Isosulfan Blue is a human prescription drug labeled by 'Meitheal Pharmaceuticals Inc.'. National Drug Code (NDC) number for Isosulfan Blue is 71288-805. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Isosulfan Blue drug includes Isosulfan Blue - 10 mg/mL . The currest status of Isosulfan Blue drug is Active.

Isosulfan blue isosulfan blue isosulfan blue isosulfan blue inner salt sodium phosphate, dibasic, anhydrous potassium phosphate, monobasic water

7 drug interactions no drug interactions have been identified with isosulfan blue 1%. no drug interactions have been identified for isosulfan blue 1% ( 7 ).

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.

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 4-9% 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. 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 c Read more...

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.

3 dosage forms and strengths 1% aqueous solution (isosulfan blue) 1% aqueous solution (isosulfan blue) ( 3 )

4 contraindications isosulfan blue 1% is contraindicated in those individuals with known hypersensitivity to triphenylmethane or related compounds. hypersensitivity to triphenylmethane or related compounds ( 4 ).

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 iv administration of a similar compound ( 6 ). to report suspected adverse reactions, contact meitheal pharmaceuticals inc. at 1-844-824-8426 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 a Read more...

7 drug interactions no drug interactions have been identified with isosulfan blue 1%. no drug interactions have been identified for isosulfan blue 1% ( 7 ).

8 use in specific populations caution should be exercised when isosulfan blue 1% is administered to nursing mothers ( 8.3 ). safety and effectiveness of isosulfan blue 1% in children have 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 1% is administered to a nursing mother. 8.4 pediatric use safety and effectiveness of isosulfan blue 1% in children have not been established.

8.4 pediatric use safety and effectiveness of isosulfan blue 1% in children have not been established.

10 overdosage do not exceed indicated recommended dosage as overdosage levels have not been identified for isosulfan blue 1%.

11 description 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 injection 1% is a sterile aqueous solution for subcutaneous administration. phosphate buffer in sterile, nonpyrogenic 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 dibasic sodium phosphate, anhydrous and 2.7 mg monobasic potassium phosphate. the solution contains no preservative. isosulfan blue injection 1% is a contrast agent for the delineation of lymphatic vessels. structural formula

12 clinical pharmacology 12.2 pharmacodynamics following subcutaneous administration, isosulfan blue 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 1% is excreted unchanged in the urine in 24 hours in human.

12.2 pharmacodynamics following subcutaneous administration, isosulfan blue 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 1% is excreted unchanged in the urine in 24 hours in human.

13 nonclinical toxicology 13.1 carcinogenesis, mutagenesis, impairment of fertility long-term studies in animals have not been performed to evaluate the carcinogenic potential of isosulfan blue 1%. reproduction studies in animals have not been conducted and, therefore, it is unknown if a problem concerning mutagenesis or impairment of fertility in either males or females exists. 13.2 teratogenic effects pregnancy category c. animal reproduction studies have not been conducted with isosulfan blue 1%. it is not known whether isosulfan blue 1% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. isosulfan blue 1% should be given to a pregnant woman only if clearly needed.

13.1 carcinogenesis, mutagenesis, impairment of fertility long-term studies in animals have not been performed to evaluate the carcinogenic potential of isosulfan blue 1%. reproduction studies in animals have not been conducted and, therefore, it is unknown if a problem concerning mutagenesis or impairment of fertility in either males or females exists.

16 how supplied/storage and handling isosulfan blue injection 1% is a dark blue aqueous solution in a phosphate buffer. it is supplied as follows: ndc isosulfan blue injection 1% package factor 71288- 805 -06 50 mg per 5 ml single-dose vial 6 vials per carton storage store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature.] avoid excessive heat. discard unused portion. sterile, nonpyrogenic, preservative-free. the container closure is not made with natural rubber latex.

17 patient counseling information inform patients that urine color may be blue for 24 hours following administration of isosulfan blue 1%. meitheal ® mfd. for meitheal pharmaceuticals chicago, il 60631 (usa) ©2020 meitheal pharmaceuticals inc. august 2020 810061-00

Principal display panel – isosulfan blue injection 1% 5 ml vial label ndc 71288- 805 -05 rx only isosulfan blue injection 1% 50 mg per 5 ml (10 mg per ml) for lymphography for subcutaneous use only 5 ml single-dose vial principal display panel – isosulfan blue injection 1% 5 ml vial label

Principal display panel – isosulfan blue injection 1% 5 ml carton ndc 71288- 805 -06 rx only isosulfan blue injection 1% 50 mg per 5 ml (10 mg per ml) for lymphography for subcutaneous use only 6 x 5 ml single-dose vials principal display panel – isosulfan blue injection 1% 5 ml carton