Products Affected - Description

• • Diphenhydramine injection, Pfizer, 50 mg/mL, 1 mL Carpuject syringe, 10 count, NDC 00409-2290-31 - discontinued

Reason for the Shortage

• • Armas Pharmaceuticals has diphenhydramine injection available.[1]
  • Fresenius Kabi has diphenhydramine injection available.[2]
  • Hikma has diphenhydramine injection available.[3]
  • Mylan has diphenhydramine injection available.[4]
  • Pfizer discontinued diphenhydramine injection in late-2020.[5]

Available Products

• • Diphenhydramine injection, Armas Pharmaceuticals, 50 mg/mL, 1 mL vial, 25 count, NDC 72485-0101-25
  • Diphenhydramine injection, Fresenius Kabi, 50 mg/mL, 1 mL Simplist syringe, 10 count, NDC 76045-0102-10
  • Diphenhydramine injection, Fresenius Kabi, 50 mg/mL, 1 mL vial, 25 count, NDC 63323-0664-01
  • Diphenhydramine injection, Hikma, 50 mg/mL, 1 mL vial, 25 count, NDC 00641-0376-25
  • Diphenhydramine injection, Mylan Institutional, 50 mg/mL, 10 mL vial, 10 count, NDC 67457-0124-10

• • All marketed presentations are available.

• • Use oral diphenhydramine tablets and liquid where possible.
  • Ensure any intravenous diphenhydramine use is appropriate.
  • Review premedication protocols and remove injectable diphenhydramine whenever feasible. For example, diphenhydramine is not effective for preventing non-hemolytic transfusion reactions.[6]
  • Oral antihistamines including non-sedating options may be of use in allergic pruritus and urticaria.
  • Hydroxyzine is another H1 receptor antagonist available for intramuscular injection.
  • Benztropine injection is an option for patients with acute dystonic reactions.
  • Low dose nalbuphine or naloxone injection is an option for patients with opioid-induced pruritus.[7-9]

• 1. Armas Pharmaceuticals (personal communications). September 18 and October 17, 2019.
  2. Fresenius Kabi (personal communications). August 17 and 29, September 6, 14, 21, and 28, October 5, 12, 20, and 26, November 2, 16, 23, and 29, December 9, 14, and 27, 2018; January 18, February 1, March 1, 15, 21, and 29, April 19 and 26, May 24, June 27, July 18, August 26, September 16, October 7, December 2 and 20, 2019; February 14, April 17, June 5, September 18, and November 25, 2020.
  3. Hikma (personal communications). August 15 and 29, September 5, 19, and 26, October 3, 17, 24, and 31, November 7, 14, 21, and 28, December 5, 12, and 20, 2018; January 23 and 30, February 27, March 13 and 20, April 17 and 24, May 22, June 27, July 17, August 21, September 11, October 2, December 11 and 18, 2019, February 19, April 15, June 3, September 16, and November 25, 2020.
  4. Mylan Institutional (personal communications). August 15, September 19, October 22, November 2 and 8, 2018; January 22, February 19, March 29, April 22 and 30, May 23, June 27, October 17, 2019; April 21, June 10, and November 25, 2020.
  5. Pfizer (personal communications). August 17 and 29, September 7 and 17, October 5, 17, and 25, November 8, 23, and 30, December 7, 2018; January 22, March 1 and 14, April 1, 19, and 30, May 24, July 19, August 23, September 17, October 8, December 13 and 20, 2019; February 21, April 21, June 5, September 18, and November 20, 2020.
  6. Mart­-Carvajal AJ, Sol I, Gonz¡lez LE, Leon de Gonzalez G, Rodriguez-Malagon N. Pharmacological interventions for the prevention of allergic and febrile non-haemolytic transfusion reactions. Cochrane Database Syst Rev. 2010 Jun 16;(6):CD007539. doi: 10.1002/14651858.CD007539.pub2. Review. PubMed PMID: 20556779
  7. Tubog TD, Harenberg JL, Buszta K, Hestand JD. Prophylactic Nalbuphine to Prevent Neuraxial Opioid-Induced Pruritus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Perianesth Nurs. 2018 Oct 30. pii: S1089-9472(18)30278-8. doi: 10.1016/j.jopan.2018.06.098. [Epub ahead of print] PubMed PMID: 30389225.
  8. He F, Jiang Y, Li L. The effect of naloxone treatment on opioid-induced side effects: A meta-analysis of randomized and controlled trails. Medicine (Baltimore). 2016 Sep;95(37):e4729. doi: 10.1097/MD.0000000000004729. Review. PubMed PMID: 27631221; PubMed Central PMCID: PMC5402564.
  9. Liao CC, Chang CS, Tseng CH, Sheen MJ, Tsai SC, Chang YL, Wong SY. Efficacy of intramuscular nalbuphine versus diphenhydramine for the prevention of epidural morphine-induced pruritus after cesarean delivery. Chang Gung Med J. 2011 Mar-Apr;34(2):172-8. PubMed PMID: 21539759.