Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates

Lê, Jennifer; Poindexter, Brenda B.; Sullivan, Janice E.; Laughon, Matthew M.; Delmore, Paula; Blackford, Martha; Yogev, Ram; James, Laura P.; Melloni, Chiara; Harper, Barrie; Mitchell, Jeff; Benjamin, Daniel K.; Boakye‐Agyeman, Felix; Cohen‐Wolkowiez, Michael

doi:10.1097/ftd.0000000000000466

Cited by 9 publications

(4 citation statements)

References 23 publications

(28 reference statements)

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“…Correction of DBS concentrations is performed based on the patientspecific or average haematocrit, often in combination with the red blood cell to plasma partition ratio [25,26]. Translation strategies without haematocrit correction are performed based on the average DBS to WB or plasma ratio [21,44,45] or the DBS to WB or plasma concentration regression fit slope or equation [44,[46][47][48][49]. To investigate the need for and extent of correction of tacrolimus and mycophenolic acid DBS concentrations in the present study, a clinical pilot study was conducted from February to June 2016.…”

Section: Translation Of Dbs To Wb Concentrationmentioning

confidence: 99%

Therapeutic drug monitoring of tacrolimus and mycophenolic acid in outpatient renal transplant recipients using a volumetric dried blood spot sampling device

Zwart

Gokoel

Boog

et al. 2018

Brit J Clinical Pharma

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Section: Translation Of Dbs To Wb Concentrationmentioning

confidence: 99%

Therapeutic drug monitoring of tacrolimus and mycophenolic acid in outpatient renal transplant recipients using a volumetric dried blood spot sampling device

Zwart

Gokoel

Boog

et al. 2018

Brit J Clinical Pharma

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“…Using the final model, the DBS concentrations of 1,000 patients were simulated after a 2g loading dose and after maintenance dosing strategies of 1-g every 4 h and 2-g every 6 h. The DBS concentrations were then converted to an estimated free plasma concentration using a DBS to plasma concentration ratio of 0.56 and a fraction unbound of 80%. 13,14 The percentage of simulated patients maintaining an unbound plasma concentration above various mean inhibitory concentration (MIC) thresholds for >50% of the dosing interval were then calculated (Table 3). 15 All 3 of the standard dosing strategies resulted in more than 90% of patients maintaining unbound plasma concentrations above an MIC of 0.25, 0.5 and 1.0 mcg/mL for >50% of the 9…”

Section: Resultsmentioning

confidence: 99%

Ampicillin Pharmacokinetics in Peripartum and Laboring Women

et al. 2021

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Objective: Ampicillin is used for multiple peripartum indications including prevention of neonatal group beta streptococcus (GBS) and treatment of chorioamnionitis. Despite its widespread use in obstetrics, existing pharmacokinetic data for ampicillin do not address contemporary indications or dosing paradigms for this population. We sought to characterize the pharmacokinetic profile of ampicillin administered to laboring women. Study Design: Using whole blood dried blood spot sampling technique, maternal blood samples were collected at specified times from 31 women receiving IV ampicillin for peripartum indications. Women received either a 2-g loading dose with 1-g administered every 4 h (GBS), or 2-g every 6 h (chorioamnionitis). Pharmacokinetics were analyzed via a population approach with non-linear mixed-effect modeling. Results: The data were best described by a two-compartment model with first-order elimination, with the following whole blood parameters: central volume of distribution (V1) 75.2 L (95% CI 56.3-93.6), clearance (CL) 82.4 L/h (95% CI 59.7-95.7), inter-compartmental clearance (Q) 20.9 L/h (95% CI 16.2-38.2), and peripheral volume of distribution (V2) 61.1 L (95% CI 26.1-310.5). Inter-patient variation in CL and V1 was large (42.0% and 56.7% respectively). Simulations of standard dosing strategies demonstrated over 98% of women are predicted to achieve an estimated free plasma concentration above MIC 0.5 mcg/mL for more than 50% of the dosing interval. Conclusions: Although large variation in the pharmacokinetics of ampicillin in pregnant women exists, as predicted by our model, current standard dosing strategies achieve adequate exposure for GBS in nearly all patients.

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“…Finally, the authors conclude that further studies are needed to validate the use of this methodology in clinical practice [ 239 ]. In 2018, Le and colleagues performed a study to test the utility and accuracy of DBS vs. plasma for evaluating the PK behavior of ampicillin in neonates [ 240 ]. In particular, 18 patients were included in this popPK analysis; 29 DBS and plasma samples were collected from each subject.…”

Section: Therapeutic Drug Monitoring (Tdm) Of Antibiotics In Pretermsmentioning

confidence: 99%

“…A strong correlation was observed between DBSs and plasma, but the bias exceeded >15%. Therefore, the authors conclude that DBSs could be used to estimate ampicillin plasma concentration in neonates, by standardizing spot coverage on the card, drying, and storage [ 240 ].…”

Section: Therapeutic Drug Monitoring (Tdm) Of Antibiotics In Pretermsmentioning

confidence: 99%

Use of Antibiotics in Preterm Newborns

et al. 2022

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Due to complex maturational and physiological changes that characterize neonates and affect their response to pharmacological treatments, neonatal pharmacology is different from children and adults and deserves particular attention. Although preterms are usually considered part of the neonatal population, they have physiological and pharmacological hallmarks different from full-terms and, therefore, need specific considerations. Antibiotics are widely used among preterms. In fact, during their stay in neonatal intensive care units (NICUs), invasive procedures, including central catheters for parental nutrition and ventilators for respiratory support, are often sources of microbes and require antimicrobial treatments. Unfortunately, the majority of drugs administered to neonates are off-label due to the lack of clinical studies conducted on this special population. In fact, physiological and ethical concerns represent a huge limit in performing pharmacokinetic (PK) studies on these subjects, since they limit the number and volume of blood sampling. Therapeutic drug monitoring (TDM) is a useful tool that allows dose adjustments aiming to fit plasma concentrations within the therapeutic range and to reach specific drug target attainment. In this review of the last ten years’ literature, we performed Pubmed research aiming to summarize the PK aspects for the most used antibiotics in preterms.

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Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates

Abstract: After transformation, DBS sampling accurately predicted ampicillin exposure in neonates.

Cited by 9 publications

References 23 publications

Therapeutic drug monitoring of tacrolimus and mycophenolic acid in outpatient renal transplant recipients using a volumetric dried blood spot sampling device

Therapeutic drug monitoring of tacrolimus and mycophenolic acid in outpatient renal transplant recipients using a volumetric dried blood spot sampling device

Ampicillin Pharmacokinetics in Peripartum and Laboring Women

Use of Antibiotics in Preterm Newborns

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