Reason for the Shortage

• • West-Ward discontinued ranitidine injection in September 2014.[1]
  • Covis had Zantac on shortage due to capacity issues at the manufacturer.[2]
  • IGI laboratories acquired Zantac injection from Covis in October 2015. IGI was renamed Teligent. Teligent has Zantac injection available.[3]
  • Zydus has ranitidine injection available.[4]
  • Oral ranitidine products are not affected by this shortage.

Available Products

• • Zantac solution for injection, Teligent, 25 mg/mL, 2 mL vial, 10 count, NDC 24987-0362-10
  • Zantac solution for injection, Teligent, 25 mg/mL, 40 mL vial, 1 count, NDC 24987-0364-01
  • Zantac solution for injection, Teligent, 25 mg/mL, 6 mL vial, 1 count, NDC 24987-0363-01
  • Ranitidine solution for injection, Zydus, 25 mg/mL, 2 mL vial, 10 count, NDC 68382-0422-02
  • Ranitidine solution for injection, Zydus, 25 mg/mL, 6 mL vial, 1 count, NDC 68382-0423-06

• • All marketed presentations are available.

• • Ranitidine is a histamine type-2 receptor antagonist, or H2 blocker, which reduces gastric acid secretion in response to physiologic and dietary stimuli. Ranitidine injection is used for patients with hypersecretory conditions, intractable ulcers, or for patients who cannot receive oral therapy.[5]

• • 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, famotidine injection may be an alternative to ranitidine 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
  Adult with active duodenal ulcer, but unable to take oral medication5-6	Ranitidine 50 mg IV every 8 hours Famotidine 20 mg IV every 12 hours
  Gastrointestinal bleeding: prevention or treatment 10-18,5,7-9	Ranitidine 6.25-10 mg/hour continuous IV infusion Famotidine 20 mg IV every 12 hours or 1.7-4 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 conditions10-17,5,7-9	Ranitidine 50 mg every 6-8 hours or 1-2.5 mg/kg/hour continuous IV infusion Famotidine 20 mg IV every 6 hours 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. West-Ward, (personal communications). July 25, August 5, November 26, 2014; and July 14, 2015.
  2. Covis Pharma (personal communications). July 29, September 5, October 13, November 10, December 3, 16, and 30, 2014; February 5, May 4, July 14, and September 21, 2015.
  3. Teligent (personal communications). October 20, and November 2, 2015; January 26, April 8, July 12, August 11, September 29, November 2, December 19, 2016; January 4 and 31, February 10 and 17, and March 17, 2017.
  4. Zydus (personal communications). February 17, May 8, July 14, and September 21, 2015; January 26, April 11, July 12, August 10, October 19, December 19, 2016; February 10, and March 21, 2017.
  5. McEvoy GK, ed. Antiulcer agents and acid suppressants. In: AHFS Drug Information 2011. Bethesda, MD: American Society of Health-System Pharmacists; 2011:2971-3021.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. Armstrong D. Intravenous proton pump inhibitor therapy: a rationale for use. Rev Gastroenterol Disord. 2005;5 Suppl 2:S18-30.
  13. Beejay U, Wolfe MM. Acute gastrointestinal bleeding in the intensive care unit. Gastroenterology Clinics. 2000;29(2):309-336.
  14. 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).
  15. Donnelly AJ, Baughman VL, Gonzales JP, et al. Anesthesiology and Critical Care Drug Handbook. 6th ed. Hudson, OH: Lexi-Comp; 2005.
  16. American Society of Health-System Pharmacists. ASHP therapeutic guidelines on stress ulcer prophylaxis. Am J Health-Syst Pharm. 1999;56:347-379.
  17. 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.
  18. 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.