Products Affected - Description
Indigo carmine injection, Akorn
8 mg/mL, 5 mL ampule (NDC 17478-0508-01)
Indigo carmine injection, American Regent
8 mg/mL, 5 mL ampule (NDC 00517-0375-10)
Reason for the Shortage
There are no presentations available.
Estimated Resupply Dates
- Akorn has discontinued production of indigo carmine and the company cannot estimate when product will return.2
- American Regent has indigo carmine 8 mg/mL 5 mL ampules on back order and the company cannot estimate a release date.1
Implications for Patient Care
Indigo carmine is indigotindisulfonate sodium, a marker dye used during cystoscopy and ureteral catheterization.3,4 Indigo carmine is also used in endoscopic procedures, lymph node and vessel delineation, and for tumor localization. Indigo carmine is an unapproved drug without FDA approved labeling.5
Ensure appropriate dosing and indications when alternative dyes are used.
Alternative Agents & Management
- There is no single dye that can replace indigo carmine. Potential options include methylene blue, isosulfan blue, and indocyanine green.3 Choice of alternative agent will depend on type of procedure and physician discretion, as well as product availability. Many of the marker dyes are on nationwide shortage.6,7
- Hui et al published a case report of 32 women who received single-dose oral phenazopyridine (100 mg - 200 mg) one hour prior to pelvic reconstructive surgery. Intraoperative cystoscopy was performed to confirm ureteric patency. Bilateral ureteric patency was confirmed in all 32 cases and bladder mucosa was also adequately inspected in all women. No postoperative ureteric injuries were identified.8
- American Regent (personal communications and website). January 10, March 8, May 22, July 25, September 19, October 28, December 9, 2013; and January 27, April 24, and May 23, 2014.
- Akorn (personal communications). January 19, March 11, May 22, June 15, July 25, September 19, October 28, December 9, 2013; and January 27, April 24, and May 21, 2014.
- Indigo Carmine. In McEvoy, GK, Snow EK, et al., Eds. AHFS Drug Information Online. Accessed May 23, 2014.
- American Regent. Indigo Carmine injection [product information]. Shirley, NY, American Regent, 2009.
- Anon, editor. Drugdex System. Micromedex 2.0 [internet database]. Greenwood Village, CO: Truven Health Analytics; 2014.
- Methylene Blue Injection Shortage. American Society of Health-System Pharmacists Drug Shortage Resource Management Center. Accessed May 23, 2014.
- Indocyanine Green Shortage. American Society of Health-System Pharmacists Drug Shortage Resource Management Center. Accessed May 23, 2014.
- Hui J, Harvey, MA, Johnston SL. Confirmation of ureteric patency during cystoscopy using phenazopyridine HCL: A Low-Cost Approach. J Obstet Gyneaecol Can 2009; 31(9): 845-9.
Updated July 17, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist. Created May 23, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.
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