HYPAQUE-CYSTO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HYPAQUE-CYSTO (HYPAQUE-CYSTO).
HYPAQUE-CYSTO (diatrizoate meglumine) is a radiopaque contrast agent that absorbs x-rays, providing contrast in radiographic imaging. It acts as an iodinated contrast medium.
| Metabolism | Diatrizoate is not metabolized; eliminated unchanged by glomerular filtration. |
| Excretion | Renal excretion via glomerular filtration: >95% unchanged within 24 hours. Fecal excretion: <5%. |
| Half-life | Terminal elimination half-life: 1.5–2.5 hours (normal renal function). Prolonged in renal impairment. |
| Protein binding | Negligible (approximately 1–5%); does not bind significantly to plasma proteins. |
| Volume of Distribution | Approximately 0.2–0.3 L/kg; primarily distributed in extracellular fluid, does not cross intact blood-brain barrier. |
| Bioavailability | Intravesical/urethral administration: local effect; minimal systemic absorption (<1%). |
| Onset of Action | Intravesical instillation: immediate opacification upon administration; intraurethral: within 1–2 minutes. |
| Duration of Action | Sufficient for cystourethrography (5–15 minutes); most diagnostic procedures completed within 20–30 minutes. |
Intravesical instillation: 100-300 mL of 30% solution for retrograde cystourethrography; single administration.
| Dosage form | SOLUTION |
| Renal impairment | Contraindicated in patients with anuria or severely impaired renal function (eGFR <30 mL/min/1.73 m²). For eGFR 30-60 mL/min/1.73 m²: use with caution, ensure adequate hydration, and consider lowest necessary dose. |
| Liver impairment | No specific dosage adjustment recommended based on Child-Pugh classification; monitor for signs of hepatotoxicity in severe hepatic impairment. |
| Pediatric use | Intravesical: 1-2 mL/kg of 30% solution (maximum 150 mL) for diagnostic imaging; adjust based on bladder capacity. |
| Geriatric use | Use lowest effective dose; monitor renal function closely due to age-related decline in GFR; ensure adequate hydration before and after administration. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HYPAQUE-CYSTO (HYPAQUE-CYSTO).
| Breastfeeding | Limited data; excreted in breast milk in low quantities. M/P ratio unknown. Use caution; discontinue breastfeeding or drug based on necessity. |
| Teratogenic Risk | FDA Pregnancy Category B. No evidence of teratogenicity in animal studies. Insufficient human data; risk cannot be excluded. Avoid first trimester unless essential. |
| Fetal Monitoring | Monitor maternal renal function (serum creatinine, BUN) and hydration status. Assess fetal heart rate if used during pregnancy. Observe for allergic reactions. |
■ FDA Black Box Warning
Not approved for intrathecal use; severe adverse reactions including seizures, cerebral hemorrhage, and death have occurred following inadvertent intrathecal administration.
| Serious Effects |
["Known hypersensitivity to diatrizoate or any component","Thrombophlebitis or active infection in the lower urinary tract","Severe renal impairment (e.g., anuria)"]
| Precautions | ["Risk of hypersensitivity reactions including anaphylaxis","Renal toxicity in patients with pre-existing renal impairment","Hydration status should be optimized before use","Thyroid toxicity in patients with hyperthyroidism or thyroid nodules"] |
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| Fertility Effects | No known adverse effects on fertility in animal studies. Human data insufficient to determine impact. |