Overview
Bacteria possess a cell wall comprising a glycopeptide polymer commonly known as peptidoglycan, which is synthesized and remodelled through the action of a family of enzymes known as "penicillin-binding proteins" (PBPs). β-lactam antibiotics, including cephalosporins, are PBP inhibitors that, through inhibition of essential PBPs, result in impaired cell wall homeostasis, loss of cell integrity, and ultimately bacterial cell death. Ceftazidime is a third-generation cephalosporin with broad-spectrum antibacterial activity, including against some treatment-resistant bacteria such as Pseudomonas aeruginosa. Ceftazidime was approved by the FDA on July 19, 1985, and is currently available either alone or in combination with the non-β-lactam β-lactamase inhibitor avibactam to treat a variety of bacterial infections.
Indication
Ceftazidime is indicated for the treatment of lower respiratory tract infections, skin and skin structure infections, urinary tract infections, bacterial septicemia, bone and joint infections, gynecologic infections, intra-abdominal infections (including peritonitis), and central nervous system infections (including meningitis) caused by susceptible bacteria. Ceftazidime is indicated in combination with avibactam to treat infections caused by susceptible Gram-negative organisms, including complicated intra-abdominal infections (cIAI), in conjunction with metronidazole, and complicated urinary tract infections (cUTI), including pyelonephritis, in patients aged three months and older. This combination is also indicated to treat hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) in patients aged 18 years and older. In all cases, to mitigate the risk of bacterial resistance and preserve clinical efficacy, ceftazidime should only be used for infections that are confirmed or strongly suspected to be caused by susceptible bacterial strains.
Associated Conditions
- Bacteremia
- Bacterial Infections
- Bacterial Septicemia
- Bone and Joint Infections
- Bronchopulmonary Infection
- Central Nervous System Infections
- Complicated Intra-Abdominal Infections (cIAIs)
- Complicated Skin and Soft Tissue Infection
- Complicated Urinary Tract Infection
- Complicated Urinary Tract Infections caused by susceptible Gram-negative microorganisms
- Fever caused by susceptible bacteria
- Gynecological Infection
- Intraabdominal Infections
- Lower Respiratory Tract Infection (LRTI)
- Meningitis, Bacterial
- Nosocomial Pneumonia
- Peritoneal Dialysis Associated Peritonitis
- Skin and skin structure infections
- Urinary Tract Infection
- Ventilator-associated Bacterial Pneumonia caused by susceptible Gram-negative microorganisms
- Chronic suppurative Otitis media
- Hospital-acquired bacterial pneumonia caused by susceptible Gram-negative microorganisms
- Malignant Otitis Externa
- Susceptible Intra-Abdominal Infection caused by susceptible Gram-negative microorganism
Research Report
An Expert Monograph on Ceftazidime (DB00438)
1.0 Executive Summary
Ceftazidime is a parenteral, third-generation cephalosporin antibiotic that has been a significant component of the antimicrobial armamentarium since its patenting in 1978 and subsequent commercial introduction in 1984.[1] Classified as a small molecule drug, it is recognized for its essential role in medicine and is included on the World Health Organization's List of Essential Medicines.[1] The bactericidal action of Ceftazidime is achieved through the inhibition of bacterial cell wall synthesis, which it accomplishes by binding to and inactivating essential penicillin-binding proteins (PBPs), with a particularly high affinity for PBP3 in Gram-negative organisms.[3]
