Indigotindisulfonate

Indigotindisulfonate is a dye excreted by the kidney through tubular secretion and enhances visualization of the ureteral orifices by its deep blue color.

• BLUDIGO is indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures. BLUDIGO is a diagnostic dye indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures.

• BLUDIGO is contraindicated in patients with known hypersensitivity to indigotindisulfonate or any of its components [see Warnings and Precautions ( 5.2 )] . Known hypersensitivity to indigotindisulfonate or any of its components.contraindicated

Recommended dose is 5 mL given intravenously over 1 minute. ( 2.1 ) Monitor blood pressure and heart rhythm during and after injection. ( 2.2 ) 2.1 Recommended Dosage The recommended dose of BLUDIGO is 5 mL given as an intravenous injection over 1 minute. The blue color is detectable at the ureteral orifices within 4 minutes to 9 minutes after the intravenous injection. 2.2 Important Administration Instructions Monitor blood pressure and cardiac rhythm during and following the injection [see Warnings and Precautions ( 5.1 )] . Use immediately after opening ampule. Withdraw the contents of the ampule through a 5 micron or smaller filter straw/filter needle to ensure that the withdrawn solution contains no particulates. The withdrawn solution should be inspected visually for particulate matter and discoloration prior to administration. Do not administer with infusion assemblies used with other diluents or drugs. Discard any unused portion.

Cardiovascular Reactions : Severe or life-threatening cardiovascular reactions including cardiac arrest, arrhythmia, asystole, atrioventricular block second degree, hypotension, elevation in blood pressure, bradycardia, and tachycardia have been reported. Closely monitor blood pressure and cardiac rhythm during and following the BLUDIGO injection. Interrupt administration if reactions are observed. ( 5.1 ) Hypersensitivity Reactions : Serious anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, or erythema have been reported. Monitor patients for anaphylactic reactions and have emergency equipment and trained personnel readily available. ( 5.2 ) Interference with Oximetry Measurements : Anesthesiologists should be aware of the potential for artifactual reduction in SpO 2 when anesthetized patients are administered BLUDIGO. ( 5.3 ) 5.1 Cardiovascular Reactions Severe or life-threatening cardiovascular reactions including cardiac arrest, arrhythmia, asystole, second degree atrioventricular block, hypotension, elevation in blood pressure, bradycardia, and tachycardia have been reported generally within 60 minutes following administration of indigotindisulfonate sodium injection products and required urgent intervention [see Adverse Reactions ( 6.2 )] . Indigotindisulfonate may cause vasoconstriction by interference with vasodilation mediated by nitric oxide dependent mechanisms and by direct vasoconstriction. Indigotindisulfonate may also cause hypotension.

Clinically significant adverse reactions are described elsewhere in the labeling: Cardiovascular Reactions [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] Adverse reactions (≥ 1%) are constipation, nausea, vomiting, abdominal pain, pyrexia, ALT increase, and dysuria. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1–800-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of BLUDIGO was evaluated in a randomized, intra-patient controlled, blind to dose of BLUDIGO, clinical trial. A total of 118 adult patients undergoing endoscopic urological or gynecological procedures were treated intravenously; 58 (49%) of these patients received one dose of BLUDIGO 2.5 mL and 60 (51%) of patients received one dose of BLUDIGO 5 mL. The 2.5 mL dose is not approved [see Dosage and Administration ( 2.1 )]. The mean age of patients was 51 years and 35 (30%) patients were 65 years of age or older. The majority of patients were White 105 (89%) and female 87 (74%). The adverse reactions (≥1%) reported in the clinical trial are provided in Table 1 . Table 1.

Renal Impairment: BLUDIGO is not recommended for use in patients with eGFR<30 mL/min. ( 8.6 ) 8.1 Pregnancy Risk Summary Available data from case reports, case series, observational studies and clinical experience with indigotindisulfonate sodium injection use in pregnant women over several decades have not identified a drug associated risk of adverse maternal and fetal adverse effects. Indigotindisulfonate sodium injection use during the first trimester of pregnancy is rare; thus, the data are insufficient to evaluate for a drug associated risk of major birth defects and miscarriage. The majority of the published data were from intra-amniotic injections. Animal reproduction studies using the intravenous route of administration have not been conducted. Oral administration of indigotindisulfonate sodium to pregnant rats and rabbits produced no evidence of fetal harm. However, oral availability is low (3%) so that the risk of intravenous administration of indigotindisulfonate sodium during pregnancy cannot be evaluated from the data available . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S.

Metabolism

The pharmacokinetic properties of BLUDIGO are presented in Table 2 . Table 2.

