Application Nr Approved Date Route Status External Links
NDA207131 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Cefazolin Injection Is A Cephalosporin Antibacterial Indicated For Preoperative Prophylaxis. ( 1.1 ) Limitations Of Use: Use An Alternative Cefazolin Product When Lengthy Surgical Procedures Require Supplemental Doses And When Postoperative Dosing Is Required. ( 1.2 ) To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Cefazolin Injection And Other Antibacterial Drugs, Cefazolin Injection Should Be Used Only To Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Bacteria. ( 1.3 ) 1.1 Preoperative Prophylaxis Cefazolin Injection Is Indicated For Preoperative Prophylaxis. The Prophylactic Administration Of Cefazolin Preoperatively May Reduce The Incidence Of Certain Postoperative Infections In Patients Undergoing Surgical Procedures Which Are Classified As Contaminated Or Potentially Contaminated (e.g., Vaginal Hysterectomy, And Cholecystectomy In High-Risk Patients Such As Those Older Than 70 Years, With Acute Cholecystitis, Obstructive Jaundice, Or Common Duct Bile Stones). The Preoperative Use Of Cefazolin May Also Be Effective In Surgical Patients In Whom Infection At The Operative Site Would Present A Serious Risk. If There Are Signs Of Infection, Specimens For Cultures Should Be Obtained For The Identification Of The Causative Organism So That Appropriate Therapy May Be Instituted. 1.2 Limitations Of Use Use An Alternative Cefazolin Product When Lengthy Surgical Procedures Require Supplemental Doses And When Postoperative Dosing Is Required. 1.3 Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Cefazolin Injection And Other Antibacterial Drugs, Cefazolin Injection Should Be Used Only To Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. When Culture And Susceptibility Information Are Available, They Should Be Considered In Selecting Or Modifying Antibacterial Therapy. In The Absence Of Such Data, Local Epidemiology And Susceptibility Patterns May Contribute To The Empiric Selection Of Therapy.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Cefazolin Sodium CEFAZOLIN SODIUM ZINC3830405

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