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MODEL-BASED EVALUATION OF DOSE REGIMENS IN PRETERM AND TERM NEONATES FOR DEXMEDETOMIDINE AND VANCOMYCIN
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences.
2017 (English)Independent thesis Advanced level (degree of Master (One Year)), 20 credits / 30 HE creditsStudent thesis
Abstract [en]

Background: Dexmedetomidine (Dexdor) is a sedative and an analgesic compound approved for intravenous use in adults, but it is also used off-label in neonates. There are no pharmacokinetic (PK) data to support buccal administration of Dexdor in neonates. Vancomycin is an antibiotic commonly used to treat methicillin-resistant Staphylococcus aureus (MRSA), and the best predictor of successful outcome is the 24-h area under the concentration-time curve (AUC24) to MIC ratio of > 400. Specific dosing guidelines to ensure efficacy and safety in preterm neonates are currently lacking. Objective: To find an appropriate dose range for Dexdor for single buccal administration to neonates with a postmenstrual age (PMA) of 32 – 44 weeks. To find a vancomycin dose regimen predicting the best efficacy/toxicity ratio for newborns at 32 – 40 gestation weeks. Methods: Published PK-models where used to simulate expected PK profiles for different dosing regimens of Dexdor and vancomycin in preterm and term neonates using Berkeley Madonna, Insight-Rx and Excel. Results: The most appropriate dose of Dexdor for buccal administration is 1 ± 0.25 μg/kg, given 0.5 - 1 hour before a minor procedure. Currently used vancomycin regimen for neonates (15 mg/kg twice daily) is most likely insufficient in treating MRSA. PMA is a significant covariate, and it is suggested that dosing in preterm neonates should be adjusted according to PMA. Conclusions: Dosing 1 ± 0.25 μg/kg of Dexdor should be a safe and adequate starting dose for buccal administration to neonates, but clinical studies are required to confirm this. For vancomycin, a revised dose regimen is suggested for preterm neonates that take into account both weight and PMA.

Place, publisher, year, edition, pages
2017.
Keywords [en]
DEXMEDETOMIDINE, VANCOMYCIN, NEONATE, MODEL, DOSE, regimen, preterm, term, buccal, intravenous, pkpd, Berkley-Madonna, Insight-RX
National Category
Social and Clinical Pharmacy
Identifiers
URN: urn:nbn:se:uu:diva-329312OAI: oai:DiVA.org:uu-329312DiVA, id: diva2:1140628
External cooperation
Insight RX; Akademiska Sjukhuset
Supervisors
Examiners
Available from: 2017-09-13 Created: 2017-09-12 Last updated: 2018-01-13Bibliographically approved

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CiteExportLink to record
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