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Prochlorperazine Maleate Tablets

Last Updated: April 29, 2020
Status: Current

Products Affected - Description
    • Prochlorperazine maleate tablet, Mylan, 10 mg, bottle, 100 count, NDC 00378-5110-01
    • Prochlorperazine maleate tablet, Mylan, 5 mg, bottle, 100 count, NDC 00378-5105-01
    • Prochlorperazine maleate tablet, Mylan Institutional, 10 mg, unit-dose blister pack, 100 count, NDC 51079-0542-20 - discontinued
    • Prochlorperazine maleate tablet, Mylan Institutional, 5 mg, unit-dose blister pack, 100 count, NDC 51079-0541-20 - discontinued
Reason for the Shortage
    • Cadista had prochlorperazine maleate tablets on shortage due to increased demand.[1]
    • Mylan did not provide a reason for the shortage.[2]
    • Mylan Institutional discontinued the prochlorperazine maleate unit-dose presentations in August 2019.[2]
Available Products
    • Prochlorperazine maleate tablet, Cadista, 10 mg, bottle, 100 count, NDC 59746-0115-06
    • Prochlorperazine maleate tablet, Cadista, 5 mg, bottle, 100 count, NDC 59746-0113-06

Estimated Resupply Dates

    • Mylan has prochlorperazine maleate 5 mg and 10 mg tablets in 100 count bottles on back order and the company cannot estimate a release date.

Implications for Patient Care

    • Prochlorperazine is a phenothiazine derivative labeled for use in adults for the control of severe nausea and vomiting and for the treatment of schizophrenia and nonpsychotic anxiety. Prochlorperazine can be especially useful in the management of chemotherapy-induced nausea and vomiting (CINV) and is considered less sedating than promethazine due to less histamine receptor blockade.[3-5]

Safety

    • Dosage recommendations and adjustments, boxed warnings, and contraindications vary among alternative oral antiemetics. Patient harm can occur if alternative agents are used incorrectly. Use caution when selecting alternative agents.[3-22]
    • Documentation of allergic cross-sensitivity between phenothiazine derivatives is limited, but the possibility of cross-sensitivity cannot be ruled out due to similarities in chemical structure and pharmacologic activity.[3-22]

Alternative Agents & Management

    • Alternative oral phenothiazine derivatives are available, but differ from prochlorperazine with regard to dosing, boxed warnings, and contraindications. Moreover, prochlorperazine may be confused with chlorpromazine, creating the potential for medication errors and patient harm.
    • The choice of alternative agent must be patient-specific and based on the clinical situation, including concomitant medications and comorbid conditions.
    • Tables 1 and 2 summarize the differences between potential alternatives to oral prochlorperazine for the treatment and prevention of nausea and vomiting.
    • During this shortage, ensure appropriate nausea control and explore all therapeutic modalities. Injectable forms of oral antiemetics are available, but several injectable antiemetics are on shortage as well. Rectal antiemetics are a potential alternatives.
    Table 1. Table 1. Comparison of Select Oral Antiemetics3-22
    Medication Description Labeled Indication (adults) How Supplied (antiemetic)
    Ondansetron 5-HT3 receptor antagonist Nausea and vomiting:
    Nausea and vomiting associated with highly emetogenic chemotherapy; nausea and vomiting associated with moderately emetogenic chemotherapy; nausea and vomiting associated with radiotherapy; postoperative nausea and vomiting
    * 4 mg tablet
    * 8 mg tablet
    * 4 mg orally disintegrating tablet (ODT)
    * 8 mg ODT
    * 4 mg/5 mL oral solution
    * 4 mg oral film
    Promethazine Phenothiazine derivative Nausea and vomiting:
    Nausea and vomiting associated with certain types of anesthesia and surgery; motion sickness; postoperative nausea and vomiting

    Other:
    Allergic rhinitis; vasomoter rhinitis; allergic conjunctivitis; mild, uncomplicated urticaria and angioedema; allergic reactions to blood or plasma; dermographism; anaphylactic reactions; sedation; postoperative pain
    * 12.5 mg tablet
    * 25 mg tablet
    * 50 mg tablet
    * 6.25 mg/5 mL oral solution
    * 6.25 mg/5 mg oral syrup
    Metoclopramide Dopamine receptor antagonist; cholinergic prokinetic Other:
    Gastroesophageal reflux disease; diabetic gastroparesis
    * 5 mg tablet
    * 10 mg tablet
    * 5 mg ODT
    * 10 mg ODT
    * 5 mg/5 mL oral solution
    Chlorpromazine Phenothiazine derivative Nausea and vomiting:
    Nausea and vomiting

    Other:
    Manifestations of psychotic disorders; schizophrenia; restlessness and apprehension before surgery; acute intermittent porphyria; tetanus; manifestations of manic-depressive illness; intractable hiccups
    * 10 mg tablet
    * 25 mg tablet
    * 50 mg tablet
    Trimethobenzamide Inhibits emetic impulse conduction to the chemoreceptor trigger zone Nausea and vomiting:
    Postoperative nausea and vomiting; nausea associated with gastroenteritis
    * 300 mg capsule

