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Cefazolin

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Cefazolin Injection

INDICATIONS

Cefazolin for Injection USP and Dextrose Injection USP (cefazolin and dextrose for injection) is indicated in the treatment of the following infections due to susceptible organisms:

Respiratory Tract Infections: Due to S. pneumoniae, S. aureus (including beta-lactamase-producing strains) and S. pyogenes.

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 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.

Urinary Tract Infections: Due to E. coli, P. mirabilis.

Skin And Skin Structure Infections: Due to S. aureus (including beta-lactamase-producing strains), S. pyogenes, and other strains of streptococci.

Biliary Tract Infections: Due to E. coli, various strains of streptococci, P. mirabilis, and S. aureus.

Bone And Joint Infections: Due to S. aureus.

Genital Infections: (i.e., prostatitis, epididymitis) Due to E. coli, P. mirabilis.

Septicemia: Due to S. pneumoniae, S. aureus (including beta-lactamase-producing strains), P. mirabilis, E. coli.

Endocarditis: Due to S. aureus (including beta-lactamase-producing strains) and S. pyogenes.

Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefazolin.

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).

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.)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin for Injection USP and Dextrose Injection USP (cefazolin and dextrose for injection) and other antibacterial drugs, Cefazolin for Injection USP and Dextrose Injection USP (cefazolin and dextrose 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.

DOSAGE AND ADMINISTRATION

Usual Adult Dosage

Type of Infection Dose Frequency
Moderate to severe infections 500 mg to 1 gram every 6 to 8 hours
Mild infections caused by susceptible gram-positive cocci 250 mg to 500 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 to 1.5 grams every 6 hours
*In rare instances, doses of up to 12 grams of cefazolin per day have been used.

Perioperative Prophylactic Use

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

  1. 1 gram IV administered 1/2 hour to 1 hour prior to the start of surgery.
  2. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified depending on the duration of the operative procedure).
  3. 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively.

It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

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.

Dosage Adjustment for Patients with Reduced Renal Function

Cefazolin may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3.0 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection.

DUPLEX® Drug Delivery System Directions for Use

  • To avoid inadvertent activation, DUPLEX Container should remain in the folded position until activation is intended.
Patient Labeling and Drug Powder/Diluent Inspection
  • Apply patient-specific label on foil side of container. USE CARE to avoid activation. Do not cover any portion of foil strip with patient label.
  • Unlatch side tab and unfold DUPLEX Contner. (See Diagram 1.)

Directions for Use - Illustration 1

  • Visually inspect diluent chamber for particulate matter.
  • Use only if container and seals are intact.
  • To inspect the drug powder for foreign matter or discoloration, peel foil strip from drug chamber. (See Diagram 2.)

Directions for Use - Illustration 2

  • Protect from light after removal of foil strip.

Note: If foil strip is removed, product must be used within 7 days, but not beyond the labeled expiration date.

  • The product should be re-folded and the side tab latched until ready to activate.
Reconstitution (Activation)
  • Do not use directly after storage by refrigeration, allow the product to equilibrate to room temperature before patient use.
  • Unfold the DUPLEX Container and point the set port in a downward direction. Starting at the hnger tab end, fold the DUPLEX Container just below the diluent meniscus trapping all air above the fold. To activate. squeeze the folded diluent chamber until the seal between the diluent and powder opens, releasing diluent into the drug powder chamber. (See Diagram 3.)

Directions for Use - Illustration 3

  • Agitate the liquid-powder mixture until the drug powder is completely dissolved.

Note: Following reconstitution (activation), product must be used within 24 hours if stored at room temperature or within 7 days if stored under refrigeration.

Administration
  • Visually inspect the reconstituted solution for particulate matter.
  • Point the set port in a downwards direction. Starting at the hanger tab end, fold the DUPLEX Container just below the solution meniscus trapping all air above the fold. Squeeze the folded DUPLEX Container until the seal between reconstituted drug solution and set port opens, releasing liquid to set port. (See Diagram 4.)

Directions for Use - Illustration 4

  • Prior to attaching the IV set, check for minute leaks by squeezing container firmly. If leaks are found, discard container and solution as sterility may be impaired.
  • Using aseptic technique, peel foil cover from the set port and attach sterile administration set. (See Diagram 5.)

Directions for Use - Illustration 5

  • Refer to Directions for Use accompanying the administration set.
Precautions
  • As with other cephalosporins, reconstituted Cefazolin for Injection USP and Dextrose Injection USP tends to darken depending on storage conditions, within the stated recommendations. However, product potency is not adversely affected.
  • Use only if prepared solution is clear and free from particulate matter.
  • Do not use in series connection.
  • Do not introduce additives into the DUPLEX® Container.
  • Do not freeze.

HOW SUPPLIED

Cefazolin for Injection USP and Dextrose Injection USP (cefazolin and dextrose for injection) in the DUPLEX Drug Delivery System is a flexible dual chamber container supplied in one concentration. After reconstitution, the concentration is equivalent to 1 g cefazolin. The diluent chamber contains approximately 50 mL of Dextrose Injection USP. Dextrose Injection USP has been adjusted to 4.0% for the 1 g dose, such that the reconstituted solution is iso-osmotic.

Cefazolin for Injection USP and Dextrose Injection USP (cefazolin and dextrose for injection) is supplied sterile and nonpyrogenic in the DUPLEX Drug Delivery System containers packaged 24 units per case.

NDC Cat. No. Dose Volume
Cefazolin for Injection USP and Dextrose Injection USP
0264-3103-11 3103-11 1g 50mL

Store the unactivated unit at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F).

Revised: April 2008. B. Braun Medical Inc. Irvine, CA USA 92614-5895. FDA Rev date: 10/31/2008

Last reviewed on RxList: 2/9/2009
This monograph has been modified to include the generic and brand name in many instances.

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