Products Affected - Description
Vasopressin 20 units/mL Injection, American Regent
0.5 mL multi-dose vial, 25 count (NDC 00517-0510-25)
1 mL multi-dose vial, 25 count (NDC 00517-1020-25)
10 mL multi-dose vial, 10 count (NDC 00517-0410-10)
Vasopressin 20 units/mL Injection, Fresenius Kabi4
1 mL vial (NDC 63323-0302-01)
Pitressin 20 units/mL Injection, Par Sterile Products (formerly JHP)3
1 mL single-dose vial, 25 count (NDC 42023-0117-25) - discontinued
Reason for the Shortage
- American Regent has vasopressin injection on shortage due to manufacturing delays.1,2
- Par Sterile Products (formerly JHP) discontinued Pitressin injection in November 2014.3
- Par Sterile Products introduced Vasostrict injection in November 2014. This is the only FDA-approved vasopressin injection.3
- Fresenius Kabi has vasopressin on shortage due to increased demand for the product.4
Vasostrict Injection, Par Sterile Products3
20 units/mL, 1 mL multi-dose vial, 25 count (NDC 42023-0164-25)
Estimated Resupply Dates
- American Regent has vasopressin 20 units/mL 0.5 mL, 1 mL, and 10 mL vials on back order and the company cannot estimate a release date.1,2
- Fresenius Kabi has vasopressin injection on back order and the company estimates a release date in 4th quarter 2014.4
Implications for Patient Care
- Vasopressin injection is a synthetic 8-arginine vasopressin, an antidiuretic hormone released from the posterior pituitary gland. Vasopressin injection (Vasostrict®) is FDA-labeled to increase blood pressure in adults with vasodilatory shock who have low blood pressure despite therapy with fluids and catecholamines.5
- Indications for unapproved vasopressin injection products include use in diabetes insipidus, for the prevention and treatment of postoperative abdominal distention, and to dispel gas that may interfere with interpretation of abdominal roentgenography.6,7,8
- Unlabeled uses of vasopressin include adjunctive treatment of gastrointestinal or esophageal variceal hemorrhage, pulseless cardiac arrest, and for donor management in brain-dead patients.7,8,9
- According to the product labeling, Vasostrict injection must be refrigerated (store between 2° and 8°C).5 A letter from Par Pharmaceuticals, Inc. states Vasostrict injection is stable for up to 90 days at room temperature (15° and 25°C) once the unopened vial is removed from refrigeration. Label the vial with the revised expiration date to prevent the medication from being used beyond the 90-day period. However, if the manufacturer’s original expiration date is shorter than the revised expiration date, use the shorter date. This information is based on extrapolated data.19
- To avoid dosing errors, be aware that vasopressin is dosed in units and desmopressin is dosed in micrograms.5,6,10
- Vasopressin and desmopressin have different indications and actions.5,8,10
Alternative Agents & Management
- Desmopressin acetate (DDAVP) is another antidiuretic peptide available in the US. Desmopressin is labeled for treatment of diabetes insipidus, primary nocturnal enuresis, Hemophilia A, and von Willebrand disease.10
- Desmopressin acetate has greater vasopressin receptor V2 selectivity compared with vasopressin and has greater anti-diuretic potency. However, desmopressin has less vasopressin receptor V1 activity, which results in lower vasopressor and smooth muscle contracting activity compared to vasopressin. Desmopressin increases Factor VIII activity to a greater degree than vasopressin in patients with hemophilia A or von Willebrand Disease.8
- Table 1 lists alternatives to vasopressin in specific situations.
- Vasopressin is used as hormone replacement therapy in brain-dead patients who are organ donors. Vasopressin is part of the United Network for Organ Sharing (UNOS) standardized donor management protocol.11 Institutions may want to consider conserving product for this indication.
- American Regent (personal communications). May 13 and October 24, 2011.
