Indigo Carmine
Indigo carmine (indigotindisulfonate sodium) is a visible blue urinary dye. BLUDIGO received initial US approval in 2022 and has a current prescribing label; the 2014 shortage should not be presented as permanent unavailability. It is indicated as a visualization aid during cystoscopic assessment of ureteral integrity in adults after urological or gynecological open, robotic or endoscopic surgery.[1] Confirm local supply and formulary access.
Pharmacology and administration
| Item | Current US BLUDIGO information |
|---|---|
| Formulation | 40 mg/5 mL (8 mg/mL), single-dose ampule |
| Adult dose | 5 mL IV over 1 minute |
| Excretion | Renal, including tubular secretion |
| Ureteral efflux | Blue urine generally appears within minutes; timing depends on renal function and urinary flow |
| Renal impairment | No adjustment for eGFR 30–89 mL/min; not recommended with eGFR <30 mL/min |
Do not mix/dilute with other solutions or drug products. The label describes one dose; a routine repeat-once-per-case instruction is not established. Follow the ampule preparation and administration instructions.[1]
What the examination establishes
Blue efflux helps identify ureteral orifices and assess urine passage at that moment. It does not exclude every partial obstruction or delayed thermal/ischemic ureteral injury. Persistent suspicion requires direct assessment and appropriate imaging or retrograde evaluation, even if efflux is seen.[2]
Indigo carmine does not provide the same through-tissue NIR mapping as retrograde ICG. These methods answer related but different questions; visible-light cystoscopy has not become obsolete because a center owns an NIR camera.
For a double-dye fistula examination, the usual distinction is oral phenazopyridine-colored upper-tract urine versus intravesical methylene blue. Adding IV blue dye can confuse that color distinction. Use the clinical vesicovaginal fistula evaluation pathway.
Safety
- Contraindicated: hypersensitivity to indigotindisulfonate or a product component.
- Cardiovascular reactions: severe hypertension or hypotension, arrhythmia, conduction abnormalities and cardiac arrest have been reported, generally within 60 minutes. Monitor blood pressure and rhythm during and after injection; interrupt administration if a reaction occurs.
- Anaphylaxis: monitor and have trained personnel and emergency equipment available.
- Pulse oximetry: may transiently underestimate oxygen saturation. Assess the patient and obtain an appropriate alternative measurement when needed rather than dismissing a low reading.
- Pregnancy data are limited; pediatric safety/effectiveness are not established in the US label.[1]
Historical shortage and alternatives
The 2014 shortage prompted evaluation of fluorescein, phenazopyridine and bladder-distension techniques. Doyle's report used 25–100 mg IV sodium fluorescein as an off-label aid.[3] Select alternatives according to the purpose, safety profile and local availability; pudexacianinium remains investigational.
See Also
References
1. BLUDIGO. US prescribing information, revised November 2025. DailyMed.
2. de'Angelis N, Schena CA, Marchegiani F, et al. 2023 WSES guidelines for prevention, detection and management of iatrogenic urinary tract injuries during emergency digestive surgery. World J Emerg Surg. 2023;18:45. doi:10.1186/s13017-023-00513-8.
3. Doyle PJ, Lipetskaia L, Duecy E, Buchsbaum G, Wood RW. Sodium fluorescein use during intraoperative cystoscopy. Obstet Gynecol. 2015;125(3):548–550. doi:10.1097/AOG.0000000000000675.