Population Pharmacokinetics and Transfer of Gabapentin When Used as a Pain Adjunct for Cesarean Deliveries

dc.contributor.authorSilvola, Rebecca
dc.contributor.authorO'Kane, Aislinn
dc.contributor.authorHeathman, Michael
dc.contributor.authorMarotta, Hannah
dc.contributor.authorTrussel, Hayley
dc.contributor.authorRay, Bobbie
dc.contributor.authorDowden, Shelley
dc.contributor.authorMasters, Andrea R.
dc.contributor.authorHaas, David M.
dc.contributor.authorQuinney, Sara K.
dc.contributor.departmentMedicine, School of Medicine
dc.date.accessioned2025-04-22T10:39:56Z
dc.date.available2025-04-22T10:39:56Z
dc.date.issued2025
dc.description.abstractEnhanced Recovery After Surgery (ERAS) protocols for cesarean deliveries (CDs) utilize multimodal pain management strategies that often include gabapentin. While gabapentin is excreted in breast milk, its pharmacokinetics in immediately postpartum lactating women are not known. This observational pharmacokinetic study (NCT05099484) enrolled 21 healthy singleton pregnant individuals, ≥ 18 years old, undergoing CD and planning to breastfeed. Participants received 300 mg oral gabapentin before CD and every 6 h for 48 h per hospital protocol. Serial maternal plasma and breast milk samples were collected over a single dosing interval. Gabapentin pharmacokinetics were assessed using two structurally distinct population pharmacokinetic (POPPK) models to describe transfer of drug into breast milk utilizing (A) milk-to-plasma ratio and (B) inter-compartmental rate constants. These models were then used to estimate exposure to breastfed infants. Postpartum gabapentin plasma concentrations fit a 1-compartment model that was adapted to include breast milk concentrations. The two POPPK models both estimated relative infant doses (RID0-48h) of gabapentin < 0.15% of maternal dose within the first 48 h postpartum. Infant daily dose (IDD) from 24 to 48 h was estimated to be 0.0137 (0.0058-0.0316) mg/kg/day and 0.0139 (0.00041-0.0469) mg/kg/day by models A and B, respectively. These findings indicate limited neonatal exposure to gabapentin administered as part of a postpartum enhanced recovery after surgery protocol.
dc.eprint.versionFinal published version
dc.identifier.citationSilvola R, O'Kane A, Heathman M, et al. Population Pharmacokinetics and Transfer of Gabapentin When Used as a Pain Adjunct for Cesarean Deliveries. CPT Pharmacometrics Syst Pharmacol. 2025;14(3):551-560. doi:10.1002/psp4.13295
dc.identifier.urihttps://hdl.handle.net/1805/47275
dc.language.isoen_US
dc.publisherWiley
dc.relation.isversionof10.1002/psp4.13295
dc.relation.journalCPT: Pharmacometrics & Systems Pharmacology
dc.rightsAttribution-NonCommercial 4.0 Internationalen
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/
dc.sourcePMC
dc.subjectBreast milk
dc.subjectCesarean delivery
dc.subjectPain
dc.subjectPopulation pharmacokinetics
dc.subjectPostpartum
dc.titlePopulation Pharmacokinetics and Transfer of Gabapentin When Used as a Pain Adjunct for Cesarean Deliveries
dc.typeArticle
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