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Hydromorphone Hydrochloride Injection

Last Updated: January 19, 2018
Status: Resolved

Hydromorphone Hydrochloride Injection

Products Affected - Description
  • Dilaudid injection, Fresenius Kabi
    0.5 mg/0.5 mL, 0.5 mL preservative-free prefilled syringe, 24 count (NDC 76045-0009-05)

1 mg/1 mL, 1 mL preservative-free prefilled syringe, 24 count (NDC 76045-0009-10)
2 mg/1 mL, 1 mL preservative-free prefilled syringe, 24 count (NDC 76045-0010-10)
4 mg/1 mL, 1 mL preservative-free prefilled syringe, 24 count (NDC 76045-0011-10)
 
Hydromorphone Hydrochloride solution for injection, Akorn
10 mg/mL, 1 mL ampule, 10 count (NDC 17478-0540-01)
10 mg/mL, 5 mL ampule, 10 count (NDC 17478-0540-05)
10 mg/mL, 50 mL vial, 10 count (NDC 17478-0540-50)
 
Hydromorphone Hydrochloride solution for injection, Pfizer
1 mg/mL, 1 mL Carpuject syringe, 10 count (NDC 00409-1283-31)
1 mg/mL, 1 mL ampule, 10 count (NDC 00409-2552-01)
1 mg/mL, 1 mL iSecure syringe, 10 count (NDC 00409-1283-10)
2 mg/mL, 1 mL Carpuject syringe, 10 count (NDC 00409-1312-30)
2 mg/mL, 1 mL ampule, 10 count (NDC 00409-3356-01)
2 mg/mL, 1 mL iSecure syringe, 10 count (NDC 00409-1312-10)
2 mg/mL, 1 mL vial, 10 count (NDC 00409-3365-01)
4 mg/mL, 1 mL Carpuject syringe, 10 count (NDC 00409-1304-31)
4 mg/mL, 1 mL ampule, 10 count (NDC 00409-2540-01)
10 mg/mL, 1 mL vial, 10 count (NDC 00409-2634-01)
0.5 mg/0.5 mL, 0.5 mL iSecure syringe, 10 count (NDC 00409-1283-05)

Hydromorphone Hydrochloride solution for injection, Teva
10 mg/mL, 1 mL vial, 10 count (NDC 00703-0110-03)
10 mg/mL, 5 mL vial, 10 count (NDC 00703-0113-03)
10 mg/mL, 50 mL vial, 1 count (NDC 00703-0018-01)
 
Hydromorphone Hydrochloride solution for injection, West-Ward
2 mg/mL, 20 mL multiple dose vial, 1 count (NDC 00641-2341-41)
Reason for the Shortage
    • Akorn has hydromorphone injection on shortage due to increased demand.1
    • Fresenius Kabi has Dilaudid syringes on shortage due to increased demand.2
    • Pfizer did not provide a reason for the shortage.3
    • Purdue discontinued Dilaudid and Dilaudid HP in May 2017 for marketing reasons.4
    • Teva did not provide a reason for the shortage.5
      West-Ward did not provide a reason for the shortage.6
Available Products
  • Hydromorphone Hydrochloride solution for injection, Pfizer

10 mg/mL, 5 mL vial, 10 count (NDC 00409-2634-05)
10 mg/mL, 50 mL vial, 1 count (NDC 00409-2634-50)
 
Hydromorphone Hydrochloride solution for injection, West-Ward
2 mg/mL, 1 mL vial, 25 count (NDC 00641-0121-25)

