ULTRAVIST 300 IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ULTRAVIST 300 IN PLASTIC CONTAINER (ULTRAVIST 300 IN PLASTIC CONTAINER).
Iopromide is a nonionic, low-osmolality iodinated contrast medium that attenuates X-rays due to its iodine content (300 mg iodine/mL). It provides radiographic contrast in vascular and parenchymal imaging by increasing the density of blood vessels and tissues, thereby enhancing the visibility of structures and lesions.
| Metabolism | Iopromide is not metabolized; it is excreted unchanged by glomerular filtration. No hepatic metabolism occurs. |
| Excretion | Renal: 90% unchanged via glomerular filtration within 24 hours; biliary: <1%; fecal: <2%. |
| Half-life | Terminal half-life: 2 hours in patients with normal renal function; prolonged up to 30 hours in severe renal impairment (CrCl <30 mL/min). |
| Protein binding | Minimal; approximately 1% bound; binding proteins: albumin (negligible). |
| Volume of Distribution | Vd: 0.25 L/kg (approximately 17.5 L in 70 kg adult); indicates distribution primarily in extracellular fluid. |
| Bioavailability | Not applicable; only administered intravenously or intra-arterially (100% bioavailability via these routes). |
| Onset of Action | Intravenous: immediate (within 1 minute) for contrast enhancement; intra-arterial: within seconds. |
| Duration of Action | Contrast enhancement in CT: 1–2 minutes after bolus; extends up to 15–20 minutes if slow infusion; elimination complete within 24 hours in normal renal function. |
Intravenous administration of 1-2 mL/kg (300 mg iodine/mL) for contrast-enhanced CT; typical adult dose 100-150 mL (30-45 g iodine) given as bolus or rapid infusion.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR <30 mL/min/1.73 m²: avoid use or use with extreme caution; consider alternative imaging. eGFR 30-59: ensure adequate hydration; dose reduction not established but use lowest necessary volume. |
| Liver impairment | No specific Child-Pugh based modifications; use caution in severe hepatic impairment due to potential for contrast-induced nephropathy. |
| Pediatric use | Weight-based dosing: 1-2 mL/kg (300 mg I/mL) IV; maximum 125 mL per dose. Adjust for body habitus and indication. |
| Geriatric use | Use lowest effective dose; assess renal function (eGFR) prior to administration; ensure adequate hydration; monitor for contrast-induced nephropathy. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ULTRAVIST 300 IN PLASTIC CONTAINER (ULTRAVIST 300 IN PLASTIC CONTAINER).
| Breastfeeding | Iopromide is excreted into breast milk in very small amounts (estimated infant dose <1% of maternal dose). M/P ratio has not been established but is likely <0.1 due to high water solubility and short half-life. Breastfeeding can be continued without interruption, but some sources recommend discarding milk for 24 hours post-procedure to minimize infant exposure. |
| Teratogenic Risk | ULTRAVIST 300 (iopromide) is an iodinated contrast medium. No teratogenic effects have been reported in animal studies. In humans, data are limited; however, as a low-osmolar nonionic contrast agent, it is considered to have low risk of fetal harm when used in standard diagnostic doses. First trimester exposure may carry a theoretical risk of fetal thyroid dysfunction due to free iodide. Second and third trimester exposure: transient fetal thyroid suppression possible if large volumes used, but clinically significant neonatal hypothyroidism is rare. |
■ FDA Black Box Warning
None
| Serious Effects |
["Absolute: known hypersensitivity to iopromide or any component of the formulation.","Absolute: history of severe anaphylactoid reaction to any iodinated contrast agent.","Relative: acute or chronic severe renal impairment (e.g., eGFR <30 mL/min/1.73 m²) without dialysis; use only if benefit outweighs risk.","Relative: concurrent administration of metformin in patients with renal dysfunction; discontinue metformin 48 hours before and after contrast use.","Relative: pregnancy (only if clearly needed); lactation (discontinue breastfeeding for 24 hours after administration)."]
| Precautions | ["Risk of contrast-induced acute kidney injury (CI-AKI), especially in patients with pre-existing renal impairment, diabetes mellitus, dehydration, or concurrent nephrotoxic drug use.","Anaphylactoid reactions (including severe hypotension, bronchospasm, laryngeal edema) requiring immediate treatment; pre-medication may be considered for high-risk patients.","Radiocontrast medium-induced encephalopathy and seizures; use caution in patients with compromised blood-brain barrier or seizure disorders.","Thyroid storm in patients with hyperthyroidism or thyroid nodules; monitor thyroid function.","Extravasation risk leading to local tissue injury; ensure proper catheter placement."] |
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| Fetal Monitoring | Monitor maternal renal function and hydration status before and after administration. Observe for signs of allergic or hypersensitivity reactions (urticaria, hypotension, bronchospasm). For fetal monitoring: assess amniotic fluid volume if multiple doses used; neonatal thyroid function testing (TSH, T4) is recommended if large volumes were administered near term or if the infant shows signs of hypothyroidism. |
| Fertility Effects | No adverse effects on fertility have been reported in animal studies. In humans, no data suggest that iopromide affects fertility. However, any effects would be transient due to rapid excretion. |