FDA
Isosulfan Blue
The FDA lists this product in 10 strengths and forms.
Indications
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 ).
1.1Lymphatic 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.
Contraindications
Isosulfan blue 1% is contraindicated in those individuals with known hypersensitivity to triphenylmethane or related compounds. Hypersensitivity to triphenylmethane or related compounds ( 4 ).
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 4-9% 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 ).
5.1Hypersensitivity Reactions
Life-threatening anaphylactic reactions (respiratory distress, shock, angioedema) have occurred after isosulfan blue 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 1%. Trained personnel should be available to administer emergency care including resuscitation.
5.2Precipitation of Isosulfan Blue 1% by Lidocaine
At a glance
- Brand name
- Isosulfan Blue
- Route
- Subcutaneous
- Dosage form
- Solution
- Applicant
- Meitheal
- Status
- Prescription
- FDA approval
- 3 Nov 2021
- Application
- ANDA213130-001
- RxCUI
- 27863



