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. |
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 | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for UROVIST CYSTO PEDIATRIC (UROVIST CYSTO PEDIATRIC).
| Breastfeeding | Not systemically absorbed after intravesical use; therefore, excretion into breast milk is minimal. M/P ratio not applicable. Considered compatible with breastfeeding; no interruption of breastfeeding necessary. |
| 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. |
■ FDA Black Box Warning
None
| Serious Effects |
["Known hypersensitivity to iodine-containing contrast media","Severe renal impairment (anuria or severe oliguria)","Thyrotoxicosis"]
| Precautions | ["Risk of hypersensitivity reactions including anaphylaxis","Acute renal failure in patients with pre-existing renal insufficiency","Extravasation leading to tissue necrosis"] |
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| 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. |