ISOVUE-370
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ISOVUE-370 (ISOVUE-370).
Iodinated contrast agent that attenuates X-rays, providing radiographic contrast by increasing the density of vascular structures and tissues.
| Metabolism | Not metabolized; eliminated unchanged via glomerular filtration. |
| Excretion | Primarily renal (glomerular filtration) with >95% of administered dose excreted unchanged in urine within 24 hours. Less than 1% excreted in feces. |
| Half-life | Terminal elimination half-life is approximately 1.5-2 hours in patients with normal renal function (creatinine clearance >60 mL/min); prolonged to up to 30 hours in severe renal impairment. |
| Protein binding | Minimal; approximately 1-5% bound to serum proteins (primarily albumin). |
| Volume of Distribution | Volume of distribution (Vd) is approximately 0.2-0.3 L/kg, reflecting distribution primarily in extracellular fluid (plasma and interstitial space). |
| Bioavailability | Not applicable (administered intravascularly); bioavailability is 100% for intravenous and intra-arterial routes as it does not undergo first-pass metabolism. |
| Onset of Action | Intravenous administration: immediate (within seconds) as iodinated contrast reaches target vasculature; intra-arterial: onset within seconds of injection. |
| Duration of Action | Duration of diagnostic contrast enhancement is short (minutes), corresponding to the vascular and interstitial phases; elimination half-life determines total body clearance, but imaging effect lasts only during initial distribution (1-2 minutes for CT). |
Intravenous injection of 50-200 mL of Isovue-370 (iopamidol 76% solution, 370 mg I/mL) for adults, administered as a bolus or infusion depending on imaging protocol. Typical dose for CT: 100-150 mL total volume.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment guidelines exist for Isovue-370 in renal impairment; however, caution is advised. In patients with GFR < 30 mL/min/1.73m², use lowest necessary dose and ensure adequate hydration. Hemodialysis may remove contrast; post-procedure dialysis can be considered. |
| Liver impairment | No specific dose adjustment is required based on hepatic impairment; monitor renal function closely in patients with severe hepatic disease due to potential reduced clearance. |
| Pediatric use | Weight-based dosing: 1-2 mL/kg (3.7-7.4 mg I/kg) intravenously, not exceeding 3 mL/kg total dose. Adjusted based on imaging indication and patient factors; for CT, 1.5-2 mL/kg typical. |
| Geriatric use | Elderly patients may require lower doses due to age-related renal impairment and increased risk of contrast-induced nephropathy. Use the minimal effective dose and ensure adequate hydration. Individualize based on renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ISOVUE-370 (ISOVUE-370).
| Breastfeeding | Iopamidol is excreted into human breast milk in minimal amounts (estimated infant dose <0.01% of maternal dose). M/P ratio not available. Because of low oral bioavailability and rapid milk clearance, breastfeeding can be continued without interruption; some sources suggest discarding milk for 12-24 hours post-procedure as a precaution. |
| Teratogenic Risk | Iodinated contrast media, including iopamidol (ISOVUE-370), cross the placenta. In animal studies, no teratogenic effects were observed at clinically relevant doses. However, due to potential fetal hypothyroidism from free iodide exposure, use in pregnancy only if clearly needed. First trimester: theoretical risk of fetal thyroid suppression; second and third trimesters: risk of neonatal hypothyroidism if high doses or repeated exposures. No documented congenital malformations in human data. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["History of hypersensitivity to iopamidol or other iodinated contrast agents.","Acute pancreatitis (for intrathecal use).","Intrathecal administration in patients with blood in CSF or increased intracranial pressure.","Anuria or severe renal impairment (relative)."]
| Precautions | ["Risk of serious anaphylactic reactions; have emergency equipment available.","Acute renal toxicity, especially in patients with pre-existing renal impairment, diabetes, or dehydration.","Contrast-induced nephropathy; ensure adequate hydration.","Extravasation risk; monitor injection site.","Thyroid storm in patients with hyperthyroidism or thyroid nodules.","Severe cutaneous adverse reactions (e.g., Stevens-Johnson syndrome).","Exacerbation of sickle cell disease.","Intrathecal use may cause neurotoxicity; avoid high doses."] |
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| Fetal Monitoring | Monitor for signs of acute hypersensitivity reactions (urticaria, bronchospasm, anaphylaxis) in mother. Assess fetal heart rate monitoring if intrauterine exposure occurs. Post-exposure, assess neonatal thyroid function (TSH, free T4) at birth if significant exposure, especially repeat studies or preterm infants. |
| Fertility Effects | No controlled studies on human fertility. Animal studies show no impairment of fertility at doses up to 1.5 g I/kg. No known effect on spermatogenesis or ovarian function. However, high-dose ionizing radiation (if combined with fluoroscopy) may temporarily affect fertility. |