OPTIRAY 320
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OPTIRAY 320 (OPTIRAY 320).
Iodinated radiocontrast agent that attenuates X-rays and enhances vascular and tissue contrast during radiographic procedures.
| Metabolism | Negligible metabolism; eliminated primarily via glomerular filtration with 90% excreted unchanged in urine within 24 hours. |
| Excretion | Renal excretion of unchanged drug via glomerular filtration; approximately 95% eliminated in urine within 24 hours. Less than 1% excreted in feces via biliary route. |
| Half-life | Terminal elimination half-life is approximately 2 hours in patients with normal renal function (creatinine clearance >60 mL/min). Prolonged in renal impairment; may exceed 20 hours in severe renal failure (CrCl <30 mL/min). |
| Protein binding | Approximately 1-2% bound to plasma proteins (primarily albumin). |
| Volume of Distribution | Approximately 0.3–0.5 L/kg (Vdss); distributes primarily in extracellular fluid and does not significantly cross the blood-brain barrier in intact brain. |
| Bioavailability | Not applicable for oral route; for intravascular administration, bioavailability is 100% as it is directly injected into the bloodstream (IV or IA). |
| Onset of Action | Intravenous: immediate onset of contrast enhancement for CT imaging within seconds to 1 minute after injection. Intra-arterial: immediate upon injection. |
| Duration of Action | Intravenous: adequate vascular enhancement persists for 5–10 minutes; diagnostic visualization typically lasts 20–40 minutes due to redistribution and renal elimination. Repeat dosing may be required for prolonged studies. |
Intravenous administration: 50-150 mL of OPTIRAY 320 (ioversol 320 mg iodine/mL) per injection for contrast-enhanced CT; total dose not to exceed 250 mL. Intra-arterial: variable per procedure.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR <30 mL/min/1.73 m²: avoid use or use lowest necessary dose with pre-hydration; consider alternative imaging. eGFR 30-60: use minimum required dose, ensure adequate hydration, monitor renal function. |
| Liver impairment | No specific dose adjustment for hepatic impairment; use with caution in severe hepatic dysfunction due to potential risk of contrast-induced nephropathy. |
| Pediatric use | Intravenous: 1-2 mL/kg (320 mg iodine/kg) for CT; maximum 3 mL/kg total. Adjust per indication; ensure adequate hydration. |
| Geriatric use | Use lowest effective dose; monitor renal function (eGFR) closely; ensure adequate hydration; consider pre- and post-contrast hydration protocol. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OPTIRAY 320 (OPTIRAY 320).
| Breastfeeding | Iodinated contrast media are excreted into breast milk in very small amounts (<1% of maternal dose). M/P ratio unknown for OPTIRAY 320. Risk to infant is negligible; continue breastfeeding, but consider discarding milk for 12-24 hours post-dose if maternal anxiety. |
| Teratogenic Risk | Iodinated contrast media cross the placenta. First trimester: theoretical risk of fetal hypothyroidism, but no well-controlled studies; avoid unless essential. Second/third trimester: possible transient neonatal hypothyroidism; monitor thyroid function in neonate if repeated or high-dose exposure. No evidence of teratogenicity in animal studies. |
■ FDA Black Box Warning
Risk of contrast-induced acute kidney injury (CI-AKI) in patients with pre-existing renal impairment, diabetes mellitus, or dehydration.
| Serious Effects |
["Absolute: History of severe anaphylactic reaction to any iodinated contrast agent","Absolute: Clinically significant thyrotoxicosis","Relative: Severe renal impairment (eGFR < 30 mL/min/1.73 m²) unless benefits outweigh risks","Relative: Pregnancy (use only if clearly needed)"]
| Precautions | ["Hypersensitivity reactions (anaphylaxis, bronchospasm, angioedema); premedicate high-risk patients","Acute kidney injury; monitor renal function before and after administration","Thyroid storm in patients with hyperthyroidism or multinodular goiter; avoid in untreated thyrotoxicosis","Extravasation risk; ensure proper catheter placement","Sickle cell crisis in patients with hemoglobinopathies"] |
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| Fetal Monitoring | Maternal: renal function (SCr, eGFR before contrast) and hydration status. Fetal: no specific monitoring required for single dose; for multiple doses or high-risk pregnancy, consider neonatal thyroid function test (TSH) after birth. |
| Fertility Effects | No known adverse effects on fertility in animal studies. No human data available; unlikely to impact fertility at clinical doses. |