Cefepime

Overview

Cefepime is a fourth-generation cephalosporin antibiotic developed in 1994. Cefepime is active against Gram-positive and Gram-negative bacteria, and has greater activity against both compared to third-generation antibiotics. Cefepime is normally used to treat severe nosocomial pneumonia and infections caused by multi-resistant microorganisms such as Pseudomonas aeruginosa, and is also indicated for the empirical treatment of febrile neutropenia. The popularity of its third-generation predecessors, its clinical efficacy, and the high prevalence of multidrug-resistant bacteria might be some of the factors leading to an increase in the use of cefepime. The activity of cefepime against Enterobacteriaceae, Pseudomonas aeruginosa, and Staphylococcus aureus is due to its high stability toward beta-lactamases. In general, cefepime seems to be well tolerated; however, patients treated with this antibiotic, especially those with renal impairment, may develop neurotoxicity.

Indication

Cefepime is indicated for the treatment of pneumonia caused by susceptible bacteria, and for empiric therapy for febrile neutropenic patients. Cefepime is also indicated for the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and complicated intra-abdominal infections (used in combination with metronidazole) in adults caused by susceptible bacteria.

Associated Conditions

Bacterial Infections
Complicated Intra-Abdominal Infections (cIAIs)
Complicated Urinary Tract Infection
Febrile Neutropenia
Meningitis, Bacterial
Pyelonephritis
Severe Pneumonia
Uncomplicated Urinary Tract Infections
Moderate Pneumonia
Uncomplicated skin and subcutaneous tissue bacterial infections

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Pragmatic Clinical Trial Comparing the Risk of Acute Kidney Injury During Treatment With Vancomycin and Piperacillin-Tazobactam vs. Vancomycin and Cefepime in Hospitalized Patients	2025/05/01	NCT06954129	Phase 4	Not yet recruiting	University of Pennsylvania
Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections	2023/09/21	NCT06048692	Phase 3	Active, not recruiting	Beni-Suef University
A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI	2023/04/24	NCT05826990	Phase 2	Recruiting	Allecra
Early Antibiotics After Aspiration in ICU Patients	2021/10/15	NCT05079620	Phase 4	Terminated	UConn Health
PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN	2021/07/30	NCT04983901	Phase 2	Completed	M.D. Anderson Cancer Center
Early Versus Late Stopping of Antibiotics in Children With Cancer and High-risk Febrile Neutropenia	2021/07/02	NCT04948463	Phase 4	Recruiting	Murdoch Childrens Research Institute
Antibiotics Continuous Infusion at Home	2021/03/25	NCT04816968	Phase 1	UNKNOWN	Ospedale San Carlo Borromeo
Efficacy of Extended Infusion of β-lactam Antibiotics for the Treatment of Febrile Neutropenia in Hematologic Patients	2020/01/21	NCT04233996	Phase 4	UNKNOWN	Hospital Universitari de Bellvitge
Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever	2019/12/05	NCT04187755	Phase 4	Completed	Indonesia University
Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic During Emergency Intrapartum Cesarean Section	2019/07/05	NCT04009772	Phase 2	UNKNOWN	Assiut University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Cefepime	Apotex Corp.	60505-6144	INTRAVENOUS, INTRAMUSCULAR	1 g in 1 1	2/21/2022
Exblifep	Allecra Therapeutics SAS	83289-101	INTRAVENOUS	2 g in 1 1	2/28/2024
Cefepime	Apotex Corp.	60505-6246	INTRAVENOUS	2 g in 1 1	8/31/2022
Cefepime	Qilu Pharmaceutical Co., Ltd.	67184-1003	INTRAVENOUS, INTRAMUSCULAR	1 g in 1 1	10/26/2021
Cefepime	WG Critical Care, LLC	44567-240	INTRAVENOUS, INTRAMUSCULAR	1 g in 20 mL	5/31/2019
Cefepime	WG Critical Care, LLC	44567-131	INTRAVENOUS	2 g in 20 mL	3/1/2022
Cefepime	Apotex Corp.	60505-6145	INTRAVENOUS	2 g in 1 1	2/21/2022
Cefepime	Apotex Corp.	60505-6147	INTRAVENOUS	2 g in 1 1	11/22/2021
Cefepime	WG Critical Care, LLC	44567-130	INTRAVENOUS, INTRAMUSCULAR	1 g in 20 mL	3/1/2022
Cefepime	Hospira, Inc.	0409-9735	INTRAVENOUS	2 g in 1 1	8/31/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
ROXIPIME POWDER FOR SOLUTION FOR INJECTION 2G/VIAL	Pharma Vision San. Ve Tic. A.Ş., Qilu Antibiotics Pharmaceutical Co., Ltd. (Blend-Cefepime Hydrochloride (Contains Arginine))	SIN15420P	INJECTION, POWDER, FOR SOLUTION	2g per vial	2/8/2018
Cefevon powder for solution for injection 2g/vial	Antibioticos do Brasil Ltda.	SIN14156P	INJECTION, POWDER, FOR SOLUTION	2000mg	6/11/2012
CEFEPIME-AFT POWDER FOR INJECTION 1G/VIAL	QILU PHARMACEUTICAL CO., LTD, QILU ANTIBIOTICS PHARMACEUTICAL CO., LTD (Blend-Cefepime Hydrochloride (Contains Arginine))	SIN14658P	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1000MG	11/6/2014
CEFEPIME KABI POWDER FOR SOLUTION FOR INJECTION OR INFUSION 2 g/vial	Labesfal Laboratorios Almiro S.A. (Fresenius Kabi Group)(primary and secondary packing), Fresenius Kabi iPSUM S.R.L	SIN14988P	INJECTION, POWDER, FOR SOLUTION	2000 mg/vial	4/12/2016
CEFEPIME KABI POWDER FOR SOLUTION FOR INJECTION OR INFUSION 1 g/vial	Labesfal Laboratorios Almiro S.A. (Fresenius Kabi Group)(primary and secondary packing), Fresenius Kabi iPSUM S.R.L (Intermediate)	SIN14987P	INJECTION, POWDER, FOR SOLUTION	1000 mg/vial	4/12/2016

