Indigotindisulfonate: Difference between revisions

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|genericName=Indigotindisulfonate sodium
|genericName=Indigotindisulfonate sodium
|aOrAn=a
|aOrAn=a
|drugClass=Diagnostic Agent
|drugClass=[[Diagnosis|Diagnostic Agent]]
|indicationType=diagnosis
|indicationType=diagnosis
|indication=ureteral orifices during cystoscopy and ureteral catheterization
|indication=[[Ureter|ureteral orifices]] during [[cystoscopy]] and [[Catheter|ureteral catheterization]]
|adverseReactions=allergic reaction
|adverseReactions=[[allergic reaction]]




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<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult=====Indications====
|fdaLIADAdult=====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.
* Originally employed as a [[kidney function test]], the chief application of Indigo Carmine at present is localizing [[Ureter|ureteral orifices]] during [[cystoscopy]] and [[Catheter|ureteral catheterization]].


====Dosage====
====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.
* Indigo Carmine solution is injected either by the [[intravenous]] or [[intramuscular]] route, and its appearance at the [[Ureter|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.
* Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


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<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|contraindications=* Indigo Carmine is contraindicated in patients who have previously experienced an adverse reaction following its use.


<!--Warnings-->
<!--Warnings-->
|warnings=* Description
|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====
====Precautions====


* Description
* Indigo Carmine should be stored in the dark, away from direct light, preferably in the original package.
 
<!--Adverse Reactions-->
<!--Adverse Reactions-->


<!--Clinical Trials Experience-->
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====




<!--Postmarketing Experience-->
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=[[allergic reaction]]
 
|drugInteractions=<!--Use in Specific Populations-->
=====Body as a Whole=====
|FDAPregCat=C
 
|useInPregnancyFDA=* 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.
 
 
=====Cardiovascular=====
 
 
 
=====Digestive=====
 
 
 
=====Endocrine=====
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
=====Metabolic and Nutritional=====
 
 
 
=====Musculoskeletal=====
 
 
 
=====Neurologic=====
 
 
 
=====Respiratory=====
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
=====Special Senses=====
 
 
 
=====Urogenital=====
 
 
 
=====Miscellaneous=====
 
 
 
<!--Drug Interactions-->
|drugInteractions=* Drug
:* Description
 
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''


There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInNursing=* 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.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
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<!--Administration and Monitoring-->
<!--Administration and Monitoring-->
|administration=* Oral
|administration=* [[Intravenous]]
 
* [[Intramuscular]]
* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


* Description


<!--IV Compatibility-->
<!--IV Compatibility-->
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<!--Overdosage-->
<!--Overdosage-->
|overdose====Acute Overdose===
|overdose=* There are no data available describing the signs, symptoms or laboratory findings accompanying overdosage.
 
====Signs and Symptoms====
 
* Description


====Management====
* 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.


* Description
====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.
===Chronic Overdose===
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacology-->
 
<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*  
|mechAction=*  


<!--Structure-->
<!--Structure-->
|structure=*  
|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.


: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


<!--Pharmacodynamics-->
<!--Pharmacodynamics-->
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<!--Pharmacokinetics-->
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
|PK=* 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-->
<!--Nonclinical Toxicology-->
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<!--How Supplied-->
<!--How Supplied-->
|howSupplied=*
|howSupplied=* NDC 17478-508-01
|storage=Store at 20° to 25°C (68° to 77°F)  
 
|packLabel=<!--Patient Counseling Information-->
: 5 mL ampules packaged in boxes of 10.
|storage=* Store at 20° to 25°C (68° to 77°F)
|packLabel=====PRINCIPAL DISPLAY PANEL====
 
: [[File:Indigo PDP 1.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
: [[File:Indigo PDP 2.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
====Ingredients and Appearance====
: [[File:Indigo I n A.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
 
<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


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<!--Brand Names-->
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title =  | url = }}</ref>
|brandNames=* INDIGO CARMINE®<ref>{{Cite web | title = Indigotindisulfonate sodium | url = http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482e3688-b942-4661-8ab5-3a0db625a405}}</ref>


<!--Look-Alike Drug Names-->
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
|lookAlike=* There is limited information regarding the look alike drug names.
 
<!--Drug Shortage Status-->
|drugShortage=
|drugShortage=
}}
}}
{{PillImage
|fileName=No image.jpg
}}
{{LabelImage
|fileName={{PAGENAME}}11.png
}}
{{LabelImage
|fileName={{PAGENAME}}11.png
}}
<!--Pill Image-->
<!--Label Display Image-->




Latest revision as of 16:30, 20 August 2015

Indigotindisulfonate
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: Rabin Bista, M.B.B.S. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

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

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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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

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
5 mL ampules packaged in boxes of 10.

Storage

  • Store at 20° to 25°C (68° to 77°F)

Images

Drug Images

{{#ask: Page Name::Indigotindisulfonate |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

PRINCIPAL DISPLAY PANEL

This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.

Ingredients and Appearance

This image is provided by the National Library of Medicine.

{{#ask: Label Page::Indigotindisulfonate |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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®[1]

Look-Alike Drug Names

  • There is limited information regarding the look alike drug names.

Drug Shortage Status

Price

References

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

  1. ↑ "Indigotindisulfonate sodium".
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