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. |
| Molecular Weight | 1550.2 |
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 | Iodinated contrast media should be used during pregnancy only if clearly needed. There is no evidence of teratogenicity from clinical use, but exposure to ionizing radiation from the procedure is a concern. |
| 2nd trimester | Use only if essential. Fetal thyroid function may be affected if the agent crosses the placenta; neonatal thyroid function should be monitored if contrast was used near term. |
| 3rd trimester | Use only if essential. Iodinated contrast can cross the placenta and potentially cause fetal hypothyroidism; however, the risk is low with single exposures. Thyroid screening of the neonate is recommended after in utero exposure. |
Clinical note
Comprehensive clinical and safety monograph for VISIPAQUE 320 (VISIPAQUE 320).
| Placental transfer | Iodixanol crosses the placenta. The exact degree is not well quantified, but it is known to cross and can accumulate in amniotic fluid. Animal studies show placental transfer, and human data confirm measurable fetal levels after maternal administration. |
| Breastfeeding |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to iodixanol or any component of the formulationClinically significant dehydrationHistory of severe adverse reaction to iodinated contrast mediaConcomitant administration of oral cholecystographic agentsIntrathecal administration (not indicated)
| Precautions | Contrast-induced nephropathy, anaphylactoid reactions, thyroid storm in hyperthyroid patients, extravasation injury |
| Food/Dietary | No specific food interactions. However, patients receiving iodinated contrast should maintain adequate hydration. Avoid alcohol consumption due to potential dehydration. Fasting may be required for some procedures; follow specific pre-procedure dietary instructions. |
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| VISIPAQUE 320 (iodixanol) is excreted into human milk in very small amounts (<0.5% of maternal dose). The amount ingested by the infant is negligible and poses minimal risk. Interruption of breastfeeding is not necessary, but if the mother is concerned, she may pump and discard milk for 12-24 hours after the procedure. |
| Lactation Rating | L2: Safer |
| 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. |
| 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. |
| Clinical Pearls | VISIPAQUE 320 (iodixanol) is an iso-osmolar, nonionic dimeric iodinated contrast agent. It has lower nephrotoxicity risk compared to high-osmolar agents, but caution is still warranted in patients with pre-existing renal impairment (eGFR <30 mL/min). Ensure adequate hydration before and after administration. Consider prophylactic N-acetylcysteine or sodium bicarbonate in high-risk patients. Hold metformin for 48 hours post-procedure if renal function is compromised. It is contraindicated in patients with known anaphylactic reactions to iodinated contrast. Pre-medication with corticosteroids and antihistamines may be considered for at-risk patients. |
| Patient Advice | Inform your doctor if you have kidney problems, diabetes, or are taking metformin. · You may need to stop taking metformin for 48 hours after the procedure. · Drink plenty of water before and after the scan unless instructed otherwise. · Tell your doctor about any allergies, especially to iodine or contrast agents. · Side effects may include warmth, nausea, or a metallic taste, which usually resolve quickly. · Report any symptoms of allergic reaction such as hives, difficulty breathing, or swelling. |