IODIXANOL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for IODIXANOL (IODIXANOL).
Iodixanol is a nonionic, iso-osmolar iodinated contrast agent that attenuates X-rays, allowing visualization of vascular structures and organ parenchyma. It does not bind to or interact with specific receptors.
| Metabolism | Iodixanol is not metabolized; it is excreted unchanged via glomerular filtration with minimal tubular reabsorption. |
| Excretion | Primarily renal: approximately 97% of the administered dose is excreted unchanged in the urine within 24 hours via glomerular filtration. Less than 3% is excreted in feces via biliary elimination. |
| Half-life | Terminal elimination half-life in patients with normal renal function is approximately 2 hours. In patients with moderate to severe renal impairment (creatinine clearance <30 mL/min), half-life may be prolonged up to 10-12 hours, requiring dose adjustment and monitoring. |
| Protein binding | Negligible protein binding (<2%), primarily bound to albumin. This low binding minimizes interference with protein-dependent transport and reduces risk of drug interactions. |
| Volume of Distribution | Volume of distribution at steady state (Vdss) is approximately 0.26 L/kg (range 0.2-0.3 L/kg), suggesting distribution primarily in extracellular fluid. This low Vd indicates limited tissue penetration. |
| Bioavailability | Not applicable for oral route as iodixanol is only administered intravascularly (intravenous, intra-arterial). Bioavailability is 100% upon intravenous administration. |
| Onset of Action | Intravenous administration: contrast enhancement observed within seconds to minutes after injection, typically reaching peak enhancement within the first 2 minutes for CT imaging. |
| Duration of Action | Duration of contrast enhancement is approximately 30-60 minutes for CT imaging, depending on the imaging protocol. Residual contrast may be detectable for up to 24 hours in patients with normal renal function, but clinical effects diminish rapidly as the agent is cleared. |
Intravenous injection of 270-350 mg iodine/kg (0.5-1.0 mL/kg of 270 mg I/mL solution) for CT; 300-400 mg iodine/kg for angiography. Administer as bolus or infusion per procedure.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR <30 mL/min/1.73m²: avoid use unless essential; if used, reduce dose by 50% and ensure hydration. eGFR 30-59: no dose reduction but ensure adequate hydration and consider lower dose per risk. |
| Liver impairment | No specific dose adjustments for Child-Pugh class A or B; use with caution in severe hepatic impairment (Child-Pugh C) due to increased risk of adverse reactions; consider lower dose and monitoring. |
| Pediatric use | Intravenous: 1.0-2.0 mL/kg of 270 mg I/mL solution (270-540 mg iodine/kg) for CT; adjust for procedure and body weight; maximum total dose not established; repeat dosing with caution. |
| Geriatric use | No specific dose adjustment, but consider age-related renal impairment; assess eGFR and avoid in severe renal dysfunction; ensure adequate hydration pre- and post-administration. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for IODIXANOL (IODIXANOL).
| Breastfeeding | Minimal excretion into breast milk. M/P ratio unknown. Contrast agent is poorly absorbed orally; unlikely to cause adverse effects in nursing infant. Manufacturer advises discontinuing breastfeeding for 24 hours after administration, though some guidelines consider it safe without interruption. Risk of neonatal hypothyroidism theoretical but negligible. |
| Teratogenic Risk | Iodixanol is a nonionic iodinated contrast agent. Limited human data; no evidence of teratogenicity in animal studies. Risk cannot be excluded; use only if clearly needed. First trimester: avoid unless essential due to theoretical risk of fetal thyroid suppression from free iodide. Second/third trimesters: minimal fetal exposure; consider fetal thyroid function if high doses or repeated exposure. |
■ FDA Black Box Warning
Risk of hypersensitivity reactions, including anaphylaxis and death. Prophylaxis is not reliable. Emergency drugs and equipment must be available.
| Serious Effects |
["Absolute: Known anaphylactoid reaction to iodinated contrast media","Relative: Severe renal impairment (eGFR <30 mL/min/1.73 m²), multiple myeloma, pheochromocytoma, sickle cell disease, unstable neurological conditions"]
| Precautions | ["Hypersensitivity reactions (urticaria, anaphylaxis)","Acute kidney injury, particularly in patients with pre-existing renal impairment, diabetes, or volume depletion","Thyroid dysfunction in patients with hyperthyroidism or goiter","Severe cardiovascular events in patients with unstable heart failure or arrhythmias","Extravasation causing local tissue injury"] |
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| Fetal Monitoring | No specific fetal monitoring required. Monitor maternal renal function before administration due to contrast-induced nephropathy risk. Assess maternal thyroid function if previous thyroid disease or high iodine load. For pregnant patients, consider pre- and post-procedure serum creatinine. |
| Fertility Effects | No known adverse effects on fertility from iodixanol. Animal studies show no impairment of fertility. No human data on fertility impact. |