VISIPAQUE 320
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VISIPAQUE 320 (VISIPAQUE 320).
Iodinated nonionic radiocontrast agent that attenuates X-rays and enhances vascular and tissue contrast.
| Metabolism | Not metabolized; excreted unchanged by glomerular filtration. |
| Excretion | Primarily renal via glomerular filtration; approximately 95% of the dose excreted unchanged in urine within 24 hours. Biliary/fecal excretion is minimal (<1%). |
| Half-life | Terminal elimination half-life is approximately 2 hours in patients with normal renal function. Clinically, clearance is prolonged in renal impairment, requiring dose adjustment. |
| Protein binding | Approximately 5-10%, primarily to albumin. |
| Volume of Distribution | 0.2-0.3 L/kg, reflecting limited extravascular distribution consistent with high water solubility and renal excretion. |
| Bioavailability | Not applicable; administered intravenously (100% bioavailable) or intra-arterially. Oral bioavailability is negligible (<1%) and not clinically relevant. |
| Onset of Action | Intravascular administration: immediate (within seconds) due to high iodine content enabling rapid opacification. |
| Duration of Action | Sufficient for diagnostic imaging; typically 30-60 minutes for contrast enhancement. Elimination is complete within 24 hours in normal renal function. |
Intravascular administration: Adult dose is 50-150 mL (16-48 g iodine) intravenously as a bolus or infusion, depending on the procedure. For CT imaging, typical dose is 75-150 mL at 1-3 mL/sec.
| Dosage form | INJECTABLE |
| Renal impairment | GFR <30 mL/min: Use lowest effective dose, ensure hydration, consider alternative if GFR <15 mL/min. No specific dose reduction formula; risk of contrast-induced nephropathy increases with reduced renal function. |
| Liver impairment | No specific dosing adjustment required for hepatic impairment. Use caution in severe hepatic disease due to potential for hepatorenal syndrome. |
| Pediatric use | Weight-based: 1-2 mL/kg (0.32-0.64 g iodine/kg) intravenously, not to exceed 150 mL total. For pediatric CT, typical dose is 1-2 mL/kg at 1-2 mL/sec. |
| Geriatric use | Use lowest effective dose; monitor renal function and hydration status due to age-related decreased GFR. Increased risk of adverse effects (e.g., nephrotoxicity, cardiovascular events). |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VISIPAQUE 320 (VISIPAQUE 320).
| Breastfeeding | Iodinated contrast media are excreted into breast milk in very small amounts (less than 1% of maternal dose). The M/P ratio is low. The American College of Radiology states that breastfeeding can be continued without interruption after contrast administration. |
| Teratogenic Risk | Iodinated contrast media cross the placenta. Animal studies have not demonstrated teratogenic effects. In humans, there is no evidence of fetal harm from routine diagnostic use. However, fetal thyroid function may be transiently affected if high doses are administered near term. Use only if clearly needed. |
■ FDA Black Box Warning
None
| Serious Effects |
["Known hypersensitivity to iodinated contrast","anuria","decompensated heart failure"]
| Precautions | ["Contrast-induced nephropathy","anaphylactoid reactions","thyroid storm in hyperthyroid patients","extravasation injury"] |
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| Fetal Monitoring | Maternal: renal function (serum creatinine) prior to administration, especially if diabetic or hypertensive. Fetal: no specific monitoring required after standard doses. Consider neonatal thyroid function tests if high doses given near delivery. |
| Fertility Effects | No known effect on fertility. Iodinated contrast media have not been associated with impaired fertility in animal studies or human data. |