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.
Background
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
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/02/17 | N/A | Not yet recruiting | Ahmed Mohammed Hussein Sayed | ||
2025/01/21 | Phase 1 | Not yet recruiting | |||
2024/09/24 | Early Phase 1 | Recruiting | State University of New York - Upstate Medical University | ||
2024/08/01 | Not Applicable | Not yet recruiting | |||
2024/07/30 | Phase 2 | Not yet recruiting | |||
2024/07/10 | Phase 4 | Recruiting | |||
2024/05/02 | Phase 4 | Recruiting | |||
2024/04/05 | Phase 4 | Not yet recruiting | |||
2024/01/24 | Phase 4 | Not yet recruiting | Sichuan Provincial People's Hospital | ||
2023/08/08 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
NorthStar Rx, LLC | 72603-220 | INTRAVENOUS, INTRAMUSCULAR | 0.5 g in 1 1 | 2/28/2024 | |
Hospira, Inc | 0409-7335 | INTRAVENOUS, INTRAMUSCULAR | 2 g in 1 1 | 6/15/2017 | |
Xellia Pharmaceuticals USA LLC | 70594-097 | INTRAVENOUS, INTRAMUSCULAR | 2 g in 1 1 | 4/7/2022 | |
REMEDYREPACK INC. | 70518-3916 | INTRAVENOUS, INTRAMUSCULAR | 500 mg in 1 1 | 4/3/2024 | |
Methapharm, Inc. | 67850-131 | INTRAVENOUS, INTRAMUSCULAR | 1 g in 1 1 | 1/21/2022 | |
WG Critical Care, LLC | 44567-211 | INTRAVENOUS, INTRAMUSCULAR | 1 g in 20 mL | 2/23/2023 | |
Fresenius Kabi USA, LLC | 63323-345 | INTRAVENOUS, INTRAMUSCULAR | 500 mg in 1 1 | 9/30/2023 | |
Xellia Pharmaceuticals USA LLC | 70594-094 | INTRAVENOUS, INTRAMUSCULAR | 250 mg in 1 1 | 4/7/2022 | |
Baxter Healthcare Company | 0338-5003 | INTRAVENOUS | 2 g in 50 mL | 1/13/2022 | |
Baxter Healthcare Corporation | 0338-5003 | INTRAVENOUS | 2 g in 50 mL | 1/13/2022 |
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 |
---|---|---|---|---|---|
ROCEPHIN FOR INJECTION 1 g/vial (INTRAMUSCULAR) | SIN00388P | INJECTION, POWDER, FOR SOLUTION | 1 g/vial | 4/27/1988 | |
CEFTRIAXONE-AFT POWDER FOR INJECTION 2G/VIAL | SIN15208P | INJECTION, POWDER, FOR SOLUTION | 2g/vial | 4/11/2017 | |
MEDAXONE POWDER FOR SOLUTION FOR INJECTION OR INFUSION 1 G/VIAL | SIN16289P | INJECTION, POWDER, FOR SOLUTION | 1000.0mg | 7/26/2021 | |
CEFTRIAXONE KABI POWDER FOR SOLUTION FOR INJECTION 1G/VIAL | SIN15008P | INJECTION, POWDER, FOR SOLUTION | 1000mg/ vial | 5/20/2016 | |
TREXOFIN FOR INJECTION 2 g/vial | SIN11037P | INJECTION, POWDER, FOR SOLUTION | 2 g/vial | 7/21/1999 | |
MEDAXONE POWDER FOR SOLUTION FOR INJECTION OR INFUSION 2 G/VIAL | SIN16288P | INJECTION, POWDER, FOR SOLUTION | 2000.0mg | 7/26/2021 | |
Ceftriaxone ADVAGEN powder for solution for injection 2g/vial | SIN16822P | INJECTION, POWDER, FOR SOLUTION | 2g/vial | 7/18/2023 | |
CEFTRIAXONE-AFT POWDER FOR INJECTION 0.5G/VIAL | SIN15207P | INJECTION, POWDER, FOR SOLUTION | 0.5g/vial | 4/11/2017 | |
TRIAXONE INJECTION 2 g/vial | SIN12134P | INJECTION, POWDER, FOR SOLUTION | 2 g/vial | 11/30/2002 | |
CEFAXONE FOR INJECTION 500 mg/vial | SIN10888P | INJECTION, POWDER, FOR SOLUTION | 500 mg/vial | 4/23/1999 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Ceftriaxone Sodium for Injection and Sodium Chloride Injection | 国药准字H20233028 | 化学药品 | 注射剂 | 1/10/2023 | |
Ceftriaxone Sodium for Injection and Sodium Chloride Injection | 国药准字H20223648 | 化学药品 | 注射剂 | 9/14/2022 | |
Ceftriaxone Sodium for Injection and Sodium Chloride Injection | 国药准字H20233029 | 化学药品 | 注射剂 | 1/10/2023 | |
Ceftriaxone Sodium for Injection | 国药准字H10920097 | 化学药品 | 注射剂 | 6/10/2020 | |
Ceftriaxone Sodium for Injection | 国药准字H20044890 | 化学药品 | 注射剂 | 6/12/2020 | |
Ceftriaxone Sodium for Injection | 国药准字H46020652 | 化学药品 | 注射剂 | 2/19/2020 | |
Ceftriaxone Sodium for Injection | 国药准字H20247074 | 化学药品 | 注射剂 | 4/19/2024 | |
Ceftriaxone Sodium for Injection | 国药准字H20044536 | 化学药品 | 注射剂 | 2/2/2021 | |
Ceftriaxone Sodium for Injection | 国药准字H20034176 | 化学药品 | 注射剂 | 2/2/2021 | |
Ceftriaxone Sodium for Injection | 国药准字H44023315 | 化学药品 | 注射剂 | 5/14/2024 |
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 |
---|---|---|---|---|---|
CEFTRIAXON ceftriaxone (as sodium) 2 g powder for injection vial | 283499 | Medicine | A | 12/8/2017 | |
CEFTRIAXONE ACT ceftriaxone (as sodium) 2g powder for injection vial | 92400 | Medicine | A | 1/28/2003 | |
CEFTRIAXON ceftriaxone (as sodium) 1 g powder for injection vial | 283498 | Medicine | A | 12/8/2017 | |
CFTRIAX ceftriaxone (as sodium) 1 g powder for injection vial | 283495 | Medicine | A | 12/8/2017 | |
CEFTRIAXONE INJECTION ceftriaxone 500mg (as sodium) powder for injection vial | 104488 | Medicine | A | 7/22/2004 | |
CEFTRIAXONE-AFT ceftriaxone (as sodium) 2g powder for injection vial | 185101 | Medicine | A | 2/20/2012 | |
CEFTRIXN ceftriaxone (as sodium) 1 g powder for injection vial | 283502 | Medicine | A | 12/8/2017 | |
CEFTRIAXONE VIATRIS ceftriaxone (as sodium) 2 g powder for injection vial | 164917 | Medicine | A | 1/20/2012 | |
CEFTRIAXONE VIATRIS ceftriaxone (as sodium) 1 g powder for injection vial | 164920 | Medicine | A | 1/20/2012 | |
CEFTRIX ceftriaxone (as sodium) 1 g powder for injection vial | 283500 | Medicine | A | 12/8/2017 |