Isosulfan Blue

Manufacturer
AnazaoHealth Corporation
Effective date
2012-06-19
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:15:28

Label at a glance#

ProductIsosulfan Blue
Active ingredientISOSULFAN BLUE
Label structure8 sections

Indications and uses

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.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Dear Medical Professional,

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

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

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

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

CONTRAINDICATIONS SECTION

Hypersensitivity to triphenylmethane or related compounds

PRECAUTIONS

PRECAUTIONS SECTION

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

ADVERSE REACTIONS SECTION

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
C:\Users\achai\Desktop\NDC Project-AC 2012\Isoblue\isoblue label.JPG

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c96fb27b-1a35-b69d-60b2-c2e272527329Product name520231206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51808-206-012019-11-13C16284748780-197449f38-bbfd-f6ea-e053-dbdaa90aa703Isosulfan Blue 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51808-206-01Isosulfan Blue5 mL in 1 VIALSOLUTION52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51808-206ISOSULFAN BLUE SOLUTION [ANAZAOHEALTH CORPORATION]2Legacy NDC, 1 package rows20120709_b0f9b119-de5a-4146-a51a-6ee7d2eedbed.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOSULFAN BLUEACTIVE INGREDIENT39N9K8S2A42
ISOSULFAN BLUEACTIVE MOIETY39N9K8S2A42

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51808-20651808-206-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOSULFAN BLUE39N9K8S2A4ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
25e39c45-5f86-400f-beab-63f773e54734b0f9b119-de5a-4146-a51a-6ee7d2eedbed2012-06-19Adverse reactionsExact identifier
spl id: 25e39c45-5f86-400f-beab-63f773e54734
spl set id: b0f9b119-de5a-4146-a51a-6ee7d2eedbed

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.