Isosulfan Blue
Generic Name: isosulfan blue
Brand Names:
Isosulfan Blue
11 DESCRIPTION The chemical name of isosulfan blue is N-[4-[[4-(diethylamino)phenyl] (2,5-disulfophenyl) methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide, inner salt, sodium salt. Isosulfan blue is a greenish blue color hygroscopic powder. Its structural formula is: Isosulfan blue injection 1% is a sterile, non-pyrogenic, aqueous dark blue color solution for subcutaneous administration.
Overview
11 DESCRIPTION The chemical name of isosulfan blue is N-[4-[[4-(diethylamino)phenyl] (2,5-disulfophenyl) methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide, inner salt, sodium salt. Isosulfan blue is a greenish blue color hygroscopic powder. Its structural formula is: Isosulfan blue injection 1% is a sterile, non-pyrogenic, aqueous dark blue color solution for subcutaneous administration.
Uses
1 INDICATIONS AND USAGE Isosulfan blue injection 1% upon subcutaneous administration, delineates the 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; lymph node response to therapeutic modalities (1.1). 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.
Dosage
2 DOSAGE AND 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 (2.1). 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.
Side Effects
6 ADVERSE REACTIONS Hypersensitivity Reactions : Hypersensitivity reactions occurring approximately 2% of patients and include life-threatening anaphylactic reactions with respiratory distress, shock, angioedema, urticaria, pruritus. A death has been reported following I.V. administration of a similar compound (6) . To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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.
Interactions
7 DRUG INTERACTIONS No drug interactions have been identified with isosulfan blue 1%. No drug interactions have been identified for isosulfan blue 1% (7).
Warnings
5 WARNINGS AND PRECAUTIONS Life-threatening anaphylactic reactions have occurred after isosulfan blue 1% administration. Monitor patients closely for at least 60 minutes after administration of isosulfan blue 1% (5.1). The admixture of isosulfan blue 1% with local anesthetics results in an immediate precipitation of 4 to 9% drug complex. Use a separate syringe for anesthetics (5.2). Isosulfan blue 1% interferes with measurements in peripheral blood pulse oximetry. Arterial blood gas analysis may be needed (5.3). 5.1 Hypersensitivity Reactions Life-threatening anaphylactic reactions (respiratory distress, shock, angioedema) have occurred after isosulfan blue 1% administration. 4 CONTRAINDICATIONS Isosulfan blue injection 1% is contraindicated in those individuals with known hypersensitivity to triphenylmethane or related compounds. Hypersensitivity to triphenylmethane or related compounds (4).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Isosulfan blue injection 1% is a sterile, non-pyrogenic, aqueous dark blue color solution and is supplied as follows: Isosulfan blue injection 1% 50 mg per 5 mL (10 mg / mL): 5 mL Single-Dose Vials in a Carton of 6 NDC 55150-240-05 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Discard unused portion.
Frequently Asked Questions
What is Isosulfan Blue used for?▼
1 INDICATIONS AND USAGE Isosulfan blue injection 1% upon subcutaneous administration, delineates the 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; lymph node response to therapeutic modalities (1.1). 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.
What are the side effects of Isosulfan Blue?▼
6 ADVERSE REACTIONS Hypersensitivity Reactions : Hypersensitivity reactions occurring approximately 2% of patients and include life-threatening anaphylactic reactions with respiratory distress, shock, angioedema, urticaria, pruritus. A death has been reported following I.V. administration of a similar compound (6) . To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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.
What are the important warnings for Isosulfan Blue?▼
5 WARNINGS AND PRECAUTIONS Life-threatening anaphylactic reactions have occurred after isosulfan blue 1% administration. Monitor patients closely for at least 60 minutes after administration of isosulfan blue 1% (5.1). The admixture of isosulfan blue 1% with local anesthetics results in an immediate precipitation of 4 to 9% drug complex. Use a separate syringe for anesthetics (5.2). Isosulfan blue 1% interferes with measurements in peripheral blood pulse oximetry. Arterial blood gas analysis may be needed (5.3). 5.1 Hypersensitivity Reactions Life-threatening anaphylactic reactions (respiratory distress, shock, angioedema) have occurred after isosulfan blue 1% administration. 4 CONTRAINDICATIONS Isosulfan blue injection 1% is contraindicated in those individuals with known hypersensitivity to triphenylmethane or related compounds. Hypersensitivity to triphenylmethane or related compounds (4).
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.