Published: November 2009

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Intravenous promethazine - reports of serious tissue injuries

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Prescriber Update 30(4): 24
November 2009

Promethazine injection is highly caustic to the intima of blood vessels and surrounding tissues.¹

Reports from the United States describe serious tissue reactions including thrombosis, nerve damage, tissue necrosis and gangrene in patients who have received intravenous promethazine. In rare cases surgical intervention such as skin graft, fasciotomy or amputation has been required.^1,2

In New Zealand promethazine injection is approved for the treatment of vomiting, allergic reactions (including anaphylaxis) and to induce sedation.

After reviewing the published literature, assessing the New Zealand case reports and consulting with healthcare professionals, Medsafe has concluded that there remains a clinical need for intravenous promethazine in New Zealand.

Medsafe however recommends that intravenous promethazine should only be used if the benefits clearly outweigh the risks in each patient. This may include emergency situations (such as treatment of anaphylaxis) or situations where intramuscular or oral administration is contraindicated.

To maximise the safe use of this medicine, Medsafe offers the following advice:

1. Deep intramuscular injection is the preferred route of administration of promethazine injection.
2. Promethazine must not be administered subcutaneously or intra-arterially.
3. An alternative medicine should be considered if intravenous administration is required.
4. Promethazine should be administered through large patent veins. Veins in the hand and wrist should be avoided if possible.¹
5. If intravenous administration is required, the maximum recommended concentration is 25mg/mL and the maximum recommended rate of administration is 25mg/minute. Further dilution and administration over 10-15 minutes may reduce the risks even further.¹
6. The injection should be stopped immediately if pain or a burning sensation occurs.
7. Patients should be advised to seek medical assistance if pain, a burning sensation, swelling or blistering occurs at any time after the administration of intravenous promethazine.

The New Zealand data sheet for DBL-Promethazine is currently being updated in line with this advice. The New Zealand data sheet is available at:
www.medsafe.govt.nz/profs/Datasheet/p/promethazinehydrochlorideinj.pdf

As with all medicines, adverse reactions associated with the use of intravenous promethazine should be reported to the CARM.

References

1. Grissiner M. Preventing Serious Tissue Injury with Intravenous Promethazine (Phenergan). P&T 2009;34(4):175-176.
2. FDA. Information for Health Professionals – Intravenous Promethazine and Severe Tissue Injury, Including Gangrene. 16 September 2009. www.fda.gov/Drugs. Accessed 28 October 2009.