The drug possesses a broad spectrum of activity, but its clinical value is most pronounced in its potent efficacy against a wide range of Gram-negative pathogens. It is especially noted for its activity against Pseudomonas aeruginosa, an opportunistic pathogen frequently associated with multi-drug resistance.[1] This makes Ceftazidime a critical agent for the treatment of severe, life-threatening infections, including hospital-acquired and ventilator-associated pneumonia (HAP/VABP), meningitis, sepsis, complicated urinary tract infections (cUTIs), and bone and joint infections.[1] Furthermore, it holds the status of a first-line therapy for melioidosis, a serious infection endemic to tropical regions.[1]
The pharmacokinetic profile of Ceftazidime is characterized by its parenteral route of administration (intravenous or intramuscular), minimal plasma protein binding of less than 10%, and excellent penetration into a wide variety of body tissues and fluids, including inflamed cerebrospinal fluid.[5] It undergoes no significant metabolism and is eliminated almost entirely unchanged via renal glomerular filtration.[5]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/25 | Not Applicable | Not yet recruiting | |||
2025/06/11 | Phase 4 | Not yet recruiting | Gadjah Mada University | ||
2024/01/18 | N/A | Not yet recruiting | Sichuan Provincial People's Hospital | ||
2022/12/19 | N/A | Completed | |||
2022/08/04 | N/A | Recruiting | |||
2021/11/03 | Phase 2 | Completed | |||
2021/07/14 | N/A | Recruiting | |||
2021/07/02 | Phase 4 | Recruiting | |||
2020/05/26 | N/A | Completed | King Abdul Aziz Specialist Hospital | ||
2020/03/24 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Hospira, Inc. | 0409-5086 | INTRAVENOUS | 6 g in 1 1 | 3/10/2023 | |
| Hospira, Inc. | 0409-5084 | INTRAVENOUS | 2 g in 1 1 | 3/10/2023 | |
| Teligent Pharma, Inc. | 52565-107 | INTRAMUSCULAR, INTRAVENOUS | 170 mg in 1 mL | 5/8/2019 | |
| Sagent Pharmaceuticals | 25021-127 | INTRAVENOUS, INTRAMUSCULAR | 1 g in 1 1 | 6/6/2018 | |
| Teligent Pharma, Inc. | 52565-109 | INTRAMUSCULAR, INTRAVENOUS | 200 mg in 1 mL | 9/12/2019 | |
| Allergan, Inc. | 0456-2700 | INTRAVENOUS | 2 g in 1 1 | 2/1/2024 | |
| Teligent Pharma, Inc. | 52565-105 | INTRAMUSCULAR, INTRAVENOUS | 100 mg in 1 mL | 5/8/2019 | |
| Teligent Pharma, Inc. | 52565-106 | INTRAMUSCULAR, INTRAVENOUS | 100 mg in 1 mL | 5/8/2019 | |
| WG Critical Care, LLC | 44567-237 | INTRAVENOUS | 6 g in 100 mL | 9/1/2021 | |
| Sagent Pharmaceuticals | 25021-129 | INTRAVENOUS | 6 g in 30 mL | 1/3/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/23/2016 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TAZIME FOR INJECTION 1 g/vial | SIN12096P | INJECTION, POWDER, FOR SOLUTION | 1 g/vial | 10/11/2002 | |
| CEFTAZIDIME ALVOGEN POWDER FOR SOLUTION FOR INJECTION AND INFUSION 1G/ VIAL | SIN14738P | INJECTION, POWDER, FOR SOLUTION | 1.0g/ vial | 2/27/2015 | |
| ZAVICEFTA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 2G/0.5G | SIN15870P | INJECTION, POWDER, FOR SOLUTION | 2g | 12/12/2019 | |
| CEFTAZIDIME KABI POWDER FOR SOLUTION FOR INJECTION 1G/VIAL | SIN15074P | INJECTION, POWDER, FOR SOLUTION | 1000mgvial | 8/25/2016 | |
| CEFTAZIDIME KABI POWDER FOR SOLUTION FOR INJECTION 2G/VIAL | SIN15075P | INJECTION, POWDER, FOR SOLUTION | 2000mg/vial | 8/25/2016 | |
| CEFAZIME FOR INJECTION 1 g/vial | SIN11470P | INJECTION | 1 g/vial | 3/26/2001 |
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 |
|---|---|---|---|---|---|
| ZAVICEFTA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 2G/0.5G | N/A | N/A | N/A | 1/14/2019 | |
| CEFTAZIDIME FOR INJ 1G | N/A | N/A | N/A | 1/11/2011 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CEFTAZIDIME SXP ceftazidime 1g powder for injection | 143195 | Medicine | A | 10/14/2008 | |
| CEFTAZIDIME KABI ceftazidime (as pentahydrate) 1 g powder for injection vial | 223563 | Medicine | A | 7/2/2015 | |
