UROVIST CYSTO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for UROVIST CYSTO (UROVIST CYSTO).
Urovist Cysto is a radiocontrast agent containing diatrizoate meglumine and diatrizoate sodium. It provides radiographic visualization of the urinary tract by attenuating X-rays due to its iodine content. It is not systemically absorbed when used intravesically; local contrast enhancement occurs through physical properties.
| Metabolism | Not metabolized; excreted unchanged via urinary tract when administered intravesically. |
| Excretion | Primarily renal excretion as unchanged drug (approximately 85-90% within 24 hours); minor biliary/fecal elimination (<5%). |
| Half-life | Terminal elimination half-life is approximately 2 hours in patients with normal renal function; may be prolonged in renal impairment. |
| Protein binding | Negligible protein binding (<5%) due to its iodinated, non-ionic nature. |
| Volume of Distribution | Following intravesical administration, systemic absorption is minimal; Vd cannot be reliably calculated due to negligible systemic distribution. For intravenous administration (if applicable), Vd is approximately 0.2-0.3 L/kg, indicating primarily extracellular fluid distribution. |
| Bioavailability | Intravesical administration results in negligible systemic absorption (<1% bioavailability into systemic circulation). |
| Onset of Action | Following intravesical instillation, local effect is near-immediate (within seconds to minutes) as the contrast agent reaches the bladder mucosa. |
| Duration of Action | Duration of diagnostic enhancement in the urinary bladder is approximately 1-2 hours post-instillation, sufficient for cystographic examination. |
Instillation of 50 mL of a 0.3% solution intravesically, retained for 10 minutes, for cystography.
| Dosage form | SOLUTION |
| Renal impairment | No adjustment required; systemic absorption minimal. |
| Liver impairment | No adjustment required; systemic absorption minimal. |
| Pediatric use | Instillation of 5 mL/kg (max 50 mL) of a 0.3% solution intravesically, retained for 10 minutes. |
| Geriatric use | Same as adult dosing; no specific adjustment needed. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for UROVIST CYSTO (UROVIST CYSTO).
| Breastfeeding | No data on excretion in human milk. M/P ratio unknown. Due to minimal systemic absorption after intravesical administration, risk to nursing infant is likely negligible. Caution is advised; consider benefits vs risks. |
| Teratogenic Risk | Urovist Cysto (diplpanolone methylsulfate) is not absorbed systemically when administered intravesically. No fetal risk is expected. No teratogenic effects reported in animal studies. However, due to lack of controlled human data, use during pregnancy only if clearly needed. First trimester: theoretical risk if systemic absorption occurs; second/third trimester: low risk due to minimal systemic exposure. |
■ FDA Black Box Warning
Not applicable (no FDA black box warnings for intravesical use).
| Serious Effects |
["Known hypersensitivity to diatrizoate or any component","Urinary tract obstruction that prevents drainage (relative contraindication)","Active urinary tract infection (relative contraindication due to risk of systemic absorption)"]
| Precautions | ["Hypersensitivity reactions including anaphylaxis (rare with intravesical use but possible if systemic absorption occurs through mucosal injury)","Avoid extravasation (may cause local tissue irritation)","Use with caution in patients with urinary tract infection or mucosal injury due to increased risk of systemic absorption","Ensure adequate hydration to minimize risk of contrast-induced nephropathy if systemic absorption occurs"] |
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| Fetal Monitoring | No specific maternal or fetal monitoring required due to lack of systemic absorption. Standard pregnancy monitoring recommended. If systemic side effects occur (unlikely), monitor maternal vital signs. |
| Fertility Effects | No known effects on fertility. No studies in humans; animal studies show no impairment of fertility at clinically relevant doses. |