- American Regent Product Releases. Accessed June 23, July 12 and 22, August 29, September 20, October 26, 2011; January 11, February 16, March 12, April 4 and 17, May 17, June 15, July 5 and 12, August 27, October 16, December 4, 2012; January 16, February 13, March 29, April 29, July 8, August 6, September 9, October 14, and December 4, 2013; February 20, March 3 and 31, May 9, June 30, August 27, October 23, and November 13, 2014.
- Par Sterile Products (formerly JHP) (personal communications). May 16, June 7 and 20, July 22, August 30, September 21, October 24, 2011; January 11, February 16, March 12, April 4 and 17, May 16, June 15, July 5 and 11, August 27, October 16, December 4, 2012; January 16, February 13, March 29, July 11, August 6, September 9, October 14, December 12, 2013; February 20, March 6 and 31, May 14, June 30, August 27, October 31, and November 11, 2014.
- Fresenius Kabi (formerly APP) (personal communications). May 16, June 7, July 12, August 30, September 16, October 24, 2011; January 11, February 15, March 9, April 4 and 17, May 14, June 12, July 3 and 9, August 27, October 16, December 4, 2012; January 16, February 13, March 29, April 23, May 7, July 8, August 6, September 9, October 8, and December 6, 2013; February 20, March 5 and 31, May 12, June 27, August 27, October 29, and November 11, 2014.
- Par Sterile Products. Vasostrict (Vasopressin) Injection [product information]. Spring Valley, NY: Par Sterile Products; May 2014.
- JHP Pharmaceuticals. Pitressin (Vasopressin) Injection Synthetic [product information]. Rochester, MI: JHP Pharmaceuticals; January 2010.
- Baughman VL, Golembiewski J, Gonzales JP, Alvarez W, eds. Anesthesiology and Critical Care Drug Handbook. 9th ed. Hudson, OH: Lexi-Comp; 2010.
- McEvoy GK, Snow EK, Kester L, Litvak K, Miller J, Welsh OH, eds. AHFS DI (Lexi-Comp Online). Bethesda, MD: American Society of Health-System Pharmacists; 2011.
- Wickersham RM, Novak KK, managing eds., eds. Drug Facts and Comparisons (eFacts). St. Louis, MO: Wolters Kluwer Health, Inc.; 2011.
- Sanofi-Aventis. DDAVP (Desmopressin) Injection [product information]. Bridgewater, NJ: Sanofi-Aventis; July 2007.
- United Network for Organ Sharing. Critical Pathway for Organ Donor. Accessed May 19, 2011.
- Anon. Drug Evaluation: Vasopressin. In: Hutchison TA, Shahan DR, Anderson ML, eds. Drugdex System [internet database]. Greenwood Village, CO: Thomson Healthcare; 2011. Updated periodically.
- Bauer SR, Lam SW. Arginine vasopressin for the treatment of septic shock in adults. Pharmacotherapy. Oct;30(10):1057-1071.
- Dictus C, Vienenkoetter B, Esmaeilzadeh M, Unterberg A, Ahmadi R. Critical care management of potential organ donors: our current standard. Clin Transplant. Dec 2009;23 Suppl 21:2-9.
- Garcia-Tsao G, Sanyal AJ, Grace ND, Carey W. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. Sep 2007;46(3):922-938.
- Maybauer MO, Walley KR. Best vasopressor for advanced vasodilatory shock: should vasopressin be part of the mix? Intensive Care Med. Sep;36(9):1484-1487.
- Shah VR. Aggressive management of multiorgan donor. Transplant Proc. May 2008;40(4):1087-1090.
- Fauci AS, Braunwald E, Kasper DL, et al., eds. Harrison's Principles of Internal Medicine. 17th ed. New York, NY: McGraw-Hill; 2008.
- Musaji, N. Personal communication: Vasostrict storage at room temperature. Par Sterile Products; Parsippany, NJ. November 11, 13, and 21, 2014.
Updated November 21, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist. Created May 19, 2011 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.
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