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IC-Green
Overview
What is IC-Green?
IC-GREEN is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. It is packaged with Sterile Water for Injection, USP used to dissolve the indocyanine green. IC-GREEN is to be administered intravenously.
Indocyanine green is a water soluble, tricarbocyanine dye with a peak spectral absorption at 800 nm. The chemical name for Indocyanine Green is 1 -Benz[]indolium, 2-[7-[1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2-benz[] indol-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-,hydroxide, inner salt, sodium salt. IC-GREEN has a pH of approximately 6.5 when reconstituted. Each vial of IC-GREEN contains 25 mg of indocyanine green as a sterile lyophilized powder.
What does IC-Green look like?
What are the available doses of IC-Green?
IC-GREEN is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. ()
What should I talk to my health care provider before I take IC-Green?
How should I use IC-Green?
IC-GREEN is indicated:
In the performance of dye dilution curves, a known amount of dye is 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 systemic arterial sampling site.
Under sterile conditions, the IC-GREEN powder should be dissolved with the Sterile Water for Injection, USP provided for this product, and the solution used within 6 hours after it is prepared. If a precipitate is present, discard the solution.
The usual doses of IC-GREEN for dilution curves are as follows:
Adults - 5.0 mg
Children - 2.5 mg
Infants - 1.25 mg
These doses of the dye are usually injected in 1 mL volume. An average of five dilution curves are recommended in the performance of a diagnostic cardiac catheterization. The total dose of dye injected should be kept below 2 mg/kg.
While sterile water for injection may be used to rinse the syringe, isotonic saline should be used to flush the residual dye from the cardiac catheter into the circulation so as to avoid hemolysis. With the exception of the rinsing of the dye injection syringe, saline should be used in all other parts of the catheterization procedure.
Calibrating Dye Curves:
If a 2.5 mg/mL concentration was used for the dilution curves, 1 mL of the 2.5 mg/mL dye is added to 3 mL of distilled water to make the most concentrated “standard” solution. This concentration is then successively halved by diluting 2 mL of the previous concentration with 2 mL of distilled water.
Then 0.2 mL portions (accurately measured from a calibrated syringe) of these dye solutions are added to 5 mL aliquots of the subject's blood, giving final concentrations of the dye in blood beginning with 24.0 mg/liter, approximately (actual concentration depends on the exact volume of dye added). This concentration is, of course, successively halved in the succeeding aliquots of the subject's blood. These aliquots of blood containing known amounts of dye, as well as a blank sample to which 0.2 mL of saline containing no dye has been added, are then passed through the detecting instrument and a calibration curve is constructed from the deflections recorded.
What interacts with IC-Green?
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What are the warnings of IC-Green?
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What are the precautions of IC-Green?
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What are the side effects of IC-Green?
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What should I look out for while using IC-Green?
IC-GREEN contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides because of the risk of anaphylaxis.
What might happen if I take too much IC-Green?
There are no data available describing the signs, symptoms, or laboratory findings accompanying overdosage. The LD after intravenous 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. Based on body surface area, these doses are 2.4 to 13-fold the maximum recommended human (MRHD) dose of 2 mg/kg for indicator-dilution studies, 10 to 52-fold the MRHD of 0.5 mg/kg for hepatic-function studies, and 7 to 39-fold the MRHD of 0.67 mg/kg for ophthalmic angiography studies.
How should I store and handle IC-Green?
Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. IC-GREEN is supplied in a kit (NDC 17478-701-02) containing six 25 mg IC-GREEN vials and six 10 mL Sterile Water for Injection, USP ampules: NDC 17478-701-25 IC-GREEN vial. 25 mg fill in 20 mL vial. NDC 17478-701-10 Sterile Water for Injection, USP ampule. 10 mL fill in 10 mL ampule. IC-GREEN is supplied in a kit (NDC 17478-701-02) containing six 25 mg IC-GREEN vials and six 10 mL Sterile Water for Injection, USP ampules: NDC 17478-701-25 IC-GREEN vial. 25 mg fill in 20 mL vial. NDC 17478-701-10 Sterile Water for Injection, USP ampule. 10 mL fill in 10 mL ampule. IC-GREEN is supplied in a kit (NDC 17478-701-02) containing six 25 mg IC-GREEN vials and six 10 mL Sterile Water for Injection, USP ampules: NDC 17478-701-25 IC-GREEN vial. 25 mg fill in 20 mL vial. NDC 17478-701-10 Sterile Water for Injection, USP ampule. 10 mL fill in 10 mL ampule.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
IC-GREEN permits recording of the indicator-dilution curves for both diagnostic and research purposes independently of fluctuations in oxygen saturation. Following intravenous injection, IC-GREEN is rapidly bound to plasma protein, of which albumin is the principle carrier (95%). IC-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. IC-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 IC-GREEN a helpful index of hepatic function.
The peak absorption and emission of IC-GREEN lie in a region (800 to 850 nm) where transmission of energy by the pigment epithelium is more efficient than in the region of visible light energy. IC-GREEN also has the property of being nearly 98% bound to blood protein, and therefore, excessive dye extravasation does not take place in the highly fenestrated choroidal vasculature. It is, therefore, useful in both absorption and fluorescence infrared angiography of the choroidal vasculature when using appropriate filters and film in a fundus camera.
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
IC-GREEN contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides because of the risk of anaphylaxis.There have been rare reports of serious adverse events in connection with the coadministration of certain ergot alkaloid drugs (e.g., dihydroergotamine and ergotamine) and potent CYP 3A4 inhibitors, resulting in vasospasm leading to cerebral ischemia and/or ischemia of the extremities. Although there have been no reports of such interactions of methylergonovine alone, potent CYP 3A4 inhibitors should not be coadministered with methylergonovine. Examples of some of the more potent CYP 3A4 inhibitors include macrolide antibiotics (e.g., erythromycin, troleandomycin, clarithromycin), HIV protease or reverse transcriptase inhibitors (e.g., ritonavir, indinavir, nelfinavir, delavirdine) or azole antifungals (e.g., ketoconazole, itraconazole, voriconazole). Less potent CYP 3A4 inhibitors should be administered with caution. Less potent inhibitors include saquinavir, nefazodone, fluconazole, grapefruit juice, fluoxetine, fluvoxamine, zileuton, and clotrimazole. These lists are not exhaustive, and the prescriber should consider the effects on CYP 3A4 of other agents being considered for concomitant use with methylergonovine.
No pharmacokinetic interactions involving other cytochrome P450 isoenzymes are known.
Caution should be exercised when methylergonovine maleate is used concurrently with other vasoconstrictors or ergot alkaloids.
Deaths from anaphylaxis have been reported following IC-GREEN administration during cardiac catheterization.
Anaphylactic or urticarial reactions have been reported in patients with or without history of allergy to iodides. If such reactions occur, treat with the appropriate agents, e.g., epinephrine, antihistamines, and corticosteroids.
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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