zyogreen
Zyogreen (Indocyanine Green) is a medication supplied as a solution.
Indocyanine Green · by Provepharm Sas
Key facts
- Active ingredient
- Indocyanine Green
- Form
- Solution
- Strength
- Indocyanine Green 25MG/10ML (2.5MG/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Provepharm Sas
- FDA application
- NDA218579
What is Zyogreen?
From the FDA label:ZYOGREEN (indocyanine green injection) is an optical imaging agent for intravenous or interstitial use. The chemical name for indocyanine green is 1 H- Benz[e]indolium, 2-[7-[1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2 H -benz[e]indol-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-, hydroxide, inner salt, sodium salt. It has a molecular formula of C 43 H 47 N 2 NaO 6 S 2 and a molecular mass of 774.96 g/mol. The structural formula is shown below. Indocyanine green has a peak spectral absorption at 805 nm in blood. ZYOGREEN is a sterile, ready-to-use solution. Each mL contains 2.5 mg of indocyanine green with not more than 0.125 mg sodium iodide and the following inactive ingredients: 1 mg sodium ascorbate and water for injection with a pH between 5.5 and 7.5. structural formula
How to use
Visualization of vessels, blood flow and tissue perfusion Pediatric patients less than 1 month of age: 0.15 mg/kg Adults and pediatric patients 1 month of age and older: 1.25 mg to 5 mg by intravenous injection ( 2.2 ) Extremity perfusion visualization through the skin Pediatric patients less than 1 month of age: 0.15 mg/kg Pediatric patients 1 month of age and older: 1.25 mg to 5 mg Adults: 3.75 mg to 10 mg by intravenous injection ( 2.2 ) Visualization of extrahepatic biliary ducts Pediatric patients from birth to less than 1 year of age: 0.1 mg/kg (not to exceed 2.5 mg) 12 to 24 hours prior to surgery Adults and pediatric patients 6 years of age and older: 2.5 mg by intravenous injection at least 45 minutes prior to surgery ( 2.3 ) Lymphatic mapping of cervical and uterine cancer in adults 5 mg interstitially as four 1.25 mg injections. See Full Prescribing Information for injection techniques. ( 2.4 ) Ophthalmic Angiography in adults and pediatric patients: doses up to 40 mg by intravenous injection. ( 2.5 ) The total dose must not exceed 2 mg/kg for all patients. 2.1 Important Administration Instructions ZYOGREEN is a ready-to-use solution, provided in ampules at a concentration of 2.5 mg per mL. Use immediately after opening ampule. Withdraw the contents of the ampule through a 5 micrometer or smaller straw/filter needle to ensure that the withdrawn solution contains no…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] . The following adverse reactions have been identified during post-approval use of indocyanine green, the active ingredient in ZYOGREEN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders : Anaphylaxis, urticaria The most common adverse reactions reported are anaphylaxis and urticaria. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1–800-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Warnings
Important safety information
Hypersensitivity reactions: Always have cardiopulmonary resuscitation personnel and equipment readily available and monitor patients. ( 5.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions including anaphylaxis, urticaria, and deaths due to anaphylaxis have been reported following intravenous administration of indocyanine green, the active ingredient in ZYOGREEN [see Adverse Reactions ( 6 )]. ZYOGREEN is contraindicated in patients with a history of hypersensitivity to indocyanine green [see Contraindications ( 4 )] . Always have cardiopulmonary resuscitation personnel and equipment readily available and monitor all patients for hypersensitivity reactions. 5.2 Interference with Thyroid Radioactive Iodine Uptake Studies Because ZYOGREEN contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration [see Drug Interactions ( 7 )].
Who should not take Zyogreen
ZYOGREEN is contraindicated in patients with a history of hypersensitivity to indocyanine green. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.1 )] . Hypersensitivity to indocyanine green ( 4 )
Interactions
Interference with Thyroid Radioactive Iodine Uptake Studies: Do not perform radioactive iodine uptake studies for at least one week following the use of ZYOGREEN. ( 7 ) Interference with Thyroid Radioactive Iodine Uptake Studies Because ZYOGREEN contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Do not perform radioactive iodine uptake studies for at least one week following administration of ZYOGREEN.
Dosage forms
Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- Is there a coupon or discount for Zyogreen?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Zyogreen. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Zyogreen?
- Zyogreen is marketed by Provepharm Sas. You can see Provepharm Sas's full profile, rating, and other products on pharmaranks.
- Is Zyogreen a brand-name or generic drug?
- Zyogreen is a brand-name product with the active ingredient Indocyanine Green.
- Is Zyogreen available over the counter?
- No. Zyogreen is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Zyogreen come in?
- Zyogreen is currently marketed as solution, per the FDA's National Drug Code Directory.
- Is Zyogreen FDA-registered?
- Zyogreen is on record with the U.S. FDA under application number NDA218579. You can verify this on its official FDA label.
- Is Zyogreen safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Zyogreen. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Zyogreen?
- Zyogreen's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] . The following adverse reactions have been identified during post-approval use of indocyanine green, the active ingredient in ZYOGREEN.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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