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Indigotindisulfonic acid | CAS No: 483-20-5 | GMP-certified suppliers
A medication that aids in visualizing ureteral orifices during cystoscopy and ureteral catheterization to assess ureter integrity in urological and gynecological surgeries.
Therapeutic categories
Coloring AgentsCompounds used in a research, industrial, or household settingDiagnostic AgentsDiagnostic DyeDrugs that are Mainly Renally ExcretedHeterocyclic Compounds, Fused-Ring
Generic name
Indigotindisulfonic acid
Molecule type
small molecule
CAS number
483-20-5
DrugBank ID
DB11577
Approval status
Approved drug, Investigational drug
ATC code
V04CH02
Primary indications
- 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
Product Snapshot
- Indigotindisulfonic acid is formulated as an injectable solution for intravenous, intramuscular, and ureteral administration
- It is primarily utilized as a visualization aid to localize ureteral orifices during cystoscopy and ureteral catheterization procedures
- The product holds approved status in the US and Canada for use in urological imaging applications
Clinical Overview
Indigotindisulfonic acid (CAS number 483-20-5) is an organic compound classified among indolines, characterized by an indole moiety comprising a pyrrolidine ring fused to a benzene ring. It is a blue-colored dye primarily utilized for its diagnostic applications in clinical medicine. The sodium salt form, indigotindisulfonate sodium, also known as indigo carmine or FD&C Blue #2, is the pharmaceutically relevant preparation used intravenously for visualization purposes.
Clinically, indigotindisulfonate sodium is indicated to localize and visualize ureteral orifices during cystoscopy and ureteral catheterization. It aids in confirming ureteral patency and assessing ureter integrity in adult patients undergoing urological and gynecological surgeries—both open and minimally invasive. The U.S. Food and Drug Administration approved its intravenous use in 2022 as an adjunct for cystoscopic procedures.
Pharmacodynamically, after an intravenous dose, the dye becomes visible at the ureteral orifices within 4 to 9 minutes due to its intense blue coloration, facilitating accurate identification during surgical visualization. Although initially considered pharmacologically inert, indigotindisulfonate sodium has been associated with cardiovascular effects including transient alpha-adrenergic receptor stimulation. This may manifest as increased peripheral vascular resistance, elevated blood pressure, altered central venous pressure, reductions in cardiac output, stroke volume, and heart rate. Severe cardiovascular adverse events such as arrhythmias, cardiac arrest, and conduction abnormalities have been documented. Additionally, hypersensitivity reactions including anaphylaxis with respiratory and cutaneous symptoms have been reported. The compound may also interfere with pulse oximetry readings due to its light absorption properties.
The mechanism of action is purely physical; the dye is biologically inert and excreted primarily via renal tubular secretion. Its blue coloration enhances visualization of urinary tract structures. Some evidence suggests that indigotindisulfonic acid can inhibit endothelium-dependent relaxation possibly through interference with nitric oxide pathways and vascular guanylyl cyclase in smooth muscle, contributing to hypertensive effects observed in some cases.
From a regulatory and practical standpoint, indigotindisulfonic acid is recognized as a diagnostic dye and is categorized under drugs mainly renally excreted, with applications in renal function and ureteral injury testing. When sourcing the API, considerations include ensuring pharmaceutical-grade purity to minimize contaminant-related adverse effects. Compliance with established pharmacopeial standards and regulatory guidelines is critical, and sourcing should prioritize manufacturers with validated quality control processes including impurity profiling and consistency in colorant properties. This is essential given the compound’s diagnostic use where accurate and reliable visualization is paramount.
Clinically, indigotindisulfonate sodium is indicated to localize and visualize ureteral orifices during cystoscopy and ureteral catheterization. It aids in confirming ureteral patency and assessing ureter integrity in adult patients undergoing urological and gynecological surgeries—both open and minimally invasive. The U.S. Food and Drug Administration approved its intravenous use in 2022 as an adjunct for cystoscopic procedures.
Pharmacodynamically, after an intravenous dose, the dye becomes visible at the ureteral orifices within 4 to 9 minutes due to its intense blue coloration, facilitating accurate identification during surgical visualization. Although initially considered pharmacologically inert, indigotindisulfonate sodium has been associated with cardiovascular effects including transient alpha-adrenergic receptor stimulation. This may manifest as increased peripheral vascular resistance, elevated blood pressure, altered central venous pressure, reductions in cardiac output, stroke volume, and heart rate. Severe cardiovascular adverse events such as arrhythmias, cardiac arrest, and conduction abnormalities have been documented. Additionally, hypersensitivity reactions including anaphylaxis with respiratory and cutaneous symptoms have been reported. The compound may also interfere with pulse oximetry readings due to its light absorption properties.
