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 Approved Products

Product Name
Manufacturer
Route
Strength
Approved
NDC Code
Ampicillin and Sulbactam
INTRAVENOUS
50 mg in 1 mL
2023/04/05
55150-118
AMPICILLIN and SULBACTAM
INTRAVENOUS, INTRAMUSCULAR
0.5 g in 1 1
2022/01/21
67850-130
UNASYN
Roerig
INTRAMUSCULAR, INTRAVENOUS
1 g in 1 1
2023/03/29
0049-0014
Ampicillin and Sulbactam
INTRAVENOUS
1 g in 1 1
2018/05/21
0409-2987
Ampicillin and Sulbactam
INTRAVENOUS, INTRAMUSCULAR
0.5 g in 1 1
2024/02/09
71288-005
Ceftriaxone
INTRAVENOUS, INTRAMUSCULAR
2 g in 1 1
2023/10/24
44567-702
Ampicillin and Sulbactam
INTRAVENOUS
5 g in 1 1
2024/02/09
71288-007
Ampicillin and Sulbactam
INTRAVENOUS
1 g in 3 g
2018/09/17
0641-6120
Ceftriaxone
INTRAVENOUS
10 g in 1 1
2022/04/07
70594-098
Ceftriaxone
Proficient Rx LP
INTRAVENOUS, INTRAMUSCULAR
2 g in 1 1
2022/11/01
71205-593

EMA Approved Products

Medicine Name
EMA Number
Auth. Holder
Country
Drug Type
Status
Issued
Opinion
Revision

No EMA products found

No EMA products found for this drug

Singapore Approved Products

Product Name
Manufacturer
Dosage Form
Strength
Approved
Approval No.
Online
ROCEPHIN FOR INJECTION 1 g/vial (INTRAMUSCULAR)
F HOFFMANN-LA ROCHE LTD, Siegfried Hameln GmbH (Solvent only)
INJECTION, POWDER, FOR SOLUTION
1 g/vial
1988/04/27
SIN00388P
Yes
CEFTRIAXONE-AFT POWDER FOR INJECTION 2G/VIAL
INJECTION, POWDER, FOR SOLUTION
2g/vial
2017/04/11
SIN15208P
Yes
MEDAXONE POWDER FOR SOLUTION FOR INJECTION OR INFUSION 1 G/VIAL
INJECTION, POWDER, FOR SOLUTION
1000.0mg
2021/07/26
SIN16289P
Yes
CEFTRIAXONE KABI POWDER FOR SOLUTION FOR INJECTION 1G/VIAL
INJECTION, POWDER, FOR SOLUTION
1000mg/ vial
2016/05/20
SIN15008P
Yes
TREXOFIN FOR INJECTION 2 g/vial
INJECTION, POWDER, FOR SOLUTION
2 g/vial
1999/07/21
SIN11037P
Yes
MEDAXONE POWDER FOR SOLUTION FOR INJECTION OR INFUSION 2 G/VIAL
INJECTION, POWDER, FOR SOLUTION
2000.0mg
2021/07/26
SIN16288P
Yes
Ceftriaxone ADVAGEN powder for solution for injection 2g/vial
INJECTION, POWDER, FOR SOLUTION
2g/vial
2023/07/18
SIN16822P
Yes
CEFTRIAXONE-AFT POWDER FOR INJECTION 0.5G/VIAL
INJECTION, POWDER, FOR SOLUTION
0.5g/vial
2017/04/11
SIN15207P
Yes
TRIAXONE INJECTION 2 g/vial
INJECTION, POWDER, FOR SOLUTION
2 g/vial
2002/11/30
SIN12134P
Yes
CEFAXONE FOR INJECTION 500 mg/vial
SHIN POONG PHARMACEUTICAL CO LTD
INJECTION, POWDER, FOR SOLUTION
500 mg/vial
1999/04/23
SIN10888P
Yes

