Indigo carmine
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
- 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
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Package and Label Display Panel
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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.
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