Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates

Shehab, Nadine; Lewis, Carrie L.; Streetman, Darcie D; Donn, Steven M.

doi:10.1097/pcc.0b013e31819a383c

Cited by 88 publications

(65 citation statements)

References 14 publications

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“…ESAs and iron can be continued. Preservative-free heparin should be used as the additive benzyl alcohol can be toxic to preterm infants [47]. Emotional support is also essential: many new mothers can no longer manage home-based dialysis and need to temporarily transition to in-center therapy.…”

Section: Management Of the Pregnant Patient On Hemodialysismentioning

confidence: 99%

Pregnancy and End-Stage Renal Disease

2018

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Pregnancy is uncommon in women with end-stage renal disease (ESRD). Fertility rates are low in women on dialysis, and physicians still frequently counsel women with ESRD against pregnancy. Advancements in the delivery of dialysis and obstetric care have led to improved live birth rates in women on dialysis, so pregnancy for young women with ESRD is now more feasible and safer. However, these pregnancies remain high-risk for both maternal and fetal complications, necessitating experienced multidisciplinary care. In this article, we review fertility issues in women with ESRD, discuss pregnancy outcomes in women on dialysis, and provide an approach for management of pregnant women with ESRD.

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Section: Management Of the Pregnant Patient On Hemodialysismentioning

confidence: 99%

Pregnancy and End-Stage Renal Disease

2018

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“…61 A number of recent studies in NICUs revealed systemic concentrations of excipients that were intolerable even in older age groups. 54,62,63 The urgent need to understand these safety concerns has led to a collaborative effort by the United States and the European Union to create a STEP (Safety and Toxicity of Excipients for Pediatrics) database. Its aim is to improve systematic data collection on excipient toxicity and tolerance in children.…”

Section: Potential Limitations Of Pediatric Drug Formulationsmentioning

confidence: 99%

Pediatric Drug Formulations: A Review of Challenges and Progress

et al. 2014

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Children differ from adults in many aspects of pharmacotherapy, including capabilities for drug administration, medicine-related toxicity, and taste preferences. It is essential that pediatric medicines are formulated to best suit a child' s age, size, physiologic condition, and treatment requirements. To ensure adequate treatment of all children, different routes of administration, dosage forms, and strengths may be required. Many existing formulations are not suitable for children, which often leads to off-label and unlicensed use of adult medicines. New regulations, additional funding opportunities, and innovative collaborative research initiatives have resulted in some recent progress in the development of pediatric formulations. These advances include a paradigm shift toward oral solid formulations and a focus on novel preparations, including flexible, dispersible, and multiparticulate oral solid dosage forms. Such developments have enabled greater dose flexibility, easier administration, and better acceptance of drug formulations in children. However, new pediatric formulations address only a small part of all therapeutic needs in children; moreover, they are not always available. Five key issues need to be addressed to stimulate the further development of better medicines for children: (1) the continued prioritization of unmet formulation needs, particularly drug delivery in neonates and treatment gaps in pediatric cancers and childhood diseases in developing countries; (2) a better use of existing data to facilitate pediatric formulation development; (3) innovative technologies in adults that can be used to develop new pediatric formulations; (4) clinical feedback and practice-based evidence on the impact of novel formulations; and (5) improved access to new pediatric formulations. Pediatrics

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“…Excipients have been associated with adverse effects and large amounts can be administered to hospitalized neonates [68][69][70] and are difficult to study [71]. The neonatal administration of propylene glycol [72] and benzyl alcohol [31] in injectable drug formulations has been associated with serious adverse effects, including death.…”

Section: Excretionmentioning

confidence: 99%

Pharmacokinetics in neonatal prescribing: evidence base, paradigms and the future

O’Hara

Wright

Schneider

et al. 2015

Brit J Clinical Pharma

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Paediatric patients, particularly preterm neonates, present many pharmacological challenges. Due to the difficulty in conducting clinical trials in these populations dosing information is often extrapolated from adult populations. As the processes of absorption, distribution, metabolism and excretion of drugs change throughout growth and development extrapolation presents risk of over or underestimating the doses required. Information about the development these processes, particularly drug metabolism pathways, is still limited with weight based dose adjustment presenting the best method of estimating pharmacokinetic changes due to growth and development. New innovations in pharmacokinetic research, such as population pharmacokinetic modelling, present unique opportunities to conduct clinical trials in these populations improving the safety and effectiveness of the drugs used. More research is required into this area to ensure the best outcomes for our most vulnerable patients.

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Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates

Cited by 88 publications

References 14 publications

Pregnancy and End-Stage Renal Disease

Pregnancy and End-Stage Renal Disease

Pediatric Drug Formulations: A Review of Challenges and Progress

Pharmacokinetics in neonatal prescribing: evidence base, paradigms and the future

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