Direction for Reconstitution: Single dose vials: Reconstitute piperacillin/tazobactam vials with a compatible reconstitution diluent from the list provided as follows. 4.5 g piperacillin/tazobactam should be reconstituted with 20 mL. Swirl until dissolved.
Compatible Reconstitution Diluents for Pharmacy and Single Dose Vials: 0.9% sodium chloride for injection; Sterile water for injection; Dextrose 5%.
Reconstituted piperacillin/tazobactam solutions for both bulk and single dose vials should be further diluted (recommended volume per dose of 50 mL to 150 mL) in a compatible intravenous solution listed as follows. 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 and Single Dose Vials: 0.9% sodium chloride for injection; sterile water for injection ;Dextrose 5%.
Maximum recommended volume per dose of sterile water for injection is 50 mL.
Piperacillin/tazobactam should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.
Piperacillin/tazobactam is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.
Piperacillin/tazobactam 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.
Stability of Piperacillin/Tazobactam Powder Formulations: Following Reconstitution Piperacillin/tazobactam reconstituted from bulk and single vials is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when used with compatible diluents. The pharmacy bulk vial should NOT be frozen after reconstitution. Discard unused portions after storage for 24 hours at room temperature or after storage for 48 hours at refrigerated temperature (2°C to 8°C).
Single dose or pharmacy vials should be used immediately after reconstitution. Discard any unused portion after 24 hours if stored at room temperature (20°C to 25°C), or after 48 hours if stored at refrigerated temperature (2°C to 8°C). Vials should not be frozen after reconstitution.
Stability studies in the I.V. 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/tazobactam contains no preservatives. Appropriate consideration of aseptic technique should be used.
Piperacillin/tazobactam reconstituted from bulk and single vials can be used in ambulatory intravenous infusion pumps. Stability of piperacillin/tazobactam 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 supplies of dosing solution were aseptically transferred into the medication reservoir (I.V. bags or cartridge). The reservoir was fitted to a preprogrammed ambulatory intravenous infusion pump per the manufacturer's instructions. Stability of piperacillin/tazobactam is not affected when administered using an ambulatory intravenous infusion pump.
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