Products Affected - Description

• • Famotidine solution for injection, Baxter, 20 mg, 50 mL premixed bag, 12 count, NDC 00338-5197-41

Reason for the Shortage

• • Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.[1]
  • Hikma did not provide a reason for the shortage.[2]
  • Pfizer launched famotidine injections in March 2012.[3]
  • Mylan Institutional acquired famotidine injections from Pfizer on December 6, 2013. The are not providing availability updates.[4]
  • Fresenius Kabi did not provide a reason for the shortage.[5]
  • Baxter did not provide a reason for the shortage.[6]

Available Products

• • Famotidine solution for injection, Fresenius Kabi, 10 mg/mL, 2 mL vial, 25 count, NDC 63323-0739-12
  • Famotidine solution for injection, Fresenius Kabi, 10 mg/mL, 20 mL vial, 10 count, NDC 63323-0738-20
  • Famotidine solution for injection, Fresenius Kabi, 10 mg/mL, 4 mL vial, 10 count, NDC 63323-0738-04
  • Famotidine solution for injection, Hikma, 10 mg/mL, 2 mL vial, 25 count, NDC 00641-6022-25
  • Famotidine solution for injection, Hikma, 10 mg/mL, 20 mL vial, 10 count, NDC 00641-6021-10
  • Famotidine solution for injection, Hikma, 10 mg/mL, 4 mL vial, 25 count, NDC 00641-6023-25

• • All marketed presentations are available.

• • Famotidine is a histamine type-2 receptor antagonist, or H2 blocker, which reduces gastric acid secretion in response to physiologic and dietary stimuli. Famotidine injection is used for patients with hypersecretory conditions, intractable ulcers, or for patients who cannot receive oral therapy.[7]

• • Ensure patients receive an appropriate alternative based on their specific clinical indication.
  • The drug interaction profile differs between the H2 blocker class and the proton pump inhibitors (PPIs). Evaluate the patient's medication profile for drug interactions when switching between different drug classes.

• • Use oral H2 blocker therapy whenever possible.
  • In patients who require IV therapy, ranitidine injection may be an alternative to famotidine injection. If IV H2 blockers are not available, consider therapy with an injectable proton pump inhibitor.
  • Table 1 summarizes potential alternatives in selected clinical situations.

  Table 1. Recommendations for Acid Suppressive Therapy In Adults in Specific Clinical Situations

  Clinical Situation	Recommendations
  * Some presentations may be on nation-wide backorder.1-5,21
  Adult with active duodenal ulcer, but unable to take oral medication7-8	Famotidine* 20 mg IV every 12 hours Ranitidine* 50 mg IV every 8 hours
  Gastrointestinal bleeding: prevention or treatment7,9-20	Famotidine* 20 mg IV every 12 hours or 1.7-4 mg/hour continuous IV infusion Ranitidine* 6.25-10 mg/hour continuous IV infusion Esomeprazole IV 80 mg bolus followed by a constant infusion of 8 mg/hr for 72 hours Pantoprazole IV 80 mg bolus followed by a constant infusion of 8 mg/hr for 72 hours
  Hypersecretory conditions7,9-20	Famotidine* 20 mg IV every 6 hours Ranitidine* 50 mg every 6-8 hours or1-2.5 mg/kg/hour continuous IV infusion Esomeprazole 20 - 40 mg IV every 24 hours Pantoprazole IV 80 mg every 12 hours or 80 mg every 8 hours (doses > 240 mg/day or for > 6 days have not been studied)Adjust doses to achieve desired response.

  
  

