通用名称

abametapir

儿科标签批准日期

2020/7/24 0:00:00

特定指示/秒

Head lice infestation in patients 6 months of age and older

标签更改摘要

-Safety and effectiveness have been established two controlled trials of 704 patients with head lice, 6 months and older. - Safety and effectiveness have not been established in pediatric patients below the age of 6 months. - Not recommended in pediatric patients under 6 months of age because of the potential for increased systemic absorption due to a high ratio of skin surface to body mass and the potential for an immature skin barrier. - Xeglyze contains benzyl alcohol. Benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants. The “gasping syndrome” has been associated with intravenously administered benzyl alcohol dosages >99 mg/kg/day in neonates and low birthweight infants. - The minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birthweight infants, as well as patients receiving high dosages, may be more likely to develop toxicity. - Because of the risk of accidental ingestion, Xeglyze should be administered to pediatric patients only under direct adult supervision. - Information on safety profile, and clinical trial. - New drug.

治疗类别

Pediculicides/Lice Agents (Topical)

立法类型

PREA Only

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