Cefazolin

Product manufactured by Hospira, Inc.

Application Nr Approved Date Route Status External Links
ANDA065226 2005-04-21 Intramuscular RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Cefazolin For Injection, Usp And Other Antibacterial Drugs, Cefazolin For Injection, Usp Should Be Used Only To Treat Or 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. Cefazolin For Injection, Usp Is Indicated For The Treatment Of The Following Serious Infections Due To Susceptible Organisms. Cefazolin For Injection, Usp Is A Cephalosporin Antibacterial Indicated In The Treatment Of The Following Infections Caused By Susceptible Isolates Of The Designated Microorganisms: •respiratory Tract Infections. (1.1) •urinary Tract Infections. (1.2) •skin And Skin Structure Infections. (1.3) •biliary Tract Infections. (1.4) •bone And Joint Infections. (1.5) •genital Infections. (1.6) •septicemia. (1.7) •endocarditis. (1.8) •perioperative Prophylaxis. (1.9) 1.1 Respiratory Tract Infections Respiratory Tract Infections Due To S. Pneumoniae, Klebsiella Species, H. Influenzae, S. Aureus (penicillin-Sensitive And Penicillin-Resistant), And Group A Beta-Hemolytic Streptococci. Injectable Benzathine Penicillin Is Considered To Be The Drug Of Choice In Treatment And Prevention Of Streptococcal Infections, Including The Prophylaxis Of Rheumatic Fever. Cefazolin For Injection Is Effective In The Eradication Of Streptococci From The Nasopharynx; However, Data Establishing The Efficacy Of Cefazolin For Injection In The Subsequent Prevention Of Rheumatic Fever Are Not Available At Present. 1.2 Urinary Tract Infections Urinary Tract Infections Due To Escherichia Coli, And Proteus Mirabilis, Klebsiella Species, And Some Strains Of Enterobacter And Enterococci. 1.3 Skin And Skin Structure Infections Skin And Skin Structure Infections Due To S. Aureus (penicillin-Sensitive And Penicillin-Resistant), Group A Beta-Hemolytic Streptococci, And Other Strains Of Streptococci. 1.4 Biliary Tract Infections Biliary Infections Due To E. Coli , Various Strains Of Streptococci, P. Mirabilis , Klebsiella Species, And S. Aureus . 1.5 Bone And Joint Infections Bone And Joint Infections Due To S. Aureus. 1.6 Genital Infections Genital Infections (i.e., Prostatitis, Epididymitis) Due To E. Coli, P. Mirabilis, Klebsiella Species, And Some Strains Of Enterococci. 1.7 Septicemia Septicemia Due To S. Pneumoniae, S. Aureus (penicillin-Sensitive And Penicillin-Resistant), P. Mirabilis, E. Coli, And Klebsiella Species. 1.8 Endocarditis Endocarditis Due To S. Aureus (penicillin-Sensitive And Penicillin-Resistant) And Group A Beta-Hemolytic Streptococci. 1.9 Perioperative Prophylaxis The Prophylactic Administration Of Cefazolin For Injection Preoperatively, Intraoperatively, And Postoperatively 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 Perioperative Use Of Cefazolin For Injection May Also Be Effective In Surgical Patients In Whom Infection At The Operative Site Would Present A Serious Risk (e.g., During Open-Heart Surgery And Prosthetic Arthroplasty). The Prophylactic Administration Of Cefazolin Should Usually Be Discontinued Within A 24 Hour Period After The Surgical Procedure. In Surgery Where The Occurrence Of Infection May Be Particularly Devastating (e.g., Open-Heart Surgery And Prosthetic Arthroplasty), The Prophylactic Administration Of Cefazolin May Be Continued For 3 To 5 Days Following The Completion Of Surgery. 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 [ See Dosage And Administration (2.1) ]. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Cefazolin For Injection And Other Antibacterial Drugs, Cefazolin For Injection Should Be Used Only To Treat Or 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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