INDICATIONS AND USAGE
For determining cardiac output, hepatic function and liver blood flow, and for ophthalmic angiography.
IC-GREEN® contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides.
Anaphylactic deaths have been reported following IC-GREEN® administration during cardiac catheterization.
General: IC-GREEN® Powder and Solution: IC-GREEN® is unstable in aqueous solution and must be used within 6 hours. However, the dye is stable in plasma and whole blood so that samples obtained in discontinuous sampling techniques may be read hours later. Sterile techniques should be used in handling the dye solution as well as in the performance of the dilution curves.
IC-GREEN® (indocyanine green for injection) powder may cling to the vial or lump together because it is freeze-dried in the vials.
Drug Interactions: Heparin preparations containing sodium bisulfite reduce the absorption peak of IC-GREEN® in blood and, therefore, should not be used as an anticoagulant for the collection of samples for analysis.
Drug/ Laboratory Test Interactions: Radioactive iodine uptake studies should not be performed for at least a week following the use of IC-GREEN®.
Carcinogenesis, Mutagenesis, Impairment of Fertility: No studies have been performed to evaluate the carcinogenicity, mutagenicity, or impairment of fertility.
Pregnancy: Teratogenic Effects: Pregnancy Category C: Animal Reproduction studies have not been conducted with IC-GREEN®. It is also not known whether IC-GREEN® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. IC-GREEN® should be given to a pregnant woman only if clearly indicated. 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 IC-GREEN® is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients have been established. Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Anaphylactic or urticarial reactions have been reported in patients with or without history of allergy to iodides. If such reactions occur, treatment with the appropriate agents, e.g., epinephrine, antihistamines, and corticosteroids should be administered.
There are no data available describing the signs, symptoms, or laboratory findings accompanying overdosage. The LD50 after I.V. administration ranges between 60 and 80 mg/kg in mice, 50 and 70 mg/kg in rats and 50 and 80 mg/kg in rabbits.