[22 May 2013]
Products Affected - Description
Indomethacin sodium trihydrate lyophilized powder for injection (Indocin I.V.)
single-dose vials, package of 3 (NDC 67386-0511-51), Lundbeck Inc.
Indomethacin sodium lyophilized powder for injection
single-dose vials, package of 1 (NDC 55390-0299-01), Bedford
Reason for the Shortage
- Indomethacin for injection is on nationwide back order due to manufacturing issues.1,2
- Bedford has indomethacin injection on shortage due to manufacturing delays. Bedford anticipates full availability of each presentation the company reintroduces to market.2
- 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. More information can be found at Bedford Laboratories website.2
Indomethacin sodium lyophilized powder for injection, single-dose vials (NDC 63323-0659-03), APP3
Estimated Resupply Dates
- Lundbeck (formerly Ovation Pharmaceuticals) has Indocin on back order and the company cannot estimate a release date. No emergency supplies are available.1
- Lundbeck has ibuprofen lysine injection (Neoprofen, NDC 67386-0122-52) available1
- Bedford has indomethacin injection on back order and this product will not be manufactured until capacity permits.2
Implications for Patient Care
Indomethacin for injection is labeled for closing hemodynamically significant patent ductus arteriosus (PDA) in premature infants who weigh between 500-1750 g, when medical management is ineffective after 48 hours and there is clinical evidence of respiratory distress, continuous heart murmur, hyperactive precordium, cardiomegaly, or pulmonary plethora (by chest radiography).4 Although not labeled uses, indomethacin for injection has also been used prophylactically to reduce the occurrence of intraventricular hemorrhage in very low birth weight neonates.5,6
Alternative Agents & Management
- Ibuprofen lysine injection (Neoprofen) is labeled for closing hemodynamically significant patent ductus arteriosus (PDA) in premature infants who weigh between 500-1750 g and are no more than 32 weeks gestational age, when medical management is ineffective.7
- Ibuprofen lysine injection has no effect on the incidence of intraventricular hemorrhage when given as prophylaxis in very low birth weight neonates.5,6
- There are different formulations of intravenous ibuprofen. Ibuprofen lysine (Neoprofen) is the only product labeled for use in premature infants. Use caution when selecting an intravenous ibuprofen product.
- Lundbeck Inc (formerly Ovation Pharmaceuticals) (personal communications). November 24, 25, and 30, 2009; January 4 and 20, February 9 and 19, March 16 and 30, May 5, June 9, July 30, August 12, September 1, October 18, December 16, 2010; February 16, March 22, April 22, May 13, June 16, July 27, August 16, September 20, 2011; January 18, March 12, May 24, August 15, October 10 and 30, November 20, 2012; January 23, March 25, and May 22, 2013.
- Bedford Laboratories (personal communications). January 5, February 19, March 16 and 30, May 5, June 9, and July 28, September 1, October 19, December 15, 2010; February 17, March 22, May 13, June 15, July 27, August 16, November 22, 2011; January 9, March 1, May 24, August 13, October 10, November 20, 2012; January 23, March 25, and May 22, 2013.
- APP Pharmaceuticals (personal communications). May 5, June 9, and August 12, September 1, October 20, December 17, 2010; February 16, March 16, June 15, July 27, August 16, September 16, 22 and 27, October 4 and 26, November 28, 2011; January 17, March 9, May 23, August 13, October 10, November 20, 2012; January 23, March 19, and May 22, 2013.
- Indocin I.V. [product information]. Deerfield, IL: Ovation Pharmaceuticals; 2006.
- Sekar, KC and Corff, KE. Treatment of patent ductus arteriosus: indomethacin or ibuprofen? J Perinatol 2008;28:S60-s62.
- McCrea HJ, Ment RM. The diagnosis, management, and postnatal prevention of intraventricular hemorrhage in the preterm neonate. Clin Perinatol. 2008 Dec;35(4):777-92.
- Neoprofen (ibuprofen lysine injection) product information. Deerfield, IL: Lundbeck Inc; 2009.
Updated May 22, 2013 by Leslie Jensen, PharmD, Drug Information Specialist. Created November 24, 2009 by Jane Chandramouli, Pharm.D. Drug Information Specialist. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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