AlRuwaili Nahar, Zaidan Faten, AlFattani Areej, Alenazi Saud
Emergency Department, King Faisal Specialist Hospital & Research Center, AlFaisal University, Saudi Arabia.
General Peadiatric Department, KFSHRC, AlMaarefa University, Saudi Arabia.
Int J Pediatr Adolesc Med. 2022 Mar;9(1):62-65. doi: 10.1016/j.ijpam.2021.09.001. Epub 2021 Sep 23.
In this study, dosing instructions in package inserts of all 12 paediatric liquid acetaminophen products registered in pharmacies in the Kingdom of Saudi Arabia were analysed to determine the potential for administering a supratherapeutic dose of acetaminophen. Doses in millilitres were calculated as mg/kg for four age groups: three months old, one year old, six years old, and twelve years old, and based on the 3rd, 50th, and 75th weight percentiles of each age group. Acetaminophen concentrations in the products varied, and only two products included Arabic language instructions. The dosing instructions in eight products included an age overlap. The most affected age group was the 1-year-old group, with 21 supratherapeutic doses across all 12 products. The least affected age group was the 12-year-old group, with 8 supratherapeutic doses in total. The absence of strict supervision and monitoring of labels of paediatric liquid acetaminophen products increases the risk of liver toxicity in children. Therefore, we call for an immediate standardisation of all dosing instructions regarding the dose per weight and the inclusion of instructions in Arabic.
在本研究中，对沙特阿拉伯王国药房登记的所有12种儿科对乙酰氨基酚液体制剂产品包装说明书中的给药说明进行了分析，以确定给予超治疗剂量对乙酰氨基酚的可能性。针对三个月大、一岁、六岁和十二岁这四个年龄组，根据每个年龄组的第3、50和75体重百分位数，将以毫升为单位的剂量换算为毫克/千克。产品中的对乙酰氨基酚浓度各不相同，只有两种产品包含阿拉伯语说明。八种产品的给药说明存在年龄重叠。受影响最大的年龄组是一岁组，在所有12种产品中共有21个超治疗剂量。受影响最小的年龄组是十二岁组，总共8个超治疗剂量。对儿科对乙酰氨基酚液体制剂产品标签缺乏严格监督和监测增加了儿童肝毒性风险。因此，我们呼吁立即对所有按体重计算剂量的给药说明进行标准化，并纳入阿拉伯语说明。
