通用名称

morphine sulfate

儿科标签批准日期

2021/6/2 0:00:00

特定指示/秒

Postoperative pain in pediatric patients 2 years through 17 years

标签更改摘要

- Safety and effectiveness of Morphine Sulfate Oral Solution (2 mg/mL and 4 mg/mL) have been established for the management of pediatric patients 2 to 17 years with acute pain severe enough to require an opioid analgesic when alternative treatments are inadequate. - Use of Morphine Sulfate Oral Solution in this age group is supported by clinical evidence in adults and supportive data from an open-label, safety and pharmacokinetic study in pediatric patients 2 through 17 years with post-operative acute pain. - Pharmacokinetic modeling and simulation indicate that an initial dose of 0.3 mg/kg to pediatric patients 2 years of age and older is expected to produce a maximum systemic exposure (Cmax) similar to that achieved after single dose administration of 10 mg Morphine Sulfate Oral Solution to adults. - The safety profile in pediatric patients consisted primarily of opioid-related adverse reactions and is similar to that observed in adults. - Safety and effectiveness of Morphine Sulfate Oral Solution (2 mg/mL and 4 mg/mL) have not been established for the management of pediatric patients 2 to 17 years of age with chronic pain severe enough to require an opioid analgesic when alternative treatments are inadequate. - Safety and effectiveness of Morphine Sulfate Oral Solution (2 mg/mL and 4 mg/mL) have not been established in pediatric patients less than 2 years of age. - Safety and effectiveness of Morphine Sulfate Oral Solution 20 mg/mL have not been established in pediatric patients. - Information on dosing, adverse reactions, PK parameters, and clinical trials. - Postmarketing study.

治疗类别

Pain, Opioid

立法类型

PREA Only

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