Stability of Aseptically Prepared Tazocin Solutions in Polyvinyl Chloride Bags

Donnelly, Ronald F

doi:10.4212/cjhp.v62i3.792

Cited by 4 publications

(4 citation statements)

References 6 publications

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“…We found several papers investigating the stability of piperacillin-tazobactam, with some conflicting results and we have accordingly assigned a shelf life of 24 hours within the concentration range 22.5–90.0 mg/mL when diluted in either sodium chloride 0.9% or glucose 5% 17–19 31–33…”

Section: Resultsmentioning

confidence: 99%

Systematic review of room temperature stability of key beta-lactam antibiotics for extended infusions in inpatient settings

Jenkins,

Jamieson,

Santillo

2023

Eur J Hosp Pharm

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BackgroundExtended infusion (EI) of beta-lactam antibiotics may offer clinical benefits aligned with improved probability of target attainment for critical pharmacokinetic/pharmacodynamic parameters that correlate with efficacy. There is much research interest in prolonged and continuous infusions (collectively, extended infusions) of beta-lactams to improve patient outcomes, particularly in critically ill patients in intensive care. While definitive clinical trial data demonstrating beneficial outcomes is awaited, there has been limited focus on the stability of the agents given by EI, which may be an equally critical parameter. EI may allow for savings in nursing time due to reduced need for drug reconstitution. We set out to examine the data for stability for EI at room temperature, consistent with the requirements of 'A Standard Protocol for Deriving and Assessment of Stability- Part 1 Aseptic Preparation (Small Molecules)’, which allows a 5% loss of active pharmaceutical ingredient (API) applicable for those territories that use the British Pharmacopoeia also for a 10% loss applicable in much of rest of the world.MethodsSearches using preferred reporting items for systematic reviews and meta-analyses (PRISMA) principles for stability data on freshly prepared beta-lactam antimicrobials for extended administration at room temperature (at or above 23°C) were conducted in November 2021 and updated in December 2022.ResultsWe found data to support the extension of the shelf life of 12 key beta-lactam antibiotics once reconstituted (aztreonam, amoxicillin, benzylpenicillin, flucloxacillin, piperacillin/tazobactam, cefazolin, cefmetazole, ceftaroline, ceftazidime, ceftriaxone, imipenem and meropenem) compliant with the NHS protocol, and data for five other agents (ticarcillin, cefepime, cefiderocol, cefoxitin and doripenem) which would be acceptable in regions outside the UK beyond that listed in the Summary of Product Characteristics.This review has not been registered under PROSPERO.

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Section: Resultsmentioning

confidence: 99%

Systematic review of room temperature stability of key beta-lactam antibiotics for extended infusions in inpatient settings

Jenkins,

Jamieson,

Santillo

2023

Eur J Hosp Pharm

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“…Table 4 shows results for antipseudomonal penicillins. Piperacillin/tazobactam has high stability up to 28 days refrigeration followed by 3 days at 23°C33 but only if buffered. Non-sequential data show stability of piperacillin/tazobactam at 25°C for 21 days 34.…”

Section: Discussionmentioning

confidence: 99%

Systematic review of stability data pertaining to selected antibiotics used for extended infusions in outpatient parenteral antimicrobial therapy (OPAT) at standard room temperature and in warmer climates

et al. 2019

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AimTo determine if there are sufficient stability data to confirm appropriate prescribing of antibiotics commonly used in outpatient parenteral antimicrobial therapy (OPAT) in warmer climates.Data sourcesFour databases were systematically searched using the terms ‘beta-lactams’, or ‘antibiotics’, or ‘anti-bacterial agents’ and ‘drug stability’ or drug storage’ for studies specific to drug stability published between 1966 and February 2018.Study selectionThe search strategy initially identified 2879 potential articles. After title and abstract review, the full-texts of 137 potential articles were assessed, with 46 articles matching the inclusion and exclusion criteria included in this review.ResultsA large volume of stability data is available for the selected drugs. Stability data at temperatures higher than 25°C were available for several of the medications, however few drugs demonstrated stability in warmer climates of 34°C or higher. Only buffered benzylpenicillin, cefoxitin and buffered flucloxacillin were found to have stability data supporting OPAT in warmer climates. Sequential data, profiling the drug for an extended period in solution under refrigeration prior to the run-out period at the higher temperatures, are also lacking.LimitationsThis study was limited by including only peer reviewed articles. There may be further grey literature supporting the stability of some of the drugs mentioned.ConclusionThere are insufficient stability data of antibiotic use in warmer climates. Studies to verify the stability and appropriate use of many antibiotics used in OPAT at standard room temperature and in warmer climates are urgently required. Several drugs in current use in the OPAT settings are lacking stability data.ImplicationsFurther research in this field is needed to develop structured evidence-based guidelines. Results of this review should be further compared with observed patient outcomes in current clinical practice.

