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Effects of breast pumping on the pharmacokinetics and pharmacodynamics of ethanol during lactation.

ABSTRACT: This study tested two hypotheses. First, that breast pumping contributes to the previously observed decrease in ethanol bioavailability in lactating women. Second, that the effects of breast pumping are more pronounced when ethanol is consumed after a meal. The within-subject factor was test condition (fed or fasted) and the between-subject factor was experimental group (pumped before, PB; pumped after, PA). Those randomly assigned to the PB group (N = 8) breast pumped 1 h before drinking, whereas those assigned to the PA group (N = 8) breast pumped 0.6 h after drinking. Pumping before drinking significantly decreased blood ethanol concentration (P < 0.05) and ethanol bioavailability (P = 0.05). Pumping after drinking sped up elimination (P = 0.008), attenuated ethanol-induced hypothermia (P = 0.002), and increased feelings of stimulation (P = 0.03). The effects were more pronounced when ethanol was consumed after a meal. Common neural/hormonal responses to food and suckling may contribute additive effects in altering the pharmacokinetics/pharmacodynamics of ethanol, and perhaps of other drugs, during lactation.

SUBMITTER: Pepino MY

PROVIDER: S-EPMC2720548 | biostudies-literature | 2008 Dec

REPOSITORIES: biostudies-literature

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Effects of breast pumping on the pharmacokinetics and pharmacodynamics of ethanol during lactation.

Pepino M Y MY Mennella J A JA

Clinical pharmacology and therapeutics 20080702 6

This study tested two hypotheses. First, that breast pumping contributes to the previously observed decrease in ethanol bioavailability in lactating women. Second, that the effects of breast pumping are more pronounced when ethanol is consumed after a meal. The within-subject factor was test condition (fed or fasted) and the between-subject factor was experimental group (pumped before, PB; pumped after, PA). Those randomly assigned to the PB group (N = 8) breast pumped 1 h before drinking, where ...[more]

PMID: 18596681

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Project description:BackgroundThe need for continuous renal replacement therapy (CRRT) in critically ill patients with serious infections is associated with clinical failure, emergence of resistance, and excess mortality. These poor outcomes are attributable in large part to subtherapeutic antimicrobial exposure and failure to achieve target pharmacokinetic/pharmacodynamic (PK/PD) thresholds during CRRT. Cefiderocol is a novel siderophore cephalosporin with broad in vitro activity against resistant pathogens and is often used to treat critically ill patients, including those receiving CRRT, despite the lack of data to guide dosing in this population.ObjectiveThe aim of this study was to evaluate the PK and PD of cefiderocol during in vitro and in vivo CRRT and provide optimal dosing recommendations.MethodsThe PK and dialytic clearance of cefiderocol was evaluated via an established in vitro CRRT model across various modes, filter types, and effluent flow rates. These data were combined with in vivo PK data from nine patients receiving cefiderocol while receiving CRRT from phase III clinical trials. Optimal dosing regimens and their respective probability of target attainment (PTA) were assessed via an established population PK model with Bayesian estimation and 1000-subject Monte Carlo simulations at each effluent flow rate.ResultsThe overall mean sieving/saturation coefficient during in vitro CRRT was 0.90 across all modes, filter types, effluent flow rates, and points of replacement fluid dilution tested. Adsorption was negligible at 10.9%. Three-way analysis of variance (ANOVA) and multiple linear regression analyses demonstrated that effluent flow rate is the primary driver of clearance during CRRT and can be used to calculate optimal cefiderocol doses required to match the systemic exposure observed in patients with normal renal function. Bayesian estimation of these effluent flow rate-based optimal doses in nine patients receiving CRRT from the phase III clinical trials of cefiderocol revealed comparable mean (± standard deviation) area under the concentration-time curve values as patients with normal renal function (1709 ± 539 mg·h/L vs. 1494 ± 58.4 mg·h/L; p = 0.26). Monte Carlo simulations confirmed these doses achieved >90% PTA against minimum inhibitory concentrations ≤4 mg/L at effluent flow rates from 0.5 to 5 L/h.ConclusionThe optimal dosing regimens developed from this work have been incorporated into the prescribing information for cefiderocol, making it the first and only antimicrobial with labeled dosing for CRRT. Future clinical studies are warranted to confirm the efficacy and safety of these regimens.

Project description:Adequate nutrition is particularly important during pregnancy since it is needed not only for maintaining the health of the mother, but also determines the course of pregnancy and its outcome, fetus development as well as the child's health after birth and during the later period of life. Data coming from epidemiological and interventions studies support the observation that carotenoids intake provide positive health effects in adults and the elderly population. These health effects are the result of their antioxidant and anti-inflammatory properties. Recent studies have also demonstrated the significant role of carotenoids during pregnancy and infancy. Some studies indicate a correlation between carotenoid status and lower risk of pregnancy pathologies induced by intensified oxidative stress, but results of these investigations are equivocal. Carotenoids have been well studied in relation to their beneficial role in the prevention of preeclampsia. It is currently hypothesized that carotenoids can play an important role in the prevention of preterm birth and intrauterine growth restriction. Carotenoid status in the newborn depends on the nutritional status of the mother, but little is known about the transfer of carotenoids from the mother to the fetus. Carotenoids are among the few nutrients found in breast milk, in which the levels are determined by the mother's diet. Nutritional status of the newborn directly depends on its diet. Both mix feeding and artificial feeding may cause depletion of carotenoids since infant formulas contain only trace amounts of these compounds. Carotenoids, particularly lutein and zeaxanthin play a significant role in the development of vision and nervous system (among others, they are important for the development of retina as well as energy metabolism and brain electrical activity). Furthermore, more scientific evidence is emerging on the role of carotenoids in the prevention of disorders affecting preterm infants, who are susceptible to oxidative stress, particularly retinopathy of prematurity.

Dataset Information

Effects of breast pumping on the pharmacokinetics and pharmacodynamics of ethanol during lactation.

Publications

Effects of breast pumping on the pharmacokinetics and pharmacodynamics of ethanol during lactation.

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