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Published Online, 14 June 2005, www.theannals.com, DOI 10.1345/aph.1E361a.
 The Annals of Pharmacotherapy: Vol. 39, No. 7, pp. 1370. DOI 10.1345/aph.1E361a
© 2005 Harvey Whitney Books Company.
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Comment: promethazine adverse events after implementation of a medication shortage interchange

Ashraf S Habib, MBBCh MSc FRCA

Assistant Professor Department of Anesthesiology Duke University Medical Center Box 3094 Durham, North Carolina 27710-0001 fax 919/668-6265 habib001{at}mc.duke.edu

Terrance W Breen, MD FRCPC

Assistant Professor Department of Anesthesiology Duke University Medical Center

Tong J Gan, MB FRCA

Professor Department of Anesthesiology Duke University Medical Center

Published Online, June 14, 2005. www.theannals.com, DOI 10.1345/aph.1E361a

TO THE EDITOR: We read with interest the report by Sheth et al.1 on the adverse events related to administration of promethazine.

Promethazine is an effective antiemetic with a long duration of action. It is used in the treatment of nausea and vomiting from a variety of causes and is particularly effective in the treatment of established postoperative nausea and vomiting (PONV).2,3 Older reports have suggested that the use of promethazine in the perioperative period is limited by prolonged recovery from anesthesia and delayed recovery room discharge.4 Recently, the Food and Drug Administration issued a black box warning stating that promethazine should not be used in children <2 years of age because of the potential for fatal respiratory depression. It also recommends that caution should be exercised when administering promethazine to children ≥2 years of age and that the lowest effective dose should be used.5

It is likely that the sedative effect of promethazine is dose-dependent. On the other hand, there is no evidence that the antiemetic effect of promethazine is dose-dependent. We recently reported that low-dose promethazine (6.25 mg) was as effective as doses ≥12.5 mg for treatment of established PONV.6 We have also found that the use of 6.25 mg for PONV prophylaxis is associated with similar efficacy and less sedation compared with 12.5 mg (unpublished data). In our institution, 6.25 mg is currently the recommended intravenous dose for promethazine, and higher doses are specifically not recommended. We note that all 14 patients reported by Sheth et al. who suffered an adverse event received promethazine >6.25 mg: 8 patients received 12.5 mg and 6 were given 25–50 mg.

While we agree with the authors in urging caution with the use of promethazine with other sedatives and narcotics in the elderly and patients with renal impairment, we recommend the use of low doses (6.25 mg) which provides good efficacy and minimizes adverse effects.

References

  1. Sheth HS, Verrico MM, Skledar SJ, Towers AL. Promethazine adverse events after implementation of a medication shortage interchange. Ann Pharmacother 2005;39:255-61. Epub 2005 Jan 11. DOI10.1345/aph.1E361[Abstract/Free Full Text]
  2. Habib AS, Breen TW, Jiao K, Gan TJ. A comparison of ondansetron and promethazine for the treatment of established postoperative nausea and vomiting in patients who received prophylaxis with ondansetron (abstract).Anesthesiology 2004;101:A76.
  3. Habib AS, Gan TJ. The effectiveness of rescue antiemetics after failure of prophylaxis with ondansetron or droperidol: a preliminary report.J Clin Anesth 2005;17:62-5. DOI10.1016/j.jclinane.2004.04.004[CrossRef][Medline]
  4. Rowbotham DJ. Current management of postoperative nausea and vomiting. Br J Anaesth 1992;69(7 suppl 1):46S -59S.
  5. FDA Medwatch. www.fda.gov/medwatch/SAFETY/2005/phenergan_deardoctorletter.pdf (accessed 2005 Mar 10).
  6. Habib AS, Breen TW, Chukwurah CN, Gan TJ. Dose response of promethazine for the treatment of postoperative nausea and vomiting (abstract). Anesthesiology 2004;101:A47.



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A. S. Habib, J. Reuveni, A. Taguchi, W. D. White, and T. J. Gan
A Comparison of Ondansetron with Promethazine for Treating Postoperative Nausea and Vomiting in Patients Who Received Prophylaxis with Ondansetron: A Retrospective Database Analysis
Anesth. Analg., March 1, 2007; 104(3): 548 - 551.
[Abstract] [Full Text] [PDF]

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