Piperacillin and Tazobactam (Page 2 of 7)

2.5 Reconstitution and Dilution of Piperacillin and Tazobactam for Injection

Reconstitution of Piperacillin and Tazobactam for Injection for Adult Patients and Pediatric Patients Weighing Over 40 kg

Pharmacy Bulk Vials

Reconstituted pharmacy bulk vial solution must be transferred and further diluted for intravenous infusion.

The pharmacy bulk vial is for use in a hospital pharmacy admixture service only under a laminar flow hood. After reconstitution, entry into the vial must be made with a sterile transfer set or other sterile dispensing device, and contents should be dispensed as aliquots into intravenous solution using aseptic technique. Use entire contents of pharmacy bulk vial promptly. Discard unused portion after 24 hours if stored at room temperature (20°C to 25°C [68°F to 77°F]), or after 48 hours if stored at refrigerated temperature (2°C to 8°C [36°F to 46°F]).

Reconstitute the pharmacy bulk vial with exactly 152 mL of a compatible reconstitution diluent, listed below, to a concentration of 200 mg/mL of piperacillin and 25 mg/mL of tazobactam. Shake well until dissolved. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to and during administration whenever solution and container permit.

Compatible Reconstitution Diluents for Pharmacy Bulk Vials

0.9% sodium chloride for injection
Sterile water for injection
Dextrose 5%
Bacteriostatic saline/parabens
Bacteriostatic water/parabens
Bacteriostatic saline/benzyl alcohol
Bacteriostatic water/benzyl alcohol

Dilution of the Reconstituted Piperacillin and Tazobactam for Injection Solution for Adult Patients and Pediatric Patients Weighing Over 40 kg

Reconstituted piperacillin and tazobactam for injection solutions for pharmacy bulk vials should be further diluted (recommended volume per dose of 50 mL to 150 mL) in a compatible intravenous solution listed below. Administer by infusion over a period of at least 30 minutes. During the infusion it is desirable to discontinue the primary infusion solution.

Compatible Intravenous Solutions for Pharmacy Bulk Vials

0.9% sodium chloride for injection
Sterile water for injection (Maximum recommended volume per dose of sterile water for injection is 50 mL)

Dextran 6% in salineDextrose 5%

LACTATED RINGER’S SOLUTION IS NOT COMPATIBLE WITH PIPERACILLIN AND TAZOBACTAM FOR INJECTION

Piperacillin and tazobactam for injection should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.

Piperacillin and tazobactam for injection is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.

Piperacillin and tazobactam for injection should not be added to blood products or albumin hydrolysates. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.

Dilution of the Reconstituted Piperacillin and Tazobactam for Injection Solution for Pediatric Patients Weighing up to 40 kg

The volume of reconstituted solution required to deliver the dose of piperacillin and tazobactam for injection is dependent on the weight of the child [see Dosage and Administration (2.4)]. Reconstituted piperacillin and tazobactam for injection solutions for bulk vials should be further diluted in a compatible intravenous solution listed above.

  1. Calculate patient dose as described in Table 2 above [see Dosage and Administration (2.4)].
  2. Reconstitute vial with a compatible reconstitution diluent, as listed above under the subheading “Compatible Reconstitution Diluents for Pharmacy Bulk Vials,” using the appropriate volume of diluent, as listed in table 4 below. Following the addition of the diluent, shake the pharmacy bulk vial until the powder is completely dissolved.
    Table 4: Reconstitution of Pharmacy Bulk Vial and Resulting Concentration
    Strength per Pharmacy Bulk VialVolume of Diluent to be Added to the VialConcentration of the Reconstituted Product
    40.5 g (36 g piperacillin and 4.5 g tazobactam)152 mL225 mg/mL(200 mg/mL piperacillin and 25 mg/mL tazobactam)
  3. Calculate the required volume (mL) of reconstituted piperacillin and tazobactam for injection solution based on the required dose.
  4. Aseptically withdraw the required volume of reconstituted piperacillin and tazobactam for injection solution from the pharmacy bulk vial. It should be further diluted to a final piperacillin concentration of between 20 mg/mL to 80 mg/mL (tazobactam between 2.5 mg/mL to 10 mg/mL) in a compatible intravenous solution (as listed above) in an appropriately sized syringe or IV bag.
  5. Administer the diluted piperacillin and tazobactam for injection solution by infusion over a period of at least 30 minutes (a programmable syringe or infusion pump is recommended). During the infusion it is desirable to discontinue the primary infusion solution.

