Overview
A semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis. It attains high serum levels and is excreted quickly via the urine.
Indication
Mainly used to treat bacterial infections of the skin. It can also be used to treat moderately severe bacterial infections involving the lung, bone, joint, stomach, blood, heart valve, and urinary tract. It is clinically effective against infections caused by staphylococci and streptococci species of Gram positive bacteria. May be used for surgical prophylaxis; if required metronidazole may be added to cover B. fragilis.
Associated Conditions
- Bacterial Septicemia caused by susceptible Bacterial Infections
- Biliary tract infection bacterial caused by susceptible Bacterial Infections
- Bone and Joint Infections caused by susceptible Bacterial Infections
- Catheter-related Bloodstream Infection (CRBSI) NOS
- Community Acquired Pneumonia (CAP)
- Endocarditis caused by susceptible Bacterial Infections
- Genital infection caused by susceptible Bacterial Infections
- Osteoarticular Infections
- Postoperative Infections
- Respiratory Tract Infection Bacterial caused by susceptible Bacterial Infections
- Skin and Soft Tissue Infections (SSTIs)
- Skin and Subcutaneous Tissue Infection caused by susceptible Bacterial Infections
- Susceptible infections
- Urinary Tract Infection caused by susceptible Bacterial Infections
- Perioperative infection
- Susceptible Bacterial Infections
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/08/28 | Phase 3 | Recruiting | |||
2024/08/23 | Phase 4 | Not yet recruiting | |||
2024/05/07 | Phase 3 | Active, not recruiting | |||
2024/04/09 | Phase 2 | Recruiting | University of Brawijaya | ||
2024/03/25 | Phase 2 | Recruiting | |||
2024/01/05 | Not Applicable | Not yet recruiting | Chang Gung Memorial Hospital | ||
2023/09/28 | Phase 4 | ENROLLING_BY_INVITATION | |||
2023/09/11 | Not Applicable | Completed | |||
2023/08/22 | Phase 4 | Recruiting | |||
2023/05/10 | Phase 4 | Recruiting | Abdul El-Rabbany |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Proficient Rx LP | 71205-679 | INTRAMUSCULAR, INTRAVENOUS | 1 g in 1 1 | 8/1/2022 | |
| Hospira, Inc | 0409-2585 | INTRAVENOUS | 1 g in 1 1 | 6/15/2017 | |
| Henry Schein, Inc. | 0404-9833 | INTRAMUSCULAR, INTRAVENOUS | 1 g in 1 1 | 1/9/2022 | |
| Civica, Inc. | 72572-056 | INTRAVENOUS | 10 g in 1 1 | 2/25/2022 | |
| Sagent Pharmaceuticals | 25021-100 | INTRAVENOUS, INTRAMUSCULAR | 500 mg in 2.2 mL | 6/9/2020 | |
| Qilu Pharmaceutical Co., Ltd. | 67184-1001 | INTRAMUSCULAR, INTRAVENOUS | 1 g in 1 1 | 12/18/2023 | |
| Samson Medical Technologies, L.L.C. | 66288-1300 | INTRAVENOUS | 300 g in 1 1 | 10/24/2018 | |
| Fresenius Kabi USA, LLC | 63323-237 | INTRAMUSCULAR, INTRAVENOUS | 1 g in 3 mL | 9/27/2023 | |
| West-Ward Pharmaceuticals Corp | 0143-9261 | INTRAVENOUS | 10 g in 1 1 | 9/17/2018 | |
| Fresenius Kabi USA, LLC | 63323-238 | INTRAVENOUS | 10 g in 1 1 | 6/17/2020 |
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 |
|---|---|---|---|---|---|
| Zepilen Powder for Injection 1g/vial | SIN14304P | INJECTION, POWDER, FOR SOLUTION | 1000 mg | 1/31/2013 | |
| CEFAZOLIN-AFT POWDER FOR INJECTION 500MG/VIAL | SIN15018P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 500MG | 5/25/2016 | |
| CEFAZOLIN-AFT POWDER FOR INJECTION 1G/VIAL | SIN14480P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 1 g/vial | 1/13/2014 | |
| CEZOLIN INJECTION 1 gm/vial | SIN12471P | INJECTION, POWDER, FOR SOLUTION | 1 gm/vial | 12/5/2003 | |
| CEFAZOLIN ALVOGEN POWDER FOR SOLUTION FOR INJECTION OR INFUSION 1G/VIAL | SIN14846P | INJECTION, POWDER, FOR SOLUTION | 1 g | 9/16/2015 | |
| CEFAZOLIN SANDOZ 1 g/vial | SIN07879P | INJECTION, POWDER, FOR SOLUTION | 1 g/vial | 10/21/1994 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Cefazolin Sodium for Injection | 国药准字H51020688 | 化学药品 | 注射剂 | 6/23/2022 | |
| Cefazolin Sodium for Injection | 国药准字H51020689 | 化学药品 | 注射剂 | 6/23/2022 | |
| Cefazolin Sodium for Injection/Sodium Chloride Injection | 国药准字H20184118 | 化学药品 | 注射剂 | 3/23/2023 | |
| Cefazolin Sodium for Injection/Sodium Chloride Injection | 国药准字H20254505 | 化学药品 | 注射剂 | 6/10/2025 | |
| Cefazolin Sodium for Injection | 国药准字H46020265 | 化学药品 | 注射剂 | 3/11/2020 | |
| Cefazolin Sodium for Injection | 国药准字H20244871 | 化学药品 | 注射剂 | 9/10/2024 | |
| Cefazolin Sodium for Injection | 国药准字H34023473 | 化学药品 | 注射剂 | 2/3/2021 | |
| Cefazolin Sodium for Injection | 国药准字H20213508 | 化学药品 | 注射剂 | 6/18/2021 | |
| Cefazolin Sodium for Injection | 国药准字HC20250003 | 化学药品 | 注射剂 | 3/25/2025 | |
| Cefazolin Sodium for Injection | 国药准字HC20250004 | 化学药品 | 注射剂 | 3/25/2025 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CEPHAZOLIN VIATRIS cefazolin 2g powder for solution for injection vial | 154640 | Medicine | A | 4/9/2010 | |
| CEFAZOLIN SXP cefazolin (as sodium) 1000 mg powder for injection vial | 322861 | Medicine | A | 9/2/2021 | |
| AURO-CEFAZOLIN 1g cefazolin (as sodium) 1g powder for injection vial | 174072 | Medicine | A | 12/23/2011 | |
| CEFAZOLIN-AFT cefazolin sodium 0.5 g powder for injection vial | 171534 | Medicine | A | 11/24/2011 | |
| AURO-CEFAZOLIN 0.5g cefazolin (as sodium) 0.5g powder for injection vial | 174066 | Medicine | A | 12/23/2011 | |
| CEFAZOLIN SANDOZ cefazolin 2g (as sodium) powder for injection infusion bottle | 97685 | Medicine | A | 5/5/2004 | |
| SRATOP 1g cefazolin (as sodium) 1g powder for injection vial | 174068 | Medicine | A | 12/23/2011 | |
| KEFZOL 1g powder for injection | 14647 | Medicine | A | 9/5/1991 | |
| CEFAZOLIN SANDOZ cefazolin sodium 1g powder for injection vial | 75956 | Medicine | A | 3/14/2002 | |
| CEFAZOLIN-AFT cefazolin sodium 1 g powder for injection vial | 171582 | Medicine | A | 11/24/2011 |
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