1 INDICATIONS AND USAGE
Cefazolin 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: (1)
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 in adults for whom appropriate dosing with this formulation can be achieved (1.9)
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 treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.10).
1.1 Respiratory Tract Infections
Cefazolin injection is indicated for the treatment of respiratory tract infections due to Streptococcus pneumoniae, Staphylococcus aureus and Streptococcus pyogenes in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1, 2.2, 2.4 and 2.5) and Use in Specific Populations (8.4)].
Limitations of Use
Injectable benzathine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.
Cefazolin injection is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available.
1.2 Urinary Tract Infections
Cefazolin injection is indicated for the treatment of urinary tract infections due to Escherichia coli, and Proteus mirabilis in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1, 2.2, 2.4 and 2.5) and Use in Specific Populations (8.4)].
1.3 Skin and Skin Structure Infections
Cefazolin injection is indicated for the treatment of skin and skin structure infections due to S. aureus, S. pyogenes, and Streptococcus agalactiae in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1, 2.2, 2.4 and 2.5) and Use in Specific Populations (8.4)].
1.4 Biliary Tract Infections
Cefazolin injection is indicated for the treatment of biliary infections due to E. coli, various isolates of streptococci, P. mirabilis, and S. aureus in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1, 2.2, 2.4 and 2.5) and Use in Specific Populations (8.4)].
1.5 Bone and Joint Infections
Cefazolin injection is indicated for the treatment of bone and joint infections due to S. aureus in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1, 2.2, 2.4 and 2.5) and Use in Specific Populations (8.4)].
1.6 Genital Infections
Cefazolin injection is indicated for the treatment of genital infections due to E. coli, and P. mirabilis in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1, 2.2, 2.4 and 2.5) and Use in Specific Populations (8.4)].
1.7 Septicemia
Cefazolin injection is indicated for the treatment of septicemia due to S. pneumoniae, S. aureus, P. mirabilis, and E. coli in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1, 2.2, 2.4 and 2.5) and Use in Specific Populations (8.4)].
1.8 Endocarditis
Cefazolin injection is indicated for the treatment of endocarditis due to S. aureus and S. pyogenes in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1, 2.2, 2.4 and 2.5) and Use in Specific Populations (8.4)].
1.9 Perioperative Prophylaxis
Cefazolin injection is indicated is indicated for perioperative prophylaxis in adults for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1, 2.3, 2.4, 2.5).
The perioperative use of cefazolin injection is indicated in adult 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 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).
Additional pediatric use information is approved for B. Braun Medical Inc.'s CEFAZOLIN FOR INJECTION AND DEXTROSE INJECTION. However, due to B. Braun Medical Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.
1.10 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 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.