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Prochlorperazine Edisylate Injection

[02 May 2016]

Products Affected - Description

Prochlorperazine Edisylate injection, Heritage
5 mg/mL, 2 mL vial, 10 count (NDC 23155-0294-42)

Reason for the Shortage

Heritage Pharmaceuticals states the reason for the shortage was manufacturing delay.

Available Products

There is insufficient supply for usual ordering.

Estimated Resupply Dates

Heritage has prochlorperazine injection on tight allocation.1

Implications for Patient Care

Prochlorperazine is a phenothiazine antiemetic used to control nausea and vomiting produced by a variety of causes.2,3,4

  • During this shortage use alternative anti-emetics. Oral and rectal prochlorperazine products are effective, however these routes may not be practical for all patients.3,4

Safety

Injectable promethazine is a possible alternative to prochlorperazine for the prevention and treatment of nausea and vomiting (the table provides a summary of additional potential alternatives).4,5 However, severe tissue injury in the event of perivascular extravasation, intraneuronal or perineuronal infiltration, or inadvertent intra-arterial administration is possible with promethazine.2,3,6 The Institute for Safe Medication Practices provides guidance on preventing tissue injury with intravenous promethazine.6
  •  The labeled route of administration for promethazine injection is deep intramuscular injection. Subcutaneous administration is contraindicated.2,3
  • Limit the concentration used in the organization to 25 mg/mL and further dilute promethazine with 10 to 20 mL normal saline when administering intravenously. This allows for slower administration, reduces vesicant effects, and allows for extravasation to be detected more quickly.6
  • Limit the starting dose of IV promethazine to 6.25 mg to 12.5 mg IV.6 Promethazine 6.25 mg IV was as effective as 12.5 mg IV for controlling postoperative nausea and vomiting in a clinical study.7
  • Administer intravenous promethazine slowly over 10 to 15 minutes through a large bore vein (ie, central venous access is preferred; avoid the hand or wrist) via a running intravenous line at the furthest port from patient's vein.6
  • Instruct patients to immediately report signs of pain or burning.2,3,6
  • Create alerts to remind healthcare workers of the risks associated with intravenous promethazine use.6

Alternative Agents & Management

  • No single agent can be substituted for prochlorperazine injection. The choice of alternative agents must be patient-specific and based on the clinical situation as well as the potential for adverse effects.4,5
  • Consensus guidelines offer evidence-based recommendations for the pharmacologic management of postoperative nausea and vomiting.5 Tables 1 and 2 incorporate these recommendations for select injectable antiemetics.

Table 1. Selected Alternative Injectable Agents for the Prevention of Postoperative Nausea and Vomiting 2,3,4,5,7

Drug

Dose

Dexamethasone*

4 to 5 mg intravenous at induction

Dimenhydrinate

1 mg/kg intravenous (maximum 100 mg every 4 hours)

Dolasetron

12.5 mg intravenous 15 minutes prior to end of surgery

Droperidol (currently not marketed)

0.625 to 1.25 mg intravenous at end of surgery

Granisetron

0.35 to 3 mg intravenous at end of surgery

Haloperidol*

0.5 to 2 mg intramuscular or intravenous

Methylprednisolone*

40 mg intravenous (single dose)

Ondansetron*

4 mg intravenous at end of surgery

Palonsetron

0.075 mg intravenous immediately prior to or at induction 

Promethazine*

6.25 to 12.5 mg intravenous at induction

*Some presentations of these products are currently in short supply. See www.ashp.org/shortages for further details.


Table 2. Selected Alternative Injectable Agents for the Treatment of Postoperative Nausea and Vomiting 2,3,4,5,7 

Drug

Dose

Dexamethasone*

2 to 4 mg intravenous

Dimenhydrinate

1 mg/kg intravenous (maximum 100 mg every 4 hours)

Dolasetron

12.5 mg intravenous postoperatively

Droperidol (currently not marketed)

0.625 to 1.25 mg intravenous as needed

Granisetron

0.1 mg intravenous postoperatively

Ondansetron*

1 to 4 mg intravenous postoperatively

Promethazine*

6.25 to 12.5 mg intravenous or 12.5 to 25 mg intramuscular every 4 to 6 hours as needed

*Some presentations of these products are currently in short supply. See www.ashp.org/shortages for further details.

Related Shortages

References

  1. Heritage Pharma, Customer Service (personal communication). October 13, November 3, December 14, 2015; February 11, and May 2, 2016.
  2. Lexi-Drugs Online. Hudson, OH: Lexi-Comp, Inc.; 2015.
  3. McEvoy GK, Snow EK, Kester L, Litvak K, Miller J, Welsh OH, eds. AHFS DI (Lexi-Comp Online). Bethesda, MD: American Society of Health-System Pharmacists; 2015.
  4. DiPiro CV, Ignoffo, RJ. Nausea and Vomiting. In: Dipiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM, eds. Pharmacotherapy: A Pathophysiologic Approach. 9th ed. New York, NY: McGraw Hill Medical Publishing; 2014:517-30.
  5. Gan TJ, Diemunsch P, Habib AS, Kovac, A, et al. Society for Ambulatory Anesthesiology. Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2014 Jan;118(1):85-113.
  6. Institute for Safe Medication Practices. Action Needed to Prevent Serious Tissue Injury with IV Promethazine. Accessed March 19, 2015.
  7. Deitrick CL, Mick DJ, Lauffer V, Prostka E, et al. A comparison of two differing doses of promethazine for the treatment of postoperative nausea and vomiting. J Perianesth Nurs. 2015 Feb;30(1):5-13.

Updated

Updated May 2, 2016 by Michelle Wheeler, PharmD, Drug Information Specialist. Created October 13, 2015 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Vizient, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Vizient, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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