Promethazine: Recommendations for Safe Use in Children

Marcia L. Buck, Pharm.D., FCCP, FPPAG

Disclosures

Pediatr Pharm. 2010;16(3) 

In This Article

Abstract and Introduction

Introduction

Promethazine was developed in 1946 and approved for use by the Food and Drug Administration (FDA) on March 29, 1951.[1] It is indicated for the treatment of allergic reactions, as an adjunct to epinephrine in patients with anaphylaxis, for sedation, for the treatment of nausea and vomiting from motion sickness or anesthesia, and as an adjunctive therapy to analgesics.[1,2] Once widely used as a sedative in children, reports of promethazine-induced respiratory depression and apnea led to a gradual decline in its use and the eventual addition of a black box warning to its labeling in 2004.[3] More recently, promethazine has been in the news after publication of several cases involving severe extravasation injury after intravenous (IV) and inadvertent intra-arterial injection. These cases led the FDA to add a second black box warning to its labeling in 2009.[4] As a result, health care providers are once again faced with determining how to best utilize this medication in their practice. This issue of Pediatric Pharmacotherapy will review the pharmacology of promethazine, as well as reports of toxicity associated with its administration, and describe measures to maximize its safe use in children.

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