isosulfan blue
isosulfan blue · by msn
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Overview
The chemical name of isosulfan blue injection 1% is N-[4- [[4-(diethylamino)phenyl] (2,5-disulfophenyl) methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide, inner salt, sodium salt. Its structural formula is: ISOSULFAN BLUE Isosulfan blue injection 1% is a clear dark blue, sterile, non-pyrogenic aqueous solution for subcutaneous administration. Phosphate buffer in sterile, pyrogen free water is added in sufficient quantity to yield a final pH of 6.8 to 7.4. Each mL of solution contains 10 mg isosulfan blue, 6.6 mg sodium monohydrogen phosphate and 2.7 mg potassium dihydrogen phosphate. Each mL of isosulfan blue injection contains 2 mg of sodium and less than 5 mg of phosphorus. The solution contains no preservative. Isosulfan blue injection 1% is a contrast agent for the delineation of lymphatic vessels. Chemical Structure
How to use
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. Discard unused portion. 2.2 Instructions for Preparation and Administration of the 1 mL or 3 mL Pre-filled Syringe To be prepared and administered by a healthcare provider only. For subcutaneous injection only. Do not inject by any other route. As a precaution, always wear gloves. Inspect isosulfan blue injection for particulate matter and discoloration prior to administration. Figure A shows an annotated drawing of the 3 mL syringe. Appearance may differ for the 1 mL syringe. Figure A 1) Grip the syringe at the luer lock collar and remove the tip cap from the prefilled syringe by twisting the cap anticlockwise and pulling upwards ( See Figure B ) Figure B 2) Hold the luer lock collar and attach the needle to the syringe with a firm clockwise twisting motion ( See Figure C ). Figure C 3) Remove the needle sheath with a straight pull. Do not twist the sheath as the needle may become loosened from the syringe…
Side effects
Hypersensitivity Reactions: Hypersensitivity reactions occur in approximately 2% of patients and include life threatening anaphylactic reactions with respiratory distress, shock, angioedema, urticaria, pruritus. A death has been reported following IV administration of a similar compound ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) 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. A death has been reported following administration of a similar compound employed to estimate the depth of a severe burn. Reactions are more likely to occur in patients with a personal or family history of bronchial asthma, significant allergies, drug reactions or previous reactions to triphenylmethane dyes [see Warnings and Precautions (5) ] . Laboratory Tests: Isosulfan blue injection 1% interferes with measurements of oxygen saturation by pulse oximetry and of methemoglobin by gas analyzer [see Warnings and Precautions (5) ] . Skin: transient or long-term (tattooing) blue coloration.
Warnings
Important safety information
5 WARNINGS AND PRECAUTIONS • Life threatening anaphylactic reactions have occurred after isosulfan blue injection 1% administration. Monitor patients closely for at least 60 minutes after administration of isosulfan blue injection 1% ( 5.1 ). • The admixture of isosulfan blue injection 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 injection 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 injection 1% administration. Reactions are more likely to occur in patients with a history of bronchial asthma, allergies, drug reactions or previous reactions to tri-phenylmethane dyes. Monitor patients closely for at least 60 minutes after administration of isosulfan blue injection 1%. Trained personnel should be available to administer emergency care including resuscitation. 5.2 Precipitation of Isosulfan Blue Injection 1% by Lidocaine The admixture of isosulfan blue injection 1% (with local anesthetics (i.e. lidocaine)) in the same syringe results in an immediate precipitation of 4% to 9% drug complex. Use a separate syringe to administer a local anesthetic. 5.3…
Interactions
No drug interactions have been identified with isosulfan blue injection 1%. No drug interactions have been identified for isosulfan blue injection 1% ( 7 ).
Dosage forms
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Frequently asked questions
- What is Isosulfan Blue?
- The chemical name of isosulfan blue injection 1% is N-[4- [[4-(diethylamino)phenyl] (2,5-disulfophenyl) methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide, inner salt, sodium salt. Its structural formula is: ISOSULFAN BLUE Isosulfan blue injection 1% is a clear dark blue, sterile, non-pyrogenic aqueous solution for subcutaneous administration. Phosphate buffer in sterile, pyrogen free water is added in sufficient quantity to yield a final pH of 6.8 to 7.4. Each mL of solution contains 10 mg isosulfan blue, 6.6 mg sodium monohydrogen phosphate and 2.7 mg potassium dihydrogen phosphate. Each mL of isosulfan blue injection contains 2 mg of sodium and less than 5 mg of phosphorus. The solution contains no preservative. Isosulfan blue injection 1% is a contrast agent for the delineation of lymphatic vessels. Chemical Structure
Clinical content sourced from the FDA label via openFDA (U.S. FDA). Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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