Overview
Ceftriaxone is a broad-spectrum third-generation cephalosporin antibiotic. It has a very long half-life compared to other cephalosporins and is high penetrable into the meninges, eyes, and inner ear. Ceftriaxone has broader and stronger gram-negative coverage then first or second-generation cephalosporins, but worse activity against methicillin-susceptible S.aureus. Ceftriaxone is a commonly used antimicrobial due to its good activity against multi-drug resistant Enterobacteriaceae, its relatively safe adverse effect profile, and its long half-life which allows for the convenience of daily or twice-daily dosing.
Indication
Ceftriaxone is used for the treatment of the infections (respiratory, skin, soft tissue, UTI, ENT) caused by susceptible organisms. Organisms that are generally susceptible to ceftriaxone include S. pneumoniae, S. pyogenes (group A beta-hemolytic streptococci), coagulase-negative staphylococci, Some Enterobacter spp, H. influenzae, N. gonorrhoeae, P. mirabilis, E. coli, Klebsiella spp, M. catarrhalis, B. burgdorferi, and some oral anaerobes.
Associated Conditions
- Abscess Brain
- Bacterial Endocarditis
- Bacterial Infections
- Bacterial Sinusitis
- Bone and Joint Infections
- Chancroid
- Community Acquired Pneumonia (CAP)
- Conjunctivitis gonococcal neonatal
- Epididymitis
- Epiglottitis
- Gonococcal arthritis
- Gonococcal infection of pharynx
- Gonococcal pelvic inflammatory disease
- Intraabdominal Infections
- Lower respiratory tract infection bacterial
- Lyme Neuroborreliosis
- Meningitis, Bacterial
- Ophthalmia neonatorum due to gonococcus
- Postoperative Infections
- Prosthetic Joint Infections
- Sepsis Bacterial
- Septic Arthritis
- Shigellosis
- Skin and Subcutaneous Tissue Bacterial Infections
- Syphilis
- Vulvovaginitis gonococcal
- Whipple Disease
- Bacterial otitis media
- Complicated Urinary Tract Infection caused by susceptible bacteria
- Disease caused by Salmonella typhi
- Susceptible Bacterial Infections
- Uncomplicated Gonorrhea
- Uncomplicated Urinary tract infection bacterial
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/05/22 | Phase 3 | Completed | Global Antibiotics Research and Development Partnership | ||
2019/03/29 | Phase 1 | Not yet recruiting | |||
2019/02/15 | Phase 1 | Completed | |||
2019/01/07 | Phase 2 | Completed | Post Graduate Institute of Medical Education and Research, Chandigarh | ||
2018/09/24 | Phase 2 | Completed | |||
2018/06/18 | Phase 4 | Terminated | Mercy Health Ohio | ||
2018/02/28 | Not Applicable | Completed | Ministry of Health, Jamaica | ||
2018/01/29 | Phase 2 | Active, not recruiting | BrainX Corporation | ||
2017/09/27 | Phase 3 | Completed | Public Health Service of Amsterdam | ||
2017/06/07 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Xellia Pharmaceuticals USA LLC | 70594-083 | INTRAMUSCULAR, INTRAVENOUS | 50 mg in 1 mL | 1/6/2023 | |
| Hospira, Inc | 0409-7334 | INTRAVENOUS | 10 g in 100 mL | 6/12/2017 | |
| Cephazone Pharma LLC | 68330-003 | INTRAMUSCULAR, INTRAVENOUS | 1 g in 1 1 | 8/31/2012 | |
| Hospira, Inc | 0409-7335 | INTRAVENOUS, INTRAMUSCULAR | 2 g in 1 1 | 7/20/2020 | |
| West-Ward Pharmaceuticals Corp. | 0641-6121 | INTRAVENOUS | 50 mg in 1 mL | 9/28/2016 | |
| Roerig | 0049-0024 | INTRAMUSCULAR, INTRAVENOUS | 50 mg in 1 mL | 3/29/2023 | |
| Civica, Inc. | 72572-062 | INTRAMUSCULAR, INTRAVENOUS | 2 g in 1 1 | 2/6/2024 | |
| Cephazone Pharma LLC | 68330-002 | INTRAMUSCULAR, INTRAVENOUS | 500 mg in 1 1 | 8/31/2012 | |
| Hospira, Inc | 0409-7333 | INTRAVENOUS | 1 g in 1 1 | 10/19/2018 | |
| Claris Life Sciences Inc. | 36000-094 | INTRAVENOUS, INTRAMUSCULAR | 0.5 g in 1 1 | 12/14/2015 |
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 |
|---|---|---|---|---|---|
| Ceftriaxone Sodium for Injection | 国药准字H14021655 | 化学药品 | 注射剂 | 8/28/2020 | |
| Ceftriaxone Sodium for Injection | 国药准字H44021532 | 化学药品 | 注射剂 | 9/14/2024 | |
| Ceftriaxone Sodium for Injection | 国药准字H20043079 | 化学药品 | 注射剂 | 6/1/2020 | |
| Ceftriaxone Sodium for Injection | 国药准字H20058023 | 化学药品 | 注射剂 | 3/3/2020 | |
| Ceftriaxone Sodium for Injection | 国药准字H20043030 | 化学药品 | 注射剂 | 6/23/2021 | |
| Ceftriaxone Sodium for Injection | 国药准字H20043825 | 化学药品 | 注射剂 | 4/15/2020 | |
| Ceftriaxone Sodium for Injection | 国药准字H20013032 | 化学药品 | 注射剂(无菌分装粉针剂) | 2/16/2020 | |
| Ceftriaxone Sodium for Injection | 国药准字H20044889 | 化学药品 | 注射剂 | 6/12/2020 | |
| Ceftriaxone Sodium for Injection | 国药准字H20033432 | 化学药品 | 注射剂 | 6/5/2020 | |
| Ceftriaxone Sodium for Injection | 台湾泛生制药厂股份有限公司 | 国药准字HC20181001 | 化学药品 | 注射剂 | 1/12/2023 |
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 |
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| No TGA approvals found for this drug. | |||||
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