Indigo carmine

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Indigo carmine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

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Overview

Indigo carmine is a dye that is FDA approved for the treatment of localizing ureteral orifices during cystoscopy and ureteral catheterization. Common adverse reactions include idiosyncratic drug reaction.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Originally employed as a kidney function test, the chief application of Indigo Carmine at present is localizing ureteral orifices during cystoscopy and ureteral catheterization.
  • 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.
  • 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.
  • 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 Indigo carmine in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Indigo carmine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Indigo carmine FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Indigo carmine 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.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Indigo carmine Clinical Trials Experience in the drug label.

Postmarketing Experience

  • An occasional idiosyncratic drug reaction may occur. A mild pressor effect may be encountered in some patients.

Drug Interactions

There is limited information regarding Indigo carmine 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.
  • 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.


Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Indigo carmine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Indigo carmine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Indigo carmine in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Indigo carmine in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Indigo carmine in geriatric settings.

Gender

There is no FDA guidance on the use of Indigo carmine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Indigo carmine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Indigo carmine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Indigo carmine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Indigo carmine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Indigo carmine in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Intra catheter

Monitoring

There is limited information regarding Indigo carmine Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Indigo carmine and IV administrations.

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 LD50was established at 300 mg/kg in mice.

Pharmacology

There is limited information regarding Indigo carmine Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Indigo carmine Mechanism of Action in the drug label.

Structure

There is limited information regarding Indigo carmine Structure in the drug label.

Pharmacodynamics

There is limited information regarding Indigo carmine Pharmacodynamics 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 Indigo carmine Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Indigo carmine Clinical Studies in the drug label.

How Supplied

There is limited information regarding Indigo carmine How Supplied in the drug label.

Storage

There is limited information regarding Indigo carmine Storage in the drug label.

Images

Drug Images

  • Indigo Carmine Injection
  • NDC 0517-0375-10 5 mL ampules packaged in boxes of 10

Package and Label Display Panel

This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
Indigo 01.jpg
This image of the FDA label is provided by the National Library of Medicine.
Indigo carmine 02.png
This image of the FDA label is provided by the National Library of Medicine.

Patient Counseling Information

There is limited information regarding Indigo carmine Patient Counseling Information in the drug label.

Precautions with Alcohol

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

Brand Names

  • INDIGO CARMINE ®[1]

Look-Alike Drug Names

There is limited information regarding Indigo carmine Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. "INDIGO CARMINE - indigotindisulfonate sodium injection, solution".

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