Wednesday, 17 April, 2024
HomeNews UpdateLabel updates for anti-nausea jab products – FDA

Label updates for anti-nausea jab products – FDA

The US Food & Drug Administration (FDA) has issued an alert regarding labelling updates intended to further reduce the risk of severe chemical irritation and damage to tissues from intravenous administration of promethazine hydrochloride injection.

The 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 the administration of the shot by deep intramuscular administration instead of intravenous administration. If promethazine hydrochloride injection must be administered intravenously, healthcare professionals should review and follow the updated information in the labelling to dilute the 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 labelling and container labels with the corresponding information.

If intramuscular injection is not possible, promethazine hydrochloride injection, it 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.

 

FDA article – FDA requires updates to labelling for promethazine hydrochloride injection products (Open access)

 

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