Garcia-Palop Beatriz, Movilla Polanco Emma, Cañete Ramirez Carmen, Cabañas Poy Maria Jose
Pharmacy Service, Vall d'Hebron University Hospital, Pº Vall d'Hebron 119-129, 08035, Barcelona, Spain.
Int J Clin Pharm. 2016 Apr;38(2):238-42. doi: 10.1007/s11096-016-0277-6. Epub 2016 Mar 9.
Neonates may respond differently from adults to drug components. Hence, ingredients that seem safe in adults may not be safe in this age group.
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.
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.
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.
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.
新生儿对药物成分的反应可能与成人不同。因此，在成人中看似安全的成分在这个年龄组中可能并不安全。
描述我们新生儿病房使用的药物中有害辅料的含量，并将新生儿可能接受的每日剂量与成人的每日允许摄入量（ADI）进行比较。
利用药品说明书或产品特性摘要中的信息，对医院新生儿治疗指南中包含的所有药物进行审查。对那些含有至少一种有害辅料（如焦亚硫酸盐、山梨醇）的药物进行分析。确定了最小和最大常用每日药物剂量，并通过将辅料的最小和最大含量外推至活性成分来估计辅料暴露量。将这些量与成人中每种辅料的ADI进行比较。
总体而言，新生儿使用的静脉制剂中有32%、口服制剂中有62%含有至少一种有害辅料。定量分析显示，25%的静脉药物和19%的口服药物含有超过成人ADI的有害辅料。
几种常用于治疗新生儿的药物含有有害辅料，其含量可能超过成人的ADI。临床医生应意识到这一点，以便为该人群开具适当的治疗方案。
