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. |
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 | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for UROVIST SODIUM 300 (UROVIST SODIUM 300).
| Breastfeeding | Iodinated contrast agents are excreted into breast milk in very small amounts (less than 1% of maternal dose). The milk-to-plasma ratio for diatrizoate is approximately 0.007. The amount ingested by a breastfed infant is negligible and unlikely to cause adverse effects. The American College of Radiology (ACR) states that breastfeeding can continue without interruption after contrast administration. However, if the mother is concerned, she may pump and discard milk for 12-24 hours. No specific monitoring of the infant is required. |
| 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. |
■ 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 |
["Known hypersensitivity to sodium diatrizoate or any component","Anuria or severe oliguria due to pre-existing renal disease","Concurrent administration of oral cholecystographic agents","Intrathecal administration"]
| 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"] |
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| 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. |