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Indigotindisulfonate sodium 0.8%
Indigotindisulfonate sodium is a vital dye that is used diagnostically to visualize the urinary tract and bladder during cystoscopy and other urological procedures.
Indigotindisulfonate sodium is a vital dye that is used diagnostically to visualize the urinary tract and bladder during cystoscopy and other urological procedures. Used for Diagnostic visualization of ureteral function and urine flow during cystoscopy, Assessment of upper urinary tract patency and obstruction.
At a glance
| Generic name | Indigotindisulfonate sodium 0.8% |
|---|---|
| Also known as | Bludigo, Bludigo® |
| Sponsor | Prove pharm |
| Drug class | Diagnostic dye |
| Modality | Small molecule |
| Therapeutic area | Urology |
| Phase | FDA-approved |
Mechanism of action
Indigotindisulfonate sodium is an azo dye that is excreted unchanged in the urine, imparting a blue color that allows visualization of ureteral jets and urine flow during cystoscopic examination. It is administered intravenously and rapidly appears in the urine, enabling clinicians to assess upper urinary tract function and identify ureteral obstruction or other abnormalities during endoscopic procedures.
Approved indications
- Diagnostic visualization of ureteral function and urine flow during cystoscopy
- Assessment of upper urinary tract patency and obstruction
Common side effects
- Discoloration of urine (blue)
- Hypersensitivity reactions
- Transient hypertension
Key clinical trials
- Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency (PHASE4)
- Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency in Pediatric Patients (PHASE3)
- Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
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