Vu Christine A, Riollano-Cruz Mariawy, Kowalsky Shanna R
J Pediatr Pharmacol Ther. 2021;26(7):753-757. doi: 10.5863/1551-6776-26.7.753. Epub 2021 Sep 24.
There are a limited number of studies that guide dosing of posaconazole delayed-release (DR) tablets for the pediatric population. Current FDA-approved doses are only recommended for patients 13 years and older. For younger patients, providers are faced with the challenge of recommending posaconazole doses extrapolated from adult studies or choosing an alternative agent. We report on a case of a 10-year-old patient who experienced a supratherapeutic trough serum concentration and transaminitis after receiving the extrapolated adult dosage of posaconazole DR tablets (300 mg twice daily for the first day, followed by 300 mg daily) for 7 days. In the end, the patient required a smaller dose of 200 mg daily to achieve the desired trough target concentration for the treatment of a neck infection. Our findings highlight the need for additional studies to determine the optimal dosing of posaconazole DR tablets for children.
指导泊沙康唑缓释(DR)片用于儿科人群给药的研究数量有限。美国食品药品监督管理局(FDA)目前批准的剂量仅适用于13岁及以上的患者。对于年龄较小的患者,医疗人员面临着推荐从成人研究中推断出的泊沙康唑剂量或选择替代药物的挑战。我们报告了一例10岁患者的病例,该患者在接受推断出的成人剂量泊沙康唑DR片(第1天每日两次,每次300mg,随后每日300mg)7天后,出现了高于治疗浓度的谷浓度血清和转氨酶升高。最后,该患者需要每日200mg的较小剂量来达到治疗颈部感染所需的谷浓度目标。我们的研究结果凸显了开展更多研究以确定儿童泊沙康唑DR片最佳给药剂量的必要性。