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“…Magnification was observed using a laboratory grade microscope n with an ocular set at 10 times Simulated Y-Site Compatibility magnification. 11 Incompatibility was determined through visual particulate matter, haze, or turbidity change from control solution. 11 A calibrated laboratory grade pH meter p was used, and incompatibility was defined as a mean absolute change from the initial reading of greater than 1 pH unit over the 4-hour observational period.…”

Section: Methodsmentioning

confidence: 99%

“…11 Incompatibility was determined through visual particulate matter, haze, or turbidity change from control solution. 11 A calibrated laboratory grade pH meter p was used, and incompatibility was defined as a mean absolute change from the initial reading of greater than 1 pH unit over the 4-hour observational period. 10 Both assessments were made immediately after mixing and at 15 minutes, 60 minutes, and 4 hours.…”

Section: Methodsmentioning

confidence: 99%

Simulated Y-Site Compatibility of Vancomycin and Piperacillin-Tazobactam

2015

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Purpose:To evaluate the physical compatibility of vancomycin with piperacillin-tazobactam during simulated Y-site administration. Methods: Vancomycin and piperacillin-tazobactam were tested using 2 different diluents: 0.9% sodium chloride and 5% dextrose for injection. Vancomycin concentrations of 2, 5, and 10 mg/mL were tested using 0.9% sodium chloride and 4 and 8 mg/mL in 5% dextrose. Piperacillin-tazobactam was diluted to 16, 30, 40, 80, and 100 mg/mL, representing common concentrations used clinically in hospitals, and concentrations were tested in both 0.9% sodium chloride and 5% dextrose for injection. Medications were reconstituted under USP <797> aseptic technique. Combinations were tested in duplicate and reverse order with control solutions. Compatibility testing for Y-site included visual inspection, inspection with a high-intensity monodirectional light source (Tyndall beam), turbidimeter for turbidity evaluation, pH, and microscopic viewing. Testing occurred immediately after mixing, 15 minutes, 60 minutes, and 4 hours. If inconsistencies were observed between samples, testing was repeated to confirm results. Solutions were deemed incompatible if any one test failed and compatible if all tests were accepted. Results: When dextrose 5% for injection was used as the diluent, vancomycin 4 mg/mL was Y-site compatible with piperacillin-tazobactam 16, 30, and 40 mg/mL and incompatible with 80 and 100 mg/mL. Vancomycin 8 mg/mL was incompatible with all tested concentrations of piperacillin-tazobactam. When 0.9% sodium chloride was used as the diluents, Y-site compatibility was found with vancomycin 2 and 5 mg/mL and all tested concentrations of piperacillin-tazobactam. Vancomycin 10 mg/mL was incompatible with piperacillin-tazobactam 40, 80, and 100 mg/mL. Incompatibilities formed a white precipitate immediately on mixing. Conclusion: Y-site incompatibility was greater for the tested concentrations of piperacillintazobactam and vancomycin when 5% dextrose was used as the diluent versus 0.9% sodium chloride. Y-site incompatibility was seen immediately in the form of a white precipitate on mixing.

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Stability of Aseptically Prepared Tazocin Solutions in Polyvinyl Chloride Bags

Abstract: Background: Tazocin, a mixture of piperacillin and tazobactam, has recently been reformulated to include edetate disodium (EDTA) and citric acid. Since the introduction of this new formulation, there have been no studies of stability in polyvinylchloride (PVC) bags.

Cited by 4 publications

References 6 publications

Systematic review of room temperature stability of key beta-lactam antibiotics for extended infusions in inpatient settings

Systematic review of room temperature stability of key beta-lactam antibiotics for extended infusions in inpatient settings

Systematic review of stability data pertaining to selected antibiotics used for extended infusions in outpatient parenteral antimicrobial therapy (OPAT) at standard room temperature and in warmer climates

Simulated Y-Site Compatibility of Vancomycin and Piperacillin-Tazobactam

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