indigotindisulfonate sodium (Rx)

Brand and Other Names:Bludigo
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    Dosing & Uses

    AdultPediatric

    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

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    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

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    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

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    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.

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    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)

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    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

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    Images

    No images available for this drug.
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    Patient Handout

    A Patient Handout is not currently available for this monograph.
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    Formulary

    FormularyPatient Discounts

    Adding plans allows you to compare formulary status to other drugs in the same class.

    To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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    • Compare formulary status to other drugs in the same class.
    • Access your plan list on any device – mobile or desktop.

    The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

    Tier Description
    1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
    2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
    3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
    4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
    5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
    6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
    NC NOT COVERED – Drugs that are not covered by the plan.
    Code Definition
    PA Prior Authorization
    Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
    QL Quantity Limits
    Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
    ST Step Therapy
    Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
    OR Other Restrictions
    Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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    Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.