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Prochlorperazine Edisylate Injection

[10 October 2014]

Products Affected - Description

Prochlorperazine injection 5 mg/mL, Ben Venue (formerly Bedford product)
2 mL vial, 10 count (NDC 55390-0077-10)
10 mL vial (NDC 55390-0077-01)

Reason for the Shortage

  • Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.1
  • Heritage launched prochlorperazine 5 mg/mL 2 mL vials in January 2014.2

Available Products

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

Estimated Resupply Dates

All marketed presentations are currently available.1

Implications for Patient Care

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

  • During this shortage use alternative antiemetics. Oral and rectal prochlorperazine products are effective; however, these routes may not be practical for all patients.

Alternative Agents & Management

  • No antiemetic is completely effective in preventing nausea and vomiting in all patients. The selection of an antiemetic is often based on the type of nausea and vomiting (eg, chemotherapy-induced, or postoperative) and patient specific criteria.
  • Administration route and recommended dose differ between prochlorperazine and other available agents used to manage CINV and PONV. Ensure that each specific product is administered at the correct dose and via the correct route.3,4,14,15,16
Chemotherapy Induced Nausea and Vomiting (CINV)
  • Treatment guidelines base antiemetic recommendations on the emetogenic potential of the chemotherapy being administered. Treatment guidelines on the management of acute and delayed CINV are available from American Society of Clinical Oncology (ASCO), the National Comprehensive Cancer Network (NCCN), the Antiemetic Subcommittee of the Multinational Association of Supportive Care in Cancer (MASCC), and the European Society for Medical Oncology (ESMO).4-6
  • The role of prochlorperazine in the management of acute CINV is limited to use for low or minimal emetogenic chemotherapy, and for refractory or breakthrough nausea and vomiting.4-6 Tables 1 and 2 summarize the dose recommendations from the NCCN clinical guidelines.4 Alternative dosing regimens may be found in other resources.

Postoperative Nausea and Vomiting (PONV)

  • PONV is best managed by prevention, as response to prophylaxis is much higher than response to treatment of established nausea or vomiting. Various medications, working by multiple mechanisms of action, are used to manage PONV.7
  • Guidelines on the management of postoperative nausea and vomiting are available from the International Anesthesia Research Society (2003), American Society of Anesthesiologists (2002), American Society of PeriAnesthesia Nurses (2006), Society for Ambulatory Anesthesia (2007), American Society of Plastic Surgeons Task Force and Committee for Patient Safety (2006), and Society for Obstetricians and Gynecologists of Canada (2008).8-13
  • The emphasis of these guidelines is to identify adults and children at moderate to high risk for PONV, reduce any baseline factors for PONV, and provide prophylaxis with 2 or 3 different types of antiemetic agents. If a patient has nausea and vomiting despite prophylaxis, treat with an antiemetic from a different pharmacological class.8-13
  • For the treatment of PONV, the 5-HT3 receptor antagonists are the most well-studied agents.7
  • Table 3 provides doses for selected agents used for the management of PONV in adults.

 

Table 1. Medications Used for the Management of Acute CINV Due to Low Emetogenic Chemotherapy4

Medications
Dose Recommendations from National Comprehensive Cancer Network (NCCN) Guidelines
Prochlorperazine
10 mg oral or intravenous every 4 to 6 hours as needed
Dexamethasone
12 mg oral or intravenous daily
Lorazepam
0.5 to 2 mg oral or intravenous every 4 or 6 hours as needed
Metoclopramide
10 to 40 mg oral or intravenous every 4 or 6 hours as needed

Table 2. Medications Used For Breakthrough Treatment for CINV4
 

Dopamine Antagonists

Metoclopramide

10 to 40 mg oral or intravenous every 4 or 6 hours

Phenothiazines

Prochlorperazine

10 mg oral or intravenous every 4 to 6 hours;

25 mg suppository rectally every 12 hours

Promethazinea

12.5 mg to 25 mg orally or intravenous via central line only every 4 hours

Serotonin Antagonists

Dolasetron

100 mg oral daily

Ondansetron

16 mg oral or intravenous daily

Granisetron

1 to 2 mg oral daily or 0.01 mg/kg intravenous (max dose 1 mg)

Cannabinoids

Dronabinol

5 to 10 mg orally every 3 or 6 hours

Nabilone

1 to 2 mg orally twice daily

Other

Dexamethasone

12 mg oral or intravenous daily

Haloperidol

0.5 to 2 mg oral or intravenous every 4 to 6 hours as needed

Lorazepam

0.5 to 2 mg oral or intravenous every 4 or 6 hours

Olanzapine

2.5 mg to 5 mg orally twice daily (use caution in elderly- carries black box warning)

Scopolamine

1 patch every 72 hours

a Extravasation risk - can cause significant tissue damage during intravenous administration
 
Table 3. Selected Agents for the Management of Postoperative Nausea and Vomiting (PONV) in Adults 7-16
 

Medication

Dose for Prevention of PONV

Dose for Treatment of PONV

Dopamine Antagonists

Metoclopramide

10 to 20 mg intravenous given at the end of surgery. Lower doses (ie, 10 mg) not effective for prophylactic management.7,8,11 Not recommended for use.7

10 mg intravenous every 4 to 6 hours as needed. Not recommended due to lack of evidence of efficacy.7

Phenothiazines

Prochlorperazine

5 to 10 mg intravenous or intramuscular at anesthesia induction or at the end of surgery.

