CEFAZOLIN AND DEXTROSE (cefazolin sodium) · B BRAUN
Cefazolin and Dextrose is a cephalosporin antibacterial indicated for the treatment of various infections caused by susceptible isolates in adults and pediatric patients. Approved indications include respiratory tract, urinary tract, skin and skin structure, biliary tract, bone and joint, and genital infections, as well as septicemia and endocarditis. It is also indicated for perioperative prophylaxis in adults and pediatric patients aged 10 to 17 years to reduce the incidence of post-operative infections.
How CEFAZOLIN AND DEXTROSE Works
Cefazolin is a bactericidal agent that acts by inhibiting bacterial cell wall synthesis. It binds to specific penicillin-binding proteins (PBPs) located within the bacterial cell wall, which inhibits the final transpeptidation step of peptidoglycan synthesis. This disruption leads to the weakening of the cell wall and subsequent bacterial cell lysis and death.
Details
- Status
- Prescription
- First Approved
- 2000-07-27
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
CEFAZOLIN AND DEXTROSE Approval History
What CEFAZOLIN AND DEXTROSE Treats
9 indicationsCEFAZOLIN AND DEXTROSE is approved for 9 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Respiratory Tract Infections
- Urinary Tract Infections
- Skin and Skin Structure Infections
- Biliary Tract Infections
- Bone and Joint Infections
- Genital Infections
- Septicemia
- Endocarditis
- Perioperative Prophylaxis
CEFAZOLIN AND DEXTROSE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00867295 TIVAD | 2009/22 | Ph 3 | completed | Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CEFAZOLIN AND DEXTROSE FDA Label Details
Indications & Usage
FDA Label (PDF)Cefazolin for Injection and Dextrose Injection is a cephalosporin antibacterial indicated for: Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved: Respiratory tract infections Urinary tract infections Skin and skin structure infections Biliary tract infections Bone and joint infections Genital infections Septicemia Endocarditis Perioperative prophylaxis in adults and pediatric patients aged 10 to 17 years old for whom appropriate dosing with this ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.