Indigotindisulfonate

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# Overview
Indigotindisulfonate is a Diagnostic Agent that is FDA approved for the diagnosis of ureteral orifices during cystoscopy and ureteral catheterization.   Common adverse reactions include allergic reaction.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

### Indications
- Originally employed as a kidney function test, the chief application of Indigo Carmine at present is localizing ureteral orifices during cystoscopy and ureteral catheterization.

### Dosage
- Indigo Carmine solution is injected either by the intravenous or intramuscular route, and its appearance at the ureteral orifices is watched with the cystoscope in place. The intravenous method is preferred because a 5 mL injection is sufficient. A lesser dosage in infants, children and underweight patients will prevent skin coloration.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Indigotindisulfonate in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Indigotindisulfonate in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
- Safety and efficacy in pediatrics patients has not been established

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Indigotindisulfonate in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Indigotindisulfonate in pediatric patients.

# Contraindications
- Indigo Carmine is contraindicated in patients who have previously experienced an adverse reaction following its use.

# Warnings
- An occasional idiosyncratic drug reaction may occur. A mild pressor effect may be encountered in some patients.
- Since precipitation of indigotindisulfonate sodium may occur, Indigo Carmine Solution must not be diluted prior to injection or injected with infusion assemblies which were used with other solutions.

### Precautions
- Indigo Carmine should be stored in the dark, away from direct light, preferably in the original package.

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Indigotindisulfonate in the drug label.

## Postmarketing Experience
allergic reaction

# Drug Interactions
There is limited information regarding Indigotindisulfonate Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): C
- Animal Reproduction studies have not been conducted with indigotindisulfonate sodium injection. It is also not known whether indigotindisulfonate sodium injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Indigotindisulfonate sodium injection should be given to a pregnant woman only if clearly needed.
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Indigotindisulfonate in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Indigotindisulfonate during labor and delivery.

### Nursing Mothers
- It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Indigo Carmine is administered to a nursing woman.

### Pediatric Use
There is no FDA guidance on the use of Indigotindisulfonate with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Indigotindisulfonate with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Indigotindisulfonate with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Indigotindisulfonate with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Indigotindisulfonate in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Indigotindisulfonate in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Indigotindisulfonate in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Indigotindisulfonate in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Intravenous
- Intramuscular

### Monitoring
There is limited information regarding Monitoring of Indigotindisulfonate in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Indigotindisulfonate in the drug label.

# Overdosage
- There are no data available describing the signs, symptoms or laboratory findings accompanying overdosage.
- No discernible symptoms of toxicity have been observed in mice with an intravenous dose of 200 mg/kg. After intravenous administration the LD80 was established at 300 mg/kg in mice.

### DRUG ABUSE AND DEPENDENCE
- Indigo Carmine is not a controlled substance listed in any of the Drug Enforcement Administration Schedules. Its use is not known to lead to dependence or abuse.

# Pharmacology
There is limited information regarding Indigotindisulfonate Pharmacology in the drug label.

## Mechanism of Action

## Structure
- Each mL contains:
- Active: Indigotindisulfonate Sodium 8 mg Inactives: Water for injection, q.s. pH adjusted when necessary with Citric Acid and/or Sodium Citrate.
- Sufficient Indigo Carmine is contained in each 5 mL ampule to permit accurate withdrawal and administration of the full dose. It gives a deep blue solution when dissolved in water.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Indigotindisulfonate in the drug label.

## Pharmacokinetics
- Indigo Carmine is excreted largely by the kidneys, retaining its blue color during passage through the body.
- Elimination of the dye begins soon after injection, appearing in the urine within 10 minutes in average cases. The biological half-life is 4 to 5 minutes following intravenous injection. Larger quantities are necessary when intramuscular injection is employed. Appearance time and elimination are delayed following intramuscular injection.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Indigotindisulfonate in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Indigotindisulfonate in the drug label.

# How Supplied
- NDC 17478-508-01

## Storage
- Store at 20 to 25C (68 to 77F)

# Images

## Drug Images

## Package and Label Display Panel

### PRINCIPAL DISPLAY PANEL

### Ingredients and Appearance

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Indigotindisulfonate in the drug label.

# Precautions with Alcohol
- Alcohol-Indigotindisulfonate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- INDIGO CARMINE

# Look-Alike Drug Names
- There is limited information regarding the look alike drug names.

# Drug Shortage Status

# Price