Stability of Piperacillin and Tazobactam for Injection Following Reconstitution and Dilution

Piperacillin and tazobactam for injection reconstituted from pharmacy bulk vials is stable in glass and plastic containers (plastic syringes, IV bags and tubing) when used with compatible diluents. The pharmacy bulk vials should NOT be frozen after reconstitution.

Pharmacy bulk vials should be used immediately after reconstitution. Discard any unused portion after storage for 24 hours at room temperature (20°C to 25°C [68°F to 77°F]), or after storage for 48 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]).

Stability studies in the IV bags have demonstrated chemical stability (potency, pH of reconstituted solution and clarity of solution) for up to 24 hours at room temperature and up to one week at refrigerated temperature. Piperacillin and tazobactam for injection contains no preservatives. Appropriate consideration of aseptic technique should be used.

Piperacillin and tazobactam for injection reconstituted from bulk vials can be used in ambulatory intravenous infusion pumps. Stability of piperacillin and tazobactam for injection in an ambulatory intravenous infusion pump has been demonstrated for a period of 12 hours at room temperature. Each dose was reconstituted and diluted to a volume of 37.5 mL or 25 mL. One-day supply of dosing solution were aseptically transferred into the medication reservoir (IV bags or cartridge). The reservoir was fitted to a preprogrammed ambulatory intravenous infusion pump per the manufacturer’s instructions. Stability of piperacillin and tazobactam for injection is not affected when administered using an ambulatory intravenous infusion pump.

2.6 Compatibility With Aminoglycosides

Due to the in vitro inactivation of aminoglycosides by piperacillin, piperacillin and tazobactam for injection and aminoglycosides are recommended for separate administration. Piperacillin and tazobactam for injection and aminoglycosides should be reconstituted, diluted, and administered separately when concomitant therapy with aminoglycosides is indicated [see Drug Interactions (7.1)].

In circumstances where co-administration via Y-site is necessary, piperacillin and tazobactam for injection is compatible for simultaneous co-administration via Y-site infusion only with the following aminoglycosides under the following conditions:

Table 5: Compatibility with Aminoglycosides
Aminoglycoside Piperacillin and Tazobactam for InjectionDose(grams) Piperacillin and Tazobactam for InjectionDiluent Volume *(mL) Aminoglycoside Concentration Range (mg/mL) Acceptable Diluents
*
Diluent volumes apply only to bulk pharmacy containers
The concentration ranges in Table 5 are based on administration of the aminoglycoside in divided doses (10–15 mg/kg/day in two daily doses for amikacin and 3–5 mg/kg/day in three daily doses for gentamicin). Administration of amikacin or gentamicin in a single daily dose or in doses exceeding those stated above via Y-site with piperacillin and tazobactam for injection has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions.
Amikacin 2.253.3754.5 50100150 1.75 – 7.5 0.9% sodium chloride or 5% dextrose
Gentamicin 2.253.3754.5 50100150 0.7 – 3.32 0.9% sodium chloride or 5% dextrose

Only the concentration and diluents for amikacin or gentamicin with the dosages of piperacillin and tazobactam for injection listed above have been established as compatible for co-administration via Y-site infusion. Simultaneous co-administration via Y-site infusion in any manner other than listed above may result in inactivation of the aminoglycoside by piperacillin and tazobactam for injection.

Piperacillin and tazobactam for injection is not compatible with tobramycin for simultaneous co-administration via Y-site infusion. Compatibility of piperacillin and tazobactam for injection with other aminoglycosides has not been established.

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

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