Description
Dear Medical Professional,
Per your order we have compounded Isosulfan Blue 1%. The characteristics of this compounded preparation are as follows:
Isosulfan Blue
FDA Label NDC 51808-206
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Anazaohealth Corporation for the product Isosulfan Blue (NDC 51808-206). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, clinical pharmacology, indications and usage, dosage and administration, contraindications, precautions, adverse reactions, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 (25e39c45 Figure 01)
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