The mechanism of action is purely physical; the dye is biologically inert and excreted primarily via renal tubular secretion. Its blue coloration enhances visualization of urinary tract structures. Some evidence suggests that indigotindisulfonic acid can inhibit endothelium-dependent relaxation possibly through interference with nitric oxide pathways and vascular guanylyl cyclase in smooth muscle, contributing to hypertensive effects observed in some cases.
From a regulatory and practical standpoint, indigotindisulfonic acid is recognized as a diagnostic dye and is categorized under drugs mainly renally excreted, with applications in renal function and ureteral injury testing. When sourcing the API, considerations include ensuring pharmaceutical-grade purity to minimize contaminant-related adverse effects. Compliance with established pharmacopeial standards and regulatory guidelines is critical, and sourcing should prioritize manufacturers with validated quality control processes including impurity profiling and consistency in colorant properties. This is essential given the compound’s diagnostic use where accurate and reliable visualization is paramount.
Identification & chemistry
| Generic name | Indigotindisulfonic acid |
|---|---|
| Molecule type | Small molecule |
| CAS | 483-20-5 |
| UNII | X7OI7JF73P |
| DrugBank ID | DB11577 |
Pharmacology
| Summary | Indigotindisulfonic acid is a blue dye primarily used to enhance visualization of ureteral orifices during urologic and gynecologic procedures by renal tubular secretion and localization. Pharmacodynamically, it may induce cardiovascular effects including transient alpha-adrenergic receptor stimulation that can alter vascular resistance and cardiac function. Its mechanism involves inhibition of endothelium-dependent nitric oxide-mediated relaxation and vascular guanylyl cyclase activity in smooth muscle. |
|---|---|
| Mechanism of action | Indigotindisulfonic acid is a biologically inert blue dye. After intravenous injection, indigotindisulfonic acid is excreted by the kidney through tubular secretion and, with its deep blue color, it enhances visualization of the ureteral orifices. Because of this, indigotindisulfonic acid is used to identify ureteral patency in urologic and gynecologic procedures. Indigotindisulfonic acid may lead to the development of hypertension. It has been suggested that indigotindisulfonic acid inhibits endothelium-dependent relaxation at the level of nitric oxide generation and/or its release from the endothelium. Also, indigotindisulfonic acid appears to inhibit vascular guanylyl cyclase in smooth muscle. |
| Pharmacodynamics | Approximately 4-9 minutes after indigotindisulfonate sodium is administered intravenously, its blue color is detectable at the ureteral orifices, enabling easier visualization for accuracy during medical procedures. Although indigotindisulfonic acid and its salt form indigotindisulfonate sodium were initially acknowledged as pharmacologically inert, their use has been associated with cardiovascular effects. Indigotindisulfonate sodium may lead to transient alpha-receptor stimulation, manifested as increased total peripheral vascular resistance, increased diastolic and systolic blood pressure, and increased central venous pressure with decreased cardiac output, stroke volume and heart rate. The use of indigotindisulfonate sodium may lead to severe or life-threatening cardiovascular reactions such as cardiac arrest, arrhythmia, asystole, second-degree atrioventricular block, hypotension, elevation in blood pressure, bradycardia, and tachycardia. Serious anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, or erythema have also been reported. Also, the use of indigotindisulfonate sodium may interfere with light absorption and pulse oximetric methods. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Alpha adrenergic receptor | Humans | agonist |
ADME / PK
| Absorption | In healthy adults given 5 ml of indigotindisulfonate sodium (salt form of indigotindisulfonic acid), the C<sub>max</sub> and AUC<sub>0-INF</sub> were 6.33 μg/mL and 1.15 μg·h/mL, respectively. Studies evaluating the pharmacokinetic properties of intravenous indigotindisulfonate sodium in patients with renal impairment have not been performed. Based on subgroup analyses in a randomized clinical trial, patients with mild to moderate renal impairment or an estimated glomerular filtration rate (eGFR) from 30 to 89 mL/min do not require dose adjustments. Indigotindisulfonate sodium is not recommended in patients with eGFR lower than 30 mL/min. |
|---|---|
| Half-life | In healthy adults given 5 ml of indigotindisulfonate sodium, the elimination half-life was 12 minutes. |
| Protein binding | The protein binding of indigotindisulfonate sodium _in vitro_ is approximately 90%. |
| Metabolism | Indigotindisulfonate sodium is mainly oxidized via primary metabolic pathways. An _in vivo_ study done in rats showed that the breakdown of indigotindisulfonate sodium (FD&C Blue No. 2) generated two products: isatin-5-sulphonic acid and 5-sulphoanthranilic acid. Clinical studies evaluating indigotindisulfonate sodium metabolism products have not been performed. |
| Route of elimination | Indigotindisulfonic acid is excreted largely by the kidneys, retaining its blue color during passage through the body. Approximately 16% of the unchanged drug is excreted in urine, and less than 2% is excreted in feces. The elimination of this dye begins rapidly after injection, appearing in the urine within 5 minutes. |
| Volume of distribution | The volume of distribution of indigotindisulfonate sodium is 10.7 L. |
| Clearance | In healthy adults given 5 ml of indigotindisulfonate sodium, the mean urinary clearance was 7.08 L/hour, and the mean total clearance was 40.2 L/hour. |
Formulation & handling
- Indigotindisulfonic acid is formulated primarily for parenteral administration, including intravenous, intramuscular, and ureteral routes.
