UROVIST MEGLUMINE DIU/CT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for UROVIST MEGLUMINE DIU/CT (UROVIST MEGLUMINE DIU/CT).
Urovist Meglumine DIU/CT is a contrast agent containing meglumine diatrizoate, an ionic monomeric iodinated radiopaque medium. It attenuates X-rays, enhancing vascular and tissue contrast during imaging. The diatrizoate ion increases plasma osmolality, potentially causing vasodilation and hemodynamic effects.
| Metabolism | Diatrizoate is not metabolized; it is excreted unchanged by glomerular filtration. |
| Excretion | Renal: >95% unchanged within 24 hours by glomerular filtration. Biliary/fecal: <5%. |
| Half-life | Terminal elimination half-life 1–2 hours in patients with normal renal function. Prolonged to >20 hours with severe renal impairment (CrCl <30 mL/min). |
| Protein binding | Negligible (<1%) primarily to albumin. |
| Volume of Distribution | 0.2–0.3 L/kg, indicating distribution primarily in extracellular fluid. |
| Bioavailability | Intravenous: 100%. Not absorbed orally. |
| Onset of Action | Intravenous: immediate (within seconds) for radiographic contrast enhancement; intravesical/subarachnoid: <5 minutes. |
| Duration of Action | Intravenous: 30–60 minutes for contrast enhancement (equilibrium phase); intravesical: 1–2 hours; subarachnoid: 2–3 hours for myelography. |
Intravenous administration: 100-200 mL of a 30% solution (containing 30% meglumine diatrizoate) infused over 10-30 minutes for CT imaging. Repeated doses may be given up to a maximum total dose equivalent to 4.0 mL/kg.
| Dosage form | INJECTABLE |
| Renal impairment | GFR >30 mL/min: No adjustment. GFR 15-30 mL/min: Use minimum effective dose with adequate hydration; consider alternative if possible. GFR <15 mL/min: Contraindicated due to risk of contrast-induced nephropathy. |
| Liver impairment | No specific dose adjustment based on Child-Pugh class; however, caution in severe hepatic impairment due to potential for altered contrast clearance. |
| Pediatric use | Weight-based: 1.0-2.0 mL/kg (up to 100 mL) of 30% solution intravenously; administered as a bolus or infusion over 10-30 minutes. Do not exceed 4.0 mL/kg total dose. |
| Geriatric use | Elderly patients may have reduced renal function; assess GFR prior to administration. Use minimum effective dose (e.g., 1.0-1.5 mL/kg) with adequate hydration to minimize nephrotoxicity risk. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for UROVIST MEGLUMINE DIU/CT (UROVIST MEGLUMINE DIU/CT).
| Breastfeeding | Diatrizoate meglumine is minimally excreted into breast milk; very low oral bioavailability in infants. M/P ratio: not established. Minimal systemic absorption by infant; risk negligible. Clinical recommendation: breastfeeding can continue without interruption, but consider pumping and discarding for 24 hours post-administration if parental concern. |
| Teratogenic Risk | Animal studies have not been conducted with diatrizoate meglumine; however, iodinated contrast agents cross the placenta. First-trimester exposure: theoretical risk of fetal hypothyroidism due to free iodide. Second/third trimesters: transient neonatal hypothyroidism possible after in utero exposure; prolonged exposure may cause fetal goiter. Risk of fetal injury is low with single diagnostic dose. Use only if clearly needed. |
■ FDA Black Box Warning
Not for intrathecal use. Inadvertent intrathecal administration may cause severe adverse reactions including coma, convulsions, and death.
| Serious Effects |
["Known hypersensitivity to diatrizoate or other iodinated contrast media","Anuria or severely impaired renal function with oliguria","Concurrent administration of intrathecal corticosteroids (for myelography route, which is contraindicated)"]
| Precautions | ["Risk of severe hypersensitivity reactions including anaphylaxis","Acute kidney injury in patients with renal impairment or dehydration","Thyroid storm in patients with hyperthyroidism","Extravasation risk during injection","Sickle cell disease exacerbation","Interference with thyroid function tests"] |
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| Fetal Monitoring | Monitor maternal renal function (serum creatinine, GFR) prior to administration given risk of contrast-induced nephropathy. Observe for immediate hypersensitivity reactions (urticaria, bronchospasm, anaphylaxis). In pregnancy, monitor fetal heart rate and uterine activity if late gestation; post-procedure neonatal thyroid function test (TSH) at birth. |
| Fertility Effects | No known effect on human fertility. Animal reproductive studies not performed. Theoretical transient ovarian exposure to radiation during CT may impact fertility, but contrast agent itself is not expected to impair fertility. |