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Ranitidine Injection

[15 May 2013]

Products Affected - Description

Ranitidine 25 mg/mL injection, Bedford
2 mL vial (NDC 55390-0616-10)
6 mL vial (NDC 55390-0616-01)
40 mL vial (NDC 55390-0618-01)
 
Zantac 1 mg/mL infusion, Covis
50 mL premixed bag (NDC 00173-0441-00)
 
Zantac 25 mg/mL injection, GlaxoSmithKline
2 mL vial (NDC 00173-0362-38) - discontinued
6 mL vial (NDC 00173-0363-01) - discontinued
40 mL vial (NDC 00173-0363-00) - discontinued

Reason for the Shortage

  • Bedford has ranitidine injection on shortage due to manufacturing delays. Bedford anticipates full availability of each presentation the company reintroduces to market.1
  • Ben Venue voluntarily entered into a consent decree with FDA in late-January 2013 which allows Ben Venue to manufacture over 100 medications as long as they are compliant with the decree. Ben Venue supplies multiple products for Bedford Laboratories, a division of Ben Venue.
  • GlaxoSmithKline sold Zantac injection to Covis Pharma in late-December, 2011.2,3
  • Oral ranitidine products are not affected by this shortage.

Available Products

Zantac 25 mg/mL injection, Covis
2 mL vial (NDC 00173-0362-38)
6 mL vial (NDC 00173-0363-01)
40 mL vial (NDC 00173-0363-00)

Estimated Resupply Dates

  • Bedford has ranitidine 25 mg/mL 2 mL, 6 mL, and 40 mL vials on long-term back order and will not be manufactured until capacity permits.1
  • Covis has Zantac 1 mg/mL, 50 mg premixed bags available with short dating. The product has an expiration date of October 31, 2013. 3  

Implications for Patient Care

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.4

Safety

  • 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.

Alternative Agents & Management

  • 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 below 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 medication4,5
Ranitidine* 50 mg IV every 8 hours

Famotidine* 20 mg IV every 12 hours

Gastrointestinal bleeding: prevention or treatment4,6-17
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 conditions4,6-16 
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.
* Some presentations may be on nation-wide back order.1-3

Related Shortages

References

  1. Bedford, (personal communications). August 11, September 7, October 5, November 9, December 14, 2011; January 9, March 1 and 20, April 5, June 4, July 9 and 11, August 30, October 26, November 7, 2012; January 16, March 12, and May 15, 2013.
  2. GlaxoSmithKline, (personal communications). August 11, September 9, October 4, November 9, and December 14, 2011; and January 17 and 31, 2012.
  3. Covis Pharma (personal communications). January 31, February 14, March 13, 20, and 29, June 4, July 10, September 17, October 26, November 7, 2012; January 16, March 11, and May 15, 2013.
  4. McEvoy GK, ed. Antiulcer agents and acid suppressants. In: AHFS Drug Information 2011. Bethesda, MD: American Society of Health-System Pharmacists; 2011:2971-3021.
  5. 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.
  6. 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. 
  7. 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. 
  8. 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. 
  9. 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. 
  10. 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. 
  11. Armstrong D. Intravenous proton pump inhibitor therapy: a rationale for use. Rev Gastroenterol Disord. 2005;5 Suppl 2:S18-30. 
  12. Beejay U, Wolfe MM. Acute gastrointestinal bleeding in the intensive care unit. Gastroenterology Clinics. 2000;29(2):309-336.
  13. 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. Cited: August 20, 2008.
  14. Donnelly AJ, Baughman VL, Gonzales JP, et al. Anesthesiology and Critical Care Drug Handbook. 6th ed. Hudson, OH: Lexi-Comp; 2005.
  15. American Society of Health-System Pharmacists. ASHP therapeutic guidelines on stress ulcer prophylaxis. Am J Health-Syst Pharm. 1999;56:347-379.
  16. 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.
  17. 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.

Updated

Updated May 15, 2013 by Leslie Jensen, PharmD, Drug Information Specialist. Created August 17, 2011 by M. Christina Beckwith, PharmD, and Jane Chandramouli, PharmD, Drug Information Specialists. Copyright 2013, 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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