ceftazidime
Trade name: fortaz
Approved
Jul 19, 1985
Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic, used especially for Pseudomonas and other gram-negative infections in debilitated patients. Ceftazidime is used to treat lower respiratory tract, skin, urinary tract, blood-stream, joint, and abdominal infections, and meningitis. The drug is given intravenously (IV) or intramuscularly (IM) every 8–12 hours (two or three times a day), with dose and frequency varying by the type of infection, severity, and/or renal function of the patient. Injectable formulations of ceftazidime are currently nebulized "off-label" to manage Cystic Fibrosis, non-Cystic Fibrosis bronchiectasis, drug-resistant nontuberculous mycobacterial infections, ventilator-associated pneumonia, and post-transplant airway infections. Ceftazidime is generally well-tolerated. When side effects do occur, they are most commonly local effects from the intravenous line site, allergic reactions, and gastrointestinal symptoms. According to one manufacturer, in clinical trials, allergic reactions including itching, rash, and fever, happened in fewer than 2% of patients. Rare but more serious allergic reactions, such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme, have been reported with this class of antibiotics, including ceftazidime. Gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal pain, were reported in fewer than 2% of patients. — NCATS
Clinical trial activity
75 trials · 98 clinical orgs · 13 marketing orgs
Earliest trial started Mar 1, 2001 (NCT00173901)
Timeline
1980s
- Jul 19, 1985
Teligent Pharmaceuticals — Earliest FDA Approval
- Jul 19, 1985
Pharmaceutical Associates — Marketing Organization
- Jul 19, 1985
Teligent Pharmaceuticals — NDA Organization
- Jul 19, 1985
Teligent Pharmaceuticals — NDA Secondary Org
- Jul 19, 1985
Pharmaceutical Associates — NDA Secondary Org
- Nov 20, 1985
ACS Dobfar — Marketing Organization
- Nov 20, 1985
Eli Lilly — Marketing Organization
- Mar 6, 1986
Hospira — Marketing Organization
1990s
- Sep 27, 1990
GlaxoSmithKline — NDA Secondary Org
- Apr 29, 1993
Baxalta — Marketing Organization
- Apr 29, 1993
Baxter — Marketing Organization
2000s
2010s
- May 28, 2010
Aurobindo Pharma — Marketing Organization
- Jun 13, 2011
B. Braun — NDA Secondary Org
- Feb 25, 2015
AbbVie — NDA Secondary Org
- Feb 25, 2015
Allergan — Marketing Organization
- Feb 25, 2015
Allergan — NDA Secondary Org
Indications
Approved for
Studied for
- Abdominal Injuries · Phase 3
- Antibiotic Prophylaxis · Phase 4
- Anti-Infective Agents · Phase 4
- Ascites · Phase 2/Phase 3
- Bacteremia · Phase 4
- Bacterial Infections · Phase 3
- Colitis, Ulcerative · Phase 2
- Community-Acquired Infections · Phase 3
- Corneal Diseases · Phase 1
- Cystic Fibrosis · Phase 4
- Drugs, Investigational · Phase 4
- Enterobacteriaceae Infections · Phase 3
- Esophageal Achalasia · Phase 2/Phase 3
- Febrile Neutropenia · Phase 4
- Feeding and Eating Disorders · Phase 4
- Fever · Phase 4
- Fibrosis · Phase 2/Phase 3
- Gram-Negative Bacterial Infections · Phase 2
- Hamartoma · Phase 4
- Healthcare-Associated Pneumonia · Phase 4
- Healthy Volunteers · Phase 1
- HIV Infections · Phase 1/Phase 2
- Intestinal Neoplasms · Phase 1
