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Dexamethasone Sodium Phosphate

[01 August 2014]

Products Affected - Description

Dexamethasone Sodium Phosphate Injection, 4 mg/mL, American Regent
1 mL single dose vial (NDC 00517-4901-25)
5 mL multiple dose vial (NDC 00517-4905-25)
30 mL multiple dose vial (NDC 00517-4930-25)
 
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, Fresenius Kabi (formerly APP)
30 mL multiple dose vial (NDC 63323-0165-30)
 
Dexamethasone Sodium Phosphate Injection, 10 mg/mL, Fresenius Kabi (formerly APP)2
1 mL single dose vial (NDC 63323-0506-01)
 
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, Mylan Institutional (formerly Pfizer products)
1 mL vial (NDC 00069-4547-02) - NDC discontinued
5 mL vial, NDC 00069-4543-02 - NDC discontinued
30 mL vial (NDC 00069-4545-02) - NDC discontinued
1 mL vial (NDC 67457-0423-12)
10 mL vial (NDC 00069-4541-02)

Reason for the Shortage

  • American Regent has dexamethasone sodium phosphate on shortage due to manufacturing delays.1
  • Fresenius Kabi (formerly APP) states the dexamethasone sodium phosphate shortage was due to supply and demand issues.2
  • Baxter could not provide a reason for the shortage. Baxter sold several products to West-Ward in mid-2011.3
  • West-Ward had dexamethasone sodium phosphate injection on shortage due to increased demand.4 
  • Pfizer divested all dexamethasone presentation to Mylan Institutional on December 6, 2013.4,5

Available Products

Dexamethasone Sodium Phosphate Injection, 4 mg/mL, Fresenius Kabi (formerly APP)
1 mL single dose vial (NDC 63323-0165-01)
5 mL multiple dose vial (NDC 63323-0165-05)
 
Dexamethasone Sodium Phosphate Injection, 10 mg/mL, Fresenius Kabi (formerly APP)
10 mL multiple-dose vial (NDC 63323-0516-10)

Dexamethasone Sodium Phosphate Injection, 4 mg/mL, Mylan Institutional (formerly Pfizer products)
5 mL vial (NDC 67457-0422-54)
30 mL vial (NDC 67457-0421-30)
 
Dexamethasone Sodium Phosphate Injection, 10 mg/mL, West-Ward
1 mL vial (NDC 00641-0367-25)

Estimated Resupply Dates

  • American Regent has dexamethasone sodium phosphate 4 mg/mL products on back order and the company cannot estimate a release date.1
  • Fresenius Kabi (formerly APP) has dexamethasone sodium phosphate 4 mg/mL 30 mL vials on back order with an estimated release date of late-August 2014. Dexamethasone sodium phosphate 10 mg/mL 1 mL vials are on intermittent back order and the company is releasing product as it becomes available. Check with wholesalers for availability.2
  • Mylan Institutional has dexamethasone sodium phosphate 4 mg/mL 1 mL and 10 mL vials on back order and the company cannot estimate a release date.5

Implications for Patient Care

Dexamethasone sodium phosphate injection is labeled for a variety of conditions including endocrine disorders, rheumatic disorders, collagen diseases, dermatologic diseases, allergic states, ophthalmic and otic diseases, gastrointestinal diseases, respiratory diseases, hematologic disorders, neoplastic diseases, edematous states, cerebral edema, tuberculosis meningitis, trichinosis with myocardial or neurologic involvement, as well as a diagnostic aid in testing adrenocortical function.6,7 Dexamethasone is also widely used to prevent chemotherapy-induced nausea and vomiting, as well as to prevent postoperative nausea and vomiting.6,7

Oral dexamethasone is as effective as injectable dexamethasone; however, the oral route may not be practical for all patients.7

Alternative Agents & Management

  • Table 1 8,9 compares dexamethasone with other available glucocorticoid products and Table 2 lists alternatives in specific situations. If dexamethasone injection is not available, methylprednisolone may be an acceptable alternative in many situations, although there are few data that specifically address its use. When oral drug administration is possible, oral dexamethasone is the preferred alternative agent.
  • There is no alternative to dexamethasone for the dexamethasone suppression test (DST). If supplies are extremely limited, institutions should consider conserving dexamethasone for DST patients until the shortage resolves.7
  • Dexamethasone has been used in the past to manage intracranial pressure in head trauma patients. The Brain Trauma Foundation’s most recent evidence-based “Guidelines for the Management of Severe Traumatic Brain Injury” do not recommend corticosteroids for managing intracranial pressure in patients with severe head injury.17,18
  • Methylprednisolone may be an acceptable alternative in many situations, although there are few data that specifically address its use.