- The compound is a small molecule with moderate water solubility, requiring appropriate solvent systems for injection formulations.
- Stability considerations should focus on maintaining solution integrity for injectable forms, with attention to light and temperature sensitivity if data indicates.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is protected by patents in the United States until late 2036 and 2037, with primary markets in the US and Canada. The product is in the growth phase of its lifecycle, with patent protection maintaining market exclusivity. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Indigotindisulfonic acid is supplied by multiple originator companies offering branded products primarily in the US and Canadian markets. The existing patents in the United States extend through late 2036 and 2037, indicating that generic competition is unlikely to emerge in the near term. This suggests a controlled manufacturing landscape with a focus on patented branded formulations in North America. |
|---|
Safety
| Toxicity | Toxicity information regarding indigotindisulfonic acid is not readily available. Patients experiencing an overdose are at an increased risk of severe adverse effects such as cardiac arrest, arrhythmia, asystole, second degree atrioventricular block, hypotension, elevation in blood pressure, bradycardia, and tachycardia. Symptomatic and supportive measures are recommended. The use of indigotindisulfonate sodium in pregnant women has not been associated with a higher risk of adverse maternal and fetal adverse effects. The use of this dye in the first trimester is rare; therefore, data are insufficient to evaluate the risk of major birth defects and miscarriage associated with the use of indigotindisulfonate sodium. It is not known whether this drug is excreted in human breastmilk. Fertility studies with indigotindisulfonate sodium using the intravenous route of administration have not been conducted. Carcinogenicity studies evaluating the effects of the intravenous administration of indigotindisulfonate sodium have not been performed. In mice, the long term subcutaneous administration of indigotindisulfonate sodium did not have carcinogenic effects. Indigotindisulfonate sodium was not genotoxic in Ames assays. The _in vitro_ mutagenicity of this dye was inconclusive, and _in vivo_ studies suggest that orally administered indigotindisulfonate was not mutagenic. The oral LD<sub>50</sub> of indigotindisulfonate sodium in rats is 2000 mg/kg. |
|---|
High Level Warnings:
- Indigotindisulfonate sodium exhibits low acute oral toxicity with an LD50 of 2000 mg/kg in rats
- However, overdose may cause severe cardiovascular disturbances including arrhythmias and cardiac arrest
- Genotoxicity assays indicate no mutagenic potential in vivo
Indigotindisulfonic acid is a type of Diagnostic agents
Diagnostic agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used in the field of medical diagnostics. These agents play a vital role in diagnosing various diseases and conditions by aiding in the visualization and identification of specific biomarkers or structures within the body.
Diagnostic agents encompass a wide range of substances, including contrast agents, radiopharmaceuticals, and imaging agents. Contrast agents are commonly used in medical imaging techniques such as X-rays, magnetic resonance imaging (MRI), and computed tomography (CT) scans. They enhance the visibility of certain tissues or organs, allowing healthcare professionals to detect abnormalities more accurately.
Radiopharmaceuticals are another type of diagnostic agent that combines a radioactive component with a pharmaceutical compound. These agents emit radiation that can be detected by specialized imaging equipment, enabling the visualization of metabolic processes and the identification of abnormal cellular activity.
Imaging agents are designed to target specific molecular structures or biomarkers within the body. They can be used to detect and visualize specific proteins, enzymes, or receptors associated with certain diseases or conditions. By targeting these specific biomarkers, imaging agents provide valuable information about the presence, location, and extent of a disease, aiding in diagnosis and treatment planning.
Overall, diagnostic agents are essential tools in modern medicine, facilitating accurate and timely diagnoses. These pharmaceutical APIs enable healthcare professionals to identify and monitor diseases at an early stage, leading to better patient outcomes and improved treatment strategies.
