Cefazolin

2 DOSAGE AND ADMINISTRATION Cefazolin for Injection, 2 grams/vial: • For intravenous infusion (2.1) • For intravenous bolus injection (2.1) • Not for intramuscular administration (2.1) Cefazolin for Injection, 3 grams/vial: • For intravenous infusion only (2.1) • Not for intravenous bolus injection administration or intramuscular administration (2.1) Table 1: Recommended Dosage for Perioperative Prophylaxis in Adults with CLcr Equal to 55 mL/min or Greater (2.2) Dose administered ½ hour to 1 hour prior to the start of surgery Additional dose during lengthy operative procedures (e.g., 2 hours or more) Dose for 24 hours postoperatively 1 gram (g) to 2 g 500 mg to 1 g 500 mg to 1 g every 6 hours to 8 hours • See full prescribing information for preparation and administration instructions. (2.3) 2.1 Important Administration Instructions • Cefazolin for Injection, 2 grams/vial: Cefazolin for Injection, 2 grams/vial, is for intravenous infusion or intravenous bolus injection in adult patients [see Dosage and Administration (2.2 and 2.3)]. Not for intramuscular administration. • Cefazolin for Injection, 3 grams/vial: Cefazolin for Injection, 3 grams/vial, is for intravenous infusion only in adult patients [see Dosage and Administration (2.2 and 2.3)] . Cefazolin for Injection, 3 grams/vial is not for intravenous bolus injection or intramuscular administration [see Dosage and Administration (2.3)] . 2.2 Recommended Dosage for Perioperative Prophylaxis Use in Adults Recommended Dosage for Perioperative Prophylaxis in Adults with Creatinine Clearance (CLcr) Equal to 55 mL/min or Greater To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended dosages are described in Table 1 below. Administration instructions are as follows: • Cefazolin for Injection, 2 grams/vial is for intravenous infusion or intravenous bolus injection in adult patients [see Dosage and Administration (2.3)] . • Cefazolin for Injection, 3 grams/vial is only for intravenous infusion in adult patients. • Cefazolin for Injection, 3 grams/vial is not for intravenous bolus injection in adult patients [see Dosage and Administration (2.3)] . • Cefazolin for Injection 2 grams/vial and 3 grams/vial are not for intramuscular injection. Table 1: Recommended Dosage for Perioperative Prophylaxis in Adults with CLcr Equal to 55 mL/min or Greater Dose administered ½ hour to 1 hour prior to the start of surgery Additional dose during lengthy operative procedures (e.g., 2 hours or more) Dose for 24 hours postoperatively 1 gram (g) to 2 g 500 mg to 1 g 500 mg to 1 g every 6 hours to 8 hours 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 the antibacterial drug at the anticipated moments of greatest exposure to infective organisms. The perioperative prophylactic administration of Cefazolin for Injection 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 for Injection may be continued for 3 to 5 days following the completion of surgery. 2.3 Preparation of Cefazolin for Injection Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded. Reconstituted solutions may range in color from pale yellow to yellow. Reconstitution and Dilution Intravenous Bolus Injection Administration (2 g vial only) For preparation of intravenous bolus injection (2 grams/vial only) use the following steps: • Reconstitute Cefazolin for Injection, 2 grams/vial single-dose vials with Sterile Water for Injection according to Table 2 below. Shake well until dissolved. • Further dilute vials with an additional 11 mL Sterile Water for Injection and shake well. • Inject the solution intravenously slowly, directly, or through tubing for patients receiving parenteral fluids as follows: a For 1 g dose, inject the solution intravenously slowly over 3 to 5 minutes and b For 2 g dose, inject the solution intravenously slowly over 7 to 11 minutes Table 2: Volume and Concentration for Intravenous Bolus Injection Reconstitution (2 g vial only) Cefazolin for Injection Vial Contents Amount of Sterile Water for Injection for Reconstitution Approximate Reconstituted Concentration Approximate Available Volume 2 grams 5.5 mL 333 mg/mL 6.6 mL Pain associated with intravenous bolus administration has been reported with Cefazolin for Injection. Intermittent or Continuous Intravenous Infusion For intermittent or continuous intravenous infusion, reconstitute Cefazolin for Injection single-dose vials with Sterile Water for Injection according to Table 3 below and shake well . After reconstitution further dilute according to Table 3 using the following diluents: For intermittent or continuous infusion: Dilute reconstituted Cefazolin for Injection in one of the following solutions: • 0.9% Sodium Chloride Injection, USP • 5% Dextrose Injection, USP Discard unused portion. Table 3: Volumes for Reconstitution and Dilution and Final Concentrations for Intermittent or Continuous Intravenous Infusion Cefazolin for Injection Vial Contents Amount of Sterile Water for Injection for Reconstitution Approximate Reconstituted Concentrations Recommended Diluent Volume Approximate Final Concentrations 2 grams 5 mL 317 mg/mL 50 mL 40 mg/mL 100 mL 20 mg/mL 3 grams 7.5 mL 319 mg/mL 100 mL 30 mg/mL Storage of Reconstituted and Diluted Solutions When reconstituted or diluted according to the instructions above, Cefazolin for Injection is stable for 4 hours at room temperature or for 3 days if stored under refrigeration at 2°C to 8°C (36°F to 46°F).

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1 INDICATIONS AND USAGE Cefazolin for Injection is a cephalosporin antibacterial indicated for perioperative prophylaxis in adult patients (1.1).