Cefazolin

CEFAZOLIN- cefazolin sodium injection, powder, for solution
General Injectables and Vaccines, Inc.

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Cefazolin for Injection, USP safely and effectively. See full prescribing information for Cefazolin for Injection, USP.

CEFAZOLIN FOR INJECTION, USP for intramuscular or intravenous use

Initial U.S. Approval: 1973

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 cause by bacteria.

———————————————-INDICATIONS AND USAGE ———————————————————

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) and perioperative prophylaxis (1.9).

——————————————DOSAGE AND ADMINISTRATION —————————————————–

For intramuscular use or intravenous use over approximately 30 minutes. (2)

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DOSAGE FORMS AND STRENGTHS

500 mg per vial and 1 gram per vial (3)

————————————————CONTRAINDICTIONS —————————————————————

Hypersensitivity to Cefazolin or other cephalosporin class antibacterial drugs, penicillins, or other beta-lactams (4.1)

——————————————-WARNINGS AND PRECAUTIONS —————————————————–

  • Hypersensitivity reactions: Cross-hypersensitivity may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue the drug. (5.1)
  • Use in patients with renal impairment: Dose adjustment required for patients with CrCl less than 55 mL/min. (5.2)
  • Clostridium difficile-associated diarrhea: May range from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. (5.3)

————————————————–ADVERSE REACTIONS ——————————————————-

Most common adverse reactions: gastrointestinal (nausea, vomiting, diarrhea), and allergic reactions (anaphylaxis, urticarial, skin rash). (6)

To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals, Inc. at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

————————————————DRUG INTERACTIONS ————————————————————

Prebenecid: may decrease renal lumbular secretion of cephalosporins when used concurrently, resulting in increased and more prolonged cephalosporin blood concentrations. (7)

——————————————-USE IN SPECIFIC POPULATIONS ——————————————————

Pediatric use: Safety and effectiveness for use in premature infants and neonates have not been established. See Dosage and Administration (2.4) for recommended dosage in pediatric patients older than 1 month (8.4).

Renal Impairment: Lower daily dosage of Cefazolin for Injection is required in patients with impaired renal function (creatinine clearance less than 55 mL/min.) (8.6)

See 17 for PATIENT COUNSELING INFORMATION

Revised 08/2014

FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin for Injection, USP for Injection 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.

1.1 Repiratory Tract Infections

Respiratory tract infections due to Streptococcus pneumonia, 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 for Injection, USP is effective in the eradication of streptococci from the nasopharynx; hoever, data establisging the efficacy of Cefazolin for Injection, USP 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 Streptoccus afalactiae.

1.4 Biliary Tract Infections

Bilary 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. pneumonia, S. aureus, P. mirabilis, and E. coli.

1.8 Endocarditis

Endocarditis due to S. aureus and S. pyogenses.

1.9 Perioperative Prophylaxis

The prophylactic administration of Cefazolin for Injection, USP 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, USP 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 arthoplasty).

2 DOSAGE AND ADMINISTRATION

2.1 Adult Population

The recommended adult dosages are outlined in Table 1. Cefazolin for Injections should be administered intramuscularly (IM) or intravenously (IV) over approximately 30 minutes.

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2.2 Perioperative Prophylactic Use

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

  • 1 gram IV or IM administered ½ hour to 1 hour prior to the start of surgery.
  • For lengthy operative procedures (e.g., 2 hour or more). 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure).
  • 500 mg to 1 gram IV or IM every 6 to 9 hours for 24 hours postoperatively.

It is important that (i) the preoperative dose be given just prior (1/2 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 for Injection be administered, if necessary, at appropriate intervals during surgery to provide sufficient concentrations of antibacterial drug at the anticipated moments of greatest exposure to infective organisms.

The prophylactic administration of Cefazolin for Injection should usually be discontinued within a 24-hourperiod after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open –heart surgery and prosthetic arthoplasty), 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 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.

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2.4 Pediatric Dosage

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 infancies and in neonates has not been established, the use of Cefazolin for Injection in these patients is not recommended.

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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.

2.5 Preparation for Use of Cefazolin for Injection
Reconstitution
Preparation of Parenteral Solution Parenteral drug products should be SHAKEN WEL 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 Injections 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.

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.

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

Intravenous Administration
Direct (bolus) injection: Following reconstitiution according to the above table, further dilute vials with approximately 3 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directl or through tubing for patients receiving parenteral fluids (see list below).
Intermittent or continuous infusion: Dilute reconstituted Cefazolin ofr Injection 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.

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