July 29, 2016
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Cefazolin

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Cefazolin Injection

Indications
Dosage
How Supplied

INDICATIONS

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 infections when caused by susceptible bacteria.

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.

Urinary Tract Infections

Urinary tract infections due to Escherichia coli, and Proteus mirabilis.

Skin And Skin Structure Infections

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

Biliary Tract Infections

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

Bone And Joint Infections

Bone and joint infections due to S. aureus.

Genital Infections

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

Septicemia

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

Endocarditis

Endocarditis due to S. aureus and S. pyogenes.

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.

DOSAGE AND ADMINISTRATION

Adult Population

The recommended adult dosages are outlined in Table 1. Cefazolin for injection should be administered intravenously (IV) or intramuscularly (IM).

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

Site and 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 to 2 gram IV 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 IV during surgery (administration modified depending on the duration of the operative procedure).
  • 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively.

It is important that (i) the preoperative dose be given just prior (½ hour to 1 hour) 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 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.

Patients With Renal Impairment

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/min. or greater full dose normal frequency
35 to 54 mL/min. full dose every 8 hours or longer
11 to 34 mL/min. ½ usual dose every 12 hours
10 mL/min. or less ½ usual dose every 18 to 24 hours

Pediatric Population

In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of cefazolin for injection in these patients is not recommended.

Pediatric Dosage Guide

Weight 25 mg/kg/Day Divided into 3 Doses 25 mg/kg/Day Divided into 4 Doses
Lbs Kg Approximate Single Dose mg/q8h Vol. (mL) needed with dilution of 125 mg/mL Approximate Single Dose mg/q6h Vol. (mL) needed with dilution of 125mg/mL
10 4.5 40 mg 0.35 mL 30 mg 0.25 mL
20 9 75 mg 0.6 mL 55 mg 0.45 mL
30 13.6 115 mg 0.9 mL 85 mg 0.7 mL
40 18.1 150 mg 1.2 mL 115 mg 0.9 mL
50 22.7 190 mg 1.5 mL 140 mg 1.1 mL
Weight 50 mg/kg/Day Divided into 3 Doses 50 mg/kg/Day Divided into 4 Doses
Lbs Kg Approximate Single Dose mg/q8h Vol. (mL) needed with dilution of 225 mg/mL Approximate Single Dose mg/q6h Vol. (mL) needed with dilution of 225 mg/mL
10 4.5 75 mg 0.35 mL 55 mg 0.25 mL
20 9 150 mg 0.7 mL 110 mg 0.5 mL
30 13.6 225 mg 1 mL 170 mg 0.75 mL
40 18.1 300 mg 1.35 mL 225 mg 1 mL
50 22.7 375 mg 1.7 mL 285 mg 1.25 mL

In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

Preparation Of Parenteral Solution

Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

When reconstituted or diluted according to the instructions below, cefazolin for injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

Single-Dose Vials

For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.

Vial Size Amount of Diluent Approximate Concentration Approximate Available Volume
1 g 2.5 mL 330 mg/mL 3 mL

Intramuscular Administration

Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin should be injected into a large muscle mass. Pain on injection is infrequent with cefazolin.

Intravenous Administration

Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

Intermittent or continuous infusion: Dilute reconstituted cefazolin in 50 to 100 mL of one of the following solutions:

Sodium Chloride Injection, USP
5% or 10% Dextrose Injection, USP
5% Dextrose in Lactated Ringer's Injection, USP
5% Dextrose and 0.9% Sodium Chloride Injection, USP
5% Dextrose and 0.45% Sodium Chloride Injection, USP
5% Dextrose and 0.2% Sodium Chloride Injection, USP
Lactated Ringer's Injection, USP
Invert Sugar 5% or 10% in Sterile Water for Injection
Ringer's Injection, USP
5% Sodium Bicarbonate Injection, USP

Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

HOW SUPPLIED

Dosage Forms And Strengths

Single-dose vials:

  • 1 g cefazolin for injection

Storage And Handling

Cefazolin for Injection, USP is supplied as a sterile, white to off-white crystalline powder. Each vial contains cefazolin sodium equivalent to 1 gram of cefazolin.

Unit of Sale Strength Each
NDC 0409-0805-01
Carton containing 25
1 Gram NDC 0409-0805-11 Vial

As with other cephalosporins, cefazolin tends to darken depending on storage conditions; within the stated recommendations, however, product potency is not adversely affected.

Before reconstitution protect from light and store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Manufactured for: Hospira, Inc., Lake Forest, IL 60045 USA. Revised: Mar 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 1/29/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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