterial Drug Dosages", Red Book: 2021-2024 Report of the Committee on Infectious Diseases. American Academy of Pediatrics [online]. Accessed 11/04/2023.AFT Pharmaceuticals Ltd. Cefepime-AFT 500 mg, 1 g, 2 g Powder for Injection data sheet 18 January 2018. Medsafe. http://www.medsafe.govt.nz. Accessed 11/04/2023.Altamax 1 g Powder for Injection [IM/IV] (JustRight Pharmaceuticals). MIMS Philippines. http://www.mims.com/philippines. Accessed 07/12/2021.Anon. Cefepime (Pediatric and Neonatal Lexi-Drugs). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 11/04/2023.Anon. Cefepime. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 11/04/2023.Anon. Cefepime. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/12/2021.Buckingham R (ed). Cefepime Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 11/04/2023.Cefepime Injection, Powder, for Solution (Hospira, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/12/2021.Cefepime. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 11/04/2023.Joint Formulary Committee. Cefepime. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/12/2021.Renapime 1 g Powder for Solution for Injection/Infusion (Renascience Pharma Ltd). MHRA. https://products.mhra.gov.uk. Accessed 11/04/2023.
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