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. |
| Molecular Weight | 809 Da (iopromide) |
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 | Avoid unless essential; iodinated contrast crosses placenta; potential neonatal hypothyroidism risk. |
| 2nd trimester | Use only if clinically indicated; fetal thyroid exposure concerns. |
| 3rd trimester | Use only if clinically indicated; risk of neonatal hypothyroidism post-exposure. |
Clinical note
Comprehensive clinical and safety monograph for ULTRAVIST 300 (ULTRAVIST 300).
| Placental transfer | Crosses placenta; fetal plasma levels approximately 10-20% of maternal levels after IV administration. |
| Breastfeeding | Excreted in human milk in very low amounts; minimal risk of direct toxicity; consider interrupting breastfeeding for 12-24 hours after administration. |
| Lactation Rating |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
History of severe hypersensitivity reaction to iopromideHereditary galactose intolerance (contains galactose)Thyrotoxicosis (uncorrected)
| 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 |
| Food/Dietary | No specific dietary restrictions are required, but maintaining adequate hydration with water or clear fluids is recommended. Avoid diuretic beverages (e.g., coffee, tea, alcohol) before and after the procedure as they may exacerbate dehydration. There are no known drug-food interactions with iopromide. |
Loading safety data…
| L2 |
| 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. |
| 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. |
| Clinical Pearls | Pre-warm contrast to body temperature to reduce viscosity and injection discomfort. Ensure adequate hydration (e.g., 1 L oral or IV fluids) before and after administration to prevent contrast-induced nephropathy. Screen for metformin use; withhold metformin for 48 hours post-procedure if eGFR < 30 mL/min/1.73 m². Have emergency equipment ready for immediate treatment of anaphylactoid reactions (epinephrine, antihistamines, corticosteroids). Use lowest possible dose to achieve diagnostic image, especially in patients with renal impairment or risk factors for adverse reactions. |
| Patient Advice | Inform your healthcare provider if you have a history of allergic reactions to contrast media, asthma, or allergies to iodine. · You may experience a warm sensation, metallic taste, or mild nausea during the injection; these sensations are usually temporary. · Drink plenty of fluids before and after the procedure to help protect your kidneys. · Report any symptoms such as hives, difficulty breathing, swelling of the face or throat, or severe itching to a medical professional immediately. · If you are taking metformin for diabetes, discuss with your doctor whether you should stop it temporarily (usually 48 hours after the procedure). · For patients with kidney disease, the use of this contrast agent may carry a risk of further kidney injury; your doctor may perform blood tests to assess your kidney function before the test. |