- Intraabdominal Infections · Phase 4
- Leukemia · Phase 4
- Leukemia, Myeloid, Acute · Phase 4
- Lung Diseases · Phase 4
- Lymphoma · Phase 4
- Lymphoma, Non-Hodgkin · Phase 4
- Melioidosis · Phase 2
- Meningitis · Phase 2
- Neoplasms · Phase 2
- Pancreatitis · Phase 4
- Peritoneal Dialysis · Phase 4
- Peritonitis · Phase 2/Phase 3
- Pharmacokinetics · Phase 1
- Pneumonia · Phase 3
- Pneumonia, Ventilator-Associated · Phase 4
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 4
- Premature Birth · Phase 4
- Pseudomonas aeruginosa · Phase 4
- Pyelonephritis · Phase 4
- Respiratory Tract Infections · Phase 2
- Safety · Phase 1
- Skin Diseases, Bacterial · Phase 3
- Skin Diseases, Infectious · Phase 3
- Staphylococcal Skin Infections · Phase 3
- Stomach Diseases · Phase 4
Mechanism of action
- Bacterial penicillin-binding proteinINHIBITOR
Bacterial penicillin-binding protein inhibitor
- D-alanyl-D-alanine carboxypeptidase DacB (dacB) ↗
- Peptidoglycan D,D-transpeptidase FtsI (ftsI) ↗
- Penicillin-binding protein 1A (mrcA) ↗
- Penicillin-binding protein 1B (mrcB) ↗
- D-alanyl-D-alanine carboxypeptidase DacA (dacA) ↗
- Peptidoglycan D,D-transpeptidase MrdA (mrdA) ↗
- D-alanyl-D-alanine carboxypeptidase DacC (dacC) ↗
Combination products
avycaz
with avibactam
Also known as avibactam and ceftazidime, zavicefta, ceftazidime-avibactam
Approval history
- approvedPriority reviewJul 19, 1985
Chemistry & pharmacology
SMILES
CC(C)(O/N=C(\C(=O)N[C@@H]1C(=O)N2C(C(=O)[O-])=C(C[n+]3ccccc3)CS[C@H]12)c1csc(N)n1)C(=O)O- Mol. weight
- 546.59 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL44354 ↗
- WikipediaCeftazidime ↗
- NCATSDZR1ENT301 ↗
- ChEMBLCHEMBL1200768 ↗
Also known as
- biotum
- caz
- caz
- cefazid
- ceftacidin
- ceftazidim
- ceftazidim
- ceftazidim
- ceftazidima
- ceftazidima
- ceftazidime
- ceftazidime
- ceftazidime
- ceftazidime
- ceftazidime
- ceftazidime
- ceftazidime
- ceftazidime
- ceftazidime
- ceftazidime anhydrous
- ceftazidime anhydrous
- ceftazidime (arginine formulation)
- ceftazidime (arginine formulation)
- ceftazidime / avibactam
- ceftazidime hydrate
- ceftazidime hydrate
- ceftazidime hydrate
- ceftazidime hydrate
- ceftazidime hydrate
- ceftazidime hydrate
- ceftazidime pentahydrate
- ceftazidime sodium
- ceftazidime sodium
- ceftazidime sodium
- ceftazidime sodium
- ceftazidimum
- ceftazidimum
- ceftazidine
- ceptaz
- ceptaz
- fortam
- fortam
- fortaz
- fortaz
- fortaz
- fortum
- fortum
- gr-20263
- gr-20263
- kefazim
- ly-139381
- ly-139381
- pentacef
- pentacef
- tazicef
- tazicef
- tazicef
- tazidime
- tazidime
- tazidime
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07085624 | N/A | Jan 31, 2026 | Government of France, University Clermont Auvergne, University of Lyon |
| NCT07016165 | Phase 4 | Jun 1, 2025 | Gadjah Mada University |
| NCT07089186 | Phase 3 | Apr 12, 2025 | Qilu Pharmaceutical Co., Ltd. |
| NCT06818565 | N/A | Feb 10, 2025 | Institute of Liver and Biliary Sciences, India |
| NCT06633718 | Phase 3 | Oct 31, 2024 | Qilu Pharmaceutical Co., Ltd. |
| NCT06528028 | Phase 4 | Jul 1, 2024 | Nanjing University |
| NCT05850871 | N/A | Jan 6, 2023 | Shandong first medical University, Shandong Province Qianfoshan Hospital |
