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Indigo carmine: Drug information

Indigo carmine: Drug information
(For additional information see "Indigo carmine: Pediatric drug information" and see "Indigo carmine: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Bludigo;
  • Indigo Carmine [DSC]
Pharmacologic Category
  • Diagnostic Agent, Kidney Function
Dosing: Adult
Localization of ureteral orifices

Localization of ureteral orifices: IV: 5 mL.

Dosing: Kidney Impairment: Adult

Note: eGFR may be estimated using the MDRD formula for dosage adjustment purposes.

eGFR ≥30 mL/minute: No dosage adjustment necessary.

eGFR <30 mL/minute: Use not recommended (has not been studied).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

(For additional information see "Indigo carmine: Pediatric drug information")

Localizing ureteral orifices

Localizing ureteral orifices: Limited data available:

Infants and Children: IV: <5 mL; to avoid skin discoloration, doses less than the usual adolescent/adult dose of 5 mL necessary; has also been administered locally into the ureter(s) during cystoscopy procedure (Ref).

Adolescents: IV: Usual dose: 5 mL; patients who are small for age may need lower dose (<5 mL) to prevent skin discoloration; has also been administered locally into the ureter(s) during cystoscopy procedure (Ref).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.

1% to 10%:

Gastrointestinal: Abdominal pain (3%), constipation (5%), nausea (3%), vomiting (3%)

Genitourinary: Dysuria (2%)

Hepatic: Increased serum alanine aminotransferase (3%)

Miscellaneous: Fever (3%)

Postmarketing:

Cardiovascular: Asystole, bradycardia (Satoh 2001; Wu 1969), cardiac arrhythmia, hypotension (including severe hypotension) (Shir 1993), increased blood pressure (Wu 1969), second-degree atrioventricular block (Hobai 2008), tachycardia

Hypersensitivity: Anaphylaxis (Nandate 2016), nonimmune anaphylaxis (Nandate 2016)

Local: Skin discoloration at injection site

Contraindications

Hypersensitivity to indigotindisulfonate sodium or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Cardiovascular: Severe or life-threatening cardiovascular reactions, including cardiac arrest, arrhythmia, asystole, second degree atrioventricular block, hypotension, hypertension, bradycardia, and tachycardia, have been reported generally within 60 minutes following administration. May also cause vasoconstriction by interference with vasodilation mediated by nitric oxide dependent mechanisms and by direct vasoconstriction.

• Hypersensitivity reactions: Serious anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, or erythema have been reported; emergency equipment and trained personnel must be available.

Other warnings/precautions:

• Oximetry measurement interference: May interfere with light absorption leading to a transient, artifactual reduction in SpO2.

• Urine discoloration: May cause a temporary blue discoloration of urine; usually resolves within 48 hours.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Injection:

Indigo Carmine: 8 mg/mL (5 mL [DSC])

Solution, Intravenous [preservative free]:

Bludigo: 8 mg/mL (5 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Bludigo Intravenous)

8 mg/mL (per mL): $96.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

IV: Administer undiluted over 1 minute; withdraw ampule contents through a ≤5-micron filter straw/filter needle.

Administration: Pediatric

Parenteral:

IV (preferred): Administer undiluted over 1 minute. Withdraw contents using a ≤5-micron filter needle/straw only.

Local: Has been administered into ureter(s) as part of cystoscopy procedure in pediatric patients (Ref).

Use: Labeled Indications

Localization of ureteral orifices: Use as a visualization aid in the cystoscopic assessment of the integrity of the ureters following urological and gynecological open, robotic, or endoscopic surgical procedures in adults.

Pregnancy Considerations

Animal reproduction studies have not been conducted with IV indigotindisulfonate sodium.

Outcome data following first trimester exposure are limited. Administration of indigotindisulfonate sodium into the amniotic fluid has been used to diagnose prelabor rupture of membranes (ACOG 2020; Adekola 2016; Ireland 2017).

Breastfeeding Considerations

It is not known if indigotindisulfonate sodium is present in breast milk.

