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Cefepime/sulbactam

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Cefepime/Sulbactam
Combination of
CefepimeCephalosporin
Sulbactamβ-Lactamase inhibitor

Cefepime/sulbactam is a 1:1 fixed-dose combination of cefepime (a fourth-generation cephalosporin[1]) and sulbactam (a β-lactamase inhibitor). The combination exerts a bactericidal effect by disrupting bacterial cell wall synthesis through transpeptidase inhibition, thereby impairing peptidoglycan cross-linking.[2] It was developed in 2006 by Russian researchers.[3]

Cefepime/sulbactam was approved for medical use in Russia in 2019[3] and is also registered in Belarus, Armenia, Azerbaijan, Uzbekistan, Kyrgyzstan, Uganda, and Mongolia under the trade name Maxictam-AF.[4]

Pharmacology

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Microbiological spectrum

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Cefepime/sulbactam demonstrates enhanced in vitro activity against:

  • Gram-positive aerobes: Staphylococcus aureus, Streptococcus spp.[8]
  • Gram-negative aerobes:[2]
  1. Acinetobacter baumannii (including carbapenem-resistant strains).
  2. Klebsiella pneumoniae (ESBL and carbapenemase producers).
  3. Pseudomonas aeruginosa, Enterobacter, Escherichia coli.

Efficacy

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From October 2019 till March 2020, an open multicenter, observational study of the use of the antibiotic cefepime/sulbactam was conducted by S.V. Yakovlev, M.P. Suvorova, and A.O. Bykov. The study was conducted in 14 clinics in the Russian Federation among patients with abdominal infection, nosocomial pneumonia, or pneumonia associated with ventilator-associated pneumonia.[10] Zhuravlyova M. V., Vasilyuk V.B., Gorelov D.S. and coauthors conducted an open randomized comparative study to study the efficacy and safety of cefepime/sulbactam and cefepime for the treatment of acute pyelonephritis. The aim of the studies: to investigate in real clinical practice the efficacy of antibiotic in patients with abdominal infection, nosocomial pneumonia (NP) or ventilator-associated pneumonia (VAP-associated pneumonia). Clinical efficacy and safety of cefepime/sulbactam correspond to those of cefepime, which is widely used in clinical practice for the same indications. The combination of cefepime and sulbactam may be the best option to replace carbapenems in clinical practice. According to studies, the bioavailability of the drug is 100%.[11] This efficacy is particularly noted:

Advantages

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This antibiotic is an alternative to carbapenems, which reduces the risk of carbapenem resistance. Its efficacy is comparable to carbapenems but with a lower risk of superinfection. Cefepime/sulbactam is suitable for implementing a strategy to contain antibiotic resistance.[13]

  • Carbapenem-sparing effect: reduces selection pressure for carbapenem-resistant A. baumannii and K. pneumoniae.
  • Lower risk of superinfection (22.2% vs. 53.3% with carbapenems[14]).
  • Effective against ESBL and AmpC producers, offering an alternative to ceftazidime-avibactam and meropenem-vaborbactam.

