ISOSULFAN BLUE injection, solution

Drug Labeling and Warnings

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 injection 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 injection 1%. Trained personnel should be available to administer emergency care including resuscitation.

    5.2 Precipitation of Isosulfan Blue Injection 1% by Lidocaine

    The admixture of isosulfan blue injection 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 injection 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 4 hours after administration. Arterial blood gas analysis may be needed to verify decreased arterial partial pressure of oxygen.

     Isosulfan blue injection 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 [seeWarnings and Precautions (5)].

    Laboratory Tests: Isosulfan blue injection 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 injection 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 injection 1% is administered to a nursing mother.


    8.4 Pediatric Use

    Safety and effectiveness of isosulfan blue injection 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 injection 1%.

  • 11 DESCRIPTION

    The chemical name of isosulfan blue injection 1% is N-[4- [[4-(diethylamino)phenyl] (2,5-disulfophenyl) methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide, inner salt, sodium salt. Its structural formula is:

     ISOSULFAN BLUE



    isosulfan-inj-structure

    Isosulfan blue injection 1% is a sterile aqueous solution for subcutaneous administration. Phosphate buffer in sterile, pyrogen free water 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 injection 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 injection 1% is excreted unchanged in the urine in 24 hours in humans.

  • 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 injection 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 injection 1%. It is not known whether isosulfan blue injection 1% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Isosulfan blue injection 1% should be given to a pregnant woman only if clearly needed.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Isosulfan Blue Injection 1% is supplied as a 5 mL single-dose vial, 1% aqueous blue color solution in a phosphate buffer prepared by appropriate manufacturing to be sterile and pyrogen-free.

    NDC: 72205-195-01


     
    Storage: Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid excessive heat.

    Discard unused portion.

  • 17 PATIENT COUNSELING INFORMATION

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

    Manufactured by:
    MSN Laboratories Private Limited
    Telangana – 509 228,
    INDIA


    Distributed by:
    Novadoz Pharmaceuticals LLC
    Piscataway, NJ 08854-3714


    Issued on: 04/2026

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Isosulfan Blue Injection 1% Carton Label

      

    isosulfan-inj-crtn-label

    Isosulfan Blue Injection 1% Vial Label

    isosulfan-inj-vial-label

  • INGREDIENTS AND APPEARANCE
    ISOSULFAN BLUE 
    isosulfan blue injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 72205-195
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOSULFAN BLUE (UNII: 39N9K8S2A4) (ISOSULFAN BLUE INNER SALT - UNII:NS6Q291771) ISOSULFAN BLUE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 72205-195-011 in 1 CARTON06/30/2026
    15 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21609009/16/2022
    Labeler - Novadoz Pharmaceuticals LLC (081109687)
    Establishment
    NameAddressID/FEIBusiness Operations
    MSN LABORATORIES PRIVATE LIMITED650786952ANALYSIS(72205-195) , MANUFACTURE(72205-195)
    • © 2026 FDA.report
    This site is not affiliated with or endorsed by the FDA.