ISOSULFAN BLUE injection, solution

Isosulfan Blue by

Drug Labeling and Warnings

Isosulfan Blue by is a Prescription medication manufactured, distributed, or labeled by AuroMedics Pharma LLC, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    1.1 Lymphatic Vessel Delineation


    Isosulfan blue injection 1% upon subcutaneous administration, delineates lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; and lymph node response to therapeutic modalities.

  • 2 DOSAGE AND ADMINISTRATION

    2.1 Subcutaneous administration

    Isosulfan blue injection 1% is to be administered subcutaneously, one-half (1/2) mL into three (3) interdigital spaces of each extremity per study. A maximum dose of 3 mL (30 mg) isosulfan blue is, therefore, injected.

  • 3 DOSAGE FORMS AND STRENGTHS

    1% aqueous solution (isosulfan blue)

  • 4 CONTRAINDICATIONS

    Isosulfan blue injection 1% is contraindicated in those individuals with known hypersensitivity to triphenylmethane or related compounds.

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Hypersensitivity Reactions

    Life-threatening anaphylactic reactions (respiratory distress, shock, angioedema) have occurred after isosulfan blue 1% administration. Reactions are more likely to occur in patients with a history of bronchial asthma, allergies, drug reactions or previous reactions to triphenylmethane dyes. Monitor patients closely for at least 60 minutes after administration of isosulfan blue 1%. Trained personnel should be available to administer emergency care including resuscitation.

    5.2 Precipitation of Isosulfan Blue 1% by Lidocaine


    The admixture of isosulfan blue 1% (with local anesthetics (i.e. lidocaine)) in the same syringe results in an immediate precipitation of 4 to 9% drug complex. Use a separate syringe to administer a local anesthetic.

    5.3 Interference with Oxygen Saturation and Methemoglobin Measurements


    Isosulfan blue 1% interferes with measurements of oxygen saturation in peripheral blood by pulse oximetry and can cause falsely low readings. The interference effect is maximal at 30 minutes and minimal generally by four hours after administration. Arterial blood gas analysis may be needed to verify decreased arterial partial pressure of oxygen.

    Isosulfan blue 1% may also cause falsely elevated readings of methemoglobin by arterial blood gas analyzer. Therefore, co-oximetry may be needed to verify methemoglobin level.

  • 6 ADVERSE REACTIONS

    6.1 Postmarketing Experience


    Hypersensitivity Reactions: Case series report an overall incidence of hypersensitivity reactions in approximately 2% of patients. Life-threatening anaphylactic reactions have occurred. Manifestations include respiratory distress, shock, angioedema, urticaria, pruritus. A death has been reported following administration of a similar compound employed to estimate the depth of a severe burn. Reactions are more likely to occur in patients with a personal or family history of bronchial asthma, significant allergies, drug reactions or previous reactions to triphenylmethane dyes [see Warnings and Precautions (5)].

    Laboratory Tests: Isosulfan blue 1% interferes with measurements of oxygen saturation by pulse oximetry and of methemoglobin by gas analyzer [see Warnings and Precautions (5)].

    Skin: transient or long-term (tattooing) blue coloration.

  • 7 DRUG INTERACTIONS

    No drug interactions have been identified with isosulfan blue 1%.

  • 8 USE IN SPECIFIC POPULATIONS

    8.3 Nursing Mothers

    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 isosulfan blue 1% is administered to a nursing mother.


    8.4 Pediatric Use

    Safety and effectiveness of isosulfan blue 1% in children have not been established.

  • 10 OVERDOSAGE

    Do not exceed indicated recommended dosage as overdosage levels have not been identified for isosulfan blue 1%.

