ULTRAVIST 300
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ULTRAVIST 300 (ULTRAVIST 300).
Nonionic iodinated contrast medium that attenuates X-rays, providing vascular and tissue enhancement for imaging.
| Metabolism | Not metabolized; eliminated unchanged by the kidneys via glomerular filtration. |
| Excretion | Renal: 95-100% as unchanged drug within 24 hours; biliary/fecal: <1%. |
| Half-life | Terminal elimination half-life: 1.5-2 hours (normal renal function); prolonged in renal impairment (up to 10 hours in severe cases). |
| Protein binding | <10% bound to plasma proteins (mainly albumin). |
| Volume of Distribution | 0.25-0.3 L/kg (extracellular fluid space, no significant tissue binding). |
| Bioavailability | Intravenous: 100%; oral: not administered orally; no oral bioavailability data; intra-arterial: effectively 100%. |
| Onset of Action | Intravenous: immediate (within minutes); intra-arterial: immediate. |
| Duration of Action | Sufficient for diagnostic imaging (30-60 minutes); contrast enhancement peaks within first 5-10 minutes after injection. |
Intravenous: 1.0-2.0 mL/kg (300-600 mg iodine/kg) body weight; maximum 200 mL per procedure. Intra-arterial: varies by procedure.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR 30-59 mL/min/1.73m2: limit to lowest necessary dose, ensure hydration. eGFR <30 mL/min: avoid use unless essential; consider alternative imaging. Hemodialysis: not removed; no specific dose adjustment. |
| Liver impairment | No specific dose adjustment for Child-Pugh class A, B, or C necessary; use caution in severe hepatic impairment due to potential coagulation disorders. |
| Pediatric use | Neonates to adolescents: 1.0-2.0 mL/kg (300-600 mg iodine/kg) IV; maximum 2.0 mL/kg per procedure. Ensure adequate hydration. |
| Geriatric use | No specific dose adjustment; monitor renal function closely due to age-related decline in GFR. Ensure adequate hydration pre- and post-procedure. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ULTRAVIST 300 (ULTRAVIST 300).
| Breastfeeding | Iodinated contrast media are excreted into breast milk in minimal amounts (M/P ratio approximately 0.01). Oral bioavailability in infant is low; negligible risk of adverse effects. The American College of Radiology states that breastfeeding may be continued without interruption after contrast administration, but some guidelines suggest discarding milk for 12-24 hours if mother prefers. |
| Teratogenic Risk | Pregnancy Category B. No evidence of teratogenicity in animal studies. In first trimester, theoretical risk of fetal hypothyroidism due to free iodide release. In second and third trimesters, risk of transient neonatal hypothyroidism if administered near term. Overall low teratogenic risk, but use only if clearly needed. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Known hypersensitivity to iopromide or any component","Anuria or severe renal impairment not on dialysis","Concurrent administration of interleukin-2 within 48 hours"]
| Precautions | ["Risk of contrast-induced nephropathy in patients with renal impairment","Anaphylactoid reactions including hypotension, bronchospasm, and angioedema","Thyroid storm in patients with hyperthyroidism or thyroid nodules","Severe cardiovascular reactions including arrest and arrhythmias","Extravasation causing tissue necrosis","Pregnancy Category B: Use only if clearly needed"] |
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| Fetal Monitoring | Monitor maternal renal function pre- and post-dose; assess for signs of allergic or anaphylactic reactions. Fetal monitoring not routinely required. In neonates exposed in utero near term, monitor thyroid function (TSH, free T4) at birth and at 1-2 weeks of age. |
| Fertility Effects | No known adverse effects on human fertility. Animal studies show no impairment of fertility. |