Related Shortages

References

  1. American Regent, Customer Service (personal communications and website). March 21, July 22, August 4, September 29, October 26, November 22, 2011; January 10 and 31, February 28, April 10, May 21, June 21, August 8, November 7, 2012; January 11 and 23, March 20 and 29, April 11, May 3, June 12, July 2 and 31, August 13 and 27, September 17, October 7 and 28, November 26, December 4 and 19, 2013; January 2, 21, and 31, February 18, March 10 and 25, April 7 and 24, May 12 and 22, and June 11, 2014.
  2. Fresenius Kabi, Customer Service (personal communications). March 21 and 24, April 4 and 20, May 11 and 23, June 23, August 4 and 18, September 27, October 26, November 22, 2011; January 10 and 31, February 28, April 10 and 17, May 21, June 18, August 7, November 7, 2012; January 14 and 19, March 17 and 29, April 11, May 3, June 10 and 28, July 30, August 12 and 26, September 17, October 3 and 28, November 26, December 6 and 20, 2013; January 6, 21, and 31, February 18, March 3, 7, and 26, April 4, 14, 24, and 30, May 12 and 28, June 10 and 20, July 3 and 21, and August 1, 2014.
  3. West-Ward, Customer Service (personal communications). March 21 and 24, April 4 and 18, May 11 and 23, June 21, September 30, October 26, November 22, 2011; January 5, 13, 18, and 31, February 6 and 27, April 6, May 23, June 21, August 6, November 9, 2012; January 14 and 21, March 15 and 29, April 11 and 22, 2013, June 7 and 28, July 26, August 9 and 23, September 13, October 4 and 28, November 26, December 6 and 20, 2013; January 17 and 31, February 14, March 7 and 26, April 4 and 24, May 12 and 23, and June 11, 2014. 
  4. Pfizer, Customer Service (personal communications). January 13 and 31, February 27, April 10, May 21, June 15, August 6, November 7, 2012; January 14, March 15 and 29, April 11, May 2, June 12 and 27, July 2 and 30, August 9 and 23, September 17, October 4 and 24, November 5 and 26, and December 6, 2013.
  5. Mylan Institutional (personal communications). December 9 and 27, 2013; January 7 and 22, February 4 and 20, March 11 and 27, April 7, 24, and 29, May 12 and 27, and June 11, 2014.
  6. Dexamethasone Sodium Phosphate. In: Mosby’s Drug Consult. St. Louis, MO. Mosby Inc., 2005: 763-766.
  7. McEvoy GK, Snow EK, Kester L, Miller J, Welsh OH, Litvak K, eds. AHFS 2005 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2005.
  8. Klasco RK, ed. Drugdex System. Greenwood Village, CO: Thomson Micromedex. (Edition expires 12/2005).
  9. Glucocorticoids. In: Drug Facts and Comparisons. St. Louis, MO: Facts and Comparisons; 2005: 320-332.
  10. American Society of Health-System Pharmacists. ASHP therapeutic guidelines on the pharmacologic management of nausea and vomiting in adult and pediatric patients receiving chemotherapy or radiation therapy or undergoing surgery. Am J Health-Syst Pharm. 1999;56:729-764.
  11. Herrstedt J, Aapro MS, Smyth JF, Del Favero A. Corticosteroids, dopamine antagonists and other drugs. Support Care Cancer. 1998;6(3):204-214.
  12. Beckwith MC, Tyler LS. Methylprednisolone. In: Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health; 2010:445-446.
  13. American Society of Clinical Oncology; Kris MG, Hesketh PJ, Somerfield MR, et al. American Society of Clinical Oncology guidelines for antiemetics in oncology: update 2006. J Clin Oncol. 2006;24(18):2932-2947.
  14. Gebbia V, Testa A, Valenza R, et al. Oral granisetron with or without methylprednisolone versus metoclopramide plus methylprednisolone in the management of delayed nausea and vomiting induced by cisplatin-based chemotherapy. A prospective randomized trial. Cancer.1995;76(10):1821-1828.
  15. Levin VA, Leibel SA, Gutin PH. Neoplasms of the central nervous system. In: DeVita VT, Hellman S, Rosenberg SA, eds. Cancer Principles and Practice of Oncology. 6th ed. Philadelphia, PA: Lippincott Williams and Wilkins;2001:2100-2160.
  16. Bjerre JS. Effect of glucocorticoids on ICP in patients with a cerebral tumour. Acta Neurol Scand. 1997;96:167-170.
  17. McCrea JB, Majumdar AK, Goldberg MR, et al. Effects of the neurokinin1 receptor antagonist aprepitant on the pharmacokinetics of dexamethasone and methylprednisolone. Clin Pharmacol Ther. 2003;74(1):17-24.
  18. Boucher BA, Phelps SJ, Timmons S. Acute management of the head injury patient. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM, eds. Pharmacotherapy: A Pathophysiologic Approach. 6th ed. Stamford, CT: Appleton & Lange;2005:1061-1074.
  19. Brain Trauma Foundation. Guidelines for the Management of Severe Traumatic Brain Injury. J Neurotrauma. 2007;24:S1-106.

Updated

Updated August 1, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist. Created March 20, 2001, by Erin R. Fox, PharmD, Drug Information Specialist, and Linda S. Tyler, 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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