| NCT05258851 | Phase 3 | Jun 1, 2022 | King Faisal University |
| NCT05105035 | Phase 2 | May 31, 2022 | Arrevus Inc. |
| NCT04927312 | Phase 3 | Oct 1, 2021 | Pfizer |
| NCT04882085 | Phase 4 | Aug 26, 2021 | Pfizer |
| NCT04948463 | Phase 4 | Jul 31, 2021 | Murdoch University |
| NCT04774094 | Phase 4 | May 21, 2021 | Pfizer |
| NCT04126031 | Phase 2 | Mar 10, 2020 | Allergan, Pfizer |
| NCT04040621 | Phase 1 | Nov 27, 2019 | Allergan, Pfizer |
| NCT03978091 | Phase 1 | Jun 14, 2019 | National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT04187755 | Phase 4 | Mar 1, 2019 | University of Indonesia |
| NCT03754387 | N/A | Jan 1, 2019 | Binzhou Medical University, Children's hospital of Dalian, Children's hospital of guiyang, Guizhou Medical University, people hospital of Suiyang, Zunyi Medical College |
| NCT03409679 | Phase 3 | Mar 23, 2018 | Polyphor Ltd. |
| NCT03439124 | Phase 3 | Nov 27, 2017 | Basilea Pharmaceutica |
Organizations
Research & Development (98)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| AstraZeneca | For profit | 17 | 17 | 3 | 2008 |
| Forest Laboratories | For profit | 7 | 1 | 3 | 2012 |
| Pfizer | For profit | 6 | 6 | 4 | 2004 |
| Basilea Pharmaceutica | For profit | 4 | 4 | 1 | 2005 |
| IQVIA | For profit | 4 | 0 | 1 | 2011 |
| Allergan | For profit | 3 | 0 | 2 | 2016 |
| Johnson and Johnson | For profit | 3 | 0 | 1 | 2005 |
| University of Paris | Academic/Hospital | 3 | 1 | 3 | 2001 |
| Chulalongkorn University | Academic/Hospital | 2 | 2 | 2 | 2012 |
| Cystic Fibrosis Foundation Therapeutics | Academic/Hospital | 2 | 0 | 2 | 2004 |
| Novexel Inc | For profit | 2 | 1 | 1 | 2008 |
| Pharmaceutical Research Associates, Inc. (PRA) | For profit | 2 | 0 | 1 | 2015 |
| Qilu Pharmaceutical Co., Ltd. | For profit | 2 | 2 | 1 | 2024 |
| University Clermont Auvergne | Academic/Hospital | 2 | 1 | 2 | 2007 |
| University of Washington | Academic/Hospital | 2 | 1 | 1 | 2004 |
| Arrevus Inc. | For profit | 1 | 1 | 1 | 2022 |
| Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche | Academic/Hospital | 1 | 1 | 1 | 2001 |
| Baxalta | For profit | 1 | 0 | 1 | 2001 |
| Belgische Vereniging voor Strijd tegen Mucoviscidose | Academic/Hospital | 1 | 0 | 1 | 2016 |
| Binzhou Medical University | Academic/Hospital | 1 | 0 | 1 | 2019 |
Marketing (17)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ACS Dobfar | For profit | MKTG | Nov 20, 1985 |
| AbbVie | For profit | NDA2 | Feb 25, 2015 |
| Allergan | For profit | MKTG | Feb 25, 2015 |
| Allergan | For profit | NDA2 | Feb 25, 2015 |
| Aurobindo Pharma | For profit | MKTG | May 28, 2010 |
| B. Braun | For profit | NDA2 | Jun 13, 2011 |
| Baxalta | For profit | MKTG | Apr 29, 1993 |
| Baxter | For profit | MKTG | Apr 29, 1993 |
| Eli Lilly | For profit | MKTG | Nov 20, 1985 |
| GlaxoSmithKline | For profit | NDA2 | Sep 27, 1990 |
| GlaxoSmithKline | For profit | MKTG | — |
| Hospira | For profit | MKTG | Mar 6, 1986 |
| Pharmaceutical Associates | For profit | MKTG | Jul 19, 1985 |
| Pharmaceutical Associates | For profit | NDA2 | Jul 19, 1985 |
| Teligent Pharmaceuticals | For profit | NDA | Jul 19, 1985 |
| Teligent Pharmaceuticals | For profit | NDA2 | Jul 19, 1985 |
| Wockhardt | For profit | MKTG | Oct 15, 2008 |