Label: INDIGO CARMINE- indigo carmine injection, solution

  • NDC Code(s): 0517-0375-01, 0517-0375-05
  • Packager: American Regent, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 19, 2018

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  • SPL UNCLASSIFIED SECTION

    Rx Only

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  • DESCRIPTION

    Each mL contains: Indigotindisulfonate Sodium 8 mg, Water for Injection q.s. pH adjusted, when necessary, with Citric Acid and/or Sodium Citrate. Sterile, nonpyrogenic.

    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.

    The structural formula is:

    0aade973-figure-01
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  • CLINICAL PHARMACOLOGY

    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.

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  • INDICATIONS AND USAGE

    Originally employed as a kidney function test, the chief application of Indigo Carmine at present is localizing ureteral orifices during cystoscopy and ureteral catheterization.

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  • CONTRAINDICATIONS

    Indigo Carmine is contraindicated in patients who have previously experienced an adverse reaction following its use.

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  • WARNINGS

    An occasional idiosyncratic drug reaction may occur. A mild pressor effect may be encountered in some patients.

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  • PRECAUTIONS

    Pregnancy

    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.

    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.

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  • ADVERSE REACTIONS
  • 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.

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  • 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 LD50 was established at 300 mg/kg in mice.

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  • DOSAGE AND ADMINISTRATION

    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.

    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.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

    NOTE: Since Indigo Carmine is a dark blue solution, visual inspection for particulate matter prior to use may not be possible.  To ensure that the withdrawn solution contains no particulates, 5 micron filter straws/filter needles must be used when withdrawing contents of ampules1.  The 5 micron nylon mesh filter is suitable for withdrawing the drug product, Indigo Carmine.

    1 ASHP Guidelines on Compounding Sterile Preparations

     PROTECT FROM LIGHT. Indigo Carmine should be stored in the dark, away from direct light, preferably in the original package.

    Store at 20º to 25º C (68º to 77º F); excursions permitted to 15º to 30º C (59º to 86º F) (See USP Controlled Room Temperature).

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  • HOW SUPPLIED

    Indigo Carmine Injection

    NDC 0517-0375-05        5 mL ampules         packaged in boxes of 5

    AMERICAN
    REGENT, INC.
    SHIRLEY, NY 11967

    IN0375

    Rev. 2/17

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 5 mL Container

    NDC 0517-0375-01

    INDIGO CARMINE
    INJECTION

    (Indigotindisulfonate Sodium Injection, USP)
    0.8% Solution

    5 mL AMPULE
    FOR IV OR IM USE

    Rx Only

    AMERICAN
    REGENT, INC.

    SHIRLEY, NY 11967

    Container Label


    PRINCIPAL DISPLAY PANEL – 5 mL Carton

    INDIGO CARMINE INJECTION
    (Indigotindisulfonate Sodium Injection, USP)
    0.8% Solution

    NDC 0517-0375-05

    5
     x 5 mL AMPULES

    Rx Only

    FOR INTRAVENOUS OR INTRAMUSCULAR USE

    Each mL contains: Indigotindisulfonate Sodium 8 mg, Water for Injection q.s. pH adjusted, when necessary, with Citric Acid and/or Sodium Citrate.

    Sterile, nonpyrogenic.

    WARNING:PROTECT FROM LIGHT. Store at 20º to 25ºC (68º  to 77ºF); excursions permitted to 15 to 30 C (59  to 86 F) (See USP Controlled Room Temperature).

    Directions for Use: See Package Insert.

    AMERICAN REGENT, INC.
    SHIRLEY, NY 11967

    Rev. 2/17

    Carton Labeling

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  • Serialization Label
  • INGREDIENTS AND APPEARANCE
    INDIGO CARMINE 
    indigo carmine injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-0375
    Route of Administration INTRAMUSCULAR, INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    INDIGOTINDISULFONATE SODIUM (UNII: D3741U8K7L) (INDIGOTINDISULFONIC ACID - UNII:X7OI7JF73P) INDIGOTINDISULFONATE SODIUM 8 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0517-0375-05 5 in 1 BOX 09/30/1990
    1 NDC:0517-0375-01 1 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 09/30/1990
    Labeler - American Regent, Inc. (622781813)
    Establishment
    Name Address ID/FEI Business Operations
    Luitpold Pharmaceuticals, Inc. 002033710 ANALYSIS(0517-0375) , MANUFACTURE(0517-0375) , STERILIZE(0517-0375)
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