Cefazolin Sodium (Page 3 of 8)

2.4 Dosage Recommendations in Adult and Pediatric Patients with Renal Impairment

Dosage Recommendations in Adult Patients with CLcr less than 55 mL/min

The dosage recommendation for Cefazolin for Injection and Dextrose Injection in adult patients with renal impairment (CLcr less than 55 mL/min) is outlined in Table 5 below.

*

If the recommended dose in adult patients with creatinine clearance equal to 35 mL/min or greater is 1 gram, then this product is not recommended for use in patients with creatinine clearance less than 35 mL/min and an alternative formulation of cefazolin should be considered.

Table 5: Dosage Recommendation for Adult Patients with CLcr less than 55 mL/min
Creatinine Clearance Dose Frequency
35 to 54 mL/min Recommended dose every 8 hours or longer
11 to 34 mL/min Half of recommended dose * every 12 hours
10 mL/min or less Half of recommended dose * every 18 to 24 hours

Dosage Recommendations in Pediatric Patients with CLcr less than 70 mL/min

The dosage recommendation for Cefazolin for Injection and Dextrose Injection in pediatric patients with renal impairment (CLcr less than 70 mL/min) is outlined in Table 6 below.

Table 6: Recommended Dosage in Pediatric Patients with CLcr less than 70 mL/min
Creatinine Clearance Recommended Dosage
40 to 70 mL/min 60% of the normal daily dose given in equally divided doses every 12 hours
20 to 40 mL/min 25% of the normal daily dose given in equally divided doses every 12 hours
5 to 20 mL/min 10% of the normal daily dose every 24 hours

*If a dose of Cefazolin for Injection and Dextrose Injection is required that does not equal 1 gram or 2 grams, this product is not recommended for use and an alternative formulation of cefazolin should be considered.

2.5 Preparation for Use of Cefazolin for Injection and Dextrose Injection in DUPLEX® Container

This reconstituted solution of Cefazolin for Injection and Dextrose Injection is for intravenous use only.

Do not use plastic containers in series connections. Such use would result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Use only if solution is clear and container and seals are intact.

DUPLEX® Container Storage

  • To avoid inadvertent activation, the 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® Container (see Diagram 1).
Diagram 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).
Diagram 2
(click image for full-size original)
  • Protect from light after removal of foil strip.

Note: If foil strip is removed, the container should be re-folded and the side tab latched until ready to activate. The product must then be used within 7 days, but not beyond the labeled expiration date.

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 hanger 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).
Diagram 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).
Diagram 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 compromised.
  • Using aseptic technique, peel foil cover from the set port and attach sterile administration set (see Diagram 5).
Diagram 5
(click image for full-size original)
  • Refer to directions for use accompanying the administration set.

Important Administration Instructions

  • Do not use in series connections.
  • Do not introduce additives into the DUPLEX® Container.
  • Administer Cefazolin for Injection and Dextrose Injection intravenously over approximately 30 minutes.
Diagram 1Diagram 2Diagram 3Diagram 4Diagram 5

3 DOSAGE FORMS AND STRENGTHS

Dual-chamber, single-dose packaged combination of Cefazolin Sodium USP (lyophilized) and sterile iso-osmotic diluent in the DUPLEX® sterile container consisting of :

• 1 g Cefazolin for Injection USP and 50 mL 4% Dextrose Injection USP

• 2 g Cefazolin for Injection USP and 50 mL 3% Dextrose Injection USP

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