UROVIST CYSTO PEDIATRIC
Clinical safety rating: caution
Comprehensive clinical and safety monograph for UROVIST CYSTO PEDIATRIC (UROVIST CYSTO PEDIATRIC).
Radiopaque contrast agent that provides enhanced visualization of the urinary tract by attenuating X-rays due to its iodine content.
| Metabolism | Not extensively metabolized; primarily excreted unchanged by the kidneys via glomerular filtration. |
| Excretion | Urovist Cysto Pediatric (diatrizoate meglumine) is not significantly absorbed systemically after intravesical administration. The small fraction absorbed is excreted unchanged in urine via glomerular filtration, with 95% eliminated within 24 hours after intravenous administration; biliary/fecal excretion is negligible. |
| Half-life | After intravesical administration, systemic absorption is minimal; therefore, a meaningful terminal half-life is not defined. If absorbed, the elimination half-life of diatrizoate is approximately 1–2 hours in patients with normal renal function, reflecting rapid renal clearance. |
| Protein binding | Negligible; diatrizoate is minimally bound to plasma proteins (<10%). |
| Volume of Distribution | For the small fraction absorbed systemically, volume of distribution is approximately 0.4–0.6 L/kg, indicating distribution primarily within the extracellular fluid. |
| Bioavailability | Not applicable; the drug is administered by intravesical instillation for local effect. Systemic absorption is minimal and not quantified; bioavailability via this route is considered negligible. |
| Onset of Action | Immediately upon intravesical instillation; radiographic visualization occurs within minutes. |
| Duration of Action | Duration of action is limited to the time the contrast agent remains in the bladder cavity, typically 30–60 minutes for diagnostic imaging, after which it is voided. |
| Molecular Weight | 1003.0 Da (average molecular weight for diatrizoate meglumine sodium, the active component) |
Not applicable; Urovist Cysto Pediatric is a contrast agent for cystourethrography, instilled intravesically as a single dose of 5-10 mL for infants and 10-30 mL for children, not a systemic drug.
| Dosage form | SOLUTION |
| Renal impairment | No systemic absorption following intravesical administration; renal adjustment not required. |
| Liver impairment | No systemic absorption; hepatic adjustment not required. |
| Pediatric use | Instill intravesically: infants 5-10 mL, children 10-30 mL; volume adjusted based on bladder capacity. |
| Geriatric use | No systemic absorption; no dose adjustment needed. |
| 1st trimester | Not recommended due to potential risks of ionizing radiation, especially during organogenesis; use only if clearly needed and benefit outweighs risk. |
| 2nd trimester | Use with caution; fetal radiation exposure should be minimized. Consider alternative imaging modalities without ionizing radiation. |
| 3rd trimester | Use with caution; potential for fetal thyroid suppression if iodinated contrast is used. Ensure neonatal thyroid function monitoring if exposure occurs. |
Clinical note
Comprehensive clinical and safety monograph for UROVIST CYSTO PEDIATRIC (UROVIST CYSTO PEDIATRIC).
| Placental transfer | Iodinated contrast agents cross the placenta minimally in animal studies; human data limited but suggest low transfer. Free iodide may cross and potentially affect fetal thyroid function. |
| Breastfeeding | Trace amounts of iodinated contrast may be excreted into breast milk; however, the risk to the nursing infant is considered negligible. The American College of Radiology states that breastfeeding can be continued without interruption after administration. If concerned, the mother may pump and discard milk for 12-24 hours post-procedure. |
■ FDA Black Box Warning
None
| Serious Effects |
Known hypersensitivity to diatrizoate meglumine or sodiumHysterosalpingography in pregnant or potentially pregnant patientsMyelography (intrathecal administration) due to neurotoxicitySevere dehydrationConcurrent administration of metformin in patients with renal impairment or who will undergo angiography (risk of lactic acidosis)
| Precautions | Risk of hypersensitivity reactions including anaphylaxis, Acute renal failure in patients with pre-existing renal insufficiency, Extravasation leading to tissue necrosis |
| Food/Dietary | No known food interactions. No dietary restrictions required before or after administration. However, patients should follow general pre-procedure fasting instructions as per institutional protocol (e.g., nil per os for 2-4 hours prior to sedation if used). |
Loading safety data…
| Lactation Rating | L2 (Safer) |
| Teratogenic Risk | UROVIST CYSTO PEDIATRIC (diatrizoate meglumine) is an iodinated contrast agent used for cystography. It is not systemically absorbed in significant amounts when instilled intravesically; thus direct fetal exposure is negligible. No teratogenic effects have been reported in humans. However, theoretical risk of fetal hypothyroidism exists if significant absorption occurs; first trimester exposure not associated with congenital anomalies. Second and third trimester: no known risks. |
| Fetal Monitoring | Monitor for signs of allergic reaction, extravasation, or infection. Fetal heart rate monitoring not required. In cases of suspected systemic absorption (e.g., intraperitoneal extravasation), monitor thyroid function in neonate. |
| Fertility Effects | No known effect on fertility. Intravesical administration avoids systemic exposure; therefore, no impact on gametogenesis or conception. |
| Clinical Pearls | Urovist Cysto Pediatric is a contrast medium for retrograde cystourethrography. Ensure adequate hydration before procedure. In infants, use low volumes (10-30 mL) to avoid overdistension. Warm contrast to body temperature to reduce discomfort. Monitor for extravasation; if occurs, apply warm compresses. Contraindicated in known hypersensitivity to contrast media. |
| Patient Advice | This medication is used for imaging the bladder and urethra during a procedure called a voiding cystourethrogram (VCUG). · Your child may feel a sensation of fullness or mild discomfort when the bladder is filled. · The contrast material will appear in the urine and be naturally eliminated after the procedure. · Inform the doctor if your child has any allergies, especially to contrast media or iodine. · Keep your child well-hydrated before and after the procedure unless instructed otherwise. |