What is Optiray Injection, and how does it work?
What are the side effects of Optiray Injection?
Common side effects of Optiray include
Some side effects of Optiray can occur up to 24 hours after receiving the medication.
[Ioversol Injection 74%]
[Ioversol Injection 68%]
[Ioversol Injection 64%]
[Ioversol Injection 51%]
NOT FOR INTRATHECAL USE
What is the dosage for Optiray Injection?
Optiray is indicated for:
- Optiray 300: cerebral arteriography, and peripheral arteriography.
- Optiray 320: cerebral arteriography, peripheral arteriography, visceral and renal arteriography, aortography, coronary arteriography, and left ventriculography.
- Optiray 350: peripheral arteriography, coronary arteriography, and left ventriculography.
In Pediatric Patients
- Optiray 320 and Optiray 350: angiocardiography.
- Optiray 300: CT imaging of the head and body, venography, and intravenous excretory urography.
- Optiray 320: CT imaging of the head and body, venography, and intravenous excretory urography.
- Optiray 350: CT imaging of the head and body, venography, intravenous excretory urography, and intravenous digital subtraction angiography (IV-DSA).
In Pediatric Patients
- Optiray 320: CT imaging of the head and body, and intravenous excretory urography.
Dosage and Administration
Important Dosage And Administration Instructions
- Optiray is for intravascular use only.
- Use sterile technique for all handling and administration of Optiray.
- Inspect glass container prior to use for breakage or other damage and do not use damaged containers.
- Warm Optiray and administer at body or room temperature.
- Inspect Optiray for particulate matter or discoloration before administration. Do not administer if Optiray contains particulate matter or is discolored.
- Do not mix Optiray with other drugs, solutions or total parenteral nutrition mixtures.
- Use the lowest dose necessary to obtain adequate visualization.
- Adjust the volume and concentration of Optiray. Modify the dose accounting for factors such as age, body weight, vessel size, blood flow rate within the vessel, Â anticipated pathology, degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed.
- Avoid extravasation when injecting Optiray; especially in patients with severe arterial or venous disease.
- Hydrate patients before and after Optiray administration.
Directions For Proper Use Of Optiray Pharmacy Bulk Package
- The Pharmacy Bulk Package is not for direct infusion.
- Penetrate the container closure only one time, utilizing a suitable sterile transfer device or dispensing set which allows measured distribution of the contents.
- Transfer Optiray from the Pharmacy Bulk Package only in a suitable work area, such as a laminar flow hood, utilizing aseptic technique.
- Withdraw container contents immediately. However, should this not be possible, a maximum time of 4 hours from initial closure entry is permitted to complete fluid transfer operations.
- Temperature of container after the closure has been entered should not exceed 25°C (77°F).
Intra-arterial Procedures In Adults
Use Optiray 300 or Optiray 320. The recommended dose for visualization of cerebral arteries is shown below (may repeat as necessary):Diagnostic areaDoseMaximum Cumulative Dosecarotid or vertebral arteries2 to 12 mL200 mLaortic arch injection (four vessel study)20 to 50 mL200 mL
Use Optiray 300, Optiray 320 or Optiray 350. The recommended dose for visualization of peripheral arteries is shown below (may repeat as necessary):Diagnostic areaDoseMaximum Cumulative Doseaorta-iliac runoff60 mL (range 20 to 90 mL)250 mLcommon iliac, femoral40 mL (range 10 to 50 mL)250 mLsubclavian, brachial20 mL (range 15 to 30 mL)250 mL
Visceral And Renal Arteriography And Aortography
Use Optiray 320. The recommended dose for visualization for the aorta and visceral arteries is shown below (may repeat as necessary):Diagnostic areaDoseMaximum Cumulative Doseaorta45 mL (range 10 to 80 mL)250 mLceliac45 mL (range 12 to 60 mL)250 mLsuperior mesenteric45 mL (range 15 to 60 mL)250 mLrenal or inferior mesenteric9 mL (range 6 to 15 mL)250 mL
Coronary Arteriography And Left Ventriculography
Use Optiray 320 or Optiray 350. The recommended dose for visualization of the coronary arteries and left ventricle is shown below (may repeat as necessary):Diagnostic areaDoseMaximum Cumulative Doseleft coronary8 mL (range 2 to 10 mL)250 mLright coronary6 mL (range 1 to 10 mL)250 mLleft ventricle40 mL (range 30 to 50 mL)250 mL
Intravenous Procedures In Adults
Use Optiray 300, Optiray 320 or Optiray 350 for head and body imaging.
