ULTRAVIST 240
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ULTRAVIST 240 (ULTRAVIST 240).
Iodinated nonionic contrast agent that attenuates X-rays by increasing the density of iodine atoms, enhancing vascular and tissue contrast during imaging procedures. It does not have intrinsic pharmacological activity.
| Metabolism | Not metabolized; eliminated unchanged via renal glomerular filtration in patients with normal renal function. No hepatic involvement. |
| Excretion | Primarily renal excretion via glomerular filtration; approximately >90% of the administered dose is excreted unchanged in the urine within 24 hours. Biliary/fecal excretion is negligible (<2%). |
| Half-life | Terminal elimination half-life is approximately 2 hours in patients with normal renal function. In patients with renal impairment, half-life may be prolonged up to 10-30 hours, necessitating dose adjustment. |
| Protein binding | Minimal binding; approximately 1-2% bound to plasma proteins (primarily albumin). |
| Volume of Distribution | Approximately 0.2-0.3 L/kg; predominantly confined to extracellular fluid and vascular space. |
| Bioavailability | Intravenous administration: 100% (bioavailability not applicable for oral route as it is not absorbed orally). |
| Onset of Action | Intravenous administration: immediate (<1 minute) due to direct vascular delivery; intra-arterial: immediate; oral or other non-vascular routes not applicable (not absorbed). |
| Duration of Action | Duration of diagnostic contrast enhancement is typically 30-60 minutes for CT imaging, with peak enhancement at 30-60 seconds for arterial phase; complete elimination by 24 hours. |
IV injection: 1.0-2.0 mL/kg (240 mg I/mL) for CT; total dose not to exceed 250 mL per procedure.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR <30 mL/min/1.73m²: use lowest possible dose; consider alternative imaging. eGFR 30-44: ensure hydration, use minimum diagnostic dose. eGFR ≥45: no adjustment needed. |
| Liver impairment | No specific Child-Pugh based adjustment; use caution in severe hepatic impairment due to potential coagulation abnormalities. |
| Pediatric use | IV: 1.0-2.0 mL/kg (240 mg I/mL) based on age and imaging; maximum 3.0 mL/kg per procedure, not to exceed 250 mL. |
| Geriatric use | Assess renal function (eGFR) and hydrate adequately; use lowest diagnostic dose due to increased risk of nephrotoxicity and dehydration. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ULTRAVIST 240 (ULTRAVIST 240).
| Breastfeeding | Iopromide is excreted into breast milk in small amounts; M/P ratio not established. Estimated infant dose <1% of maternal dose. Clinically insignificant risk of adverse effects. Breastfeeding can continue without interruption, but cautious approach advises pumping and discarding milk for 24-48 hours post-exposure if mother is concerned. |
| Teratogenic Risk | ULTRAVIST 240 (iopromide) is an iodinated contrast agent. In pregnant women, exposure is generally avoided unless essential. Animal studies have not shown teratogenic effects, but adequate human studies are lacking. First trimester: theoretical risk of fetal thyroid suppression if large doses are used, but no structural teratogenicity documented. Second and third trimesters: consider fetal hypothyroidism risk due to free iodide; neonatal thyroid function monitoring recommended if exposure occurred. |
■ FDA Black Box Warning
None listed by FDA (nonionic contrast agents may carry risk of contrast-induced nephropathy, but no boxed warning for ULTRAVIST 240 specifically).
| Serious Effects |
["Absolute: Known hypersensitivity to iodinated contrast agents, anuria/decompensated renal failure","Relative: Preexisting renal impairment (eGFR <30), concurrent use of nephrotoxic drugs, hyperthyroidism, pregnancy"]
| Precautions | ["Contrast-induced nephropathy risk, especially in preexisting renal impairment, diabetes, dehydration","Anaphylaxis risk; premedication recommended for high-risk patients","Thyroid toxicity in patients with hyperthyroidism or thyroid nodules","Severe cutaneous adverse reactions (SCARs)","CNS adverse effects with intrathecal use: seizures, cerebral edema"] |
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| Fetal Monitoring | Monitor maternal vital signs (blood pressure, heart rate) during and post-procedure for anaphylactoid reactions. Assess fetal heart rate if late pregnancy. Neonatal thyroid function tests (TSH, T4) recommended if significant maternal exposure in second or third trimester. |
| Fertility Effects | No known adverse effects on human fertility. Animal studies have not reported impaired fertility. Transient effects are unlikely given single use and rapid elimination. |