- DESCRIPTION
-
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
- CONTRAINDICATIONS
-
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
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ISOSULFAN BLUE
isosulfan blue solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51808-206 Route of Administration SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOSULFAN BLUE (UNII: 39N9K8S2A4) (ISOSULFAN BLUE - UNII:39N9K8S2A4) ISOSULFAN BLUE 10 mg in 1 mL Product Characteristics Color BLUE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51808-206-01 5 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 06/19/2012 Labeler - AnazaoHealth Corporation (011038762) Establishment Name Address ID/FEI Business Operations AnazaoHealth Corporation 011038762 MANUFACTURE