The recommended dosing is shown below:
- Scan immediately after completion of the intravenous administration.
Optiray may be administered by bolus injection, by rapid infusion, or by a combination of both. The recommended dosing is shown below:
- Scanning interval will vary with indication and target organ
Use Optiray 300, Optiray 320 or Optiray 350. The recommended dose is 50 to 100 mL per extremity; with a maximum cumulative dose of 250 mL.
Use Optiray 350, Optiray 320, or Optiray 300. The recommended dose is shown below:Usual DoseHigh Dose UrographyMaximum DoseOptiray 30050 to 75 mL1.6 mL/kg150 mLOptiray 32050 to 75 mL1.5 to 2 mL/kg150 mLOptiray 35050 to 75 mL1.4 mL/kg140 mL
Intravenous Digital Subtraction Angiography (IV-DSA)
Use Optiray 350. The recommended dose range per injection is 30 to 50 mL; may repeat as necessary with a maximum cumulative dose of 250mL.
Injection rates will vary depending on the site of catheter placement and vessel size.
- Central catheter injections are usually made at a rate of between 10 and 30 mL/second.
- Peripheral injections are usually made at a rate of between 12 and 20 mL/second.
Use Optiray 350 or Optiray 320. The recommended single ventricular dose is 1.25 mL/kg (range 1 mL/kg to 1.5 mL/kg). The maximum cumulative dose is 5 mL/kg up to a maximum total volume of 250 mL.
Use Optiray 320.
Head And Body Imaging
The recommended dose in pediatric patients is 1.5 mL/kg to 2 mL/kg (range 1 mL/kg to 3 mL/kg).
Use Optiray 320. The recommended dose for pediatric patients is 1 mL/kg to 1.5 mL/kg (range 0.5 mL/kg to 3 mL/kg); with a maximum cumulative dose not exceeding 3 mL/kg.
Dosage Forms And Strengths
Injection: clear, colorless to pale yellow solutions containing no undissolved solids, available in a pharmacy bulk package multiple-dose container in the following strengths:
- OPTIRAY 300 (Ioversol 64%): 300 mg of organically bound iodine per mL (636 mg of ioversol per mL)
- OPTIRAY 320 (Ioversol 68%): 320 mg of organically bound iodine per mL (678 mg of ioversol per mL)
- OPTIRAY 350 (Ioversol 74%): 350 mg of organically bound iodine per mL (741 mg of ioversol per mL)
About how much does an adult human brain weigh?
What drugs interact with Optiray Injection?
- In patients with renal impairment, metformin can cause lactic acidosis.
- Iodinated contrast agents appear to increase the risk of metformin induced lactic acidosis, possibly as a result of worsening renal function.
- Stop metformin at the time of, or prior to, Optiray administration in patients with an eGFR between 30 and 60 mL/min/1.73 m²; in patients with a history of hepatic impairment, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast agents.
- Re-evaluate eGFR 48 hours after the imaging procedure, and reinstitute only after renal function is stable.
- Administration of iodinated contrast agents may interfere with thyroid uptake of radioactive iodine (I-131) and decrease therapeutic efficacy in patients with carcinoma of the thyroid. The decrease in efficacy lasts for 6-8 weeks.
Oral Cholecystographic Contrast Agents
- Renal toxicity has been reported in patients with liver impairment who were given oral cholecystographic agents followed by intravascular contrast agents.
- Administration of Optiray should be postponed in patients who have recently received a cholecystographic contrast agent.
Drug/Laboratory Test Interactions
Protein-Bound Iodine, Radioactive Iodine Determinations
- The results of protein bound iodine and radioactive iodine uptake studies, which depend on iodine estimation, will not accurately reflect thyroid function for up to 16 days following administration of iodinated contrast agent.
- However, thyroid function tests that do not depend on iodine estimations, e.g., T3 resin uptake and total or free thyroxine (T4) assays are not affected.
Is Optiray Injection safe to use while pregnant or breastfeeding?
- Postmarketing data with Optiray use in pregnant women are insufficient to determine if there is a risk of drug-associated adverse developmental outcomes.
- Ioversol crosses the placenta and reaches fetal tissues in small amounts.
- There is no information about the presence of ioversol in human or animal milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.
- However, iodinated contrast agents are excreted unchanged in human milk in very low amounts with poor absorption from the gastrointestinal tract of the breastfed infant.
- The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Optiray and any potential adverse effects on the breastfed infant from Optiray or from the underlying maternal condition.