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ISMP Adverse Drug Reactions: Longitudinal Thumbnail Fissures Due to Erlotinib Priapism Associated With the Use of ExtenZe Blindness From a Nevirapine-Based HAART Regimen Hyperprolactinemia and Galactorrhea Due to Aripiprazole Trypophobia Associated With Gabapentin Coadministered Linezolid and Methadone Cause Serotonin Syndrome.

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ISMP Adverse Drug Reactions: Longitudinal Thumbnail Fissures Due to Erlotinib Priapism Associated With the Use of ExtenZe Blindness From a Nevirapine-Based HAART Regimen Hyperprolactinemia and Galactorrhea Due to Aripiprazole…

Compatibility of Ceftazidime-Avibactam, Ceftolozane-Tazobactam, and Piperacillin-Tazobactam with Vancomycin in Dextrose 5% in Water.

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Compatibility of Ceftazidime-Avibactam, Ceftolozane-Tazobactam, and Piperacillin-Tazobactam with Vancomycin in Dextrose 5% in Water.

Hosp Pharm. 2017 Mar;52(3):221-228

Authors: Meyer K, Santarossa M, Danziger LH, Wenzler E

Abstract
Objectives: The compatibility of vancomycin with existing and novel β-lactam/β-lactamase inhibitors at clinically relevant concentrations in 5% dextrose in water has not been fully explored to date. Methods: Vancomycin concentrations tested ranged from 5 to 20 mg/mL. Ceftazidime-avibactam was tested at 8, 20, and 40 mg/mL, ceftolozane-tazobactam at 15 mg/mL, and piperacillin-tazobactam at 28 mg/mL. Compatibility of drug admixtures were tested via both simulated and actual y-site infusion. For the simulated y-site compatibility assessment, 1:1 mixtures of each respective drug were analyzed over 24 hours. Actual y-site infusion followed a 4-hour extended-infusion protocol, with aliquots tested hourly for 4 hours. At all time points, the compatibility of each admixture was determined using 6 different methods: visual, microscopic, Tyndall beam, nephelometric, pH, and microbiologic bioassay assessment. If any admixture failed any one of these 6 assays, it was considered incompatible. Any combination deemed incompatible was filtered through a 0.22 μm filter and reanalyzed to assess impact of particle size. Results: There were no differences in compatibility categorizations between simulated and actual y-site infusion. There were no changes in compatibility over the time course of any experiment. Ceftazidime-avibactam at 8 mg/mL was incompatible with vancomycin at 5 mg/mL. The maximum compatible vancomycin concentrations were 5 mg/mL and 10 mg/mL with 20 and 40 mg/mL of ceftazidime-avibactam, respectively. Ceftolozane-tazobactam 15 mg/mL was compatible with vancomycin concentrations up to 10 mg/mL. The maximum compatible vancomycin concentration with piperacillin-tazobactam 28 mg/mL was 5 mg/mL. None of the β-lactam/β-lactamase inhibitors tested were compatible with 15 or 20 mg/mL of vancomycin. None of the admixtures considered incompatible by other methods displayed any decrease in antimicrobial activity as assessed by bioassay. After filtration, all admixtures originally deemed incompatible maintained their visual turbidity and microscopic particulate matter. Conclusions: Ceftazidime-avibactam prepared at the lowest concentration recommended in the package insert is incompatible with vancomycin. Ceftolozane-tazobactam did not display incompatibility until vancomycin concentrations above 10 mg/mL were tested. Piperacillin-tazobactam at a typical extended-infusion concentration is compatible with vancomycin in D5W. To our knowledge, this is the first study to assess compatibility of antibiotic admixtures via direct measurement of antimicrobial activity. The lack of any decrement in antibacterial activity of any apparently incompatible admixture and maintenance of incompatibility after passage through a 0.22 μm filter may suggest a lack of clinically relevant adverse effects when co-administered. Future compatibility studies should incorporate appropriate methods to accurately assess both efficacy and safety of co-administered drug products.

PMID: 28439137 [PubMed – in process]

Stability of Reconstituted Telavancin Drug Product in Frozen Intravenous Bags.

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Stability of Reconstituted Telavancin Drug Product in Frozen Intravenous Bags.

Hosp Pharm. 2015 Jul;50(7):609-614

Authors: Gu Z, Wong A, Raquinio E, Nguyen A

Abstract
BACKGROUND AND OBJECTIVE: Intravenous (IV) infusions of telavancin for injection are generally administered in-hospital, but in some circumstances they may be administered in an outpatient environment. In that setting, antibiotics may be premixed and frozen. This study determined the chemical stability of nonpreserved telavancin in various commonly used reconstitution diluents stored in IV bags (polyvinyl chloride [PVC] and PVC-free) at -20°C (-4°F) without light.
METHODS: Telavancin (750 mg/vial) was reconstituted with 5% dextrose injection USP (D5W) or 0.9% sodium chloride injection USP (NS) to obtain drug solutions at approximately 15 mg/mL. Infusion solutions of telavancin at diluted concentrations of 0.6 mg/mL and 8.0 mg/mL covering the range utilized in clinical practice were prepared in both PVC and PVC-free IV bags using D5W or NS solutions. The infusion solutions were stored under frozen conditions (-20°C ± 5°C [-4°F ± 41°F]) and the chemical stability was evaluated for up to 32 days. Telavancin concentration, purity, and degradant levels were determined using a stability-indicating high-performance liquid chromatography (HPLC) method.
RESULTS: Telavancin IV infusion solutions in D5W or NS at 0.6 mg/mL and 8 mg/mL and stored at -20°C (-4°F) met the chemical stability criteria when tested on days 0, 7, 14, and 32. The assayed telavancin concentration at each time point was within 97% to 103% of the initial mean assay value. The total degradants quantified by the HPLC stability-indicating method did not show any significant change over the 32-day study period.
CONCLUSION: Telavancin IV infusion solutions (in D5W or NS) in both PVC and PVC-free IV bags were stable for at least 32 days when stored at -20°C (-4°F) without light. These results provide prolonged frozen stability data further to that previously established for 7 days under refrigerated conditions (2°C-8°C [36°F -46°F]), and for 12 hours at room temperature when diluted into IV bags containing D5W, NS, or lactated Ringer’s solution.

PMID: 26448673 [PubMed – as supplied by publisher]

High-Dose Loperamide Abuse Inducing Life-Threatening Cardiac Arrhythmias; Topiramate-Induced Diarrhea in a Breastfed Infant; Danazol-Induced Stevens-Johnson Syndrome; Asenapine-Induced Myasthenic Syndrome; Black Hairy Tongue Due to Linezolid; Adalimumab-Induced Priapism.

High-Dose Loperamide Abuse Inducing Life-Threatening Cardiac Arrhythmias; Topiramate-Induced Diarrhea in a Breastfed Infant; Danazol-Induced Stevens-Johnson Syndrome; Asenapine-Induced Myasthenic Syndrome; Black Hairy Tongue Due to Linezolid…