• Jul 8, 2022NDANDA216264Provepharm Sas

1. 1Anaphylactic Reaction125%
2. 2Cheilitis125%
3. 3Dermatitis125%
4. 4Drug Ineffective125%
5. 5Extravasation125%
6. 6Radiation Skin Injury125%
7. 7Reaction To Excipient125%
8. 8Stomatitis125%

Recent PubMed references pinned to Indigotindisulfonate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Effect of indigo on the reproductive biology of Aedes aegypti.
  Anais da Academia Brasileira de Ciencias · 2026 · Silva TMSD, Silva AM, Faierstein GB, et al.
  PMID 42233974DOI 10.1590/0001-3765202620241190
• SAFETY AND EFFECTIVENESS OF BLUE EYE HYPERTONIC SOLUTION VERSUS SALINE SOLUTION IN THE TREATMENT OF FLAT COLONIC LESIONS: A RANDOMIZED CLINICAL TRIAL.
  Arquivos de gastroenterologia · 2026 · Coimbra CC, DA Gama IFL, Kaiser Junior RL, et al.
  PMID 42207084DOI 10.1590/S0004-2803.24612025-115
• Utility of texture and color enhancement imaging combined with acetic acid-indigo carmine for improving visibility of gastric tumors: a single-center prospective study.
  Surgical endoscopy · 2026 · Yamaguchi K, Fujimoto A, Sato N, et al.
  PMID 42191959DOI 10.1007/s00464-026-12913-3
• Biocatalytic Indigo Synthesis From L-Tryptophan Using a Three-Step Cascade Without Cofactor Regeneration.
  Chembiochem : a European journal of chemical biology · 2026 · Willers VP, Lončar N, Fraaije MW, et al.
  PMID 42011133DOI 10.1002/cbic.70342
• Indigo Naturalis regulates the gut microbiota to increase SCFAs content and improve ulcerative colitis lesions.
  Frontiers in cellular and infection microbiology · 2026 · Zhan XY, Xu R, Hu LZ, et al.
  PMID 41987898DOI 10.3389/fcimb.2026.1772977
• Elucidating the Multi-Enzymatic Mechanism of Bacterial Decolorization of Azo and Indigoid Dyes: An Integrated Study of Degradation Pathways and Molecular Docking.
  International journal of molecular sciences · 2026 · Wang C, Liu T, Song H, et al.
  PMID 41977166DOI 10.3390/ijms27072980
• Research on overdyeing process of indigo and turmeric on nylon knitted fabrics.
  Scientific reports · 2026 · Wu Y, Yuan X, Chen X, et al.
  PMID 41904193DOI 10.1038/s41598-026-45744-2
• Sodium alginate-based Fe(2)O(3)/NiO nanocomposite: A green-engineered and sustainable platform for antioxidant, antimicrobial, and catalytic degradation of indigo carmine dye.
  International journal of biological macromolecules · 2026 · Alanazi AA, Elattar KM, Abdulaziz F, et al.
  PMID 41802517DOI 10.1016/j.ijbiomac.2026.151300

The 4 most recently updated of 4 ClinicalTrials.gov registrations naming Indigotindisulfonate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency in Pediatric Patients
  Not yet recruiting · Phase 3 · Interventional · 18 enrolled · Prove pharm
  NCT06448143updated 2026-01-22
• Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment
  Recruiting · Phase 4 · Interventional · 48 enrolled · Prove pharm
  NCT06085183updated 2026-01-22
• Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency
  Recruiting · Phase 4 · Interventional · 116 enrolled · Prove pharm
  NCT06054880updated 2026-01-22
• Intra-operative Use of Indigo Carmine Dye for the Delineation of Ill Defined Tumor Borders Using Stereotactic Injection
  Completed · Phase 1 · Phase 2 · Interventional · 10 enrolled · Weill Medical College of Cornell University
  NCT01767415updated 2018-12-11

Frequently asked questions

How does Indigotindisulfonate work?

Indigotindisulfonate is a dye excreted by the kidney through tubular secretion and enhances visualization of the ureteral orifices by its deep blue color.

What is Indigotindisulfonate used for?

According to FDA labeling, Indigotindisulfonate carries indications including: BLUDIGO is indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures. BLUDIGO is a diagnostic dye indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the contraindications for Indigotindisulfonate?

Indigotindisulfonate labeling lists contraindications including: BLUDIGO is contraindicated in patients with known hypersensitivity to indigotindisulfonate or any of its components [see Warnings and Precautions ( 5.2 )] . Known hypersensitivity to indigotindisulfonate or any of its components.. Always consult the full prescribing information and a clinician.