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Optiray 320 (IOVERSOL)
Optiray 320 works by blocking X-rays, allowing for clearer images during medical imaging procedures.
Optiray 320 (IOVERSOL) is a radiographic contrast agent developed by Liebel-Flarsheim, used to enhance the visibility of internal structures during medical imaging procedures. It is a small molecule drug that works by blocking X-rays, allowing for clearer images. Optiray 320 is off-patent and has no generic manufacturers, but its commercial status is still maintained by Liebel-Flarsheim. It has been FDA-approved since 1988 for use in various medical imaging procedures. Key safety considerations include its short half-life of 1.5 hours.
At a glance
| Generic name | IOVERSOL |
|---|---|
| Sponsor | Liebel-Flarsheim |
| Drug class | Radiographic Contrast Agent [EPC] |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 1988 |
Mechanism of action
Intravascular injection of ioversol opacifies those vessels in the path of the flow of the contrast medium, permitting radiographic visualization of the internal structures until significant hemodilution occurs.Ioversol may be visualized in the renal parenchyma within 30 to 60 seconds following rapid intravenous injection. Opacification of the calyces and pelves in patients with normal renal function becomes apparent within to minutes, with optimum contrast occurring within to 15 minutes.Optiray enhances computed tomographic imaging through augmentation of radiographic efficiency. The degree of density enhancement is directly related to the iodine content in an administered dose; peak iodine blood levels occur immediately following rapid intravenous injection. Blood levels fall rapidly within to 10 minutes and the vascular compartment half-life is approximately 20 minutes. This can be accounted for by the dilution in the vascular and extravascular fluid compar
Approved indications
Boxed warnings
- WARNING: RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION FOR INTRA-ARTERIAL AND INTRAVENOUS USE ONLY 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: RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION FOR INTRA-ARTERIAL AND INTRAVENOUS USE ONLY Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. ( 5.1 )
Common side effects
- Nausea
- Fever
- Vomiting
- Abdominal pain
- Dysphagia
- Dry mouth
- Chest pain
- Injection site pain
- Injection site hematoma
- Extravasation
- Pyrexia
- Swelling
Key clinical trials
- Low-acid Contrast Media for Preventing Post ERCP Pancreatitis
- Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis (PHASE2)
- Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment (PHASE1,PHASE2)
- Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis LipioJoint-2 (PHASE3)
- Oil-based Vs. Water-based Contrast Medium in Hysterosalpingography for Infertile Women in Improving Fertility Outcome (NA)
- Use of a Water Soluble Contrast-Based Protocol to Assist in the Management of Pediatric Adhesive Small Bowel Obstruction
- Safety and Efficacy of a Lipiodol Emulsion for the Embolization of Hypervascularizations in Patients With Knee Pain (LipioJoint1) (PHASE1)
- Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Optiray 320 CI brief — competitive landscape report
- Optiray 320 updates RSS · CI watch RSS
- Liebel-Flarsheim portfolio CI