| CEFTAZIDIME-AFT ceftazidime (as pentahydrate) 2g powder for injection vial | 277679 | Medicine | A | 9/22/2017 | |
| FORTUM 1g powder for injection vial | 12508 | Medicine | A | 8/13/1991 | |
| CEFTAZIDIME KABI ceftazidime (as pentahydrate) 2 g powder for injection vial | 223569 | Medicine | A | 7/2/2015 | |
| ZETAF 1g ceftazidime (as pentahydrate) 1g powder for injection vial | 170892 | Medicine | A | 1/9/2012 | |
| CEFTAZIDIME JUNO ceftazidime (as pentahydrate) 2g powder for injection vial | 120544 | Medicine | A | 9/19/2006 | |
| CEFTAZIDIME SANDOZ ceftazidime 1g (as pentahydrate) powder for injection vial | 90915 | Medicine | A | 6/5/2003 | |
| AURO-CEFTAZIDIME ceftazidime (as pentahydrate) 1g powder for injection vial | 158791 | Medicine | A | 10/19/2010 | |
| CEFTAZIDIME VIATRIS ceftazidime 1g (as pentahydrate) powder for injection vial | 154398 | Medicine | A | 5/21/2010 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| CEFTAZIDIME FOR INJECTION, USP | fresenius kabi canada ltd | 00886963 | Powder For Solution - Intravenous | 6 G / VIAL | 12/31/1991 |
| CEFTAZIDIME FOR INJECTION, USP | fresenius kabi canada ltd | 00886971 | Powder For Solution - Intramuscular
,
Intravenous | 1 G / VIAL | 12/31/1991 |
| CEFTAZIDIME FOR INJECTION, USP | fresenius kabi canada ltd | 00886955 | Powder For Solution - Intravenous | 2 G / VIAL | 12/31/1991 |
| CEPTAZ INJECTION - PWS IM IV 1G/VIAL | 02215012 | Powder For Solution - Intravenous
,
Intramuscular | 1 G / VIAL | 9/1/2001 | |
| TAZIDIME INJ 500MG/VIAL | eli lilly canada inc | 00888338 | Powder - Intramuscular
,
Intravenous | 500 MG / VIAL | 12/31/1991 |
| CEPTAZ INJ 10GM/VIAL | glaxo canada inc | 01968092 | Powder For Solution - Intravenous | 10 G / VIAL | 12/31/1993 |
| CEPTAZ INJ 2GM/VIAL | glaxo canada inc | 01974416 | Powder For Solution - Intravenous | 2 G / VIAL | 12/31/1993 |
| CEPTAZ INJECTION - PWS IV 2GM/VIAL | 02215020 | Powder For Solution - Intravenous | 2 G / VIAL | 12/28/2001 | |
| CEPTAZ INJECTION - PWS IV 10GM/VIAL | 02213737 | Powder For Solution - Intravenous | 10 G / VIAL | 11/7/2001 | |
| TAZIDIME ADD-VANTAGE INJ 1.0GM/VIAL | eli lilly canada inc | 00887129 | Powder For Solution - Intravenous | 1 G / VIAL | 12/31/1991 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| CEFTAZIDIMA KABI 2 g POLVO PARA SOLUCION INYECTABLE Y PARA PERFUSION EFG | Fresenius Kabi España, S.A.U. | 72674 | POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
| CEFTAZIDIMA KABI 1 g POLVO PARA SOLUCION INYECTABLE EFG | Fresenius Kabi España, S.A.U. | 71574 | POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Diagnóstico Hospitalario | Commercialized |
| CEFTAZIDIMA NOVOCAT FARMA 1 g POLVO PARA SOLUCION PARA PERFUSION EFG | Novocat Farma S.A. | 67382 | POLVO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
| CEFTAZIDIMA NOVOCAT FARMA 2 g POLVO PARA SOLUCION PARA PERFUSION EFG | Novocat Farma S.A. | 67383 | POLVO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
| CEFTAZIDIMA LDP TORLAN 2 G POLVO PARA SOLUCION PARA PERFUSION EFG | Ldp Laboratorios Torlan S.A. | 68122 | POLVO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
| CEFTAZIDIMA LDP TORLAN 1.000 mg polvo y disolvente para solución inyectable EFG | Ldp Laboratorios Torlan S.A. | 68124 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Diagnóstico Hospitalario | Commercialized |
| CEFTAZIDIMA LDP TORLAN 500 mg POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE EFG | Ldp Laboratorios Torlan S.A. | 68123 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Diagnóstico Hospitalario | Not Commercialized |
| CEFTAZIDIMA LDP TORLAN 1.000 mg POLVO PARA SOLUCION PARA PERFUSION EFG | Ldp Laboratorios Torlan S.A. | 68121 | POLVO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not 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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