Other safety alerts
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| The United States: FDA requires updates to labeling for promethazine hydrochloride injection products |
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The US Food and Drug Administration (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 updated preparation and infusion instructions in adult and pediatric patients.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-updates-labeling-promethazine-hydrochloride-injection-products
In Hong Kong, there is no registered pharmaceutical product containing promethazine hydrochloride in injectable dose form. Related news was previously issued by FDA, and was posted on the Drug Office website on 17 Sep 2009.
Ends/Thursday, Dec 28, 2023
Issued at HKT 15:00
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