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Prochlorperazine Edisylate Injection

[20 March 2015]

Products Affected - Description

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

Reason for the Shortage

Heritage Pharmaceuticals could not provide a reason for the shortage.1

Available Products

There are no presentations available.

Estimated Resupply Dates

Heritage has prochlorperazine injection on back order and the company cannot estimate a release date.1

Implications for Patient Care

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

  • 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 (IV) 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 IV 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 IV 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 IV 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 situtation.4,5
  • Consensus guidelines offer evidence-based recommendations for the pharmacologic management of postoperative nausea and vomiting.5 The table incorporates these recommendations for select injectable antiemetics.
Table. Selected Alternative Injectable Agents for the Management of Postoperative Nausea and Vomiting in Adults2-5,7 

Prevention of postoperative nausea and vomiting (PONV)

Dexamethasone*

4 to 5 mg IV at induction

Dimenhydrinate

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

Dolasetron

12.5 mg IV 15 minutes prior to end of surgery

Droperidol (currently not marketed)

0.625 to 1.25 mg IV at end of surgery

Granisetron

0.35 to 3 mg IV at end of surgery

Haloperidol*

0.5 to 2 mg IM or IV

Methylprednisolone*

40 mg IV (single dose)

Ondansetron*

4 mg IV at end of surgery

Palonsetron

0.075 mg IV immediately prior to or at induction  

Promethazine*

6.25 to 12.5 mg IV at induction

Treatment of postoperative nausea and vomiting (PONV)

Dexamethasone*

2 to 4 mg IV

Dimenhydrinate

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

Dolasetron

12.5 mg IV postoperatively

Droperidol (currently not marketed)

0.625 to 1.25 mg IV prn

Granisetron

0.1 mg IV postoperatively

Ondansetron*

1 to 4 mg IV postoperatively

Promethazine*

6.25 to 12.5 mg IV or 12.5 to 25 mg IM every 4 to 6 hours prn

*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). March 2, 2015.
  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

Created March 20, 2015, by John Schoen, PharmD, BCPS, PGY2 Drug Information Resident. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation 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. Novation, 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 Novation, 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 Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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