Peltola H, Ukkonen P, Saxén H, Stass H
Helsinki University Central Hospital, Hospital for Children and Adolescents, Helsinki, Finland.
Pediatrics. 1998 Apr;101(4 Pt 1):658-62. doi: 10.1542/peds.101.4.658.
Quinolones are used ever increasingly in pediatrics, although officially they are still contraindicated. Lack of evidence of arthropathic effects in human offspring favors their use, but little is known about the pharmacokinetics of oral or parenteral ciprofloxacin in children, especially those without cystic fibrosis.
We studied 16 non-cystic fibrosis patients ranging in age from 0.3 to 7.1 years to whom the new suspension formulation of ciprofloxacin (10 mg/kg body weight) was given orally three times daily. Single-dose and steady-state pharmacokinetic parameters were elucidated.
Ciprofloxacin was rapidly absorbed. The maximum plasma concentrations, with the means varying from 1.7 to 3.6 mg/L, were reached within 1 hour, almost regardless of whether single-dose administration or steady state. The mean oral clearance was lower in children <6 years of age than in those >/=6 years. Terminal half-life values, with the means varying only between 4.2 and 5.1, suggest that dosing recommendations based on body weight are pertinent, although caution should be exercised in small infants. No arthropathic or other adverse events attributable to ciprofloxacin suspension were observed.
A dose of the suspension form of ciprofloxacin of 10 mg/kg body weight given orally three times daily seems appropriate in children, provided the drug is clearly indicated.
喹诺酮类药物在儿科的使用日益增加，尽管官方仍将其列为禁忌。缺乏人类后代关节病影响的证据有利于其使用，但对于口服或静脉注射环丙沙星在儿童，尤其是非囊性纤维化儿童中的药代动力学知之甚少。
我们研究了16名年龄在0.3至7.1岁之间的非囊性纤维化患者，给他们口服新的环丙沙星混悬液制剂（10毫克/千克体重），每日三次。阐明了单剂量和稳态药代动力学参数。
环丙沙星吸收迅速。无论单剂量给药还是稳态给药，几乎都在1小时内达到最大血浆浓度，平均值在1.7至3.6毫克/升之间。6岁以下儿童的平均口服清除率低于6岁及以上儿童。终末半衰期值的平均值仅在4.2至5.1之间变化，这表明基于体重的给药建议是恰当的，不过对小婴儿用药时应谨慎。未观察到环丙沙星混悬液引起的关节病或其他不良事件。
对于儿童，若明确有用药指征，每日三次口服10毫克/千克体重的环丙沙星混悬液似乎是合适的。
