OPTIRAY 300
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OPTIRAY 300 (OPTIRAY 300).
Optiray 300 (ioversol) is a nonionic iodinated contrast medium that attenuates X-rays, enhancing vascular and tissue contrast during imaging. It acts by increasing the density of blood vessels and tissues to X-rays, thereby improving visualization of anatomical structures.
| Metabolism | Ioversol is not metabolized; it is excreted unchanged by glomerular filtration with negligible plasma protein binding. Less than 2% is recovered in feces. |
| Excretion | Primarily renal elimination via glomerular filtration; approximately 95-100% of the administered dose is excreted unchanged in urine within 24 hours. A negligible amount is eliminated via biliary/fecal routes (<1%). |
| Half-life | Terminal elimination half-life is approximately 1.5-2 hours in patients with normal renal function. In patients with impaired renal function, half-life may be prolonged significantly (up to 30 hours or more), necessitating dose adjustment or avoidance. |
| Protein binding | Negligible protein binding; less than 5% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution (Vd) is approximately 0.26-0.30 L/kg, consistent with distribution primarily in extracellular fluid. This reflects rapid equilibration with the interstitial space. |
| Bioavailability | Intravenous administration results in 100% bioavailability. Not administered via other routes. |
| Onset of Action | Intravenous administration: Onset of contrast enhancement is immediate during injection, with peak vascular opacification occurring within 1-2 minutes after injection. |
| Duration of Action | Duration of contrast enhancement for vascular imaging is approximately 5-10 minutes after injection due to rapid distribution and elimination. For delayed-phase imaging (e.g., excretory urography), opacification may persist up to 30-60 minutes. |
Intravenous administration: 50-150 mL per injection (up to 250 mL for CT imaging). Typical adult dose: 1-2 mL/kg body weight (up to 150 mL) given as a bolus or rapid infusion. Intrathecal administration: 8-12 mL for myelography.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in acute renal impairment or severe chronic kidney disease (eGFR < 30 mL/min/1.73 m²). For eGFR 30-59 mL/min/1.73 m²: use lowest effective dose, ensure adequate hydration, and consider holding nephrotoxic drugs. No specific dose reduction; alternative imaging preferred. |
| Liver impairment | No dose adjustment required for Child-Pugh Class A or B. For Child-Pugh Class C: use with caution; no specific dose modification but increased risk of adverse effects. |
| Pediatric use | Intravenous: 1-2 mL/kg (up to 2.5 mL/kg in neonates) per injection, not to exceed 150 mL total. Bolus or rapid infusion. Intrathecal: 0.2-0.5 mL/kg (max 12 mL). |
| Geriatric use | Use lowest effective dose due to age-related renal impairment. Ensure adequate hydration before and after administration. Monitor renal function (eGFR) and adjust accordingly to avoid contrast-induced nephropathy. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OPTIRAY 300 (OPTIRAY 300).
| Breastfeeding | Ioversol is excreted into breast milk in very small quantities (M/P ratio unknown but estimated <1% of maternal dose). The risk to nursing infant is minimal, but caution should be exercised, especially in neonates. Temporary cessation of breastfeeding for 12-24 hours after administration is optional. |
| Teratogenic Risk | Optiray 300 (ioversol) is a nonionic iodinated contrast medium. In pregnant women, iodinated contrast crosses the placenta. Animal studies have not shown teratogenic effects, but there are no adequate human studies. First trimester exposure carries a theoretical risk of fetal thyroid suppression; second and third trimester exposure may cause neonatal hypothyroidism if contrast reaches fetal thyroid. Use only if clearly needed. |
■ FDA Black Box Warning
Not for intrathecal use; severe adverse reactions including convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, and death may occur.
| Serious Effects |
["Intrathecal administration (absolute)","History of serious hypersensitivity reaction to ioversol or other iodinated contrast media","Pre-existing severe renal impairment (e.g., eGFR < 30 mL/min/1.73 m²) without dialysis","Decompensated congestive heart failure with fluid overload","Active systemic lupus erythematosus (relative)","Severe hypertension unresponsive to treatment (relative)"]
| Precautions | ["Risk of serious hypersensitivity reactions (e.g., anaphylaxis, angioedema)","Acute kidney injury, especially in patients with pre-existing renal impairment, diabetes mellitus, or dehydration","Contrast-induced nephropathy: ensure adequate hydration prior to administration","Cardiovascular adverse events including arrhythmias, myocardial ischemia, and hypotension","Thyrotoxicosis potential: avoid in patients with hyperthyroidism or autonomous thyroid nodules","Severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome (rare)","Interference with thyroid function tests; may cause iodine-induced hyperthyroidism","Extravasation risk: may cause tissue damage and necrosis"] |
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| Fetal Monitoring | Monitor maternal vital signs and oxygen saturation during and after administration. Assess renal function and hydration status. In pregnancy, monitor fetal heart rate if clinically indicated. Thyroid function tests in neonate if contrast administered near term. |
| Fertility Effects | No formal studies on human fertility. Animal studies with ioversol did not show impairment of fertility. There is no known effect on female or male fertility; however, iodine-based contrast may rarely cause transient alterations in thyroid function, which could theoretically affect fertility. |