Overview
Cefotaxime is a third-generation cephalosporin antibiotic. Like other third-generation cephalosporins, it has broad spectrum activity against Gram positive and Gram negative bacteria. In most cases, it is considered to be equivalent to ceftriaxone in terms of safety and efficacy. Cefotaxime sodium is marketed under various trade names including Claforan (Sanofi-Aventis).
Background
Cefotaxime is a third-generation cephalosporin antibiotic. Like other third-generation cephalosporins, it has broad spectrum activity against Gram positive and Gram negative bacteria. In most cases, it is considered to be equivalent to ceftriaxone in terms of safety and efficacy. Cefotaxime sodium is marketed under various trade names including Claforan (Sanofi-Aventis).
Indication
Used to treat gonorrhoea, meningitis, and severe infections including infections of the kidney (pyelonephritis) and urinary system. Also used before an operation to prevent infection after surgery.
Associated Conditions
- Bone and Joint Infections caused by susceptible Bacterial Infections
- Central Nervous System Infections caused by susceptible Bacterial Infections
- Genitourinary tract infection caused by susceptible Bacterial Infections
- Gynaecological infection caused by susceptible bacteria
- Intraabdominal Infections caused by susceptible Bacterial Infections
- Lower Respiratory Tract Infection (LRTI) caused by susceptible bacteria
- Postoperative Wound Infection
- Septicemia caused by susceptible Bacterial Infections
- Skin and skin-structure infections caused by susceptible bacteria
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2013/03/28 | Phase 4 | UNKNOWN | University of Roma La Sapienza | ||
2011/08/31 | N/A | Completed | |||
2010/12/23 | Phase 4 | Completed | |||
2010/02/01 | Phase 1 | Completed | |||
2007/05/04 | Phase 2 | Completed | Göteborg University | ||
2005/09/16 | Phase 1 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| WOCKHARDT LIMITED | 55648-948 | INTRAMUSCULAR, INTRAVENOUS | 2 g in 1 mL | 11/20/2009 | |
| WOCKHARDT LIMITED | 55648-947 | INTRAMUSCULAR, INTRAVENOUS | 500 mg in 1 mL | 11/20/2009 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Cefotaxime Sodium for Injection | 国药准字H20003166 | 化学药品 | 注射剂 | 3/17/2020 | |
| Cefotaxime Sodium for Injection | 国药准字H20044561 | 化学药品 | 注射剂 | 5/28/2020 | |
| Cefotaxime Sodium for Injection | 国药准字H20023560 | 化学药品 | 注射剂 | 3/4/2022 | |
| Cefotaxime Sodium for Injection | 国药准字H20023369 | 化学药品 | 注射剂 | 6/15/2020 | |
| Cefotaxime Sodium for Injection | 国药准字H43020386 | 化学药品 | 注射剂 | 10/12/2020 | |
| Cefotaxime Sodium for Injection | 国药准字H20046583 | 化学药品 | 注射剂 | 11/23/2020 | |
| Cefotaxime Sodium for Injection | 国药准字H23021933 | 化学药品 | 注射剂 | 3/30/2021 | |
| Cefotaxime Sodium for Injection | 国药准字H51020690 | 化学药品 | 注射剂 | 6/23/2021 | |
| Cefotaxime Sodium for Injection | 国药准字H53021564 | 化学药品 | 注射剂 | 8/19/2020 | |
| Cefotaxime Sodium for Injection | 国药准字H20045212 | 化学药品 | 注射剂 | 2/3/2021 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||