Updated Safety Information for Promethazine Hydrochloride Injection

Information Update
2010-58
April 26, 2010
For immediate release

OTTAWA - Health Canada is informing health care professionals and Canadians, including parents and caregivers, of recent changes to the prescribing information for the injectable form of the prescription drug promethazine.

Injectable promethazine is an antihistamine drug that is administered by health professionals in health care settings such as hospitals. It is used to treat a wide range of conditions, including certain types of allergic reactions, motion sickness, nausea, vomiting and as a sedative.

The revised labelling strengthens the warning information for the drug, including the addition of a boxed warning that highlights the following new or updated safety information:

• Promethazine is not to be used in children under the age of two years due to the potentially fatal risk of respiratory depression (slowed breathing).
• Caution should be used when administering promethazine in children aged two and up: health care professionals are recommended to use the lowest effective dose, and the use of other drugs that may also slow breathing should be avoided.
• Promethazine is not to be injected under the skin (subcutaneously) due to the risk of serious tissue injury.
• The preferred route of administration for promethazine is by injection directly and deeply into a muscle (deep intramuscular injection). Other routes of injection, particularly into arteries or veins, have been associated with serious tissue injury.
• Regardless of where on the body the drug is injected, promethazine has the potential to occasionally cause chemical irritation and in rare cases severe tissue damage at the site of injection, including cases of gangrene. Patients should immediately report any persistent or worsening pain or burning sensation they feel at the site of injection.

This information has been incorporated into the prescribing information for promethazine.*

As well, a new section entitled "Information for the Patients" has also been added to the prescribing information that identifies important safety information that physicians should discuss with their patients. Patients with questions or concerns regarding the use of promethazine should talk to a health care professional.

Promethazine Hydrochloride Injection was first authorized in Canada in 1949 and is marketed by Bioniche Pharma (Canada) Ltd., and Sandoz Canada Inc.

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at the MedEffect™ Canada section of the Health Canada website
• Call toll-free at 1-866-234-2345
• Complete a Canada Vigilance Reporting Form and either:
  • Fax toll-free to 1-866-678-6789
  • Mail to: Canada Vigilance Program
    Health Canada
    AL 0701D
    Ottawa, ON K1A 0K9

To have postage pre-paid, download the postage paid label from the MedEffect™ Canada section of the Health Canada website. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this section.

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Media Inquiries:
Health Canada
(613) 957-2983

Public Inquiries:
(613) 957-2991
1-866 225-0709