FDA requires updates to labeling for promethazine hydrochloride injection products

[12/27/2023] FDA is alerting health care professionals of labeling updates intended to further reduce the risk of severe chemical irritation and damage to tissues from intravenous administration of promethazine hydrochloride injection.

Promethazine hydrochloride injection is indicated to help manage certain allergic reactions, motion sickness, post-operative nausea and vomiting, and as a sedative or adjunct to analgesics.

FDA recommends health care professionals administer promethazine hydrochloride injection by deep intramuscular administration instead of intravenous administration. If promethazine hydrochloride injection must be administered intravenously, health care professionals should review and follow the updated information in the labeling to dilute promethazine hydrochloride injection and administer by intravenous infusion to reduce the risk of severe tissue injury.

FDA has required that manufacturers update their prescribing information for promethazine hydrochloride injection to include new safety information and update the carton labeling and container labels with the corresponding information.

If intramuscular injection is not possible, promethazine hydrochloride injection:

• Can be administered intravenously only after dilution, as recommended, and infused through an intravenous catheter inserted in a large vein and preferably through a central venous catheter. Do not administer using intravenous catheters placed into veins in the hand or wrist.
• Should not be mixed with other drugs or diluted with solutions other than 0.9% sodium chloride injection.
• Is contraindicated for intravenous injection at concentrations greater than 1 mg/mL.

When diluting and administering promethazine hydrochloride injection by intravenous infusion, infuse over 20 to 40 minutes and follow the below preparation and infusion instructions in adult and pediatric patients (see the first and second tables below, respectively):

Table 1: Preparation and Infusion Information by Adult Dose of Promethazine Hydrochloride Injection

Dose of Promethazine Hydrochloride Injection	Volume of 0.9% Sodium Chloride Injection for Dilution	Maximum Concentration of the Diluted Promethazine Hydrochloride Injection Solution	Maximum Rate of Infusion
12.5 mg	50 mL	1 mg/mL	2.5 mL/minute
25 mg	50 mL		2.5 mL/minute
50 mg	50 mL		2.5 mL/minute
75 mg	100 mL		5 mL/minute

 

Table 2: Preparation and Infusion Information by Pediatric Dose of Promethazine Hydrochloride Injection

Dose of Promethazine Hydrochloride Injection	Volume of 0.9% Sodium Chloride Injection for Dilution	Maximum Concentration of the Diluted Promethazine Hydrochloride Injection Solution	Maximum Rate of Infusion
Up to 25 mg	25 mL	1 mg/mL	1.25 mL/minute
25 mg to 50 mg	50 mL

Health care professionals, caregivers, and patients should report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or;
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.