MedPath

Ceftriaxone

Generic Name
Ceftriaxone
Brand Names
Rocephin
Drug Type
Small Molecule
Chemical Formula
C18H18N8O7S3
CAS Number
73384-59-5
Unique Ingredient Identifier
75J73V1629

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.
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