Background and purpose of the study: Propylene glycol (PG) is a frequently co-administered solvent in formulations\r\nadministered to neonates, but reports on its (in)tolerance are limited. We aimed to report on renal, metabolic and\r\nhepatic tolerance before, during and following intravenous (iv) PG-paracetamol exposure and compared these data with\r\nsimilar datasets reported in literature on neonates exposed to PG without paracetamol or paracetamol without PG.\r\nMethods: Renal (diuresis, creatinemia, sodium), metabolic (Base Excess, Anion Gap, lactate, bicarbonate) and hepatic\r\n(liver enzymes, bilirubinemia) indicators before, during and following iv paracetamol-PG exposure in neonates as\r\nincluded in the PARANEO (paracetamol in neonates) study (intra-individual trends, ANOVA) were collected and analysed.\r\nComparison with observations collected in cases exposed to either iv phenobarbital-PG or iv paracetamol-mannitol\r\n(inter-individual comparison, Mann Whitney-U test) were made.\r\nResults: PG exposure (median 34.1 mg/kg/24 h) did not affect postnatal renal, metabolic and hepatic adaptations in 60\r\ncases exposed to paracetamol-PG. These indicators were similar when compared to 29 cases exposed to phenobarbital-\r\nPG or 172 cases exposed to paracetamol-mannitol.\r\nMajor conclusion: Based on observations in 89 neonates, low dose PG exposure was tolerated well. Studies on PG\r\npharmacokinetics and its covariates are needed to estimate the upper level of PG tolerance in neonates.
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