通用名称

naloxone hydrochloride

儿科标签批准日期

2021/10/15 0:00:00

特定指示/秒

Emergency treatment of known or suspected opioid overdose in pediatric patients of all ages

标签更改摘要

- Safety and effectiveness for intramuscular and subcutaneous use have been established in pediatric patients of all ages for the emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression. - Use of naloxone hydrochloride in all pediatric patients is supported by adult bioequivalence studies coupled with evidence from the safe and effective use of another naloxone hydrochloride injectable product. - In opioid-dependent pediatric patients, (including neonates), administration of naloxone hydrochloride may result in an abrupt and complete reversal of opioid effects, precipitating an acute opioid withdrawal syndrome. In settings where it may be preferable to avoid the abrupt precipitation of acute opioid withdrawal symptoms, consider use of an alternative, naloxone hydrochloride product that can be dosed according to weight and titrated to effect. - In pediatric patients under the age of one year, the caregiver should pinch the thigh muscle while administering ZIMHI. Carefully observe the administration site for evidence of residual needle parts, signs of infection, or both. - Information on dosing and administration.

治疗类别

Antidotes

立法类型

PREA Only

产品说明书链接