  • 11 DESCRIPTION

    The chemical name of isosulfan blue is N-[4-[[4-(diethylamino)phenyl] (2,5-disulfophenyl) methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide, inner salt, sodium salt. Isosulfan blue is a greenish blue color hygroscopic powder. Its structural formula is:
    Isosulfan Blue Chemical structure
    Isosulfan blue injection 1% is a sterile, non-pyrogenic, aqueous dark blue color solution for subcutaneous administration. Phosphate buffer in water for injection is added in sufficient quantity to yield a final pH of 6.8 to 7.4. Each mL of solution contains 10 mg isosulfan blue, 6.6 mg sodium monohydrogen phosphate and 2.7 mg potassium dihydrogen phosphate. The solution contains no preservative. Isosulfan blue injection 1% is a contrast agent for the delineation of lymphatic vessels.

  • 12 CLINICAL PHARMACOLOGY

    12.2 Pharmacodynamics

    Following subcutaneous administration, isosulfan blue 1% binds to serum proteins and is picked up by the lymphatic vessels. Thus, the lymphatic vessels are delineated by the blue dye.

    12.3 Pharmacokinetics

    Up to 10% of the subcutaneously administered dose of isosulfan blue 1% is excreted unchanged in the urine in 24 hours in human.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    Long-term studies in animals have not been performed to evaluate the carcinogenic potential of isosulfan blue 1%. Reproduction studies in animals have not been conducted and, therefore, it is unknown if a problem concerning mutagenesis or impairment of fertility in either males or females exists.

    13.2 Teratogenic Effects

    Pregnancy Category C. Animal reproduction studies have not been conducted with isosulfan blue 1%. It is not known whether isosulfan blue 1% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Isosulfan blue 1% should be given to a pregnant woman only if clearly needed.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Isosulfan blue injection 1% is a sterile, non-pyrogenic, aqueous dark blue color solution and is supplied as follows:

    Isosulfan blue injection 1%
    50 mg per 5 mL (10 mg / mL):
    5 mL Single Dose Vials
    in a Carton of 6                                                                      NDC: 55150-240-06

    Store at     20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Avoid excessive heat.

    Discard Unused Portion.

    The vial stoppers are not made with natural rubber latex.

  • 17 PATIENT COUNSELING INFORMATION

    Inform patients that urine color may be blue for 24 hours following administration of isosulfan blue injection 1%.

    Manufactured by:
    Aurobindo Pharma Limited
    IDA, Pashamylaram - 502307
    India

    Distributed by:
    AuroMedics Pharma LLC
    6 Wheeling Road
    Dayton, NJ 08810

    NOVAPLUS is a registered trademark of Vizient Inc.

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1% [50 mg per 5 mL (10 mg / mL)] - Container Label

    NDC: 55150-240-06           Rx only
    Isosulfan Blue
    Injection 1%
    Sterile                               5 mL
    Non-Pyrogenic                 Single Dose Vial
    50 mg per 5 mL (10 mg / mL)
    For Subcutaneous Use Only
    For Lymphography
    NOVAPLUS®

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1% [50 mg per 5 mL (10 mg / mL)] - Container Label

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1% [50 mg per 5 mL (10 mg / mL)] - Container-Carton (6 Vials)

    NDC: 55150-240-06                           Rx only
    Isosulfan Blue
    Injection 1%
    For Lymphography
    Sterile Non-Pyrogenic                     6 X 5 mL Single Dose Vials
    50 mg per 5 mL (10 mg / mL)
    For Subcutaneous Use Only
    N+ and NOVAPLUS are registered trademarks of Vizient, Inc.
    NOVAPLUS®

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1% [50 mg per 5 mL (10 mg / mL)] - Container-Carton (6 Vials)

  • INGREDIENTS AND APPEARANCE
    ISOSULFAN BLUE 
    isosulfan blue injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 55150-240
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOSULFAN BLUE (UNII: 39N9K8S2A4) (ISOSULFAN BLUE INNER SALT - UNII:NS6Q291771) ISOSULFAN BLUE50 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 55150-240-066 in 1 CARTON02/02/2016
    15 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20683102/02/2016
    Labeler - AuroMedics Pharma LLC (968961354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited918917662API MANUFACTURE(55150-240)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650498244ANALYSIS(55150-240) , MANUFACTURE(55150-240)
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