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6/27/2019

Prochlorperazine Maleate Tablets

Reason for the Shortage

    • Cadista had prochlorperazine maleate tablets on shortage due to increased demand.[1]
    • Mylan refuses to provide availability updates.[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

    • Cadista has prochlorperazine maleate 5 mg and 10 mg tablets available.[1]

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
    MedicationDescriptionLabeled Indication (adults)How Supplied (antiemetic)
    Ondansetron5-HT3 receptor antagonistNausea 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
    PromethazinePhenothiazine derivativeNausea 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
    MetoclopramideDopamine receptor antagonist; cholinergic prokineticOther:
    Gastroesophageal reflux disease; diabetic gastroparesis
    * 5 mg tablet
    * 10 mg tablet
    * 5 mg ODT
    * 10 mg ODT
    * 5 mg/5 mL oral solution
    ChlorpromazinePhenothiazine derivativeNausea 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
    TrimethobenzamideInhibits emetic impulse conduction to the chemoreceptor trigger zoneNausea 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
    MedicationOnsetDose AdjustmentMean Half-Life (Normal Adult)
    Boxed WarningContraindications
    Ondansetron30 minHepatic dysfunction3-6 hours Hypersensitivity to ondansetron; concomitant use of apomorphine
    Promethazine20 min16-19 hoursRespiratory depression in patients <2 years old; severe tissue injury from extravasationPediatric patients <2 years old; comatose states; known hypersensitivty or idiosyncratic reaction to phenothiazines; lower respiratory tract symptoms
    Metoclopramide30-60 minRenal dysfunction, hepatic dysfunction5-6 hoursTardive dyskinesiaHistory 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
    Chlorpromazine30-60 min6 hoursIncreased mortality in elderly patients with dementia-related psychosisHypersensitivity to phenothiazines; comatose states or concomitant use of large amount of central nervous system depressants
    Trimethobenzamide10-40 minAvoid use in hepatic dysfunction7-9 hoursHypersensitivity to trimethobenzamide

References

    1. Cadista (personal communication). March 22, 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 June 27, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. Created March 22, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

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