title: Harmful excipients in medicines for neonates in Spain.
abstract: BACKGROUND
  Neonates may respond differently from adults to drug components. Hence, ingredients that seem safe in adults may not be safe in this age group.
  
  
  OBJECTIVE
  To describe the content of harmful excipients in drugs used in our neonatal wards and compare the daily dose a neonate may receive with the accepted daily intake (ADI) in adults.
  
  
  METHODS
  All drugs included in the hospital's neonatal treatment guide were reviewed, using information from the package inserts or the summary of product characteristics. Those containing at least one harmful excipient (e.g., metabisulfite, sorbitol) were analyzed. Minimum and maximum usual daily drug doses were determined, and excipient exposure was estimated by extrapolation of the minimum and maximum of excipient referred to the active ingredient. These amounts were compared with ADIs for each excipient in adults.
  
  
  RESULTS
  In total, 32 % of intravenous and 62 % of oral formulations used in neonates contained at least one harmful excipient. On quantitative analysis, 25 % of intravenous and 19 % of oral drugs contained harmful excipients exceeding the ADI in adults.
  
  
  CONCLUSIONS
  Several drugs commonly used to treat neonates contain harmful excipients in amounts that may exceed the ADI in adults. Clinicians should be aware of this to prescribe appropriate treatment in this population.
authors.affiliation: Pharmacy Service, Vall d'Hebron University Hospital, Pº Vall d'Hebron 119-129, 08035, Barcelona, Spain. b.garcia.palop@gmail.com.
authors.forename: Beatriz
authors.identifier: http://orcid.org/0000-0002-3302-4864
authors.initials: B
authors.lastname: Garcia-Palop
authors.affiliation: Pharmacy Service, Vall d'Hebron University Hospital, Pº Vall d'Hebron 119-129, 08035, Barcelona, Spain.
authors.forename: Emma
authors.initials: E
authors.lastname: Movilla Polanco
authors.affiliation: Pharmacy Service, Vall d'Hebron University Hospital, Pº Vall d'Hebron 119-129, 08035, Barcelona, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Cañete Ramirez
authors.affiliation: Pharmacy Service, Vall d'Hebron University Hospital, Pº Vall d'Hebron 119-129, 08035, Barcelona, Spain.
authors.forename: Maria Jose
authors.initials: MJ
authors.lastname: Cabañas Poy
mesh_terms: D061605:Administration, Intravenous; D000284:Administration, Oral; D004339:Drug Compounding / Q000592:standards*; D005079:Excipients / Q000008:administration & dosage* / Q000009:adverse effects*; D006760:Hospitalization; D006801:Humans; D007231:Infant, Newborn; D055553:Prescription Drugs / Q000008:administration & dosage* / Q000009:adverse effects*; D013030:Spain / Q000453:epidemiology
chemical_list: D005079:Excipients; D055553:Prescription Drugs
keywords: Excipients; Neonatal care; Pediatrics; Spain