Lansoprazole Injection

31 July 2007

Products Affected - Description

Lansoprazole for injection (Prevacid I.V.), TAP Pharmaceuticals - discontinued
30 mg single dose vials, package of 10, NDC 00300-3954-25

Reason for the Shortage

• Wyeth would not provide a reason for the recent pantoprazole for injection shortage.¹
• Nexium IV supplies are not affected by this shortage.²
• TAP Pharmaceuticals has discontinued Prevacid IV.³

Estimated Resupply Dates

• Wyeth has pantoprazole products available and is shipping to wholesalers.¹
• TAP Pharmaceuticals is no longer manufacturing Prevacid IV, and all inventory is depleted.³

Implications for Patient Care

• Pantoprazole injection is labeled for the short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) as an alternative to oral therapy in patients who are unable to take pantoprazole delayed-release tablets.⁴ Pantoprazole injection is also labeled for the treatment of pathological hypersecretory conditions associated with neoplasia, such as Zollinger-Ellison syndrome.⁴
• While not among the FDA-approved indications, pantoprazole injection is also used to treat gastrointestinal bleeding and prevent gastrointestinal rebleeding.^5-7
• Lansoprazole injection has been discontinued. The product was an injectable proton-pump inhibitor (PPI) labeled for the short-term treatment (up to 7 days) of erosive esophagitis, as an alternative to oral medications.⁸
• Esomeprazole injection is another alternative injectable PPI labeled for the short-term treatment (up to 10 days) of erosive esophagitis, as an alternative to oral medications.⁹

Safety

• Pantoprazole injection contains edetate disodium (EDTA), which is a potent chelator of zinc. For patients prone to zinc deficiency, zinc supplementation should be considered while patients are receiving IV pantoprazole.⁴
• Lansoprazole injection must be filtered during administration, using an in-line 1.2 micron filter.⁸
• The doses of IV lansoprazole and IV esomeprazole are different from the dose of IV pantoprazole.^4,8,9

Alternative Agents & Management

• During this shortage, clinicians may consider using other injectable proton-pump inhibitors, injectable histamine H₂-receptor antagonists, or oral PPI preparations. Table 1 (PDF) provides alternatives to pantoprazole injection for selected clinical situations.
• Dosage equivalences among the oral PPIs have been established in clinical trials. The following doses administered at the same interval give approximately equivalent therapeutic results: esomeprazole 20 mg, lansoprazole 30 mg, omeprazole 20 mg, pantoprazole 40 mg, or rabeprazole 20 mg.^10-12 A 40-mg dose of pantoprazole IV is approximately equivalent to a 40-mg oral dose.⁴ Similarly, a 30-mg dose of lansoprazole IV is approximately equivalent to a 30-mg oral dose.^8,13
• Simplified suspensions of lansoprazole or omeprazole may be given by the enteral route to patients with a swallowing difficulty or an enteral feeding tube; see Table 2 (PDF) for details. There are no data on the effectiveness of esomeprazole, pantoprazole, or rabeprazole tablets or capsules when administered enterally but not swallowed whole.
• The PPIs are weak bases that are degraded in an acidic environment, such as the stomach.^14,15
• Oral PPIs are formulated to minimize the amount of drug lost to acid hydrolysis. The oral dosage forms of lansoprazole, omeprazole, and esomeprazole are formulated as enteric-coated capsules containing acid-resistant granules.^14,15 The enteric coating dissolves in the stomach, delivering the intact granules to the intestine for dissolution, where the drug is absorbed.¹⁶ The oral dosage forms of pantoprazole and rabeprazole are formulated as delayed-release, enteric-coated tablets that deliver the intact drug to the intestine for absorption. None of these products may be crushed.¹⁵
• For maximal effectiveness, simplified PPI suspensions should be administered only into the intestine and intact granules should be administered only into the stomach.^17,18

Related Shortages

• Esomeprazole for Injection— Resolved
• Omeprazole Tablets— Resolved
• Pantoprazole Sodium Injection— Resolved
• Ranitidine Injection