China Approved Products

Product Name
Approval No.
Manufacturer
Dosage Form
Trade Name
Strength
Type
Status
Date
Import
Ceftriaxone Sodium for Injection and Sodium Chloride Injection
国药准字H20233028
注射剂
N/A
粉体室:按头孢曲松(C₁₈H₁₈N₈O₇S₃)计1.0g;液体室:氯化钠注射液100ml∶0.9g
Chemical Drug
Approved
2023/01/10
Domestic
Ceftriaxone Sodium for Injection and Sodium Chloride Injection
国药准字H20223648
注射剂
N/A
粉体室:按头孢曲松(C₁₈H₁₈N₈O₇S₃)计1.0g;液体室:氯化钠注射液 100ml:0.9g
Chemical Drug
Approved
2022/09/14
Domestic
Ceftriaxone Sodium for Injection and Sodium Chloride Injection
国药准字H20233029
注射剂
N/A
粉体室:按头孢曲松(C₁₈H₁₈N₈O₇S₃)计2.0g;液体室:氯化钠注射液100ml∶0.9g
Chemical Drug
Approved
2023/01/10
Domestic
Ceftriaxone Sodium for Injection
国药准字H20056797
注射剂(粉针剂)
N/A
按C18H18N8O7S3计0.75g
Chemical Drug
Approved
2015/12/21
Domestic
Ceftriaxone Sodium for Injection
国药准字H20067960
N/A
N/A
0.5g(按C18H16N8Na2O7S3计算)
Chemical Drug
Approved
2006/11/09
Domestic
Ceftriaxone Sodium for Injection
国药准字H20053004
N/A
N/A
1.5g(按C18H18N8O7S3计算)
Chemical Drug
Approved
2005/01/04
Domestic
Ceftriaxone Sodium for Injection
国药准字H10920097
注射剂
罗塞秦
0.5g( 按C18H18N8O7S3计)
Chemical Drug
Approved
2020/06/10
Domestic
Ceftriaxone Sodium for Injection
国药准字H20044890
注射剂
N/A
4.0g(按C18H18N8O7S3计)
Chemical Drug
Approved
2020/06/12
Domestic
Ceftriaxone Sodium for Injection
国药准字H46020652
注射剂
N/A
1.0g(按C₁₈H₁₈N₈O₇S₃计)
Chemical Drug
Approved
2020/02/19
Domestic
Ceftriaxone Sodium for Injection
国药准字H20044041
注射剂
N/A
3.0g
Chemical Drug
Approved
2019/07/02
Domestic

Australia Approved Products

Product Name
ARTG ID
Sponsor
Status
Reg. Date
Ingredient
CEFTRIAXON ceftriaxone (as sodium) 2 g powder for injection vial
283499
MedTAS Pty Ltd
Active
2017/12/08
ceftriaxone sodium
CEFTRIAXONE ACT ceftriaxone (as sodium) 2g powder for injection vial
92400
Juno Pharmaceuticals Pty Ltd
Active
2003/01/28
ceftriaxone sodium
CEFTRIAXON ceftriaxone (as sodium) 1 g powder for injection vial
283498
MedTAS Pty Ltd
Active
2017/12/08
ceftriaxone sodium
CFTRIAX ceftriaxone (as sodium) 1 g powder for injection vial
283495
Steriscience Pty Ltd
Active
2017/12/08
ceftriaxone sodium
CEFTRIAXONE INJECTION ceftriaxone 500mg (as sodium) powder for injection vial
104488
Generic Health Pty Ltd
Active
2004/07/22
ceftriaxone sodium
CEFTRIAXONE-AFT ceftriaxone (as sodium) 2g powder for injection vial
185101
AFT Pharmaceuticals Pty Ltd
Active
2012/02/20
ceftriaxone sodium
CEFTRIXN ceftriaxone (as sodium) 1 g powder for injection vial
283502
MedTAS Pty Ltd
Active
2017/12/08
ceftriaxone sodium
CEFTRIAXONE VIATRIS ceftriaxone (as sodium) 2 g powder for injection vial
164917
Active
2012/01/20
ceftriaxone sodium
CEFTRIAXONE VIATRIS ceftriaxone (as sodium) 1 g powder for injection vial
164920
Active
2012/01/20
ceftriaxone sodium
CEFTRIX ceftriaxone (as sodium) 1 g powder for injection vial
283500
MedTAS Pty Ltd
Active
2017/12/08
ceftriaxone sodium
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