Indigotindisulfonic acid

Overview

Indigotindisulfonic acid is a blue-colored dye with a variety of uses. Its salt form, indigotindisulfonate sodium, is also known as indigo carmine, indigotine or FD&C Blue #2. This compound is an acid-base indicator and is used in the production of food colorants and pH tests. Indigotindisulfonic acid is used in clinical medicine to determine patency of the urinary collecting system, and to assist in specific surgical procedures such as cystourethroscopy. In 2022, the FDA approved the intravenous use of indigotindisulfonate sodium to aid in visualizing ureter integrity in cystoscopic assessments.

Indication

The main application of indigotindisulfonic acid is localizing and visualizing ureteral orifices during cystoscopy and ureteral catheterization procedures . Indigotindisulfonate sodium (salt form) 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.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency in Pediatric Patients	2024/06/07	NCT06448143	Phase 3	Not yet recruiting	Prove pharm
Indigotindisulfonate Sodium Injection, USP As an Aid in the Determination of Ureteral Patency in Patient's with Renal Impairment	2023/10/16	NCT06085183	Phase 4	Recruiting	Prove pharm
Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency	2023/09/26	NCT06054880	Phase 4	Recruiting	Prove pharm
Chromoendoscopy of the Colon After Oral Administration of Indigo Carmine	2013/08/02	NCT01914445	Not Applicable	UNKNOWN	Hillel Yaffe Medical Center
Intra-operative Use of Indigo Carmine Dye for the Delineation of Ill Defined Tumor Borders Using Stereotactic Injection	2013/01/14	NCT01767415	Phase 1	Completed	Weill Medical College of Cornell University
Comparative Efficacy of Water & Indigo Carmine vs. Water or Air Method on Adenoma Detection Rate (ADR) - a Randomized Controlled Trial (RCT)	2012/05/30	NCT01607255	Phase 4	Completed	VA Office of Research and Development

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
INDIGO CARMINE INJECTION 20 mg/5 ml	Hospira Australia Pty Ltd	SIN11374P	INJECTION	4 mg/mL	8/16/2000

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Indigo Carmine Injection	西南药业股份有限公司	国药准字H50021944	化学药品	注射剂	9/25/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
DBL INDIGO CARMINE 20mg/5mL Injection	16350	Phebra Pty Ltd	Medicine	A	10/8/1991

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