• 1. Bedford, (personal communications). June 15, July 7 and 19, August 5, November 4, December 7, 2011; February 16 and 27, April 5, June 5, August 6, October 9, December 14, 2012; January 23, February 21, April 8, May 29, July 17, August 7 and 14, September 19, November 11, December 2, 2013; January 7, February 18, March 4 and 19, April 8, May 19 and 27, June 30, and July 2 and 23, 2014.
  2. Hikma, (personal communications). June 15, July 7 and 18, August 10, 16, and 23, September 20, October 4 and 26, November 4, December 7 and 28, 2011; February 4, 24, and 27, April 3, June 14, August 6, October 5, December 14, 2012; January 23, February 21, April 5, June 7, July 26, August 16 and 30, September 23, November 11, December 4 and 6, 2013; January 7, 11, and 17, February 21 and 27, March 3 and 21, April 10, May 2, 16, and 28, June 11 and 30, July 10 and 30, August 13, September 5, October 8 and 29, November 6 and 20, December 17, 2014; January 28, March 18, June 3 and 10, July 29, September 2 and 15, December 7 and 16, 2015; January 25, February 18, April 29, June 20, July 18, August 2, November 2 and 10, December 7, 2016; February 16, April 4, May 3, July 5 and 19, September 7 and 29, October 26, November 9 and 30, 2017; January 18, February 28, March 21 and 28, April 11 and 18, May 16 and 23, June 6 and 27, July 25, August 1, 15, 22, and 29, September 5 and 26, October 3, 24, and 31, November 7, December 12 and 20, 2018; January 17 and 30, February 6 and 27, March 6, May 2, and July 24, 2019.
  3. Pfizer, (personal communications). March 1, April 4, May 29, August 14, October 11, December 14, 2012; January 23 April 5, June 7, July 19, August 16, September 3, and 20, November 11, and December 4, 2013.
  4. Mylan Institutional, (personal communications). December 9, 2013; January 9 and 14, February 24, March 25, April 11 and 14, May 6, 20, and 28, June 16, July 30, August 20, 2014; January 29, March 18, May 29, August 12, September 21, December 15, 2015; January 25, April 15, June 27, July 18, November 8, 2016; March 2, April 3, May 9, July 10, August 1, September 20, and October 5, November 1, December 4, 2017; February 16, March 27, May 16, July 3, and August 20, October 23, December 18, 2018; March 5, and April 22, 2019.
  5. Fresenius Kabi, (personal communications). June 15, July 7, 11, and 21, August 10 and 23, September 16, October 4 and 26, November 8, December 7, 2011; January 10, February 6 and 22, April 4, June 12, August 13, October 10, December 14, 2012; January 23, February 21, April 8, June 10, July 24, August 19 and 30, September 24, November 11, December 3 and 6, 2013; January 8 and 13, February 24, March 7 and 18, April 8 and 14, May 6, 19, and 28, June 17, July 3, 11, and 25, August 1 and 14, September 5 and 8, October 7 and 29, November 4 and 19, December 17, 2014; January 26, March 18, June 3 and 9, August 5, September 17, December 11, 2015; January 14, 20, and 28, February 18, March 3, May 11, June 24, July 15, August 3 and 11, November 11 and 21, December 8, 2016; February 28, April 3, May 9, July 6 and 27, September 15, October 4 and 27, November 10 and 30, 2017; January 19, March 9, 20, 23, and 29, April 6 and 21, May 10 and 19, June 5 and 28, July 19, August 3, 13, 17, 23, and 29, September 6 and 21, October 5 and 26, November 9, December 14 and 20, 2018; January 11, February 1 and 7, March 1 and 8, May 3, and July 26, 2019.
  6. Baxter, (personal communications). September 20, October 26, 2011; January 10, February 24, August 14, December 14, 2012; January 23, February 21, April 8, June 14, July 29, September 3, November 11, December 3, 2013; January 7, February 24, March 21, May 8, June 16, July 30, 2014; January 29, March 18, May 29, August 11, September 2, December 14, 2015; December 9, 2016; February 21, April 3, May 9, July 7, October 5, November 1, December 3, 2017; February 9, July 6, September 26, 2018; March 5, May 8, and July 29, 2019.
  7. McEvoy GK, ed. Antiulcer agents and acid suppressants. In: AHFS Drug Information 2011. Bethesda, MD: American Society of Health-System Pharmacists; 2011:2971-3021.
  8. Cooper DH, Krainik AJ, Lubner SJ, Reno HEL. Esophageal disorders. Gastroesophageal reflux disease. In: The Washington Manual of Medical Therapeutics. 32nd edition. Philadelphia, PA: Wolters Kluwer Health; 2007:444-446.
  9. Bajaj JS, Dua KS, Hanson K, Presberg K. Prospective, randomized trial comparing effect of oral versus intravenous pantoprazole on rebleeding after nonvariceal upper gastrointestinal bleeding: a pilot study. Dig Dis Sci. Sep 2007;52(9):2190-2194.
  10. Hartmann D, Eickhoff A, Damian U, Riemann JF, Schilling D. Effect of intravenous application of esomeprazole 40 mg versus pantoprazole 40 mg on 24-hour intragastric pH in healthy adults. Eur J Gastroenterol Hepatol. Feb 2007;19(2):133-137.
  11. Tsibouris P, Zintzaras E, Lappas C, et al. High-dose pantoprazole continuous infusion is superior to somatostatin after endoscopic hemostasis in patients with peptic ulcer bleeding. Am J Gastroenterol. Jun 2007;102(6):1192-1199.
  12. Zargar SA, Javid G, Khan BA, et al. Pantoprazole infusion as adjuvant therapy to endoscopic treatment in patients with peptic ulcer bleeding: prospective randomized controlled trial. J Gastroenterol Hepatol. Apr 2006;21(4):716-721.
  13. Rohss K, Wilder-Smith C, Kilhamn J, Fjellman M, Lind T. Suppression of gastric acid with intravenous esomeprazole and omeprazole: results of 3 studies in healthy subjects. Int J Clin Pharmacol Ther. Jun 2007;45(6):345-354.
  14. Armstrong D. Intravenous proton pump inhibitor therapy: a rationale for use. Rev Gastroenterol Disord. 2005;5 Suppl 2:S18-30.
  15. Beejay U, Wolfe MM. Acute gastrointestinal bleeding in the intensive care unit. Gastroenterology Clinics. 2000;29(2):309-336.
  16. Reynolds MS, Petros BA: H2-Antagonists: Continuous infusion for Stress Ulcer Prophylaxis (Drug Consult). In: Klasco RK (Ed): DRUGDEX® System (electronic version). Thomson Micromedex, Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com (cited: August 20, 2008).
  17. Donnelly AJ, Baughman VL, Gonzales JP, et al. Anesthesiology and Critical Care Drug Handbook. 6th ed. Hudson, OH: Lexi-Comp; 2005.
  18. American Society of Health-System Pharmacists. ASHP therapeutic guidelines on stress ulcer prophylaxis. Am J Health-Syst Pharm. 1999;56:347-379.
  19. Leontiadis GI, Sreedharan A, Dorward S, et al. Systematic reviews of the clinical effectiveness and cost-effectiveness of proton pump inhibitors in acute upper gastrointestinal bleeding. Health Technol Assess. Dec 2007;11(51):iii-iv, 1-164.
  20. Sung JJ, Barkun A, Kuipers EJ, et al; Peptic Ulcer Bleed Study Group. Intravenous esomeprazole for prevention of recurrent peptic ulcer bleeding: a randomized trial. Ann Intern Med. 2009;150(7):455-464.
  21. GlaxoSmithKline, (personal communication). August 12, 2011.