Estimated Resupply Dates

    • Akorn has hydromorphone 10 mg/mL 1 mL ampule in limited quantities. Hydromorphone 10 mg/mL 5 mL ampules and 50 mL vials are on back order and the company estimates a release date of mid- to late-February 2018 for the 5 mL ampules and late-January to early-February 2018 for the 50 mL vials.1
    • Fresenius Kabi has Dilaudid 0.5 mg/mL 0.5 mL syringes on back order and the company estimates a release date of mid-February 2018. The 1 mg/mL 1 mL syringes are on back order and the company estimates a release date of 2nd quarter 2018. The 2 mg/mL 1 mL syringes and 4 mg/mL 1 mL syringes are on back order and the company cannot estimate a release date.2
    • Pfizer has hydromorphone 0.5 mg/0.5 mL 0.5 mL iSecure syringes are on back order and the company estimates a release date of early-February 2018. The 1 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of late-February 2018. The 2 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of mid-March 2018. The 1 mg/mL 1 mL iSecure syringes are on back order and the company estimates a release date of mid-February 2018. The 2 mg/mL 1 mL vials are on back order and the company estimates a release date of late-January 2018. The 10 mg/mL 1 mL vials are on back order and the company estimates a release date of September 2018. The 1 mg/mL 1 mL ampules, 2 mg/mL 1 mL ampules, and 4 mg/mL 1 mL ampules are on back order and the company cannot estimate a release date. The 2 mg/mL 1 mL iSecure syringes and 4 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of June 2019.3
    • Teva has hydromorphone 10 mg/mL 1 mL and 5 mL vials on intermittent back order and the company is allocating product upon release. The 10 mg/mL 50 mL vials are on allocation.5
    • West-Ward has hydromorphone 2 mg/mL 20 mL vials on back order and the company estimates a release date of February 2018. The 2 mg/mL 1 mL vials are on allocation.6

Safety

  • Exercise extreme caution when switching hydromorphone concentrations or interchanging to other injectable opioid products (eg, morphine). Equianalgesic dosing conversions are based on limited data and do not account for patient specific factors (eg, end organ function, pharmacogenomics) or incomplete cross-tolerance between opioids. No equianalgesic dosing conversion factors are universally accepted.7-8

Alternative Agents & Management

    • Use oral opioid dosage forms if the enteral route is available.9
    • Use patient controlled analgesia (PCA) presentations or prepare PCAs from multidose vials to conserve unit dose presentations. Patient controlled analgesia is the preferred method of parenteral opioid administration in postoperative patients.9
    • Avoid using high concentration hydromorphone presentation (eg, 4 mg/mL, 10 mg/mL) for intermittent parenteral doses lower than 1 mg to prevent dosing errors.
    • Work with prescribers to convert to an appropriate dose of another parenteral opioid if needed and available.

References

    1. Akorn (personal communication). May 30, August 2, December 8, 2017; and January 10, 2018.
    2. Fresenius Kabi (personal communication). June 7, July 7 and 27, August 31, September 28, October 27, November 17 and 30, December 15 and 22, 2017; and January 7 and 12, 2018.
    3. Pfizer (personal communication and website). June 1, 2, 9, and 22, July 7 and 14, August 2, September 6, 11, and 29, November 2 and 28, December 12 and 29, 2017; and January 5 and 18, 2018.
    4. Purdue Pharma (personal communication). May 30, 2017.
    5. Teva (personal communication). May 30, 2017, July 28, September 6, October 17, November 27, December 4, 2017; and January 8, 2018.
    6. West-Ward (personal communication). May 23, July 7 and 19, September 6 and 29, October 26, November 22 and 30, December 14 and 30, 2017; and January 5 and 18, 2018.
    7. Fishman SM, Ballantyne JC, Rathmell JP, eds. Bonica's Management of Pain. 4th ed. Baltimore, MD: Lippincott Williams & Wilkins; 2010.
    8. McPherson ML, ed. Demystifying Opioid Conversion Calculations. Bethesda, MD: American Society of Health-System Pharmacists; 2010.
    9. Chou R, Gordon DB, de Leon-Casasola OA, et al. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016;17(2):131-157.

Updated

Updated January 19, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. Created June 5, 2017 by Leslie Jensen, PharmD, Drug Information Specialist. Copyright 2018, Drug Information Service, University of Utah, Salt Lake City, UT.

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