Overview
Tazobactam is an antibiotic of the beta-lactamase inhibitor class that prevents the breakdown of other antibiotics by beta-lactamase enzyme producing organisms. It is combined with Piperacillin and Ceftolozane for the treatment of a variety of bacterial infections. Piperacillin-tazobactam was initially approved by the FDA in 1994, and ceftolozane-tazobactam was approved by the FDA in 2014, providing wider antibacterial coverage for gram-negative infections. In June 2019, ceftolozane-tazobactam was approved by the FDA for treating hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, which are significant causes of morbidity and mortality in hospitalized patients.
Background
Tazobactam is an antibiotic of the beta-lactamase inhibitor class that prevents the breakdown of other antibiotics by beta-lactamase enzyme producing organisms. It is combined with Piperacillin and Ceftolozane for the treatment of a variety of bacterial infections. Piperacillin-tazobactam was initially approved by the FDA in 1994, and ceftolozane-tazobactam was approved by the FDA in 2014, providing wider antibacterial coverage for gram-negative infections. In June 2019, ceftolozane-tazobactam was approved by the FDA for treating hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, which are significant causes of morbidity and mortality in hospitalized patients.
Indication
临床上他唑巴坦常与β内酰胺类抗生素联合应用，可用于治疗敏感细菌所致的下呼吸道、腹腔、妇科、泌尿、骨和关节、皮肤组织等部位的感染和败血症。也可用于多种细菌的混合感染和患中性粒细胞缺乏者的感染。
Associated Conditions
- Complicated Urinary Tract Infection
- Nosocomial Pneumonia
- Pyelonephritis
- Ventilator Associated Bacterial Pneumonia (VABP)
- Complicated intra-abdominal bacterial infections
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/21 | Not Applicable | Recruiting | Instituto Nacional de Cancerologia de Mexico | ||
2023/09/13 | Phase 4 | Not yet recruiting | |||
2020/04/20 | N/A | UNKNOWN | |||
2020/02/06 | N/A | UNKNOWN | |||
2020/01/10 | Phase 1 | Completed | |||
2019/12/12 | N/A | UNKNOWN | Emilio Bouza | ||
2019/02/05 | Phase 3 | Completed | |||
2018/04/03 | Phase 2 | Completed | |||
2017/10/13 | Phase 1 | Completed | |||
2017/07/26 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Eugia US LLC | 55150-120 | INTRAVENOUS | 0.375 g in 1 1 | 1/25/2024 | |
| Fresenius Kabi USA, LLC | 65219-259 | INTRAVENOUS | 0.5 g in 20 mL | 5/19/2021 | |
| Eugia US LLC | 55150-121 | INTRAVENOUS | 0.5 g in 1 1 | 1/25/2024 | |
| BluePoint Laboratories | 68001-508 | INTRAVENOUS | 0.5 g in 20 mL | 2/28/2024 | |
| Fresenius Kabi USA, LLC | 63323-982 | INTRAVENOUS | 0.5 g in 20 mL | 1/23/2020 | |
| Fresenius Kabi USA, LLC | 63323-300 | INTRAVENOUS | 0.375 g in 15 mL | 12/31/2019 | |
| Steriscience Specialties Private Limited | 82449-501 | INTRAVENOUS | 0.375 g in 15 mL | 7/5/2023 | |
| Xellia Pharmaceuticals USA LLC | 70594-080 | INTRAVENOUS | 500 mg in 150 mL | 8/26/2022 | |
| Fresenius Kabi USA, LLC | 65219-434 | INTRAVENOUS | 0.25 g in 10 mL | 11/30/2023 | |
| Fresenius Kabi USA, LLC | 63323-309 | INTRAVENOUS | 0.25 g in 10 mL | 12/31/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/18/2015 | ||
Authorised | 9/18/2015 | ||
Authorised | 9/18/2015 | ||
Authorised | 9/18/2015 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SALATAZ POWDER FOR SOLUTION FOR INJECTION/INFUSION 4.5G/VIAL | SIN15299P | INJECTION, POWDER, FOR SOLUTION | 500mg | 7/14/2017 | |
| TAZOCIN FOR INJECTION 4.5 g/vial | SIN08362P | INJECTION, POWDER, FOR SOLUTION | 500 mg/vial | 10/3/1995 | |
| PIPTAZ-AFT POWDER FOR SOLUTION FOR INJECTION 4.5G/VIAL | SIN15482P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 0.5g | 5/11/2018 | |
| ZERBAXA POWDER FOR SOLUTION FOR INJECTION 1G/0.5G | SIN15317P | INJECTION, POWDER, FOR SOLUTION | 500mg | 8/14/2017 | |
| TAZPEN FOR INJECTION 4.5g/VIAL | SIN13758P | INJECTION, POWDER, FOR SOLUTION | 0.50g | 1/26/2010 | |
| PIPERACILLIN/TAZOBACTAM KABI POWDER FOR SOLUTION FOR INFUSION 4G/0.5G | SIN15308P | INJECTION, POWDER, FOR SOLUTION | 0.5g | 7/31/2017 | |
| Piperacillin/Tazobactam Sandoz Powder for solution for Injection/Infusion 4.5g vials | SIN13985P | POWDER, FOR SOLUTION | 500mg | 7/7/2011 | |
| Piperacillin-Tazobactam Stragen For Injection 4.5g/vial | SIN13978P | INJECTION, POWDER, FOR SOLUTION | 500 mg | 6/20/2011 |
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. | |||||