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. |
| Molecular Weight | 791 |
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 | Iodinated contrast media should be avoided in the first trimester unless essential, as fetal thyroid exposure may occur from around 10-12 weeks gestation. Risk of fetal hypothyroidism is theoretical; use only if diagnostic benefit outweighs risk. |
| 2nd trimester | Use only if clearly needed. Iodinated contrast crosses the placenta and can affect fetal thyroid function. Neonatal thyroid function should be monitored if contrast was administered during pregnancy. |
| 3rd trimester | Use only if essential. Contrast crosses placenta; neonatal thyroid function should be checked after birth. Transient fetal hypothyroidism reported occasionally. |
Clinical note
Comprehensive clinical and safety monograph for ULTRAVIST 300 IN PLASTIC CONTAINER (ULTRAVIST 300 IN PLASTIC CONTAINER).
| Placental transfer | Iopromide crosses the placenta. In animal studies, it was detected in fetal tissues. In humans, transplacental passage occurs, and the fetal thyroid may be exposed to free iodide after deiodination of the contrast agent. The degree is considered low but clinically relevant for thyroid function. |
■ FDA Black Box Warning
None
| Serious Effects |
Previous severe adverse reaction to iopromide or any iodinated contrast mediumManifest hyperthyroidismDecompensated cardiac insufficiency
| 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. |
| Food/Dietary | No specific food restrictions. However, patients should maintain adequate hydration. Fasting may be required for certain procedures (e.g., CT angiography) per institutional protocol. |
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| Breastfeeding |
| Iopromide is excreted into breast milk in very small amounts (less than 0.01% of maternal dose). The amount absorbed by the infant is negligible. Breastfeeding can be continued without interruption; however, some sources suggest discarding milk for 24 hours post-administration if maternal anxiety is high. |
| Lactation Rating | L1 (Compatible) |
| 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. |
| 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. |
| Clinical Pearls | Ultravist 300 (iopromide) is a low-osmolar nonionic iodinated contrast medium. Pre-warming to body temperature reduces viscosity and improves tolerability. Ensure adequate hydration before and after administration to minimize risk of contrast-induced nephropathy. Screen for history of allergic reactions to iodinated contrast; premedication with corticosteroids and antihistamines may be indicated for high-risk patients. Metformin should be withheld for 48 hours post-procedure and renal function monitored due to risk of lactic acidosis. Have emergency equipment available for anaphylaxis. |
| Patient Advice | Inform your doctor if you have any allergies, especially to iodine or contrast dyes. · You may experience a warm sensation, metallic taste, or nausea during the injection; this is temporary. · Drink plenty of water before and after the procedure to help protect your kidneys. · If you take metformin for diabetes, your doctor may advise you to stop it for 48 hours after the scan. · Report any symptoms of an allergic reaction such as hives, difficulty breathing, or swelling of the face or throat immediately. · Breastfeeding mothers may need to pump and discard breast milk for 24 hours after the procedure. |