Ioversol
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: NOT FOR INTRATHECAL USE Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema [see Warnings and Precautions ( 5.1 )]. WARNING: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning . Inadvertent intrathecal administration may cause death, convulsion, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema [see Warnings and Precautions ( 5.1 )].
Radiographic Contrast Agent
Dosing in kidney impairment
Renal Impairment In patients with impaired renal function, the elimination half-life is prolonged. Ioversol can be removed by dialysis.
| Diagnostic area | Dose | Maximum Cumulative Dose |
| aorta | 45 mL (range 10 to 80 mL) | 250 mL |
| celiac | 45 mL (range 12 to 60 mL) | 250 mL |
| superior mesenteric | 45 mL (range 15 to 60 mL) | 250 mL |
| renal or inferior mesenteric | 9 mL (range 6 to 15 mL) | 250 mL |
Preparation and administration
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Important Dosage and Administration Instructions OPTIRAY is for intravascular use only [see Boxed Warning, Contraindications, Warnings and Precautions] . 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, 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 [see Warnings and Precautions] . Hydrate patients before and after OPTIRAY administration [see Warnings and Precautions]. 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).
| Infusion | |
| OPTIRAY 320 | 50 to 150 mL |
| OPTIRAY 350 | 50 to 150 mL |
| Bolus Injection | Infusion | |
| OPTIRAY 320 | 25 to 75mL | 50 to 150 mL |
| OPTIRAY 350 | 25 to 75mL | 50 to 150 mL |
Drug interactions
Check ioversol against a medication listLabel text (4 paragraphs)
7 DRUG INTERACTIONS
7.1 Drug-Drug Interactions Metformin 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.
Radioactive Iodine 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.
7.2 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.
Contraindications
Symptomatic hyperthyroidism. Symptomatic Hyperthyroidism ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary 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 [see Data]. In animal reproduction studies, no adverse developmental effects were observed following daily intravenous administrations of ioversol to pregnant rats (from Gestation Day 7 to 17) and rabbits (Gestation Day 6 to 18) at doses 0.35 and 0.71 times, respectively, the maximum recommended human dose. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of major birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data Literature reports show that ioversol crosses the placenta and is visualized in the digestive tract of exposed infants after birth. Animal Data Developmental toxicity studies were conducted with ioversol given intravenously at doses of 0, 0.2, 0.8, and 3.2 g iodine/kg/day from Gestation Day7 to 17 and 6 to 18, in rats and rabbits, respectively.
No adverse effects on embryo-fetal development were observed in either species at the maximum dose tested (3.2 g iodine/kg/day). Maternal toxicity was observed in rabbits at 0.8 and 3.2 g iodine/kg/day.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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