Prospective assessment of short-term propylene glycol tolerance in neonates

Allegaert, Karel; Vanhaesebrouck, Sophie; Kulo, Aida; Cosaert, Katrien; Verbesselt, René; Debeer, Anne; Hoon, Jan de

doi:10.1136/adc.2010.190330

Cited by 47 publications

(53 citation statements)

References 22 publications

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“…Critically ill neonates receiving medications by continuous infusions are at higher risk of being exposed to PG. However, a median PG exposure of 34 mg/kg per 24 h seems to be well tolerated [53][54][55]. Treatment of toxicity includes termination of any PG-containing medication and initiation of hemodialysis in severe cases to effectively remove PG [49].…”

Section: Pathophysiologymentioning

confidence: 99%

Drug-induced acid-base disorders

et al. 2014

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The incidence of acid-base disorders (ABDs) is high, especially in hospitalized patients. ABDs are often indicators for severe systemic disorders. In everyday clinical practice, analysis of ABDs must be performed in a standardized manner. Highly sensitive diagnostic tools to distinguish the various ABDs include the anion gap and the serum osmolar gap. Drug-induced ABDs can be classified into five different categories in terms of their pathophysiology: (1) metabolic acidosis caused by acid overload, which may occur through accumulation of acids by endogenous (e.g., lactic acidosis by biguanides, propofol-related syndrome) or exogenous (e.g., glycol-dependant drugs, such as diazepam or salicylates) mechanisms or by decreased renal acid excretion (e.g., distal renal tubular acidosis by amphotericin B, nonsteroidal antiinflammatory drugs, vitamin D); (2) base loss: proximal renal tubular acidosis by drugs (e.g., ifosfamide, aminoglycosides, carbonic anhydrase inhibitors, antiretrovirals, oxaliplatin or cisplatin) in the context of Fanconi syndrome; (3) alkalosis resulting from acid and/or chloride loss by renal (e.g., diuretics, penicillins, aminoglycosides) or extrarenal (e.g., laxative drugs) mechanisms; (4) exogenous bicarbonate loads: milk-alkali syndrome, overshoot alkalosis after bicarbonate therapy or citrate administration; and (5) respiratory acidosis or alkalosis resulting from drug-induced depression of the respiratory center or neuromuscular impairment (e.g

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Section: Pathophysiologymentioning

confidence: 99%

Drug-induced acid-base disorders

et al. 2014

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“…A significant accumulation of PG in patients aged 1-15 months was indeed confirmed but no significant laboratory anomalies were observed [10]. Recently, our group also reported on biochemical tolerance (hepatic, metabolic and renal) during PG exposure (median exposure 34 mg kg -1 24 h -1 ) in neonates [11] and, considering the other author conclusions [12,13], suggested that further studies on PG disposition and accumulation were needed. In addition, maturational aspects likely will affect PG clearance capacity in neonates [14] making differentiation between renal and non-renal routes of primary PG elimination relevant in this population and therefore requiring quantification of PG in urine samples.…”

Section: Introductionmentioning

confidence: 79%

Determination of Propylene Glycol in Low Volume Plasma and Urine Samples of Neonates by LC with Photodiode Array Detection

et al. 2011

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In order to enhance the sensitivity and to develop a method suitable for quantification of propylene glycol (PG) in low volume neonate plasma and urine samples, several steps in earlier described high performance liquid chromatographic methods were optimised. Chromatographic separation on a reversed-phase column and ultraviolet detection resulted in cleaner chromatograms without interfering compounds. Linearity of the standard curves was validated in the concentration range 0.25-50 mg L -1 . The lower limit of quantification was 20 times lower than in earlier described methods. Presented method was suitable for quantification of PG concentrations in low volume neonate plasma (15-46 mg L -1 ) and urine samples (20-175 mg L -1 ) enabling us to document very low renal versus non-renal contribution of PG clearance in neonates.

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“…The inclusion of propylene glycol in formulations used in neonates (such as cetirizine oral solution) has historically raised concerns for ototoxicity and CNS toxicity [48]. However, Allegaert et al performed a prospective study of propylene glycol exposure in neonates and determined that a median unintended exposure of 34 mg/kg/day for 2 days was well tolerated in both term and preterm neonates, thereby providing a short-term safety limit for exposure [49]. Based on the sometimes unpredictable activity/toxicity of excipients in the developing neonate, additional studies such as Allegaert's are required to bolster understanding of excipient effects in the neonatal population.…”

Section: Oralmentioning

confidence: 97%

Challenges Associated with Route of Administration in Neonatal Drug Delivery

et al. 2015

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The administration of drugs to neonates poses significant challenges. The aim of this review was to provide insight into some of these challenges and resolutions that may be encountered with several of the most commonly used routes of administration and dosage forms in neonatal care, including oral, parenteral, transdermal, intrapulmonary, and rectal. Important considerations include fluctuations in stomach pH hours to years after birth, the logistics of setting up an intravenous infusion, the need for reduced particle size for aerosol delivery to the developing neonatal lung, and variation in perirectal venous drainage. Additionally, some of the recently developed technologies for use in neonatal care are described. While the understanding of neonatal drug delivery has advanced over the past several decades, there is still a deficiency of technologies and formulations developed specifically for this population.

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Prospective assessment of short-term propylene glycol tolerance in neonates

Cited by 47 publications

References 22 publications

Drug-induced acid-base disorders

Drug-induced acid-base disorders

Determination of Propylene Glycol in Low Volume Plasma and Urine Samples of Neonates by LC with Photodiode Array Detection

Challenges Associated with Route of Administration in Neonatal Drug Delivery

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