    Table 2. Table 2. Comparison of Select Oral Antiemetics: Pharmacokinetic Parameters, Warnings, and Contraindications3-22
    Medication Onset Dose Adjustment Mean Half-Life (Normal Adult)
    Boxed Warning Contraindications
    Ondansetron 30 min Hepatic dysfunction 3-6 hours Hypersensitivity to ondansetron; concomitant use of apomorphine
    Promethazine 20 min 16-19 hours Respiratory depression in patients <2 years old; severe tissue injury from extravasation Pediatric patients <2 years old; comatose states; known hypersensitivty or idiosyncratic reaction to phenothiazines; lower respiratory tract symptoms
    Metoclopramide 30-60 min Renal dysfunction, hepatic dysfunction 5-6 hours Tardive dyskinesia History of tardive dyskinesia or dystonic reaction to metoclopramide; pheochromocytoma or catecholamine-releasing paragangliomas; epilepsy; hypersensitivity to metoclopramide; situations where stimulation of gastrointestinal motility may be dangerous; concomitant use of other agents likely to increase extrapyramidal reactions
    Chlorpromazine 30-60 min 6 hours Increased mortality in elderly patients with dementia-related psychosis Hypersensitivity to phenothiazines; comatose states or concomitant use of large amount of central nervous system depressants
    Trimethobenzamide 10-40 min Avoid use in hepatic dysfunction 7-9 hours Hypersensitivity to trimethobenzamide

References

    1. Cadista (personal communication). March 22, June 27, and August 19, 2019.
    2. Mylan (personal communication). March 22, and May 24, 2019.
    3. Prochlorperazine maleate tablet [product information]. Morgantown, WV: Mylan Pharmaceuticals Inc. 2016.
    4. National Comprehensive Cancer Network. Antiemesis (Version 1.2019). Available at: https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf. Accessed March 26, 2019
    5. Prochlorperazine. Lexi-Drugs. Wolters Kluwer Health, Inc. Riverwoods, IL. Available at: http://online.online.lexi.com. Accessed March 27, 2019.
    6. Ondansetron hydrochloride tablet; ondansetron hydrochloride tablet, orally disintegrating; ondansetron hydrochloride solution [product information]. Research Triangle Park, NC: GlaxoSmithKline LLC. 2014.
    7. Ondansetron film [product information]. Raleigh, NC: Midatech Pharma US Inc. 2018.
    8. Ondansetron. Lexi-Drugs. Wolters Kluwer Health, Inc. Riverwoods, IL. Available at: http://online.online.lexi.com. Accessed March 27, 2019.
    9. Promethazine hydrochloride tablet [product information]. Princeton, NJ: Sandoz Inc. 2017.
    10. Promethazine hydrochloride solution [product information]. Bryan, OH: Nostrum Laboratories, Inc. 2018.
    11. Promethazine hydrochloride syrup [product information]. Morton Grove, IL: Morton Grove Pharmaceuticals, Inc 2018.
    12. Promethazine. Lexi-Drugs. Wolters Kluwer Health, Inc. Riverwoods, IL. Available at: http://online.online.lexi.com. Accessed March 27, 2019.
    13. Promethazine Hydrochloride. Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Available at: http://www.micromedexsolutions.com. Accessed March 27, 2019.
    14. Metoclopramide hydrochloride tablet [product information]. North Wales, PA: Teva Pharmaceuticals USA, Inc. 2017.
    15. Metoclopramide hydrochloride tablet, orally disintegrating [product information]. Somerset, NJ: Gavis Pharmaceuticals, LLC 2015.
    16. Metoclopramide hydrochloride solution [product information]. Largo, FL: VistaPharm Inc. 2018.
    17. Metoclopramide. Lexi-Drugs. Wolters Kluwer Health, Inc. Riverwoods, IL. Available at: http://online.online.lexi.com. Accessed March 27, 2019.
    18. Chlorpromazine hydrochloride tablet, sugar coated [product information]. Princeton, NJ: Sandoz Inc. 2017.
    19. Chlorpromazine. Lexi-Drugs. Wolters Kluwer Health, Inc. Riverwoods, IL. Available at: http://online.online.lexi.com. Accessed March 27, 2019.
    20. Chlorpromazine Hydrochloride. Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Available at: http://www.micromedexsolutions.com. Accessed March 27, 2019.
    21. Trimethobenzamide hydrochloride capsule [product information]. New York, NY: Pfizer Laboratories Div Pfizer Inc, 2018.
    22. Trimethobenzamide. Lexi-Drugs. Wolters Kluwer Health, Inc. Riverwoods, IL. Available at: http://online.online.lexi.com. Accessed March 27, 2019.

Updated

Updated April 29, 2020 by Leslie Jensen, PharmD, Drug Information Specialist. Created March 22, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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