Indigo carmine 40mg/10ml solution for injection vials

IntroductionAggressive colorectal cancer (CRC) frequently originates from serrated lesions (SLs), particularly in the proximal colon, which are challenging to detect using standard screening colonoscopy. Although duplicate examinations or chromocolonoscopies are recommended for detecting proximal SLs, evidence from randomized trials is limited. We evaluated the effectiveness of tandem colonoscopy with an acetic acid-indigo carmine mixture (AIM) for detecting SLs in the proximal colon compared with white-light imaging (WLI) and indigo carmine (IC).MethodsThis 3-arm, multicenter, randomized controlled trial involving 9 institutions enrolled patients undergoing colonoscopy and assigned them randomly to the WLI, IC, or AIM group. The primary outcomes were the SL-detection rate (SDR) of proximal lesions during the second examination (SDR 2nd ) and SL additional rate (SAR). Secondary outcomes included the detection and additional rates of other polyps, factors contributing to SAR, and complications.ResultsBetween 2021 and 2024, 1,319 participants with 1,267 polyps were included in the analysis. With AIM, the SDR 2nd and SAR were significantly higher compared with WLI or IC (WLI vs AIM: 2.7% vs 14.0%, P DiscussionAIM significantly improved proximal colon SDRs and outperformed WLI and IC. The relationship between SDR and CRC incidence warrants further investigation.

Abstract licence: CC BY-NC-ND

Importance Despite its frequent use for visualization of ureteral efflux during pelvic/abdominal surgery, there are limited data on indigo carmine pharmacokinetics and duration of blue color in postdose urine. Understanding how long the blue color persists allows the clinician to make accurate assessments of the urinary system during complex surgical procedures. Objectives This study observed the plasma and urinary pharmacokinetics of indigo carmine in healthy volunteers and the voided urine color. Study Design This study was an open-label, randomized clinical trial in 16 healthy participants who received either a 2.5-mL or a 5.0-mL intravenous injection of indigo carmine. Blood (pre, 2, 5, 7, 10, 15, 20, 30, 40 minutes and 1, 2, 3, 4, 6, 12 hours post) and urine (predose, 0–2, 2–6, 6–12 hours post) were collected. The first postdose stool was collected. Results Plasma concentration peaked within 5 minutes, and all plasma concentrations were below the limit of quantification by 2 hours postdose. The estimated plasma half-life of indigo carmine was 12 minutes. Voided urine through 2 hours postdose was visibly discolored compared with the matched predose urine. In some cases, urine discoloration persisted through 6 hours (10/16) and 12 hours (1/16). Unchanged indigo carmine eliminated in stool was observed in 4 of 16 participants (25%). Conclusions The short half-life and rapid urinary excretion of indigo carmine favor its clinical use for intraoperative cystoscopy and are consistent with the reported median time of 6 minutes postinjection to ureteral efflux in patients undergoing surgical procedures.

Abstract licence: CC BY-NC-ND 4.0

Dyes, such as indigo carmine, have become indispensable to modern life, being widely used in the food, textile, pharmaceutical, medicine, and cosmetic industry. Although indigo carmine is considered toxic and has many adverse effects, it is found in many foods, and the maximum permitted level is 500 mg/kg. Indigo carmine is one of the most used dyes in the textile industry, especially for dyeing denim, and it is also used in medicine due to its impressive applicability in diagnostic methods and surgical procedures, such as in gynecological and urological surgeries and microsurgery. It is reported that indigo carmine is toxic for humans and can cause various pathologies, such as hypertension, hypotension, skin irritations, or gastrointestinal disorders. In this review, we discuss the structure and properties of indigo carmine; its use in various industries and medicine; the adverse effects of its ingestion, injection, or skin contact; the effects on environmental pollution; and its toxicity testing. For this review, 147 studies were considered relevant. Most of the cited articles were those about environmental pollution with indigo carmine (51), uses of indigo carmine in medicine (45), and indigo carmine as a food additive (17).

Abstract licence: CC BY 4.0