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 |
|---|---|---|---|---|---|
2025/05/01 | Phase 4 | Not yet recruiting | |||
2023/09/21 | Phase 3 | Active, not recruiting | |||
2023/04/24 | Phase 2 | Recruiting | Allecra | ||
2021/10/15 | Phase 4 | Terminated | UConn Health | ||
2021/07/30 | Phase 2 | Completed | |||
2021/07/02 | Phase 4 | Recruiting | |||
2021/03/25 | Phase 1 | UNKNOWN | Ospedale San Carlo Borromeo | ||
2020/01/21 | Phase 4 | UNKNOWN | Hospital Universitari de Bellvitge | ||
2019/12/05 | Phase 4 | Completed | |||
2019/07/05 | Phase 2 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Apotex Corp. | 60505-6144 | INTRAVENOUS, INTRAMUSCULAR | 1 g in 1 1 | 2/21/2022 | |
| Allecra Therapeutics SAS | 83289-101 | INTRAVENOUS | 2 g in 1 1 | 2/28/2024 | |
| Apotex Corp. | 60505-6246 | INTRAVENOUS | 2 g in 1 1 | 8/31/2022 | |
| Qilu Pharmaceutical Co., Ltd. | 67184-1003 | INTRAVENOUS, INTRAMUSCULAR | 1 g in 1 1 | 10/26/2021 | |
| WG Critical Care, LLC | 44567-240 | INTRAVENOUS, INTRAMUSCULAR | 1 g in 20 mL | 5/31/2019 | |
| WG Critical Care, LLC | 44567-131 | INTRAVENOUS | 2 g in 20 mL | 3/1/2022 | |
| Apotex Corp. | 60505-6145 | INTRAVENOUS | 2 g in 1 1 | 2/21/2022 | |
| Apotex Corp. | 60505-6147 | INTRAVENOUS | 2 g in 1 1 | 11/22/2021 | |
| WG Critical Care, LLC | 44567-130 | INTRAVENOUS, INTRAMUSCULAR | 1 g in 20 mL | 3/1/2022 | |
| 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 | SIN15420P | INJECTION, POWDER, FOR SOLUTION | 2g per vial | 2/8/2018 | |
| Cefevon powder for solution for injection 2g/vial | SIN14156P | INJECTION, POWDER, FOR SOLUTION | 2000mg | 6/11/2012 | |
| CEFEPIME-AFT POWDER FOR INJECTION 1G/VIAL | SIN14658P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 1000MG | 11/6/2014 | |
| CEFEPIME KABI POWDER FOR SOLUTION FOR INJECTION OR INFUSION 2 g/vial | SIN14988P | INJECTION, POWDER, FOR SOLUTION | 2000 mg/vial | 4/12/2016 | |
| CEFEPIME KABI POWDER FOR SOLUTION FOR INJECTION OR INFUSION 1 g/vial | 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 |
|---|---|---|---|---|---|
| Cefepime Hydrochloride for Injection/Sodium Chloride Injection | 国药准字H20203071 | 化学药品 | 注射剂 | 3/3/2020 | |
| Cefepime Hydrochloride for Injection/Sodium Chloride Injection | 国药准字H20234019 | 化学药品 | 注射剂 | 8/8/2023 | |
| Cefepime Hydrochloride for Injection/Sodium Chloride Injection | 国药准字H20203070 | 化学药品 | 注射剂 | 3/3/2020 | |
| Cefepime Hydrochloride for Injection/Sodium Chloride Injection | 国药准字H20234018 | 化学药品 | 注射剂 | 8/8/2023 | |
| Cefepime Hydrochloride for Injection | 国药准字H20123259 | 化学药品 | 注射剂 | 12/6/2021 | |
| Cefepime Hydrochloride for Injection | 国药准字H20123266 | 化学药品 | 注射剂 | 4/12/2022 | |
| Cefepime Hydrochloride for Injection | 国药准字H20153143 | 化学药品 | 注射剂 | 3/3/2020 | |
| Cefepime Hydrochloride for Injection | 国药准字H20060991 | 化学药品 | 注射剂(无菌分装粉针剂) | 5/20/2020 | |
| Cefepime Hydrochloride for Injection | 国药准字H20050582 | 化学药品 | 注射剂 | 7/31/2020 | |
| Cefepime Hydrochloride for Injection | 国药准字H20183028 | 化学药品 | 注射剂 | 6/30/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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