Dosing & Uses
Dosage Forms & Strengths
injection
- 8 mg/mL (5-mL ampule)
Diagnostic Aid for Cystoscopy
Indicated for use as a visualization aid in cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures
5 mL IV over 1 minute
Blue color detectable at ureteral orifices within 4-9 minutes after IV injection
Dosage Modifications
Renal impairment
- Mild-to-moderate (eGFR 30-89 mL/min): No dosage adjustment necessary
- Severe (eGFR <30 mL/min): Not studied; use not recommended
Dosing Considerations
Monitor blood pressure and cardiac rhythm during and following injection
Safety and efficacy not established
Adverse Effects
1-10%
Constipation (5%)
Nausea (3.3%)
Vomiting (3.3%)
Abdominal pain (3.3%)
Pyrexia (3.3%)
ALT increase (3.3%)
Dysuria (1.7%)
Postmarketing Reports
Cardiovascular disorders: Cardiac arrest, arrhythmia, asystole, atrioventricular block second degree, hypotension, elevation in blood pressure, bradycardia, tachycardia
General disorders and administration site conditions: Injection site discoloration
Immune system disorders: anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, erythema
Warnings
Contraindications
Hypersensitivity to indigotindisulfonate or any of its components
Cautions
Severe or life-threatening cardiovascular reactions (eg, cardiac arrest, arrhythmia, asystole, second degree atrioventricular block, hypotension, elevated blood pressure, bradycardia, tachycardia) reported generally within 60 minutes following administration
Patients with hypertension, heart rate and conduction disorders, or medications causing bradycardia may be at increased risk for elevated blood pressure, hypotension, and bradycardia; closely monitor blood pressure and cardiac rhythm during and following the injection; interrupt administration if reactions observed
Serious anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, or erythema reported; monitor for anaphylactic reactions and have emergency equipment and trained personnel readily available
May interfere with light absorption and transiently interfere with pulse oximetric methods; be aware of potential for artifactual reduction in SpO2 when anesthetized patients are administered indigotindisulfonate
Pregnancy & Lactation
Pregnancy
Available data on use in pregnant females over several decades have not identified a drug associated risk of adverse maternal and fetal adverse effects
Use during first trimester of pregnancy is rare; thus, data are insufficient to evaluate for a drug associated risk of major birth defects and miscarriage
Lactation
Unknown if present in animal or human milk
Transfer into breastmilk is likely to be low and adverse effects on breastfed infants are not expected
There are no data on regarding effects on breastfed infants or milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Dye excreted by kidneys through tubular secretion that enhances visualization of ureteral orifices by its deep blue color
Absorption
Peak plasma concentration: 6.33 mcg/mL
AUC: 1.15 mcg·hr/mL
Distribution
Vd: 10.7 L
Protein bound: ~90%
Metabolism
Primary metabolic pathways: Oxidative metabolism
Elimination
Half-life: 12 min
Clearance: 7.08 L/hr (urinary); 40.2 L/hr (total)
Administration
Preparation
Monitor blood pressure and cardiac rhythm during and following injection
Use immediately after opening ampule
Withdraw ampule contents through <5-micron filter straw/filter needle to ensure withdrawn solution contains no particulates
Visually inspect withdrawn solution for particulate matter and discoloration before administering; do not administer with infusion assemblies used with other diluents or drugs
Discard any unused portion
Storage
Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
Store in original carton to protect from light
Do not refrigerate or freeze
Use immediately after opening ampule
Images
Formulary
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