ULTRAVIST 370
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ULTRAVIST 370 (ULTRAVIST 370).
Iodinated non-ionic contrast agent that attenuates X-rays due to its high iodine content (370 mg I/mL), enhancing vascular and tissue contrast during imaging. Does not bind to plasma proteins and has minimal pharmacological effects.
| Metabolism | Not metabolized; excreted unchanged by the kidneys via glomerular filtration with negligible plasma protein binding. |
| Excretion | Renal: 95% unchanged within 24 hours via glomerular filtration; Biliary/Fecal: <5%; negligible biliary excretion. |
| Half-life | Terminal elimination half-life: 2 hours (normal renal function); prolonged to up to 36 hours in severe renal impairment (CrCl <30 mL/min). |
| Protein binding | Low: approximately 1-2% bound to plasma proteins (albumin). |
| Volume of Distribution | 0.2–0.3 L/kg; primarily extracellular fluid with minimal intracellular penetration. |
| Bioavailability | Intravenous: 100%; not administered orally (non-absorbable, gastrointestinal studies use direct administration). |
| Onset of Action | Intravenous: immediate opacification within seconds; Intra-arterial: within 1-2 seconds; oral or other non-vascular routes not applicable. |
| Duration of Action | IV contrast enhancement lasts 15-30 minutes for CT; excreted within 24 hours; delayed clearance in renal impairment. |
Adult: IV administration of 370 mg iodine/mL at 1-1.5 mL/kg (370-555 mg I/kg) for CT; up to 300 mL total. Rate: 1-5 mL/sec.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR <30 mL/min/1.73m²: Avoid use or consider lowest necessary dose with adequate hydration. eGFR 30-45: Use minimal dose and ensure hydration. No adjustment for eGFR >45. |
| Liver impairment | Child-Pugh A, B, C: No dose adjustment required; however, caution in severe hepatic impairment due to potential systemic effects. |
| Pediatric use | Children: 1-2 mL/kg (370-740 mg I/kg) IV, not to exceed 3 mL/kg or 100 mL total. Adjust for age and weight; neonates may require lower doses. |
| Geriatric use | Elderly (>65 years): Use lowest effective dose (0.5-1 mL/kg). Monitor renal function; ensure adequate hydration. Increased risk of contrast-induced nephropathy. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ULTRAVIST 370 (ULTRAVIST 370).
| Breastfeeding | Ultravist 370 (iopromide) is excreted into breast milk in trace amounts (estimated infant dose <0.01% of maternal dose). M/P ratio not established. Due to low oral bioavailability and short half-life, breastfeeding can be resumed 12-24 hours after administration. Discard milk for 24 hours if concern. Considered compatible with breastfeeding. |
| Teratogenic Risk | Iodinated contrast agents cross the placenta. Embryotoxicity and teratogenicity have been observed in animal studies at high doses. In humans, first trimester exposure is associated with limited data; theoretical risk of fetal thyroid dysfunction due to free iodide. Second and third trimester exposure may cause transient neonatal hypothyroidism. Overall, risk of major malformations not significantly increased, but use only when clearly needed. |
■ FDA Black Box Warning
Not approved for intrathecal use. Inadvertent intrathecal administration may cause severe adverse reactions including seizure, cerebral hemorrhage, coma, and death.
| Serious Effects |
["Absolute: Hypersensitivity to iopromide or any component of the formulation","Absolute: Known history of anaphylactic reaction to any iodinated contrast agent","Relative: Pre-existing severe renal impairment (eGFR <30 mL/min/1.73m²) unless benefit outweighs risk","Relative: Uncontrolled hyperthyroidism or thyroid storm","Relative: Pregnancy (use only if clearly needed)"]
| Precautions | ["Risk of contrast-induced acute kidney injury (CI-AKI), especially in patients with pre-existing renal impairment, diabetes, or volume depletion","Anaphylactic/anaphylactoid reactions including fatal anaphylaxis; prophylactic corticosteroids and antihistamines may be considered in high-risk patients","Severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome or toxic epidermal necrolysis","Thyroid function disturbance; contrast-induced thyrotoxicosis in patients with hyperthyroidism or thyroid nodules","Extravasation risk causing tissue necrosis and compartment syndrome","Sickle cell disease patients may experience vaso-occlusive crises"] |
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| Fetal Monitoring | Monitor maternal renal function (serum creatinine) before administration. Assess fetal thyroid function (cord blood TSH, T4) at birth if exposure during pregnancy. Observe neonate for signs of respiratory distress or allergic reaction. No specific fetal monitoring required during administration. |
| Fertility Effects | No evidence of impaired fertility in animal studies. No human data on fertility effects. Transient effects on spermatogenesis reported with some iodinated agents, but clinically insignificant. No known impact on ovarian function. |