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CEFEPIME KABI cefepime (as hydrochloride) 2 g powder for injection vial	227965	Fresenius Kabi Australia Pty Ltd	Medicine	A	9/7/2015
BINDOZEF INJECTION 2g cefepime (as hydrochloride) 2 g powder for injection vial	170375	Strides Pharma Science Pty Ltd	Medicine	A	9/13/2011
Cefepime-AFT cefepime hydrochloride monohydrate equivalent to cefepime 2 g, powder for injection, vial	196280	AFT Pharmaceuticals Pty Ltd	Medicine	A	2/13/2013
AURO CEFEPIME 1 g; cefepime (as hydrochloride) 1 g powder for injection vial	156640	Strides Pharma Science Pty Ltd	Medicine	A	8/26/2010
AURO-CEFEPIME 2 g; cefepime (as hydrochloride) 2 g powder for injection vial	156639	Strides Pharma Science Pty Ltd	Medicine	A	8/26/2010
CEFEPIME KABI cefepime (as hydrochloride) 1 g powder for injection vial	227966	Fresenius Kabi Australia Pty Ltd	Medicine	A	9/7/2015
BINDOZEF INJECTION 1g cefepime (as hydrochloride) 1 g powder for injection vial	170374	Strides Pharma Science Pty Ltd	Medicine	A	9/13/2011
Cefepime-AFT cefepime hydrochloride monohydrate equivalent to cefepime 1 g, powder for injection, vial	196279	AFT Pharmaceuticals Pty Ltd	Medicine	A	2/13/2013
Cefepime-AFT cefepime hydrochloride monohydrate equivalent to cefepime 500 mg, powder for injection, vial	196281	AFT Pharmaceuticals Pty Ltd	Medicine	A	2/13/2013

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
CEFEPIMA NORMON 2 G POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE Y PARA PERFUSION EFG	Laboratorios Normon S.A.	78772	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN	Uso Hospitalario	Commercialized
CEFEPIMA NORMON 1 G POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE Y PARA PEFUSION EFG	Laboratorios Normon S.A.	78773	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN	Diagnóstico Hospitalario	Commercialized
CEFEPIMA MIP 2 G POLVO PARA SOLUCION INYECTABLE Y PARA PERFUSION EFG	Mip Pharma Gmbh	79714	POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized
CEFEPIMA ACCORD 2 g POLVO PARA SOLUCION INYECTABLE Y PARA PERFUSION EFG	Accord Healthcare S.L.U.	75147	POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN	Uso Hospitalario	Commercialized
CEFEPIMA MIP 1 G POLVO PARA SOLUCION INYECTABLE Y PARA PERFUSION EFG	Mip Pharma Gmbh	79713	POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized
CEFEPIMA ACCORD 1 g POLVO PARA SOLUCION INYECTABLE Y PARA PERFUSION EFG	Accord Healthcare S.L.U.	75148	POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN	Diagnóstico Hospitalario	Commercialized
CEFEPIMA KABI 2G POLVO PARA SOLUCION INYECTABLE Y PARA PERFUSION EFG	Fresenius Kabi España, S.A.U.	72751	POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN	Uso Hospitalario	Commercialized
CEFEPIMA KABI 1G POLVO PARA SOLUCION INYECTABLE Y PARA PERFUSION EFG	Fresenius Kabi España, S.A.U.	72750	POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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