1. Wyeth (personal communications). January 25 and February 1, March 1, and April 13, May 26, and June 2, September 11, 2006; and January 31, 2007, and February 5 and 9, 2007.
2. AstraZeneca (personal communications). January 26 and 27, and February 1, March 1, April 13, May 26, and June 2, 2006.
3. TAP Pharmaceuticals (personal communications). January 26 and 27, February 1, March 1, April 13, May 26, June 2, July 7, September 11, and October 16, 2006, January 16 and 31, February 9, and July 30, 2007.
4. Protonix I.V. [product information]. Philadelphia, PA: Wyeth Laboratories; September 2005.
5. Van Rensburg CJ, Thorpe A, Warren B, et al. Intragastric pH in patients with bleeding peptic ulceration during pantoprazole infusion of 8 mg/hour (abstract). Gastroenterology. 1997;112:A321.
6. Van Rensburg CJ, Thorpe A, Warren B, et al. Intragastric pH during pantoprazole infusion of 6 mg/hour in patients with bleeding peptic ulceration (abstract). Gastroenterology. 1999;116:A344.
7. Fried M. Comparison of intravenous pantoprazole with intravenous ranitidine in peptic ulcer bleeding (abstract). Gut. 1999;45:A100.
8. Prevacid I.V. [product information]. Lake Forest, IL: TAP Pharmaceuticals, Inc.; December 2004.
9. Nexium I.V. [product information]. Wilmington, DE: AstraZeneca; March 2005.
10. Stedman CA, Barclay ML. Review article: comparison of the pharmacokinetics, acid suppression and efficacy of proton pump inhibitors. Aliment Pharmacol Ther. 2000;14:963-978.
11. Richardson P, Hawkey CJ, Stack WA. Proton pump inhibitors. Pharmacology and rationale for use in gastrointestinal disorders. Drugs. 1198;56(3):307-335.
12. Nexium Science. Available online at: http://www.nexium-us.com (accessed on June 24, 2009). Wilmington, DE: AstraZeneca. Updated September 2004.
13. Maisch NM, Smith C. Lansoprazole IV: a new delivery method for an established PPI. Formulary 2003;38:705-9.
14. McEvoy GK, ed. Miscellaneous GI Drugs. AHFS Drug Information 2001. Bethesda, MD: American Society of Health-System Pharmacists; 2001:2807-2865.
15. Sharma VK, Vasudeva R, Howden CW. Simplified lansoprazole suspensiona liquid formulation of lansoprazoleeffectively suppresses intragastric acidity when administered through a gastrostomy. Am J Gastroenterol. 1999;94:1813-1817.
16. Phillips JO, Metzler MH. The stability of simplified lansoprazole suspension (SLS). Gastroenterology. 1999;116(4 part 2):A89.
17. Song JC, Quercia RA, Fan C, Tsikouris J, White CM. A prospective study of simplified omeprazole suspension for the prophylaxis of stress-related mucosal damage. Am J Health-Syst Pharm. 2001;58:689-694.
18. Sharma VK, Peyton B, Spears T, Raufman JP, Howden CW. Oral pharmacokinetics of omeprazole and lansoprazole after single and repeated doses as intact capsules or as suspensions in sodium bicarbonate. Aliment Pharmacol Ther. 2000;14:887-892.
19. Beejay U, Wolfe MM. Acute gastrointestinal bleeding in the intensive care unit. Gastroenterology Clinics. 2000;29(2):309-336.
20. Reynolds MS, Petros BA. H2-antagonists-continuous infusion for stress ulcer prophylaxis (Drug Consult). In: Hutchison TA & Shahan DR (Eds): Drugdex System. Greenwood Village, CO: Micromedex. (Edition expires 03/2006.)
21. Donnelly AJ, Cunningham FE, Baughman VL. Anesthesiology and Critical Care Drug Handbook. 3rd ed. Hudson, OH: Lexi-Comp; 2000.
22. American Society of Health-System Pharmacists. ASHP therapeutic guidelines on stress ulcer prophylaxis. Am J Health-Syst Pharm. 1999;56:347-379.
23. Khuroo MS, Khuroo MS, Farahat KL, Kagevi IE. Treatment with proton pump inhibitors in acute non-variceal upper gastrointestinal bleeding: a meta-analysis. J Gastroenterol Hepatol. 2005;20(1):11-25.
24. Lansoprazole (Drug Evaluation). In: Hutchison TA & Shahan DR (Eds): Drugdex System. Greenwood Village, CO: Micromedex. (Edition expires 03/2006.)
25. Zimmermann A, Walters JK, Katona B, Souney P. Alternative methods of proton pump inhibitor administration. Consult Pharm. 1997;12:990-998.
26. Prevacid [product information]. Lake Forest, IL: TAP Pharmaceuticals; July 2004
27. Zegerid [product information]. San Diego, CA: Santarus, Inc.; December 2004.
28. Nexium capsules [product information]. Wilmington, DE: AstraZeneca; June 2005.
29. White CW, Kalus JS, Quercia R, Fortier C, et al. Delivery of esomeprazole magnesium enteric-coated pellets through small caliber and standard nasogastric tubes and gastrostomy tubes in vitro. Am J Health-Syst Pharm. 2002;59(1):2085-8.
30. Sostek MB, Chen Y, Skammer W, Winter H et al. Esomeprazole administered through a nasogastric tube provides bioavailability similar to oral dosing. Aliment Pharmacol Ther 2003;18:581-6.
31. Phillips JO, Metzler MH, Palmieri TL, Huckfeldt RE, Dahl NG. A prospective study of simplified omeprazole suspension for the prophylaxis of stress-related mucosal damage. Crit Care Med. 1996;24:1793-1800.
32. Ferron GM, Ku Sherry, Abell M, et al. Oral bioavailability of pantoprazole suspended in sodium bicarbonate solution. Am J Health-Syst Pharm. 2003; 60:1324-9.
33. Safety briefs. ISMP Medication Safety Alert! 2002;7(12):1-2
34. DiGiacinto JL, Olsen KM, Bergman KL, Hoie EB. Stability of suspension formulations of lansoprazole and omeprazole stored in amber-colored plastic oral syringes. Ann Pharmacother. 2000;34:600-605.
35. McAndrews KL, Eastham JH. Omeprazole and lansoprazole suspensions for nasogastric administration. Am J Health-Syst Pharm. 1999;56:81.
36. Quercia RA, Fan C, Liu X, Chow MSS. Stability of omeprazole in an extemporaneously prepared oral liquid. Am J Health-Syst Pharm. 1997;54:1833-1836.

Updated

Updated July 31, 2007 by Erin R. Fox, Pharm.D., Drug Information Specialist. Created February 17, 2002, by Andrew Martin, Pharm.D., Erin R. Fox, Pharm.D., and M. Christina Beckwith, Pharm.D., Drug Information Specialists. Copyright 2006, Drug Information Service, University of Utah, Salt Lake City, UT.

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