CYSTOGRAFIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CYSTOGRAFIN (CYSTOGRAFIN).
Cystografin is an ionic, water-soluble, iodinated radiographic contrast agent. It contains diatrizoate meglumine and diatrizoate sodium. Iodine atoms absorb X-rays, providing enhanced contrast in imaging studies. It is administered into body cavities for visualization.
| Metabolism | Not significantly metabolized; eliminated primarily via renal excretion in unchanged form. |
| Excretion | Renal excretion of unchanged drug via glomerular filtration; >95% eliminated in urine within 24 hours. Less than 5% biliary/fecal. |
| Half-life | Terminal elimination half-life approximately 2 hours in patients with normal renal function; prolonged in renal impairment (up to 30+ hours in severe impairment). |
| Protein binding | Minimal; less than 10% bound to serum albumin. |
| Volume of Distribution | 0.15-0.3 L/kg; distributes primarily in extracellular fluid, minimal intracellular penetration. |
| Bioavailability | Intravesical: ~100% (local administration); intravenous: 100%; oral: negligible (not absorbed). |
| Onset of Action | Intravesical: immediate upon instillation; intravenous: within minutes for contrast enhancement. |
| Duration of Action | Intravesical: up to 1-2 hours for cystography; intravenous: 1-2 hours for contrast studies, depending on renal function. |
Intravesical instillation: 300-500 mL of 30% solution via urethral catheter for cystography; Intravenous: 0.5-1.0 mL/kg of 30-60% solution for urography, maximum 100 mL.
| Dosage form | SOLUTION |
| Renal impairment | Contraindicated in anuria or severe renal impairment (eGFR <30 mL/min/1.73m²). In moderate impairment (eGFR 30-59 mL/min/1.73m²), use with caution, ensure adequate hydration, and consider lowest effective dose; no specific dose reduction formula established. |
| Liver impairment | No dose adjustment required for Child-Pugh Class A or B. For Class C, use caution due to potential systemic accumulation; no specific dose modification guidelines available. |
| Pediatric use | Intravesical: 5-10 mL/kg of 30% solution, maximum 300 mL; Intravenous: 0.5-1.0 mL/kg of 30-60% solution, maximum 50 mL. For neonates, consider lower volumes and concentrations. |
| Geriatric use | Initiate with lowest effective dose; monitor renal function closely (eGFR may be reduced). Ensure adequate hydration before and after procedure. Consider reducing volume or concentration in frail elderly. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CYSTOGRAFIN (CYSTOGRAFIN).
| Breastfeeding | SYSTEMIC ABSORPTION FOLLOWING INTRAVESICAL ADMINISTRATION IS MINIMAL; THEREFORE, EXCRETION INTO BREAST MILK IS NEGLIGIBLE. NO M/P RATIO IS AVAILABLE. BREASTFEEDING CAN CONTINUE WITHOUT INTERRUPTION AFTER INTRAVESICAL USE. IF INTRAVASCULAR EXPOSURE OCCURS (OFF-LABEL), IODINATED CONTRAST IS POORLY ABSORBED ORALLY, SO INFANT RISK IS LOW. |
| Teratogenic Risk | DIATRIZOATE MEGLUMINE (CYSTOGRAFIN) IS AN IODINATED CONTRAST MEDIUM. SYSTEMIC ABSORPTION FROM INTRAVESICAL ADMINISTRATION FOR CYSTOGRAPHY IS MINIMAL. THEREFORE, DIRECT FETAL EXPOSURE IS NEGLIGIBLE. NO TERATOGENIC EFFECTS HAVE BEEN REPORTED WITH THIS ROUTE IN ANY TRIMESTER. HOWEVER, INTRAVASCULAR ADMINISTRATION IS NOT INDICATED AND IS ASSOCIATED WITH POTENTIAL FETAL THYROID SUPPRESSION FROM FREE IODIDE, PARTICULARLY AFTER THE FIRST TRIMESTER. AS A PRECAUTION, NEONATAL THYROID FUNCTION SHOULD BE MONITORED IF SIGNIFICANT MATERNAL SYSTEMIC ABSORPTION OCCURS. |
■ FDA Black Box Warning
Not applicable for Cystografin as it is not commonly associated with a black box warning. However, caution is advised for patients with a history of severe reactions to contrast media.
| Serious Effects |
["Known hypersensitivity to diatrizoate or any component of the formulation","Severe renal impairment (anuria or significant oliguria) in certain procedures","Active hemorrhage or severe bleeding disorders if injection into vascular or body cavity is contraindicated"]
| Precautions | ["Risk of hypersensitivity reactions, including anaphylaxis, particularly in patients with prior reaction to contrast agents or asthma","Caution in patients with impaired renal function due to risk of contrast-induced nephropathy","Dehydration before administration may increase risk of renal toxicity; ensure adequate hydration","May interfere with thyroid function tests due to iodine content","Use caution in patients with multiple myeloma, diabetes, or sickle cell disease"] |
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| Fetal Monitoring | MONITOR MATERNAL VITAL SIGNS DURING AND AFTER PROCEDURE FOR ALLERGIC REACTIONS (E.G., URTICARIA, ANAPHYLAXIS) AND RENAL FUNCTION IF UNDERLYING IMPAIRMENT. FETAL MONITORING IS NOT ROUTINELY REQUIRED. IF SIGNIFICANT SYSTEMIC ABSORPTION IS SUSPECTED, ASSESS NEONATAL THYROID FUNCTION (TSH, FREE T4) AT BIRTH. |
| Fertility Effects | NO KNOWN ADVERSE EFFECTS ON FERTILITY IN MALES OR FEMALES FOLLOWING INTRAVESICAL ADMINISTRATION. NO HUMAN OR ANIMAL DATA SUGGEST IMPAIRED REPRODUCTIVE CAPACITY. |