ISOSULFAN BLUE SOLUTION [ANAZAOHEALTH CORPORATION]

ISOSULFAN BLUE SOLUTION [ANAZAOHEALTH CORPORATION]
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NDC 51808-206-01
Set ID b0f9b119-de5a-4146-a51a-6ee7d2eedbed
Category HUMAN PRESCRIPTION DRUG LABEL
Packager AnazaoHealth Corporation
Generic Name
Product Class
Product Number
Application Number
  • DESCRIPTION

    Dear Medical Professional,

    Per your order we have compounded Isosulfan Blue  1%. The characteristics of this compounded preparation are as follows:

  • CLINICAL PHARMACOLOGY

    Isosulfan Blue has no known pharmacologic action.  Following subcutaneous administration, Isosulfan blue 1% is selectively picked up by the lymphatic vessels.  Thus, the lymphatic vessels are delineated by a bright blue color making them discernible from surrounding tissue.  There is some evidence that 50% of the isosulfan blue, from aqueous solution, is weakly bound to serum protein (albumin).  Since interstitial protein is presumed to be carried almost exclusively by lymphtics, and in view of evidence of binding of dyes to proteins, visualization may be due to protein binding phenomenon.

  • INDICATIONS AND USAGE

    Isosulfan Blue 1% Injection delineates the lymphatic vessels following subcutaneous administration. 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) for visualization to the lymphatic system draining the region of injection

  • DOSAGE AND ADMINISTRATION

    Isosulfan Blue 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 injected.

  • CONTRAINDICATIONS

    Hypersensitivity to triphenylmethane or related compounds

  • PRECAUTIONS

    After subcutaneous administration of Isosulfan blue 1%, competent personnel and emergency facilities should be available for at least 30-60 minutes, since severe delayed reactions have been known to occur with similar compounds.

    The admixture of Isosulfan blue with local anesthetics (i.e. lidocaine) in the same syringe prior to administration resulted in an immediate precipitation of 4-9% of the drug complex.  This technique is not recommended

  • ADVERSE REACTIONS

    Isosulfan blue 1% has demonstrated a 1.5% incidence of adverse reactions.  All the reactions were of an allergic type such as localized swelling at the site of administration and mild pruritis of hands, abdomen and neck have been reported within several minutes following administration of the drug.

    Storage and Handling

    Store at room temperature

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Figure 1

    C:\Users\achai\Desktop\NDC Project-AC 2012\Isoblue\isoblue label.JPG
  • INGREDIENTS AND APPEARANCE
    ISOSULFAN BLUE 
    isosulfan blue solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51808-206
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOSULFAN BLUE (UNII: 39N9K8S2A4) (ISOSULFAN BLUE - UNII:39N9K8S2A4) ISOSULFAN BLUE10 mg  in 1 mL
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51808-206-015 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other06/19/2012
    Labeler - AnazaoHealth Corporation (011038762)
    Establishment
    NameAddressID/FEIBusiness Operations
    AnazaoHealth Corporation011038762MANUFACTURE

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