Prochlorperazine Edisylate Injection Shortage

• • Heritage Pharmaceuticals states the reason for the shortage was manufacturing delay.[1]

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

Estimated Resupply Dates

• • Heritage has prochlorperazine injection available.[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 (Tables 1 and 2 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 intravenous promethazine to 6.25 mg to 12.5 mg intravenous.[6] Promethazine 6.25 mg intravenous was as effective as 12.5 mg intravenous 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 Vomiting2,3,4,5,7

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

  
  

  Table 2. Selected Alternative Injectable Agents for the Treatment of Postoperative Nausea and Vomiting2,3,4,5,7

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

  
  

References

• 1. Heritage Pharma, Customer Service (personal communication). October 13, November 3, December 14, 2015; February 11, May 2, and August 1, 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. http://www.ismp.org/newsletters/acutecare/articles/20060810.asp. 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.