Overview
Broad-spectrum cephalosporin antibiotic resistant to beta-lactamase. It has been proposed for infections with gram-negative and gram-positive organisms, gonorrhea, and haemophilus.
Indication
For the treatment of many different types of bacterial infections such as bronchitis, sinusitis, tonsillitis, ear infections, skin infections, gonorrhea, and urinary tract infections.
Associated Conditions
- Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)
- Animal bite
- Bacterial Infections
- Bone and Joint Infections
- Impetigo
- Lower Respiratory Tract Infection (LRTI)
- Lyme Disease
- Maxillary Sinusitis
- Meningitis
- Neisseria Gonorrhoeae Infection
- Septicemia
- Skin and Subcutaneous Tissue Bacterial Infections
- Urinary Tract Infection
- Bacterial otitis media
- Mild Streptococcal pharyngitis
- Mild Streptococcal tonsillitis
- Moderate Streptococcal pharyngitis
- Moderate Streptococcal tonsillitis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/29 | Phase 4 | Recruiting | |||
2024/07/30 | Phase 4 | Not yet recruiting | |||
2024/04/08 | Phase 4 | Not yet recruiting | |||
2023/03/24 | Phase 4 | Recruiting | Leiden University Medical Center | ||
2022/11/08 | Phase 2 | Recruiting | |||
2022/10/13 | Not Applicable | ENROLLING_BY_INVITATION | Omri Schwarztuch Gildor | ||
2022/05/31 | Phase 2 | Completed | Dr. Promise Tamunoipiriala Jaja | ||
2022/05/24 | N/A | Recruiting | Shandong University | ||
2021/01/25 | Not Applicable | Suspended | Shanghai East Hospital | ||
2020/07/21 | Early Phase 1 | Recruiting | Zhong Wang |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| American Health Packaging | 60687-272 | ORAL | 250 mg in 1 1 | 3/9/2023 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9568 | INTRAMUSCULAR, INTRAVENOUS | 750 mg in 1 1 | 9/27/2018 | |
| LUPIN LIMITED | 57297-303 | ORAL | 500 mg in 1 1 | 5/6/2016 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9979 | INTRAMUSCULAR, INTRAVENOUS | 750 mg in 1 1 | 4/8/2020 | |
| RPK Pharmaceuticals, Inc. | 53002-2750 | ORAL | 250 mg in 1 1 | 7/29/2022 | |
| Physicians Total Care, Inc. | 54868-4987 | ORAL | 250 mg in 1 1 | 12/9/2010 | |
| Bryant Ranch Prepack | 63629-9447 | ORAL | 250 mg in 1 1 | 11/23/2021 | |
| DIRECT RX | 61919-145 | ORAL | 250 mg in 1 1 | 11/3/2015 | |
| Rebel Distributors Corp | 21695-150 | ORAL | 500 mg in 1 1 | 1/17/2008 | |
| H.J. Harkins Company, Inc. | 52959-939 | ORAL | 500 mg in 1 1 | 12/29/2011 |
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 |
|---|---|---|---|---|---|
| CEFUROXIME-AFT POWDER FOR INJECTION 1.5G/VIAL | SIN15154P | INJECTION, POWDER, FOR SOLUTION | 1.5g | 1/12/2017 | |
| CEFUROXIME-AFT POWDER FOR INJECTION 750MG/VIAL | SIN15155P | INJECTION, POWDER, FOR SOLUTION | 750mg | 1/12/2017 | |
| ZINNAT FOR SUSPENSION 125 mg/5 ml | SIN07013P | GRANULE, FOR SUSPENSION | 125 mg/5 ml | 5/15/1992 | |
| SHINCEF FOR INJECTION 1.5 g/ vial | SIN10947P | INJECTION, POWDER, FOR SOLUTION | 1.5 g/ vial | 5/25/1999 | |
| AXETINE film coated tablet 500mg | SIN14346P | TABLET, FILM COATED | 500mg | 5/6/2013 | |
| SHINCEF FOR INJECTION 750 mg/ vial | SIN10946P | INJECTION, POWDER, FOR SOLUTION | 750 mg/vial | 5/25/1999 | |
| AXETINE FILM COATED TABLET 250MG | SIN14566P | TABLET, FILM COATED | 250 mg | 6/30/2014 | |
| ZINNAT TABLET 250 mg | SIN02365P | TABLET, FILM COATED | 250 mg | 11/3/1988 | |
| Xorimax 250mg coated tablets | SIN13287P | TABLET, COATED | 250 mg | 6/1/2007 | |
| CEFUROXIME-AFT POWDER FOR INJECTION 250MG/VIAL | SIN15156P | INJECTION, POWDER, FOR SOLUTION | 250mg | 1/12/2017 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Cefuroxime Sodium for Injection and Sodium Chloride Injection | 国药准字H20234035 | 化学药品 | 注射剂 | 8/8/2023 | |
| Cefuroxime Sodium for Injection and Sodium Chloride Injection | 国药准字H20193161 | 化学药品 | 注射剂 | 6/4/2024 | |
| Cefuroxime Sodium for Injection and Sodium Chloride Injection | 国药准字H20234034 | 化学药品 | 注射剂 | 8/8/2023 | |
| Cefuroxime Sodium for Injection and Sodium Chloride Injection | 国药准字H20217060 | 化学药品 | 注射剂 | 6/4/2024 | |
| Cefuroxime Axetil Capsules | 国药准字H20000401 | 化学药品 | 胶囊剂 | 11/18/2019 | |
| Cefuroxime Axetil Capsules | 国药准字H20113057 | 化学药品 | 胶囊剂 | 12/18/2020 | |
| Cefuroxime Axetil Capsules | 国药准字H19990252 | 化学药品 | 胶囊剂 | 3/9/2020 | |
| Cefuroxime Axetil Capsules | 国药准字H20133100 | 化学药品 | 胶囊剂 | 11/14/2022 | |
| Cefuroxime Axetil Capsules | 国药准字H19990251 | 化学药品 | 胶囊剂 | 3/10/2020 | |
| Cefuroxime Axetil Capsules | 国药准字H20030889 | 化学药品 | 胶囊剂 | 6/5/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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