CEFAZOLIN (Page 2 of 4)

2.4 Preparation for Use of Cefazolin for Injection, USP bag SmartPak® Pharmacy Bulk Package

Cefazolin for Injection USP, Pharmacy Bulk Package bag SmartPak ® should not be used in patients who require less than a 250 mg dose of cefazolin.

Directions for Proper Use of a Pharmacy Bulk Package

  • NOT FOR DIRECT INFUSION. The Pharmacy Bulk Package is for use in the hospital pharmacy admixture service only in a suitable work area, such as a laminar flow hood. Using aseptic technique, the container closure may be penetrated only one time after reconstitution using a suitable sterile dispensing set or transfer device that allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage. The withdrawal of container contents should be accomplished without delay. However, should this not be possible, a maximum time of 4 HOURS from initial reconstitution port closure entry is permitted to complete fluid transfer operations. This time limit should begin with the introduction of the solvent or diluent into the Pharmacy Bulk Package. Discard any unused portion after 4 HOURS. This pharmacy bulk package is not intended to be dispensed as a unit.
  • PRIOR TO RECONSTITUTION: Visually examine outer (natural foil) bag for damage. IF THE SEAL IS BROKEN OR DAMAGE IS OBSERVED, DO NOT OPEN THE OUTER BAG. STERILITY OF THE INNER BAG SURFACE MAY BE COMPROMISED. DISCARD BOTH BAGS IMMEDIATELY. DO NOT USE THE INNER BAG IF PARTICULATE OR FOREIGN MATTER IS PRESENT, IF THE DRY POWDER IS DARK YELLOW OR BROWN, IF THE SEALS ARE NOT INTACT, OR IF THERE IS ANY OTHER DAMAGE TO THE BAG. IN SUCH CASES, DISCARD THE BAG IMMEDIATELY.
  • After initial reconstitution port entry, use entire contents of the Pharmacy Bulk Package promptly. Any unused portion must be discarded after 4 HOURS.
  • Gather the following items prior to the reconstitution of the product: Appropriate number of bags of Sterile Water for Injection and, depending upon the method of filling, appropriate sterile tubing and adapters.

INSTRUCTION FOR RECONSTITUTION OF THE PHARMACY BULK PACKAGE BAG SmartPak ®

The entire contents of the bag and the preparation process (reconstitution and dilution) should be completed within 4 hours of initial entry.

Figure
  • Document the date and time reconstitution starts in the designated place on the container label. The entire contents of the bag must be used within 4 hours from the time of initial entry.
  • Remove the translucent unthreaded cap from the reconstitution (smaller) port and discard it.
  • Reconstitute the powder through the reconstitution (smaller) port, using Sterile Water for Injection according to the table below
Reconstitution Table
SmartPak ® Bag Size Amount of Sterile Water Approximate Concentration
100 grams960 mL100 mg/mL (1 g/10 mL)
300 grams2880 mL100 mg/mL (1 g/10 mL)
  • After reconstitution is complete, remove the transfer needle from the reconstitution port.
  • Place the bag on a flat surface of a laminar flow hood and mix for at least 15 minutes for the 100 gram product or 25 minutes for the 300 gram product by rocking gently from side to side. CAUTION: To avoid possible leakage caused by the heavy weight of the added water, do not shake vigorously or pull strongly on the bag.
  • When foam dissipates, visually inspect the bag to verify the solution is clear, colorless to pale yellow and free of particulate matter. DO NOT USE THE INNER BAG IF PARTICULATE OR FOREIGN MATTER IS PRESENT.
  • Unscrew the clear threaded cap from the transfer (larger) port and discard it. Attach sterile tubing and filling adapter unit to the transfer port.
  • Reconstituted solution can now be transferred using the transfer port and the filling adapter.

It should be noted that the spike placed into the transfer port of the Pharmacy Bulk Package SmartPak® is NEVER removed during this procedure and that the reconstitution port is self-sealing.

Dilution

  • Hang the bag from two eyelets.
  • Following reconstitution, transfer 10 mL of the reconstituted solution into transfusion bags, each containing 50 mL of one of the compatible solutions below.

Compatible solutions for dilution are the following:

Sodium Chloride Injection, USP 5% Detrose Injection, USP

  • Dilution should be completed within the 4 hour preparation process.
  • When diluted according to the instructions above, cefazolin is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F).

Administration

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

3 DOSAGE FORMS AND STRENGTHS

  • 100 grams Cefazolin for Injection, USP, Pharmacy Bulk Package bag SmartPak®
  • 300 grams Cefazolin for Injection, USP, Pharmacy Bulk Package bag SmartPak®

THIS IS A PHARMACY BULK PACKAGE – NOT FOR DIRECT INJECTION

4 CONTRAINDICATIONS

4.1 Hypersensitivity to Cefazolin or the Cephalosporin Class of Antibacterial Drugs, Penicillins or Other Beta-lactams

Cefazolin for Injection, USP is contraindicated in patients who have a history of immediate hypersensitivity reactions (e.g., anaphylaxis, serious skin reactions) to cefazolin or the cephalosporin class of antibacterial drugs, penicillins or other beta-lactams [see Warnings and Precautions (5.1) ].

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions to Cefazolin, Cephalosporins, Penicillins or Other Beta-lactams

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with Cefazolin for Injection, USP is instituted, careful inquiry should be made to determine whether the patient has had previous immediate hypersensitivity reactions to cefazolin, cephalosporins, penicillins, or carbapenems. Exercise caution if this product is to be given to penicillin-sensitive patients because cross-hypersensitivity among beta-lactam antibacterial drugs has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Cefazolin for Injection, USP occurs, discontinue the drug.

5.2 Use in Patients with Renal Impairment

Cefazolin for Injection USP – Pharmacy Bulk Package bags SmartPak ® should not be used in renally impaired patients who require less than a 250 mg dose of cefazolin.

As with other beta-lactam antibacterial drugs, seizures may occur if inappropriately high doses are administered to patients with impaired renal function (creatinine clearance less than 55 mL/minute) [see Dosage and Administration (2.3) ].

5.3 Clostridium difficile -associated Diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including cefazolin and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin- producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

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