Isosulfan Blue
10 mg/mL · Injection, Solution
- Prescription only
- Active substance
- Isosulfan Blue
- Made by
- Devatis, Inc.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2026-07-01
- Isosulfan blue injection upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection.
A maximum dose of 3 mL (30 mg) isosulfan blue is, therefore, injected( 2.1 ).
Full directions ↓Isosulfan blue injection is contraindicated in those individuals with known hypersensitivity to triphenylmethane or related compounds. Hypersensitivity to triphenylmethane or related compounds ( 4 ).
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
It is an adjunct to lymphography in:
- Isosulfan blue injection upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection.
- 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.
- 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.
From the official label · 2026-07-01 · DailyMed
How it works
From this product’s own US prescribing label.
12 CLINICAL PHARMACOLOGY 12.2 Pharmacodynamics Following subcutaneous administration, isosulfan blue injection 1% binds to serum proteins and is picked up by the lymphatic vessels.
Thus, the lymphatic vessels are delineated by the blue dye. 12.3 Pharmacokinetics Up to 10% of the subcutaneously administered dose of isosulfan blue injection 1% is excreted unchanged in the urine in 24 hours in humans.
Up to 10% of the subcutaneously administered dose of isosulfan blue injection 1% is excreted unchanged in the urine in 24 hours in humans.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-07-01
Do not take it if
Isosulfan blue injection is contraindicated in those individuals with known hypersensitivity to triphenylmethane or related compounds. Hypersensitivity to triphenylmethane or related compounds ( 4 ).
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- Isosulfan blue injection 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 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.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- Life threatening anaphylactic reactions have occurred after isosulfan blue injection administration.
- Monitor patients closely for at least 60 minutes after administration of isosulfan blue injection ( 5.1 ).
- The admixture of isosulfan blue injection 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 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, angio-edema) 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 triphenylmethane 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 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 Interference with Oxygen Saturation and Methemoglobin Measurements Isosulfan blue injection 1% interferes with measurements of oxygen saturation in peripheral blood by pulse oximetry and can cause falsely low readings.
- The interference effect is maximal at 30 minutes and minimal generally by 4 hours after administration.
- Arterial blood gas analysis may be needed to verify decreased arterial partial pressure of oxygen.
- Isosulfan blue injection 1% may also cause falsely elevated readings of methemoglobin by arterial blood gas analyzer.
- Therefore, cooximetry may be needed to verify methemoglobin level.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when isosulfan blue injection 1% is administered to a nursing mother.
- IN SPECIFIC POPULATIONS Caution should be exercised when isosulfan blue injection 1% is administered to nursing mothers ( 8.3 ).
- Safety and effectiveness of isosulfan blue injection 1% in children has not been established ( 8.4 ).
- 8.3 Nursing Mothers It is not known whether this drug is excreted in human milk.
- Because many drugs are excreted in human milk, caution should be exercised when isosulfan blue injection 1% is administered to a nursing mother.
- 8.4 Pediatric Use Safety and effectiveness of isosulfan blue injection 1% in children have not been established.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Other medicines
No drug interactions have been identified with isosulfan blue injection. No drug interactions have been identified for isosulfan blue injection ( 7 ).
Quoted from the official label, section “Drug Interactions”.
If you take too much
In an emergency, call your local emergency number or a poison control centre.
Do not exceed indicated recommended dosage as overdosage levels have not been identified for isosulfan blue injection 1%.
Quoted from the official label, section “Overdosage”.
Use in children
Safety and effectiveness of isosulfan blue injection 1% in children have not been established.
Quoted from the official label, section “Pediatric Use”.
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 Devatis, Inc. at 1-833-534-4406 or druginfo@devatis.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- 6.1 Post-Marketing 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 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.
Quoted from the official label, section “Adverse Reactions”.
What to discuss with your doctor
- Inform patients that urine color may be blue for 24 hours following administration of isosulfan blue injection 1%.
- Made in Turkey Distributed by: Devatis, Inc.
- San Clemente, CA 92672 For more information, call 1-833-534-4406 or go to www.devatis.com.
- REVISED February 2016
Quoted from the official label, section “Patient Counseling Information”.
Strengths and forms
FORMS AND STRENGTHS 1% aqueous solution (isosulfan blue) 1% aqueous solution (isosulfan blue)( 3 )
Quoted from the official label, section “Dosage Forms & Strengths”.
What it looks like and how it is packed
- Isosulfan blue injection 1% is supplied as a 7 mL single-use vial, 1% aqueous blue solution in a phosphate buffer prepared by appropriate manufacturing to be sterile and pyrogen-free. 50 mg per 5 mL (10 mg/mL):
- 7 mL Single-Dose Vials, Carton of 6 vials NDC 73043-093-06 Storage:
- Vials should be stored at 20° to 25°C (68° to 77°F). [See USP Con trolled Room Temperature.]
- Avoid excessive heat.
Quoted from the official label, section “How Supplied”.
What is in it
- 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 sterile 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.
- The solution contains no preservative.
- Isosulfan blue injection 1% is a contrast agent for the delineation of lymphatic vessels.
- Chemical Structure
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (5)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 5 of 5
- Isosulfan BlueThis onePrescription onlyDevatis, Inc.No ingredient list on the stored label
- Isosulfan BluePrescription onlyMeitheal Pharmaceuticals Inc.No ingredient list on the stored label
- Isosulfan BluePrescription onlyMylan Institutional LLCNo ingredient list on the stored label
- Isosulfan BluePrescription onlyNovadoz Pharmaceuticals LLCNo ingredient list on the stored label
- Isosulfan BluePrescription onlySomerset Therapeutics, LLCNo ingredient list on the stored label
Details
| Made by | Devatis, Inc. |
|---|---|
| Active substance | Isosulfan Blue |
| Strength | 10 mg/mL |
| Form | Injection, Solution |
| Route | Subcutaneous |
| Packs | 6 VIAL, GLASS in 1 CARTON / 5 mL in 1 VIAL, GLASS |
| NDC | 73043-093 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
6 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Injection, Solution6 products
10 mg/mL5
10 mg/mL · 5 companies
- 50 mg/5mL
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.