RX ITEM-Isosulfan 0.01 Vial 6X5Ml By Mylan Institutional

SOSULFAN BLUE- isosulfan blue injection, solution
Mylan Institutional LLC

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

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.

3 DOSAGE FORMS AND STRENGTHS

1% aqueous solution (isosulfan blue)

4 CONTRAINDICATIONS

Isosulfan blue injection 1% is contraindicated in those individuals with known hypersensitivity to triphenylmethane or related compounds.

5 WARNINGS AND PRECAUTIONS

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 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 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.

RX ITEM-Isosulfan 0.01 Vial 6X5Ml By Myl
NDC 67457-0586-05 UPC/GTIN No. Mfg.Part No.58605

Isosulfan 0.01 Vial 6X5Ml By Mylan Insti
BRAND: ISOSULFAN-BLUE NDC: 67457-0586-05,67457058605 UPC: , Mylan Institutional/Gen

ISOSULFAN BLUE SUB-Q VIAL
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