Study supports body-weight dosing of 5.0 mg and 2.5 mg for children >50 kg and <50 kg, respectively
THURSDAY, June 8, 2017 (HealthDay News) — In a report published online June 5 in the Journal of Clinical Pharmacology, recommended dosing regimens of zolmitriptan are suggested for children with migraine.
Wangda Zhou, Ph.D., from AstraZeneca Pharmaceuticals in Waltham, Mass., and colleagues developed a population pharmacokinetic model for zolmitriptan and its active metabolite in adults and adolescents, and provided appropriate dosing regimens for use in clinical trials in 6- to 11-year-old children. Data from a single-dose study involving 5.0-mg zolmitriptan nasal spray (ZNS) conducted in adult and adolescents with migraine were applied.
The researchers found that adults and adolescents had similar plasma concentration profiles of zolmitriptan and its metabolite 183C91. The estimated typical apparent volume of distribution and clearance of zolmitriptan were 136 L and 121 L/h, respectively; between-subject variability was 56.5 and 42.6 percent, respectively. To achieve exposures similar to those of the adult and adolescent population administered 5.0 mg ZNS, a body-weight dosing scheme of 5.0 and 2.5 mg ZNS is recommended in children greater than and less than 50 kg, respectively.
“The recommended doses for children to achieve exposure similar to that observed in adults given 2.5 mg ZNS are 2.5 mg (≥50 kg) and 1.0 mg (15 to 50 kg),” the authors write. “These dosing regimens could be used in future clinical trials.”
The authors disclosed financial ties to AstraZeneca, a manufacturer of zolmitriptan.
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