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Indocyanine Green and Water
Overview
What is Indocyanine Green?
Indocyanine Green for Injection USP is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. Indocyanine Green for Injection USP is dissolved using Sterile Water for Injection, and is to be administered intravenously.
Indocyanine green is a water-soluble, tricarbocyanine dye with peak spectral absorption at 800 nm. The chemical name for Indocyanine Green is 1H-benz[
]indolium, 2-[7-[1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2
-benz[
]indo-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-,hydroxide, inner salt, sodium, or 2-[7-[1,1-dimethyl-3-(4-sulfobutyl)benz[e]indolin-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-1H-benz[e]indolium hydroxide, inner salt, sodium salt. Indocyanine Green for Injection USP has a pH of approximately 6.5 when reconstituted. Each vial of Indocyanine Green for Injection USP contains 25 mg of indocyanine green as a sterile lyophilized powder.
What does Indocyanine Green look like?
What are the available doses of Indocyanine Green?
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What should I talk to my health care provider before I take Indocyanine Green?
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How should I use Indocyanine Green?
For determining cardiac output, hepatic function and liver blood flow, and for ophthalmic angiography.
Indocyanine Green permits recording of the indicator-dilution curves for both diagnostic and research purposes independently of fluctuations in oxygen saturation. In the performance of dye dilution curves, a known amount of dye is usually injected as a single bolus as rapidly as possible via a cardiac catheter into selected sites in the vascular system. A recording instrument (oximeter or densitometer) is attached to a needle or catheter for sampling of the dye-blood mixture from a systematic arterial sampling site.
Under sterile conditions, the Indocyanine Green for Injection USP powder should be dissolved with Sterile Water for Injection,
, and the solution used within 6 hours after it is prepared. If a precipitate is present, discard the solution. The amount of solvent to be used can be calculated from the dosage form which follows. It is recommended that the syringe used for injection of the dye be rinsed with this diluent. Saline is used in all other parts of the catheterization procedure.
This matter of rinsing the dye syringe with distilled water may not be critical, since it is known that an amount of sodium chloride sufficient to make an isotonic solution may be added to dye
. This procedure has been used for constant-rate injection techniques without precipitation of the dye.
The usual doses of Indocyanine Green which have been used for dilution curves are as follows:
Adults—5 mg
Children—2.5 mg
Infants—1.25 mg
These doses of the dye are usually injected in a 1-mL volume. An average of five dilution curves is required in the performance of a diagnostic cardiac catheterization. The total dose of dye injected should be kept below 2 mg/kg.
What interacts with Indocyanine Green?
Indocyanine Green for Injection USP contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides.
What are the warnings of Indocyanine Green?
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What are the precautions of Indocyanine Green?
General
Indocyanine Green Powder and Solution: Indocyanine 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.
Indocyanine Green 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 Indocyanine 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 Indocyanine 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 Indocyanine Green. It is also not known whether Indocyanine Green can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Indocyanine 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 Indocyanine 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.
What are the side effects of Indocyanine Green?
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.
What should I look out for while using Indocyanine Green?
Indocyanine Green for Injection USP 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 Indocyanine Green for Injection USP administration during cardiac catheterization.
What might happen if I take too much Indocyanine Green?
There are no data available describing the signs, symptoms, or laboratory findings accompanying overdosage. The LD
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.
How should I store and handle Indocyanine Green?
Indocyanine Green for Injection USP, is supplied in a kit, (NDC 17238-424-02) containing six 25-mg Indocyanine Green for Injection USP vials and six 10-mL Sterile Water for Injection vials:NDC 17238-424-01 Indocyanine Green for Injection 25-mg fill in 30-mL vial.NDC 63323-185-10 (or NDC 0409-4887-17) Sterile Water for Injection 10-mL fill in 10-mL vial.Indocyanine Green for Injection USP, is supplied in a kit, (NDC 17238-424-02) containing six 25-mg Indocyanine Green for Injection USP vials and six 10-mL Sterile Water for Injection vials:NDC 17238-424-01 Indocyanine Green for Injection 25-mg fill in 30-mL vial.NDC 63323-185-10 (or NDC 0409-4887-17) Sterile Water for Injection 10-mL fill in 10-mL vial.Indocyanine Green for Injection USP, is supplied in a kit, (NDC 17238-424-02) containing six 25-mg Indocyanine Green for Injection USP vials and six 10-mL Sterile Water for Injection vials:NDC 17238-424-01 Indocyanine Green for Injection 25-mg fill in 30-mL vial.NDC 63323-185-10 (or NDC 0409-4887-17) Sterile Water for Injection 10-mL fill in 10-mL vial.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Following intravenous injection, Indocyanine Green is rapidly bound to plasma protein, of which albumin is the principle carrier (95%). Indocyanine Green undergoes no significant extrahepatic or enterohepatic circulation; simultaneous arterial and venous blood estimations have shown negligible renal, peripheral, lung or cerebro-spinal uptake of the dye. Indocyanine Green is taken up from the plasma almost exclusively by the hepatic parenchymal cells and is secreted entirely into the bile. After biliary obstruction, the dye appears in the hepatic lymph, independently of the bile, suggesting that the biliary mucosa is sufficiently intact to prevent diffusion of the dye, though allowing diffusion of bilirubin. These characteristics make Indocyanine Green a helpful index of hepatic function.
The plasma fractional disappearance rate at the recommended 0.5 mg/kg dose has been reported to be significantly greater in women than in men, although there was no significant difference in the calculated value for clearance.
Non-Clinical Toxicology
Indocyanine Green for Injection USP 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 Indocyanine Green for Injection USP administration during cardiac catheterization.
Heparin preparations containing sodium bisulfite reduce the absorption peak of Indocyanine Green in blood and, therefore, should not be used as an anticoagulant for the collection of samples for analysis.
Indocyanine Green Powder and Solution: Indocyanine 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.
Indocyanine Green powder may cling to the vial or lump together because it is freeze-dried in the vials.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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