Pediatric Use of Paclitaxel Injection

Taxol's safety and efficacy in children have not been established. Central nervous system (CNS) toxicity (rarely causing death) has been reported in a clinical trial in pediatric patients. In this study, paclitaxel was infused intravenously at doses of 350-420 mg/m2 for more than 3 hours. The short infusion of the high-dose ethanol component of the tylosin formulation may be the most significant cause of central nervous system (CNS) toxicity. This effect may be enhanced by the combined use of antihistamines. Although the direct effects produced by paclitaxel itself cannot be ignored, the high doses used in this study (more than two times higher than the recommended adult dose) must be taken into account when evaluating the safety of Tesso for use in this population.