5 to 10 mg intravenous or intramuscular; may repeat once if needed.

Promethazine

25 mg orally one hour before anesthesia induction.16 Intravenous route not recommended due to extravasation risk.a

12.5 to 25 mg oral or rectal every 4 to 6 hours as needed.15,16 Intravenous route not recommended due to extravasation risk.a

Serotonin Antagonists

Dolasetron

12.5 mg intravenous at the end of surgery or 100 mg orally once within 2 hours before surgery.

12.5 mg intravenous as soon as nausea or vomiting begins.

Granisetron

1 mg intravenous once at the end of surgery.

1 mg intravenous as soon as nausea or vomiting begins.

Ondansetron

4 mg intravenous at the end of surgery or

16 mg orally once one hour before anesthesia induction.

4 mg intravenously if nausea and vomiting begin soon after surgery.

Palonosetron

0.075 mg intravenous before anesthesia induction.

Not labeled for treatment.

Other

Aprepitant

40 mg orally given once within 3 hours before anesthesia induction.

Not labeled for treatment.

Dexamethasone

4 to 10 mg intravenous before anesthesia induction.

2 to 4 mg intravenous; do not use if patient received dexamethasone for prophylaxis.

Droperidol b

0.625 to 1.25 mg intravenous given at the end of surgery.

0.625 to 1.25 mg intravenous as needed.

Scopolamine

Apply 1.5 mg/2.5 cm2 transdermal patch the evening prior to surgery or 4 hours before the end of surgery.

Not recommended due to longer onset of action.

a Extravasation risk - can cause significant tissue damage during intravenous administration.
b Droperidol has a black-box warning for cardiac arrhythmias (torsade de pointes and prolongation of the QT interval). This is a dose-related adverse effect.

Related Shortages

References

  1. Bedford, Customer Service (personal communication and website). October 21, November 20, December 10, 2013; January 8, February 11, April 14, June 16 and 25, August 21, and October 8, 2014.
  2. Heritage (personal communication). January 9 and 15, February 11, April 23, June 23, August 20, and October 8, 2014.
  3. McEvoy GK, Snow EK, Kester L, Litvak K, Miller J, Welsh OH, eds. AHFS 2011 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2011.
  4. Ettinger DS, Armstrong D, Barbour S, et al. Antiemesis. National Comprehensive Cancer Network, Practice Guidelines in Oncology, v.1.2012. Available at: http://www.nccn.org. Accessed September 21, 2011.
  5. Kris MG, Hesketh PJ, Somerfield MR, et al. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol. Jun 20 2006;24(18):2932-2947.
  6. Roila F, Herrstedt J, Aapro M et al. Guideline update for MASCC and ESMO in the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting: results of the Perugia consensus conference. Ann Oncol. May 2010:21(suppl 5):v232-v243.
  7. Le TP, Gan TJ. Update on the management of postoperative nausea and vomiting and postdischarge nausea and vomiting in ambulatory surgery. Anesthesiology Clin 2010; 28:225-249.
  8. Gan TJ, Meyer TA, Apfel CC, et al. Society for Ambulatory Anesthesia guidelines for the management of postoperative nausea and vomiting. Anesth Analg. Dec 2007;105(6):1615-1628.
  9. Gan TJ, Meyer T, Apfel CC, et al. Consensus guidelines for managing postoperative nausea and vomiting. Anesth Analg. Jul 2003;97(1):62-71.
  10. Practice guidelines for postanesthetic care: a report by the American Society of Anesthesiologists Task Force on Postanesthetic Care. Anesthesiology. Mar 2002;96(3):742-752.
  11. ASPAN'S evidence-based clinical practice guideline for the prevention and/or management of PONV/PDNV. J Perianesth Nurs. Aug 2006;21(4):230-250.
  12. Iverson RE, Lynch DJ. Practice advisory on pain management and prevention of postoperative nausea and vomiting. Plast Reconstr Surg. Sep 15 2006;118(4):1060-1069.
  13. McCracken G, Houston P, Lefebvre G. Guideline for the management of postoperative nausea and vomiting. J Obstet Gynaecol Can. Jul 2008;30(7):600-607, 608-616.
  14. Ignoffo RJ. Current research on PONV/PDNV: Practical implications for today's pharmacist. Am J Health Syst Pharm. Jan 1 2009;66(1 Suppl 1):S19-24.
  15. Baughman VL, Golembiewski J, Gonzales JP, Alvarez W, eds. Anesthesiology and Critical Care Drug Handbook. 9th ed. Hudson, OH: Lexi-Comp; 2011.
  16. Hutchison, T. A., D. R. Shahan, et al., Eds. (2011. Updated periodically). Drugdex System [internet database]. Greenwood Village, CO, Thomson Healthcare.

Updated

Updated October 10, 2014 by Leslie Jensen, PharmD, Drug Information Specialist. Created September 22, 2011, by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2014, 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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