According to the manufacturer, the decision to breastfeed following the procedure should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Monitoring Parameters

BP and cardiac rhythm during and following the injection. Note: Duration of monitoring is not defined in the manufacturer's labeling; however, severe or life-threatening cardiovascular reactions have been reported generally within 60 minutes following administration.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Blue color is detectable at the ureteral orifices within 4 to 9 minutes following injection.

Distribution: Vd: 10.7 L.

Protein binding: ~90%.

Half-life elimination: IV injection: 12 minutes.

Excretion: Urine (16%, as unchanged drug); feces (<2%).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (BE) Belgium: Carmyne;
  • (DE) Germany: Indigocarmin;
  • (FR) France: Carmyne;
  • (HU) Hungary: Indigocarmin;
  • (JP) Japan: Indigocarmine daiichi;
  • (KR) Korea, Republic of: Carmin;
  • (NL) Netherlands: Indigokarmijn serb;
  • (RU) Russian Federation: Indigocarmin
  1. Adekola H, Gill N, Sakr S, et al. Outcomes following intra-amniotic instillation with indigo carmine to diagnose prelabor rupture of membranes in singleton pregnancies: a single center experience. J Matern Fetal Neonatal Med. 2016;29(4):544-549. doi:10.3109/14767058.2015.1015982 [PubMed 25714481]
  2. American College of Obstetricians and Gynecologists (ACOG). Prelabor rupture of membranes: ACOG practice bulletin, number 217. Obstet Gynecol. 2020;135(3):e80-e97. doi:10.1097/AOG.0000000000003700 [PubMed 32080050]
  3. Bludigo (indigotindisulfonate sodium) [prescribing information]. Collegeville, Pennsylvania: Provepharm Inc; July 2022.
  4. Hobai IA. Atrioventricular block induced by indigo carmine. Can J Anaesth. 2008;55(10):717-718. doi:10.1007/BF03017750 [PubMed 18835972]
  5. Indigo Carmine (indigotindisulfonate sodium) [prescribing information]. Shirley, NY: American Regent, Inc.; February 2017.
  6. Ireland KE, Rodriguez EI, Acosta OM, Ramsey PS. Intra-amniotic dye alternatives for the diagnosis of preterm prelabor rupture of membranes. Obstet Gynecol. 2017;129(6):1040-1045. doi:10.1097/AOG.0000000000002056 [PubMed 28486367]
  7. Nandate K, Voelzke BB. Severe hypotension, hypoxia, and subcutaneous erythema induced by indigo carmine administration during open prostatectomy. Case Rep Urol. 2016;2016:5237387. doi:10.1155/2016/5237387 [PubMed 27610263]
  8. Okawada M, Murakami H, Tanaka N, et al. Incidence of ureterovesical obstruction and Cohen antireflux surgery after Deflux treatment for vesicoureteric reflux. J Pediatr Surg. 2018;53(2):310-312. doi:10.1016/j.jpedsurg.2017.11.027 [PubMed 29217322]
  9. Okawada M, Shibuya S, Doi T, et al. Ureteric patency after Deflux injection for the treatment of vesicoureteric reflux in children confirmed by a novel epidural catheter-assisted endoscopic technique. Pediatr Surg Int. 2015;31(10):977-982. doi:10.1007/s00383-015-3778-9 [PubMed 26285894]
  10. Satoh K, Sakamoto N, Shinohe Y, Satoh M, Joh S. Indigo carmine-induced bradycardia in a patient during general anesthesia. Anesth Analg. 2001;92(1):276-277. doi:10.1097/00000539-200101000-00056 [PubMed 11133645]
  11. Shir Y, Raja SN. Indigo carmine-induced severe hypotension in patients undergoing radical prostatectomy. Anesthesiology. 1993;79(2):378-381. doi:10.1097/00000542-199308000-00024 [PubMed 8342846]
  12. Wu CC, Johnson AJ. The vasopressor effect of indigo carmine. Henry Ford Hosp Med J. 1969;17(2):131-137. [PubMed 5783815]
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