Bulletin

Prochlorperazine Injection

01 February 2010

Products Affected - Description

Prochlorperazine injection 5 mg/mL, Baxter
2 mL vial, 25 count (NDC 00641-0491-25) - discontinued

Prochlorperazine injection 5 mg/mL, Bedford
2 mL vial, 10 count (NDC 55390-0077-10)

10 mL vial, 1 count (NDC 55390-0077-01)

Reason for the Shortage

Baxter has discontinued their prochlorperazine injection.¹
Bedford cannot provide a reason for the shortage.²

Estimated Resupply Dates

Bedford has both prochlorperazine injection presentations on back order and the company estimates a partial release in mid-February, 2010.²

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.

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).^4-8
The role of prochlorperazine in the management of acute CINV is limited to use for low or minimal emetogenic chemotherapy,^4,5 and for refractory or breakthrough nausea and vomiting.⁸ Tables 1 and 2 summarize the dose recommendations from the NCCN clinical guidelines.^5,8Alternative 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.^10,11
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), and American Society of Plastic Surgeons Task Force and Committee for Patient Safety (2006), and Society for Obstetricians and Gynecologists of Canada (2008).^12-17
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.^12-17
Antiemetic therapy for PONV prophylaxis or treatment in adults includes: 5-HT₃ receptor antagonists, dexamethasone, aprepitant, droperidol, prochlorperazine, promethazine, scopolamine patch, dimenhydrinate, ephedrine, or propofol anesthesia. Most guidelines recommend using a prophylactic antiemetic regimen that contains a 5-HT3 antagonist.^12-18 For the treatment of PONV, the 5-HT3 receptor antagonists are the most well-studied agents.¹⁰
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 Chemotherapy⁵

Medications	Dose Recommendations from National Comprehensive Cancer Network (NCCN) Guidelines
Prochlorperazine	10 mg oral or intravenous every 4 to 6 hours
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

Table 2. Medications Used For Breakthrough Treatment for CINV⁵

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
Promethazine^a	12.5 mg to 25 mg orally or intravenous every 4 hours
Serotonin Antagonists
Dolasetron	100 mg oral daily or 100 mg intravenous, or 1.8 mg/kg intravenous
Ondansetron	16 mg oral or 8 mg intravenous daily
Granisetron	1 to 2 mg oral daily or 0.01 mg/kg intravenous (max dose 1 mg) or 52 cm² transdermal patch
Other
Dexamethasone	12 mg oral or intravenous daily
Dronabinol	5 to 10 mg orally every 3 or 6 hours
Haloperidol	1 to 2 mg oral every 4 to 6 hours as needed
Lorazepam	0.5 to 2 mg oral or intravenous every 4 or 6 hours
Nabilone	1 to 2 mg orally twice daily
Olanzapine	2.5 mg to 5 mg orally twice daily (use caution in elderly- carries black box warning)

^aExtravasation risk - can cause significant tissue damage during intravenous administration

Table 3. Selected Agents for the Management of Postoperative Nausea and Vomiting (PONV) in Adults^10,12-20

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.^12,14	10 mg intravenous every 4 to 6 hours as needed.
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^a	6.25 to 25 mg intramuscular or intravenous at the end of surgery.	6.25 to 12.5 mg intramuscular or intravenous every 4 hours as needed.
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.

References

Baxter, Customer Service (personal communication). August 3, and October 14, 2009.
Bedford, Customer Service (personal communication). August 3, and October 14, November 4, 6, and 17, and December 9, 2009; and January 4, 12, 15, and 25, and February 1, 2010.
McEvoy GK, Snow EK, Kester L, Litvak K, Miller J, Welsh OH, eds. AHFS 2008 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2008.
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.
Ettinger DS, Armstrong D, Barbour S, et al. Antiemesis. National Comprehensive Cancer Network, Practice Guidelines in Oncology, v.3.2009. Available at: www.nccn.org. Accessed August 5, 2009
Ettinger DS, Bierman PJ, Bradbury B, et al. Antiemesis. J Natl Compr Canc Netw. Jan 2007;5(1):12-33.
Herrstedt J. Antiemetics: an update and the MASCC guidelines applied in clinical practice. Nat Clin Pract Oncol. Jan 2008;5(1):32-43.
Herrstedt J, Roila F. Chemotherapy-induced nausea and vomiting: ESMO clinical recommendations for prophylaxis. Ann Oncol. May 2008;19 Suppl 2:ii110-112.
Hesketh PJ. Chemotherapy-induced nausea and vomiting. N Engl J Med. Jun 5 2008;358(23):2482-2494.
Golembiewski J, Chernin E, Chopra T. Prevention and treatment of postoperative nausea and vomiting. Am J Health Syst Pharm. Jun 15 2005;62(12):1247-1260; quiz 1261-1242.
Golembiewski JA, O'Brien D. A systematic approach to the management of postoperative nausea and vomiting. J Perianesth Nurs. Dec 2002;17(6):364-376.
Gan TJ, Meyer T, Apfel CC, et al. Consensus guidelines for managing postoperative nausea and vomiting. Anesth Analg. Jul 2003;97(1):62-71.
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.
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.
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, table of contents.
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.
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.
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.
Donnelly AJ, Baughman VL, Gonzales JP, Golembiewski J, Tomsik EA, eds. Anesthesiology and Critical Care Drug Handbook. 8th ed. Hudson, OH: Lexi-Comp; 2008.
Aloxi (palonosetron hydrochloride) capsules package insert. Bloomington, MN: Eisai Inc.; August 2008.

Updated

Updated February 1, 2010 by Michelle Wheeler, Pharm.D., Drug Information Specialist. Created August 6, 2009, by Jane Chandramouli, Pharm.D., Drug Information Specialist. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.

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