[14 February 2014]
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. - discontinued1
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
- Lundbeck sold several products to Recordati in January 2013 including Indocin IV and NeoProfen IV. Recordati is not currently manufacturing Indocin IV but NeoProfen is available.3
- 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.2
- Fresenius Kabi (formerly APP) had indomethacin injection on shortage due to increase demand for the product.4
Indomethacin sodium lyophilized powder for injection, single-dose vials (NDC 63323-0659-03) Fresenius Kabi (formerly APP)4
Estimated Resupply Dates
- Recordati has Indocin unavailable and the company cannot estimate a release date.1
- Recordati has ibuprofen lysine injection (Neoprofen, NDC 55292-0122-52) available through wholesalers or ASD Healthcare.1
- Bedford has indomethacin injection on long-term back order and the company cannot estimate a release date. Ben Venue manufactured indomethacin injection for Bedford.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).5 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.6,7
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.8
- Ibuprofen lysine injection has no effect on the incidence of intraventricular hemorrhage when given as prophylaxis in very low birth weight neonates.6,7
- 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, May 22, July 25, August 22, and October 15, 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, May 22, July 17, August 7, October 1, December 2, 2013; and February 11, 2014.
- Recordati (personal communications). October 15, December 9, 2013; and February 13, 2014.
- Fresenius Kabi (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, May 22, and August 1, 22, and 30, October 10, December 6, 2013; and February 11, 2014.
- 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 February 14, 2014 by Michelle Wheeler, PharmD, Drug Information Specialist. Created November 24, 2009 by Jane Chandramouli, Pharm.D. Drug Information Specialist. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.
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