Piperacillin and Tazobactam (Page 2 of 9)

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

Single-Dose Vials

Reconstitute piperacillin and tazobactam for injection single-dose vials with a compatible reconstitution diluent from the list provided below.

2.25 g, 3.375 g, and 4.5 g piperacillin and tazobactam for injection should be reconstituted with 10 mL, 15 mL, and 20 mL, respectively. Swirl until dissolved. After reconstitution, the single-dose vials will have a concentration of 202.5 mg/mL (180 mg/mL of piperacillin and 22.5 mg/mL of tazobactam).

Compatible Reconstitution Diluents for Single-Dose 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 Solution for Adult Patients and Pediatric Patients Weighing Over 40 kg

Reconstituted piperacillin and tazobactam for injection solutions for single-dose 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 Single-Dose 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 saline

Dextrose 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 Solution for Pediatric Patients Weighing up to 40 kg

The volume of reconstituted solution required to deliver the dose of piperacillin and tazobactam is dependent on the weight of the child [see Dosage and Administration (2.4)]. Reconstituted piperacillin and tazobactam solutions for single-dose 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 Single-Dose Vials,” using the appropriate volume of diluent, as listed in Table 3 below. Following the addition of the diluent, swirl the single-dose vial until the powder is completely dissolved.
Table 3 : Reconstitution of Single-Dose Vials and Resulting Concentration

Strength per Single-Dose Vial

Volume of Diluent to be Added to the Vial

Concentration of the Reconstituted Product

2.25 g (2 g piperacillin and 0.25 g tazobactam)

10 mL

202.5 mg/mL (180 mg/mL piperacillin and 22.5 mg/mL tazobactam)

3.375 g (3 g piperacillin and 0.375 g tazobactam)

15 mL

4.5 g (4 g piperacillin and 0.5 g tazobactam)

20 mL

3.
Calculate the required volume (mL) of reconstituted piperacillin and tazobactam solution based on the required dose.
4.
Aseptically withdraw the required volume of reconstituted piperacillin and tazobactam solution from single-dose 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 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 single-dose vials is stable in glass and plastic containers (plastic syringes, IV bags and tubing) when used with compatible diluents. The single-dose vials should NOT be frozen after reconstitution.

Single-dose 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 single-dose 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 andTazobactam forInjection Dose(grams)

Piperacillin andTazobactam forInjection DiluentVolume* (mL)

AminoglycosideConcentrationRange (mg/mL)

AcceptableDiluents

Amikacin

2.25

3.375

4.5

50

100

150

1.75 – 7.5

0.9% sodium chloride or 5% dextrose

Gentamicin

2.25

3.375

4.5

50

100

150

0.7 – 3.32

0.9% sodium chloride or 5% dextrose

* Diluent volumes apply only to single vials and bulk pharmacy containers.

† The concentration ranges in Table 5 are based on administration of the aminoglycoside in divided doses (10 to 15 mg/kg/day in two daily doses for amikacin and 3 to 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.

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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