Is Promethazine Hydrochloride Injection Putting Patients at Risk? FDA Alerts Healthcare Professionals

The U.S. Food and Drug Administration (FDA) is taking action to ensure patient safety by alerting healthcare professionals to labeling updates for promethazine hydrochloride injection. These updates are designed to reduce the risk of severe chemical irritation and tissue damage that can occur from intravenous administration of the medication.

Promethazine hydrochloride injection is commonly used to manage various conditions, including allergic reactions, motion sickness, post-operative nausea and vomiting, and as a sedative or adjunct to analgesics.

To mitigate the risk of adverse effects, the FDA recommends that healthcare professionals administer promethazine hydrochloride injection by deep intramuscular administration instead of intravenous administration. However, if intravenous administration is necessary, healthcare professionals should carefully review and follow the updated information in the labeling.

In cases where intravenous administration is required, the FDA advises diluting promethazine hydrochloride injection and administering it by intravenous infusion. This approach helps reduce the risk of severe tissue injury. Manufacturers have been instructed by the FDA to update the prescribing information, as well as carton and container labels, to incorporate this new safety information.

When administering promethazine hydrochloride injection intravenously, healthcare professionals should adhere to the following guidelines:

1. Administer the medication intravenously only after dilution, as recommended. It should be infused through an intravenous catheter placed in a large vein, preferably a central venous catheter. Intravenous catheters placed in veins in the hand or wrist should not be used for this purpose.

2. Avoid mixing promethazine hydrochloride injection with other drugs or diluting it with solutions other than 0.9% sodium chloride injection.

3. It is contraindicated to administer promethazine hydrochloride injection intravenously at concentrations greater than 1 mg/mL.

When diluting and administering promethazine hydrochloride injection via intravenous infusion, it should be infused over a period of 20 to 40 minutes. Healthcare professionals should carefully follow the preparation and infusion instructions provided in the updated labeling for both adult and pediatric patients.

By implementing these labeling updates and following the recommended administration guidelines, healthcare professionals can help minimize the risk of severe chemical irritation and tissue damage associated with promethazine hydrochloride injection. The FDA's proactive measures aim to enhance patient safety and ensure the appropriate use of this medication.