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).
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Indigo carmine: Drug information")
Localization of ureteral orifices: IV: 5 mL.
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).
There are no dosage adjustments provided in the manufacturer's labeling.
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
Hypersensitivity to indigotindisulfonate sodium or any component of the formulation.
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.
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)
Yes
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.
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).
IV: Administer undiluted over 1 minute; withdraw ampule contents through a ≤5-micron filter straw/filter needle.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store in original carton to protect from light. Do not refrigerate or freeze. Use ampule immediately after opening; discard unused portion.
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 (Bludigo: FDA approved in adults).
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).
Blood pressure, heart rate/rhythm.
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%).
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