OPTIRAY 160
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OPTIRAY 160 (OPTIRAY 160).
Radiopaque contrast agent that attenuates X-rays, providing enhanced visualization of vascular structures and organs during imaging procedures.
| Metabolism | Minimal metabolism; primarily excreted unchanged via glomerular filtration by the kidneys. |
| Excretion | Primarily renal excretion via glomerular filtration; approximately 95% of the administered dose is excreted unchanged in the urine within 24 hours. Fecal excretion is negligible (<1%). |
| Half-life | Terminal elimination half-life is approximately 1.5 to 2 hours in patients with normal renal function. Prolonged in renal impairment, up to 20–30 hours in severe renal failure. |
| Protein binding | Approximately 5–10% bound to plasma proteins, primarily albumin. Minimal binding. |
| Volume of Distribution | Approximately 0.25 L/kg, reflecting distribution primarily in extracellular fluid space with limited tissue penetration. |
| Bioavailability | Intravenous: 100% (administered as an intravenous bolus or infusion). Not administered via other routes. |
| Onset of Action | Intravenous administration: immediate opacification of vasculature within seconds; peaks at 1–2 minutes for vascular imaging. No other relevant routes. |
| Duration of Action | Vascular opacification lasts approximately 30–60 minutes after injection; sufficient for diagnostic imaging procedures. Prolonged in patients with renal impairment. |
Intravenous: 50-150 mL (total dose 8-30 g iodine) as a bolus or rapid infusion; Intra-arterial: Variable per procedure; maximum 250 mL per procedure.
| Dosage form | INJECTABLE |
| Renal impairment | GFR ≥60 mL/min: no adjustment; GFR 30-59 mL/min: reduce dose to minimum necessary or consider alternative; GFR <30 mL/min: avoid use; consider prophylactic hydration and N-acetylcysteine. |
| Liver impairment | Child-Pugh A/B: no specific adjustment; Child-Pugh C: use with caution, monitor for contrast-induced nephropathy; no dose reduction established. |
| Pediatric use | Intravenous: 1-2 mL/kg (160-320 mg iodine/kg) as a bolus; maximum 3 mL/kg (480 mg iodine/kg) per procedure. |
| Geriatric use | Use lowest effective dose; assess renal function (eGFR) and adjust accordingly; ensure adequate hydration; monitor for acute kidney injury. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OPTIRAY 160 (OPTIRAY 160).
| Breastfeeding | Ioversol is excreted into breast milk in very small amounts (<1% of the maternal dose). The estimated infant dose is negligible, and no adverse effects in nursing infants have been reported. The milk-to-plasma (M/P) ratio is approximately 0.3. Breastfeeding can be continued without interruption, but some sources suggest discarding milk for 24 hours after contrast administration. |
| Teratogenic Risk | Iodinated contrast agents are generally considered low risk for teratogenicity in humans. Animal studies have not shown fetal harm. However, fetal hypothyroidism can occur if maternal thyroid function is suppressed by excess iodide, particularly in the second and third trimesters. The risk is dose-dependent and transient. Optiray 160 (ioversol) is classified as FDA Pregnancy Category B. |
■ FDA Black Box Warning
WARNING: NOT FOR INTRATHECAL USE. Accidental intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
| Serious Effects |
["Hypersensitivity to ioversol or any component of the formulation.","Intrathecal administration (absolute contraindication).","Anuria or severe renal impairment (contraindicated for excretory urography).","Acute myocardial infarction with hemodynamic instability (relative contraindication)."]
| Precautions | ["Risk of contrast-induced acute kidney injury (CI-AKI), especially in patients with pre-existing renal impairment, diabetes, dehydration, or concurrent use of nephrotoxic drugs.","Hypersensitivity reactions: anaphylaxis, angioedema, bronchospasm, skin reactions. Pretreatment may be considered for high-risk patients.","Thyroid storm: in patients with hyperthyroidism or multinodular goiter, iodinated contrast may precipitate thyrotoxic crisis.","Cardiovascular effects: arrhythmias, hypotension, hypertension, bradycardia, cardiac arrest.","Central nervous system reactions: seizures (especially in patients with history of epilepsy), confusion, coma.","Severe cutaneous adverse reactions (SCARs): Stevens-Johnson syndrome, toxic epidermal necrolysis.","Extravasation may cause tissue necrosis, compartment syndrome."] |
Loading safety data…
| Fetal Monitoring | Monitor maternal thyroid function (TSH, free T4) if large doses are given or in women with pre-existing thyroid disorders, as fetal hypothyroidism is a potential risk. Assess fetal heart rate during administration if indicated. Post-contrast, observe mother for allergic reactions or contrast-induced nephropathy, especially if pre-existing renal impairment. |
| Fertility Effects | No known adverse effects on human fertility. Animal studies have not shown impaired fertility. There are no reports of reduced fertility or reproductive toxicity associated with ioversol. |