Future directions

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References

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  1. ^ "List of Fourth generation cephalosporins".
  2. ^ a b Wareham DW, Momin MH, Phee LM, Hornsey M, Standing JF (2020-01-01). "Cefepime/sulbactam as an enhanced antimicrobial combination therapy for the treatment of MDR Gram-negative infections". The Journal of Antimicrobial Chemotherapy. 75 (1): 135–139. doi:10.1093/jac/dkz420. ISSN 1460-2091. PMID 31617905.
  3. ^ a b Yakovlev SV, Suvorova MP, Bykov AO (2021). Cefepime/Sulbactam — A New Innovative Antibiotic for In-Hospital Treatment of Severe Infections and the Implementation of Carbapenem-Replacement Strategy to Contain Antibiotic Resistance. Antibiotics and Chemotherapy. Vol. 66. pp. 82–98. doi:10.37489/0235-2990-2021-66-3-4-82-98.
  4. ^ "Максиктам-АФ – ГРЛС: Справочник РУ – Государственный реестр лекарственных средств".
  5. ^ Queenan AM, Bush K (2007). "Carbapenemases: The Versatile β-Lactamases". Clinical Microbiology Reviews. 20 (3): 440–58, table of contents. doi:10.1128/CMR.00001-07. PMC 1932750. PMID 17630334.
  6. ^ Patel HB, Lusk KA, Cota JM (2019-08-01). "The Role of Cefepime in the Treatment of Extended-Spectrum Beta-Lactamase Infections". Journal of Pharmacy Practice. 32 (4): 458–463. doi:10.1177/0897190017743134. ISSN 0897-1900. PMID 29166830.
  7. ^ "Activity of imipenem, meropenem, cefepime, and sulbactam in combination with the β-lactamase inhibitor ln-1-255 against acinetobacter spp". CiQUS -USC - University of Santiago de Compostela. 2021-03-18. Retrieved 2025-05-27.
  8. ^ Bell JM, Turnidge JD, et al. (Cefepime Study Group) (2001-02-01). "Multicentre study of the in vitro activity of cefepime, a broad-spectrum cephalosporin, compared to other broad-spectrum agents". Pathology. 33 (1): 53–60. doi:10.1080/00313020125000. ISSN 0031-3025. PMID 11280610.
  9. ^ Yakovlev SV, Suvorova MP, Bykov AO (2021-06-25). Cefepime/Sulbactam — A New Innovative Antibiotic for In-Hospital Treatment of Severe Infections and the Implementation of Carbapenem-Replacement Strategy to Contain Antibiotic Resistance. Antibiotics and Chemotherapy (in Russian). Vol. 66. pp. 82–98. doi:10.37489/0235-2990-2021-66-3-4-82-98. ISSN 0235-2990. Archived from the original on 2024-09-03. Retrieved 2025-05-23.
  10. ^ Yakovlev SV, Suvorova MP, Bykov AO, Zhuravel SV, Popugaev KA, Kulagina LY, et al. (13 February 2021). An Open-Label, Multicenter, Observational Study of the Effectiveness of the Cefepime/Sulbactam Antibiotic (Maxictam®-AF) in Patients with Intra Abdominal Infection, Nosocomial Pneumonia or Ventilator-Associated Pneumonia (Study MAXI-2019). Antibiotics and Chemotherapy. Vol. 65. pp. 49–58. doi:10.37489/0235-2990-2020-65-11-12-49-58.
  11. ^ Yakovlev SV, Suvorova MP, Bykov AO, Zhuravel SV, Popugaev KA, Kulagina LY, et al. (2021-02-13). An Open-Label, Multicenter, Observational Study of the Effectiveness of the Cefepime/Sulbactam Antibiotic (Maxictam®-AF) in Patients with Intra Abdominal Infection, Nosocomial Pneumonia or Ventilator-Associated Pneumonia (Study MAXI-2019). Antibiotics and Chemotherapy (in Russian). Vol. 65. pp. 49–58. doi:10.37489/0235-2990-2020-65-11-12-49-58. ISSN 0235-2990. Archived from the original on 2024-12-06. Retrieved 2025-05-30.
  12. ^ a b Yakovlev SV, Suvorova MP, Bykov AO (2021). Cefepime/Sulbactam — A New Innovative Antibiotic for In-Hospital Treatment of Severe Infections and the Implementation of Carbapenem-Replacement Strategy to Contain Antibiotic Resistance. Antibiotics and Chemotherapy. Vol. 66. pp. 82–98. doi:10.37489/0235-2990-2021-66-3-4-82-98.
  13. ^ a b Yakovlev SV, Suvorova MP, Bykov AO (2021-06-25). Cefepime/Sulbactam — A New Innovative Antibiotic for In-Hospital Treatment of Severe Infections and the Implementation of Carbapenem-Replacement Strategy to Contain Antibiotic Resistance. Antibiotics and Chemotherapy (in Russian). Vol. 66. pp. 82–98. doi:10.37489/0235-2990-2021-66-3-4-82-98. ISSN 0235-2990. Archived from the original on 2022-02-25. Retrieved 2025-05-23.
  14. ^ Karaiskos I, Giamarellou H (2020). "Carbapenem-Sparing Strategies for ESBL Producers: When and How". Antibiotics. 9 (2). Basel, Switzerland: 61. doi:10.3390/antibiotics9020061. PMC 7167803. PMID 32033322.
  15. ^ Sader HS, Jones RN (2005-05-01). "Comprehensive in vitro evaluation of cefepime combined with aztreonam or ampicillin/sulbactam against multi-drug resistant Pseudomonas aeruginosa and Acinetobacter spp". International Journal of Antimicrobial Agents. 25 (5): 380–384. doi:10.1016/j.ijantimicag.2005.01.011. ISSN 0924-8579. PMID 15848291.
  16. ^ Lasarte-Monterrubio C, Vázquez-Ucha JC, Maneiro M, Arca-Suárez J, Alonso I, Guijarro-Sánchez P, et al. (2021-02-20). "Activity of Imipenem, Meropenem, Cefepime, and Sulbactam in Combination with the β-Lactamase Inhibitor LN-1-255 against Acinetobacter spp". Antibiotics. 10 (2). Basel, Switzerland: 210. doi:10.3390/antibiotics10020210. ISSN 2079-6382. PMC 7924334. PMID 33672671.
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