Ceftriaxone (Page 2 of 7)

2.2 Pediatric Patients

To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the adult 1 gram dose of ceftriaxone. [see Use in Specific Populations (8.4)]

2.3 Preparation for Use of Ceftriaxone for Injection, USP, Pharmacy Bulk Package bags, SmartPak®

Ceftriaxone for Injection, USP Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof.

Ceftriaxone for Injection USP, Pharmacy Bulk Package SmartPak® bag should not be used in patients who require less than the 1 gram dose of ceftriaxone.

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: 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.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Use only if solution is clear.
  • Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute Ceftriaxone for Injection SmartPak® Pharmacy Bulk Package or to further dilute a reconstituted solution for intravenous administration. Particulate formation can result.

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.

inner bag
  • 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 2 below:
*
Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute or further dilute reconstituted ceftriaxone because a precipitate can form. STERILE WATER FOR INJECTION IS THE ONLY RECOMMENDED DILUENT FOR RECONSTITUTION. [see Warnings and Precautions [(5.2)].
Table 2: Reconstitution Table
SmartPak® Bag Size Amount of Sterile Water * Approximate Concentration
100 grams 950 mL 100 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 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, USP5% Dextrose Injection, USP
  • Dilution should be completed within the 4 hour preparation process.
  • When diluted according to the instructions above, ceftriaxone is stable for 48 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F).

Important Administration Instructions

  • Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute Ceftriaxone for Injection SmartPak® Pharmacy Bulk Package or to further dilute a reconstituted solution for intravenous administration. Particulate formation can result. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration line. Ceftriaxone for Injection, USP must not be administered simultaneously with calcium-containing intravenous solutions, including continuous calcium-containing infusions, such as parenteral nutrition via a Y-site. However, in patients other than neonates, Ceftriaxone for Injection, USP and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid [see Warnings and Precautions (5.2)].
  • Prior to administration, parenteral products should be inspected visually for particulate matter and discoloration whenever solution and container permit.
  • Administer diluted ceftriaxone solutions intravenously over approximately 30 minutes.
  • After the indicated stability times, unused portions of solutions should be discarded.
  • Vancomycin, amsacrine, aminoglycosides and fluconazole are physically incompatible with ceftriaxone in admixtures. When any of these drugs are to be administered concomitantly with ceftriaxone by intermittent intravenous infusion, it is recommended that they be given sequentially with thorough flushing of the intravenous lines with 0.9% Sodium Chloride Injection or 5% Dextrose in Water (D5W) between the administrations.
  • Ceftriaxone for Injection should not be physically mixed with or piggybacked into solutions containing other antimicrobial drugs due to possible incompatibility [see Drug Interactions (7.1)].
  • There have been no reports of an interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (intravenous or oral).

3 DOSAGE FORMS AND STRENGTHS

  • 100 grams Ceftriaxone for Injection, USP, Pharmacy Bulk Package bag, SmartPak® THIS IS A PHARMACY BULK PACKAGE – NOT FOR DIRECT INJECTION

4 CONTRAINDICATIONS

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