CEFAZOLIN

CEFAZOLIN- cefazolin sodium injection, powder, lyophilized, for solution
Samson Medical Technologies, L.L.C.

1 INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefazolin and other antibacterial drugs, cefazolin 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 is indicated for the treatment of the following infections when caused by susceptible bacteria.

1.1 Respiratory Tract Infections

Respiratory tract infections due to Streptococcus pneumoniae , Staphylococcus aureus and Streptococcus pyogenes.

Injectable benzathine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.

Cefazolin 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

Urinary tract infections due to Escherichia coli and Proteus mirabilis.

1.3 Skin and Skin Structure Infections

Skin and skin structure infections due to S. aureus , S. pyogenes , and Streptococcus agalactiae.

1.4 Biliary Tract Infections

Biliary infections due to E. coli , various isolates of streptococci, P. mirabilis , and S. aureus.

1.5 Bone and Joint Infections

Bone and joint infections due to S. aureus.

1.6 Genital Infections

Genital infections due to E. coli and P. mirabilis.

1.7 Septicemia

Septicemia due to S. pneumoniae , S. aureus , P. mirabilis, and E. coli.

1.8 Endocarditis

Endocarditis due to S. aureus and S. pyogenes.

1.9 Perioperative Prophylaxis

The prophylactic administration of cefazolin 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 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).

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.

2 DOSAGE AND ADMINISTRATION

Cefazolin for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in patients who require less than a 250 mg dose of Cefazolin.

THIS PHARMACY BULK PACKAGE REQUIRES RECONSTITUTION WITH STERILE WATER FOR INJECTION, USP TO A CONCENTRATION OF 100 mg per mL AND FURTHER DILUTION IN 50 mL OF A COMPATIBLE SOLUTION.

THIS IS A PHARMACY BULK PACKAGE — NOT FOR DIRECT INJECTION

2.1 Adult Population

Cefazolin for Injection USP, Pharmacy Bulk Package bag SmartPak ® should not be used in patients who require less than a 250 mg dose of Cefazolin.

Cefazolin for Injection should be reconstituted with Sterile Water for Injection, USP to a concentration of 100 mg per mL and further diluted in 50 mL of a compatible solution. The recommended adult dosages are outlined in Table 1. Cefazolin for Injection should be administered intravenously (IV) over approximately 30 minutes.

Table 1: Recommended Dosing Schedule in Adult Patients with CrCl Greater Than or Equal to 55 mL/min.

*In rare instances, doses up to 12 grams of cefazolin per day have been used.

Site and Type of Infection Dose Frequency
Moderate to severe infections 500 mg to 1gram Every 6 to 8 hours
Mild infections caused by susceptible gram-positive cocci 250 mg to500 mg Every 8 hours
Acute, uncomplicated urinary tract infections 1 gram Every 12 hours
Pneumococcal pneumonia 500 mg Every 12 hours
Severe, life- threatening infections (e.g., endocarditis, septicemia)* 1 gram to1.5 grams Every 6 hours

2.2 Perioperative Prophylactic Use

Cefazolin for Injection USP, Pharmacy Bulk Package bag SmartPak ® should not be used in patients who require less than a 250 mg dose of cefazolin.

To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  • 1 gram to 2 grams I.V. administered ½ hour to 1 hour prior to the start of surgery.
  • For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram I.V. during surgery (administration modified depending on the duration of the operative procedure).
  • 500 mg to 1 gram I.V. every 6 to 8 hours for 24 hours postoperatively.

It is important that (i) the preoperative dose be given just (½ to 1 hour) prior to the start of surgery so that adequate antibacterial concentrations are present in the serum and tissues at the time of initial surgical incision; and (ii) cefazolin may be administered, if necessary, at appropriate intervals during surgery to provide sufficient concentrations of the antibacterial drug at the anticipated moments of greatest exposure to infective organisms. 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.

2.3 Patients with Renal Impairment

Cefazolin for Injection USP, Pharmacy Bulk Package bag SmartPak ® should not be used in patients with renal impairment who require less than a 250 mg dose of cefazolin. Cefazolin may be used in patients with renal impairment with the dosage adjustments outlined in Table 2. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection.

Table 2: Dosage Adjustment for Patients with Renal Impairment
Creatinine Clearance Dose Frequency
55 mL/minute or greater Full dose Normal frequency
35 to 54 mL/minute Full dose Every 8 hours or longer
11 to 34 mL/minute ½ usual dose Every 12 hours
10 mL/minute or less ½ usual dose Every 18 to 24 hours
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