ULTRAVIST 150
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ULTRAVIST 150 (ULTRAVIST 150).
Nonionic iodinated contrast medium that attenuates X-rays, enhancing vascular and tissue contrast due to iodine content. It distributes in extracellular fluid and is excreted unchanged by glomerular filtration.
| Metabolism | Not metabolized; eliminated unchanged via glomerular filtration. |
| Excretion | Primarily renal (glomerular filtration, >95% of injected dose excreted unchanged in urine within 24 hours; negligible biliary/fecal excretion <2%) |
| Half-life | Terminal elimination half-life approximately 2 hours (range 1.5–3 hours) in patients with normal renal function; prolonged in renal impairment (up to 30 hours in severe impairment) |
| Protein binding | Negligible (<2%) bound to plasma proteins (primarily albumin) |
| Volume of Distribution | Approximately 0.3–0.4 L/kg, reflecting distribution primarily in extracellular fluid space; does not cross intact blood-brain barrier |
| Bioavailability | Intravenous: 100% (administered directly into bloodstream); no oral bioavailability due to degradation in GI tract; other routes not relevant |
| Onset of Action | Intravenous: immediate (within seconds to 1 minute) for contrast enhancement in CT or angiography; intra-arterial: immediate upon injection |
| Duration of Action | Intravenous: imaging window approximately 15–30 minutes for CT; redistribution and elimination reduce diagnostic contrast within 1 hour; complete clearance by 24 hours |
Intravascular administration: 1-2 mL/kg of ULTRAVIST 150 (150 mg iodine/mL) as a bolus or rapid infusion. Typical adult dose ranges from 50-200 mL depending on procedure and patient weight. Not to exceed 7.5 mL/kg.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR 30-59 mL/min/1.73m²: Use lowest diagnostic dose, ensure adequate hydration, consider alternative imaging if possible. eGFR <30 mL/min/1.73m²: Avoid use unless essential; if necessary, use minimum dose, hydrate, and monitor renal function for 48-72 hours. Hemodialysis patients: Use only if clearly indicated; no dose adjustment needed but contrast removal via dialysis is minimal. |
| Liver impairment | No specific dose adjustment required for hepatic impairment. Caution in severe hepatic disease due to increased risk of contrast-induced nephropathy. |
| Pediatric use | Weight-based: 1-2 mL/kg intravenously, not to exceed total dose of 5 mL/kg. Specific protocols: CT head: 1-2 mL/kg; CT body: 2 mL/kg. Administer as slow bolus or infusion. |
| Geriatric use | Use lowest diagnostic dose. Ensure adequate hydration before and after procedure. Monitor renal function (eGFR) and adjust volume accordingly. Higher risk of adverse reactions, especially in frail elderly with comorbidities. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ULTRAVIST 150 (ULTRAVIST 150).
| Breastfeeding | Iopromide is excreted into breast milk in very small amounts. The M/P ratio is unknown. The estimated infant dose is less than 1% of the maternal dose, which is considered clinically insignificant. Breastfeeding can be continued without interruption, although some guidelines suggest discontinuation for 24 hours as a precaution. The benefits of breastfeeding generally outweigh the negligible risk. |
| Teratogenic Risk | ULTRAVIST 150 (iopromide) is a nonionic iodinated contrast medium. Animal studies have not shown teratogenic effects. In humans, the risk of fetal harm is considered low with standard diagnostic use. However, fetal hypothyroidism may occur if the agent crosses the placenta, particularly in the second and third trimesters, as iodine can affect fetal thyroid function. Transient neonatal hypothyroidism has been reported. The risk is dose-dependent and higher with repeated exposure. Generally, use is avoided in pregnancy unless essential, and if used, neonatal thyroid function should be assessed. |
■ FDA Black Box Warning
Not approved for intrathecal use; severe adverse reactions including seizures, coma, and death have occurred with inadvertent intrathecal administration.
| Serious Effects |
["Known hypersensitivity to iopromide or any excipient","Manifest hyperthyroidism","Anuria or severe oliguria due to renal failure","Concurrent use of intrathecal corticosteroids"]
| Precautions | ["Risk of acute kidney injury in patients with pre-existing renal impairment, diabetes, or dehydration","Hypersensitivity reactions including anaphylaxis","Thyroid storm in patients with hyperthyroidism","Extravasation leading to tissue necrosis","Sickle cell crisis in susceptible individuals","Interference with thyroid function tests"] |
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| Fetal Monitoring | No specific maternal or fetal monitoring is routinely required after diagnostic use. However, if administered during pregnancy, consider neonatal thyroid function testing (TSH, free T4) within 1-2 weeks after birth to rule out transient hypothyroidism. Maternal renal function should be assessed prior to administration due to contrast-induced nephropathy risk. |
| Fertility Effects | No known adverse effects on fertility in animal studies or human data. Transient, reversible effects on sperm motility and morphology have been reported with other iodinated contrast agents, but specific data for ULTRAVIST 150 are lacking. Clinically, no significant impact on fertility is expected. |