[14 January 2014]
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)
Reason for the Shortage
- Ben Venue has stopped production in its plant in Bedford, Ohio and will close in early 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure.1
- GlaxoSmithKline sold Zantac injection to Covis Pharma in late-December, 2011.2,3
- Oral ranitidine products are not affected by this shortage.
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 the company cannot estimate a release date. Ben Venue manufactured ranitidine for Bedford.1
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
- 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
* Some presentations may be on nation-wide back order.1-3
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
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.
- Bedford, (personal communications and website). 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, May 15, July 16, September 9, October 21, 2013; and January 8, 2014.
- GlaxoSmithKline, (personal communications). August 11, September 9, October 4, November 9, and December 14, 2011; and January 17 and 31, 2012.
- 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, May 15, July 16, September 16, November 11, 2013; and January 14, 2014.
- McEvoy GK, ed. Antiulcer agents and acid suppressants. In: AHFS Drug Information 2011. Bethesda, MD: American Society of Health-System Pharmacists; 2011:2971-3021.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Armstrong D. Intravenous proton pump inhibitor therapy: a rationale for use. Rev Gastroenterol Disord. 2005;5 Suppl 2:S18-30.
- Beejay U, Wolfe MM. Acute gastrointestinal bleeding in the intensive care unit. Gastroenterology Clinics. 2000;29(2):309-336.
- 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).
- Donnelly AJ, Baughman VL, Gonzales JP, et al. Anesthesiology and Critical Care Drug Handbook. 6th ed. Hudson, OH: Lexi-Comp; 2005.
- American Society of Health-System Pharmacists. ASHP therapeutic guidelines on stress ulcer prophylaxis. Am J Health-Syst Pharm. 1999;56:347-379.
- 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.
- 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 January 14, 2014 by Michelle Wheeler, PharmD, Drug Information Specialist. Created August 17, 2011 by M. Christina Beckwith, PharmD, and Jane Chandramouli, PharmD, Drug Information Specialists. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.
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.
« Back to Drug Shortage Product Bulletins