Promethazine FDA Alerts

FDA Requires Updates to Labeling for Promethazine Hydrochloride Injection Products

Dec 27, 2023 | Audience: Health Care Professionals

December 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

 

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

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.

Content current as of: December 27, 2023

Source: FDA

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Promethazine Hydrochloride Injection

Sep 16, 2009 | Audience: All healthcare professionals

FDA notified healthcare professionals that a Boxed Warning is being added to the prescribing information for Promethazine Hydrochloride products, describing the risks of severe tissue injury, including gangrene, requiring amputation following intravenous administration of promethazine. The Boxed Warning will remind practitioners that due to the risks of intravenous injection, the preferred route of administration is deep intramuscular injection and that subcutaneous injection is contraindicated.

Perivascular extravasation, unintentional intra-arterial injection and intraneuronal or perineuronal infiltration of the drug may result in irritation and tissue damage. Healthcare professionals should be alert for signs and symptoms of potential tissue injury including burning or pain at the site of injection, phlebitis, swelling, and blistering.

[09/16/2009 - Information for Healthcare Professionals - FDA]
[09/16/2009 - News Release - FDA]

    

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Promethazine HCl (marketed as Phenergan and generic products)

Apr 25, 2006 | Audience: Pediatricians, emergency service professionals and patients[Posted 04/25/2006] FDA notified healthcare professionals and patients that cases of breathing problems, some causing death, have been reported to the FDA when the drug was used in children less than two years old. Parents and caregivers should also be careful and get a doctor's advice about giving promethazine HCl in any form to children age two and older. The labeling on all products, brand name and generic, has been changed to reflect these strengthened warnings.

[April 25, 2006 - Drug Information Page - FDA]

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Phenergan (promethazine hydrochloride)

Feb 17, 2005 | Audience: Pediatricians and other healthcare professionalsFDA and Wyeth notified healthcare professionals of revisions to the CONTRAINDICATIONS, WARNINGS/Use in Pediatric Patients, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Phenergan. Phenergan is contraindicated for use in pediatric patients less than two years of age because of the potential for fatal respiratory depression. Postmarketing cases of respiratory depression including fatalities, have been reported with use of Phenergan in pediatric patients less than two years of age. Caution should also be exercised when administering Phenergan to pediatric patients two years of age and older.

[January 21, 2005 Letter - Wyeth]
[December, 2004 Revised Label - Wyeth]

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