Cefepime


Generic Medicine Info
Indications and Dosage
Intramuscular, Intravenous
Intra-abdominal infections, Lower respiratory tract infections, Skin and skin structure infections
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).

Intramuscular, Intravenous
Urinary tract infections
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 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 and 1 g or 2 g with 5 mL and 10 mL of compatible diluent, respectively, to yield a final concentration of 100 mg/mL (500 mg and 1 g vial) and 160 mg/mL (2 g vial). Dilute further 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, 0.9% NaCl, 5% dextrose in water, lidocaine 0.5% or 1%, or bacteriostatic water for inj to 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). 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 e.g. encephalopathy, aphasia, myoclonus, seizures, non-convulsive status epilepticus (in patients with renal impairment who did not receive appropriate dosage adjustment).
IM/IV/Parenteral: B
Monitoring Parameters
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 false-positive results for Coombs test (without evidence of haemolysis) and urinary glucose with Cu reduction tests (e.g. Benedict's solution, Fehling's solution, Clinitest® tab).
Action
Description: 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

Chemical Structure Image
Cefepime

Source: National Center for Biotechnology Information. PubChem Database. Cefepime, CID=5479537, https://pubchem.ncbi.nlm.nih.gov/compound/Cefepime (accessed on Jan. 21, 2020)

Storage
Store intact vials between 20-25°C. Protect from light. Once reconstituted, may store solutions diluted in 0.9% NaCl and 5% dextrose 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 guideline.
MIMS Class
Cephalosporins
ATC Classification
J01DE01 - cefepime ; Belongs to the class of fourth generation cephalosporins. Used in the systemic treatment of infections.
References
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 07/12/2021.

Altamax 1 g Powder for Injection [IM/IV] (JustRight Pharmaceuticals). MIMS Philippines. http://www.mims.com/philippines. Accessed 07/12/2021.

Anon. Cefepime. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 15/02/2022.

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 07/12/2021.

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.

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 07/12/2021.

Disclaimer: This information is independently developed by MIMS based on Cefepime from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 MIMS. All rights reserved. Powered by MIMS.com
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