UROVIST SODIUM 300
Clinical safety rating: caution
Comprehensive clinical and safety monograph for UROVIST SODIUM 300 (UROVIST SODIUM 300).
Iodinated contrast agent that attenuates X-rays, improving visualization of vascular structures and organs during imaging.
| Metabolism | Minimal metabolism; eliminated primarily via glomerular filtration without tubular reabsorption. |
| Excretion | Primarily renal (glomerular filtration), with >90% of the administered dose excreted unchanged in urine within 24 hours. Biliary/fecal excretion is negligible (<5%). |
| Half-life | Terminal elimination half-life is approximately 2 hours in patients with normal renal function (GFR >90 mL/min). In renal impairment, half-life may be prolonged up to 10 hours or more, correlating with decreased GFR. |
| Protein binding | Approximately 10% bound to plasma proteins (primarily albumin). |
| Volume of Distribution | Volume of distribution is approximately 0.25-0.30 L/kg, indicating distribution mainly in extracellular fluid. It does not cross the blood-brain barrier significantly. |
| Bioavailability | Not applicable; UROVIST SODIUM 300 is administered only intravenously (100% bioavailability by IV route). No oral formulation exists. |
| Onset of Action | Intravenous administration: Radiographic opacification of the renal collecting system occurs within 1-2 minutes; vascular opacification begins immediately after injection. |
| Duration of Action | Intravenous: Renal opacification lasts 30-60 minutes; vascular opacification persists for 5-10 minutes. Adequate for diagnostic imaging procedures. |
| Molecular Weight | Approximately 590 Da (iopamidol, average MW 590.06) |
Intravenous injection of 50-100 mL for contrast imaging, typically a single dose of 300 mg iodine/mL.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in patients with GFR <30 mL/min. For GFR 30-60 mL/min, use lowest effective dose and ensure adequate hydration. No dose reduction specified for GFR >60 mL/min. |
| Liver impairment | No specific dose adjustment based on Child-Pugh classification. Use caution in severe hepatic impairment due to potential for contrast-induced nephropathy. |
| Pediatric use | 0.5-1.5 mL/kg intravenously, not to exceed 2 mL/kg. Maximum total dose 150 mL. Adjust for patient size and clinical indication. |
| Geriatric use | No specific dose adjustment for age alone. Assess renal function (eGFR) prior to administration; consider lower doses and adequate hydration due to age-related renal decline. |
| 1st trimester | Avoid. Iodinated contrast crosses placenta; potential fetal thyroid effects, especially in first trimester when fetal thyroid begins concentrating iodine. Use only if essential for maternal diagnosis. |
| 2nd trimester | Avoid unless benefit clearly outweighs risk. Fetal thyroid is functional from 10-12 weeks; exposure may cause transient neonatal hypothyroidism. |
| 3rd trimester | Avoid unless essential. Risk of neonatal hypothyroidism; consider thyroid function testing in neonate if exposure occurs. |
Clinical note
Comprehensive clinical and safety monograph for UROVIST SODIUM 300 (UROVIST SODIUM 300).
| Placental transfer | Iodinated contrast media cross the placenta. Transfer is minimal early in pregnancy but increases as gestation progresses. Fetal exposure is approximately 0.01-0.05% of maternal dose. Free iodide can cross and affect fetal thyroid. |
| Breastfeeding | Iodinated contrast agents are excreted in breast milk in very small amounts (less than 0.01% of maternal dose). The amount absorbed by infant is negligible and unlikely to cause clinically significant effects. However, due to theoretical risk of iodine-induced hypothyroidism in neonates, some experts recommend pumping and discarding milk for 12-24 hours after contrast administration. |
■ FDA Black Box Warning
Not for intrathecal use; severe adverse reactions including convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, and death may occur.
| Serious Effects |
Hypersensitivity to iopamidol or any component of the formulationAnuria due to preexisting renal impairment (risk of contrast-induced nephropathy)
| Precautions | Risk of contrast-induced nephropathy (especially in pre-existing renal impairment, diabetes, dehydration), Anaphylactoid reactions (treat with appropriate resuscitative measures), Thyroid storm in patients with hyperthyroidism or thyroid tumors, Sickle cell crisis in homozygous sickle cell disease, Severe cutaneous adverse reactions (SCARs), Fluid and electrolyte disturbances |
| Food/Dietary | No specific dietary restrictions are associated with Urovist Sodium 300. However, patients may be advised to maintain adequate hydration before and after the procedure. No known food-drug interactions. |
Loading safety data…
| Lactation Rating | L2 (Probably Compatible) |
| Teratogenic Risk | UROVIST SODIUM 300 (sodium diatrizoate) is an iodinated contrast agent. In pregnant women, iodinated contrast crosses the placenta and can potentially affect fetal thyroid function. First trimester exposure is associated with theoretical risk of fetal hypothyroidism, but human data are limited. No teratogenicity has been observed in animal studies. Second and third trimester risks include neonatal thyroid dysfunction if high doses are given near term. Use only if clearly needed and after risk-benefit assessment. |
| Fetal Monitoring | No specific fetal monitoring is required for routine use of UROVIST SODIUM 300 during pregnancy. However, due to potential fetal thyroid effects, neonatal thyroid function testing (TSH, free T4) may be considered if the agent was administered during the third trimester, especially at high doses or repeated studies. Maternal monitoring includes assessment for allergic reactions, renal function, and hydration status. Fetal heart rate monitoring is not indicated. |
| Fertility Effects | No adverse effects on fertility have been reported with UROVIST SODIUM 300. Animal studies do not indicate impairment of fertility. There is no known effect on spermatogenesis or oogenesis in humans at clinical doses. Iodinated contrast agents are not associated with long-term reproductive toxicity. |
| Clinical Pearls | Urovist Sodium 300 is a radiographic contrast agent for retrograde pyelography. Pre-warm to body temperature to reduce viscosity. Use aseptic technique. Monitor for extravasation; if occurs, discontinue and apply warm compresses. Not for intravenous use. Assess for previous hypersensitivity reactions. |
| Patient Advice | This medication is used for imaging of the urinary tract. · Inform your doctor if you have ever had an allergic reaction to contrast agents. · You may experience a temporary urge to urinate, pelvic discomfort, or a warm sensation. · Drink plenty of water before and after the procedure unless instructed otherwise. · Report any signs of allergic reaction: rash, itching, difficulty breathing, or swelling. |